Green-top Guideline No.

60
May 2011

Cervical Cerclage
Cervical Cerclage
1. Purpose and scope
Since the 1960s, the use of cerclage has expanded to include the management of women considered to be at
high risk of mid-trimester loss and spontaneous preterm birth by virtue of factors such as multiple pregnancy,
uterine anomalies, a history of cervical trauma (e.g. conisation or operations requiring forced dilatation of the
cervical canal) and cervical shortening seen on sonographic examination. However, the use and efficacy of
cerclage in these different groups is highly controversial since there is contradiction in the results of
individual studies and meta-analyses.

Cerclage remains a commonly performed prophylactic intervention used by most obstetricians despite the
absence of a well-defined population for whom there is clear evidence of benefit. Furthermore, there is little
consensus on the optimal cerclage technique and timing of suture placement. The role of amniocentesis
before emergency (rescue) cerclage insertion and the optimal management following insertion are also
poorly defined. Complications are not well documented and often difficult to separate from risks inherent to
the underlying condition.The purpose of this guideline is to review the literature and provide evidence-based
guidance on the use of cerclage.

2. Background
Prematurity is the leading cause of perinatal death and disability. Preterm birth before 37+0 weeks of gestation
accounted for 7.6% of all live births in England and Wales in 2005. Although preterm birth is defined as
delivery before 37+0 weeks of gestation, the majority of prematurity-related adverse outcomes relate to birth
before 33+0 weeks of gestation. Mortality increases from about 2% for infants born at 32 weeks of gestation to
more than 90% for those born at 23 weeks of gestation.1 Two-thirds of preterm births are the consequence of
spontaneous preterm labour and/or preterm prelabour rupture of membranes (PPROM). The rate of
spontaneous preterm birth continues to rise globally despite efforts to the contrary, and interventions aimed
at reducing preterm birth have been largely disappointing.

Cervical cerclage was first performed in 1902 in women with a history of mid-trimester abortion or
spontaneous preterm birth suggestive of cervical ‘incompetence’, with the aim of preventing recurrent loss.
Cervical incompetence is an imprecise clinical diagnosis frequently applied to women with such a history
where it is assumed that the cervix is weak and unable to remain closed during the pregnancy. However,
recent evidence suggests that rather than being a dichotomous variable, cervical ‘competence’ is likely to be
a continuum influenced by factors related not solely to the intrinsic structure of the cervix but also to
processes driving premature effacement and dilatation. While cerclage may provide a degree of structural
support to a ‘weak’ cervix, its role in maintaining the cervical length and the endocervical mucus plug as a
mechanical barrier to ascending infection may be more important.

All decisions about cerclage are difficult and should be made with senior involvement. A doctor with the
necessary skills and expertise to perform cerclage should carry out the procedure. P

3. Identification and assessment of evidence

This RCOG guideline was developed in accordance with standard methodology for producing RCOG Green-
top Guidelines.2–4 The Cochrane Library (including the Cochrane Database of Systematic Reviews), DARE,
EMBASE,TRIP, Medline and PubMed (electronic databases) were searched for relevant randomised controlled
trials, systematic reviews and meta-analyses.The search was restricted to articles published between 1980 and
November 2008. The databases were searched using the relevant MeSH terms, including all subheadings, and
this was combined with a keyword search. Search words included ‘cervical cerclage’, ‘cervical suture’,

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‘midtrimester miscarriage’, ‘McDonald cerclage’, ‘Shirodkar cerclage’, ‘infection and cerclage’, ‘tocolytics and
cerclage’ and ‘inflammatory mediators and cerclage’, and the search was limited to humans and the English
language.The National Library for Health and the National Guidelines Clearing House were also searched for
relevant guidelines and reviews.

4. Definitions
Previous terminology (prophylactic, elective, emergency, urgent, rescue) of cervical sutures (cerclage) can be
ambiguous. More appropriate nomenclature based on indication for cervical suture is recommended. The
terms below are increasingly used in the scientific literature.

History-indicated cerclage
Insertion of a cerclage as a result of factors in a woman’s obstetric or gynaecological history which increase
the risk of spontaneous second-trimester loss or preterm delivery. A history-indicated suture is performed as
a prophylactic measure in asymptomatic women and normally inserted electively at 12–14 weeks of
gestation.

Ultrasound-indicated cerclage
Insertion of a cerclage as a therapeutic measure in cases of cervical length shortening seen on transvaginal
ultrasound. Ultrasound-indicated cerclage is performed on asymptomatic women who do not have exposed
fetal membranes in the vagina. Sonographic assessment of the cervix is usually performed between 14 and 24
weeks of gestation.

Rescue cerclage
Insertion of cerclage as a salvage measure in the case of premature cervical dilatation with exposed fetal
membranes in the vagina. This may be discovered by ultrasound examination of the cervix or as a result of a
speculum/physical examination performed for symptoms such as vaginal discharge, bleeding or ‘sensation of
pressure’.

Transvaginal cerclage (McDonald)

A transvaginal purse-string suture placed at the cervicovaginal junction, without bladder mobilisation.5

High transvaginal cerclage (Shirodkar)

A transvaginal purse-string suture placed following bladder mobilisation, to allow insertion above the level of
the cardinal ligaments.6

Transabdominal cerclage
A suture performed via a laparotomy or laparoscopy, placing the suture at the cervicoisthmic junction.7

Occlusion cerclage
Occlusion of the external os by placement of continuous non-absorbable suture. The theory behind the
potential benefit of occlusion cerclage is retention of the mucus plug.8

5. History-indicated cerclage
5.1 When should a history-indicated cerclage be offered?
History-indicated cerclage should be offered to women with three or more previous preterm births
and/or second-trimester losses.
B

History-indicated cerclage should not be routinely offered to women with two or fewer previous preterm
births and/or second-trimester losses.
B

Characteristics of the previous adverse event, such as painless dilatation of the cervix or rupture of the
membranes before the onset of contractions, or additional risk factors, such as cervical surgery, are not P
helpful in the decision to place a history-indicated cerclage.

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There is insufficient evidence to recommend the use of prepregnancy diagnostic techniques aimed at
diagnosing ‘cervical weakness’ in women with a history of preterm birth and/or second-trimester loss P
in the decision to place a history-indicated cerclage. Such techniques include assessment of cervical
resistance index, hysterography or insertion of cervical dilators.

Three randomised controlled trials (RCTs) have been conducted comparing history-indicated cerclage with
expectant management.9–11 The largest trial, coordinated by the Medical Research Council and Royal College
of Obstetricians and Gynaecologists, was an international multicentre trial which recruited 1292 women
whose obstetrician was uncertain as to whether a cerclage would be of benefit (71% of the study population
had a history of second-trimester loss or preterm birth before 37 weeks of gestation). Randomisation allocated
647 women to cerclage and 645 to no cerclage.11 Overall, there were fewer deliveries before 33 weeks of
gestation in the cerclage group compared with the controls (13% versus 17%; RR 0.75; 95% CI 0.58–0.98),
which was compatible with the prevention of one delivery before 33 weeks of gestation for every 25 cerclage
insertions. There was no significant difference between the two groups in fetal/neonatal outcome (total
numbers of miscarriages, stillbirths and deaths following live birth 55 [8.5%] in the cerclage group compared
with 68 [10.5%] in the control group; OR 0.79; 95% CI 0.54–1.14). However, two of the eight infant deaths in
the cerclage group were ascribed to conditions subsequent to preterm birth, compared with seven of the 14
in the control group.There were insufficient data to allow any conclusions to be drawn as to whether women
were more likely to benefit if the previous loss had features suggestive of cervical incompetence (e.g. painless
cervical dilatation or rupture of the membranes before the onset of contractions). Of six prespecified
subgroup analyses, only women with a history of three or more pregnancies ending before 37 weeks of
gestation (n = 104) benefitted from cerclage, which halved the incidence of preterm delivery before 33 weeks
of gestation (15% versus 32%, P < 0.05). No effect was observed in those with only one (delivery before 33
weeks of gestation in the cerclage group 14% versus 17% in the expectant group) or two previous early
deliveries (delivery before 33 weeks of gestation in the cerclage group 12% versus 14% in the expectant
group), previous cervical surgery or first-trimester loss/uterine anomaly; however, the authors concluded that
the relatively small numbers in each group limited the reliability of these results.

One further trial of 506 women considered at moderate risk of cervical incompetence, based on a
scoring system to assess risk factors, randomised 268 to a McDonald cerclage and 238 to a policy
of no cerclage. Women with prior second-trimester losses of a live fetus were excluded. There was
no significant difference in preterm delivery (6.7% in the cerclage group versus 5.5% in the
expectant group), although those with cerclage were more likely to be admitted to hospital and Evidence
receive tocolytics.9 A third trial recruited 194 women who had had at least two previous preterm level 1+

deliveries before 37 weeks of gestation (or one or more preterm delivery before 34 weeks of
gestation); 96 women were randomised to McDonald cerclage and 98 to expectant management.
There was no difference in outcome, with 34% delivering before 37 weeks of gestation in the
cerclage group and 34% in the no cerclage group.10

No studies provide sufficient data to examine the influence of additional risk factors such as cervical surgery
or the characteristics of the previous delivery/miscarriage on the effect of history-indicated cerclage.

The studies that have examined the use of prepregnancy techniques (e.g. hysterography, cervical resistance
indices, insertion of cervical dilators) to assess cervical weakness were observational and not designed to test
the hypothesis that their use optimised the selection of women for history-indicated cerclage.12,13 The largest
study of cervical resistance indices (force required to dilate the cervix to 8 mm) reported that 175 women
with a history of mid-trimester loss had a lower cervical resistance index than 123 parous women with no
such history (P < 0.001). However, in this study all women with a history of low cervical resistance index had
a suture inserted, with a successful pregnancy outcome in 75%.This rate is no higher than that expected with
expectant management11 and the absence of a control group makes it inappropriate to draw any evidence-
based conclusions on the usefulness of this technique.13

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6. Ultrasound-indicated cerclage
6.1 When should an ultrasound-indicated cerclage be offered?
6.1.1 Women with a singleton pregnancy and no history of spontaneous mid-trimester loss or
preterm birth

The insertion of an ultrasound-indicated cerclage is not recommended in women without a history of

spontaneous preterm delivery or second-trimester loss who have an incidentally identified short cervix
B
of 25 mm or less.

To et al. screened 47 123 women at 22–24 weeks of gestation using transvaginal ultrasound to
measure cervical length. In 470 women (1%), the cervix was 15 mm or less. Of these women, 253
(54%) agreed to participate in a randomised study comparing Shirodkar cerclage (n = 127) with
expectant management (n = 126).The incidence of preterm delivery before 33 weeks of gestation
was similar in both groups, at 22% (28 of 127) in the cerclage group versus 26% (33 of 126) in the
control group (RR 0.84; 95% CI 0.54–1.3; P = 0.44), with no significant differences in perinatal or
Evidence
maternal morbidity or mortality.14 level 1++

This was further confirmed in an individual patient data (IPD) meta-analysis of four RCTs of
cerclage versus expectant management in women with a short cervix (in which women from the
previously discussed RCT were included). This meta-analysis reported no overall evidence of
benefit of cerclage in women with cervical length less than 25 mm who had no other risk factors
for spontaneous preterm birth.15

6.1.2 Women with a singleton pregnancy and a history of spontaneous mid-trimester loss or
preterm birth

Women with a history of one or more spontaneous mid-trimester losses or preterm births who are
undergoing transvaginal sonographic surveillance of cervical length should be offered an ultrasound-
A
indicated cerclage if the cervix is 25 mm or less and before 24 weeks of gestation.

An ultrasound-indicated cerclage is not recommended for funnelling of the cervix (dilatation of the
internal os on ultrasound) in the absence of cervical shortening to 25 mm or less.
C

An RCT of ultrasound-indicated cerclage involving 302 women with singleton pregnancies with a
history of spontaneous preterm birth between 17+0 and 33+6 weeks of gestation, who were found
to have a cervical length of less than 25 mm detected during serial sonographic examinations
between 16+0 and 21+6 weeks of gestation, reported that when compared with expectant
management, cerclage reduced previable birth (at less than 24+0 weeks of gestation: 6.1% versus
14%; P = 0.03) and perinatal death (8.8% versus 16%; P = 0.046) but did not prevent birth at less
than 35 weeks of gestation (32% versus 42%; OR = 0.67; 95% CI 0.42–1.07) unless cervical length
was less than 15 mm (OR 0.23; 95% CI 0.08–0.66).16 Evidence
level 1++

Similar results were reported from a meta-analysis that included 607 pregnancies from four RCTs
of ultrasound-indicated cerclage.15 This study reported that in the subgroup of women with
singleton pregnancies with a history of preterm second-trimester loss (16–23 weeks of gestation)
or birth before 36 weeks of gestation, when compared with expectant management, cerclage
resulted in a significant reduction in delivery before 35 weeks of gestation (RR 0.57; 95% CI
0.33–0.99 and RR 0.61; 95% CI 0.40–0.92, respectively), which was of a similar magnitude to the
reduction observed in the previous study.16

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There are no studies evaluating ultrasound-indicated cerclage performed solely on the presence of
funnelling. However, studies have demonstrated that funnelling is a function of cervical shortening Evidence
and does not appear to independently add to the risk of preterm birth associated with cervical level 2++

length.17,18

6.2 Who should be offered serial sonographic surveillance ± ultrasound-indicated cerclage?

Women with a history of spontaneous second-trimester loss or preterm delivery who have not
B
undergone a history-indicated cerclage may be offered serial sonographic surveillance, as there is
evidence to suggest that those who experience cervical shortening are at an increased risk of
subsequent second-trimester loss/preterm birth and may benefit from ultrasound-indicated cerclage
(see 6.1), while those whose cervix remains long have a low risk of second-trimester loss/premature
delivery.

Women should be informed that expectant management is a reasonable alternative since there is a
D
lack of direct evidence to support serial sonographic surveillance over expectant management.
Furthermore, the majority of women with a history of second-trimester loss/preterm delivery will
deliver after 33 weeks of gestation.

In studies where serial sonographic surveillance of cervical length has been carried out in women
with a history of second-trimester loss and/or spontaneous preterm delivery, between 40% and 70%
of women maintain a cervical length of more than 25 mm before 24+0 weeks of gestation.11,16,19–21 In
three of these studies which reported the outcome of pregnancy in those who maintained a Evidence
cervical length of more than 25 mm and hence did not receive cerclage, more than 90% of women level 2+

delivered after 34 weeks of gestation. This suggests that serial sonographic surveillance may
differentiate between women with a prior second-trimester loss/preterm birth who might benefit
from cerclage and women who do not need intervention.

In the Medical Research Council/RCOG randomised study, women with a history of one, two or
three or more previous second-trimester losses or spontaneous preterm births had an 83%, 86% and
68% chance, respectively, of delivery after 33 weeks of gestation when managed expectantly.11 Given
Evidence
that there are no randomised studies directly comparing a policy of serial sonographic surveillance level 4
± ultrasound-indicated cerclage with expectant management in women with a history of one or
more spontaneous preterm births/mid-trimester losses, and given the significant chance of delivery
after 33 weeks of gestation in such women, expectant management is a reasonable alternative.

7. Can cervical cerclage be recommended in any other groups considered at increased risk
of spontaneous preterm delivery?
7.1 Multiple pregnancies
The insertion of a history- or ultrasound-indicated cerclage in women with multiple pregnancies is not
B
recommended, as there is some evidence to suggest it may be detrimental and associated with an
increase in preterm delivery and pregnancy loss.

In a meta-analysis, subgroup examination of 39 twin pregnancies demonstrated a doubling in

delivery rates before 35 weeks of gestation with the use of ultrasound-indicated cerclage compared
Evidence
with expectant management in women with a cervical length less than 25 mm (RR 2.15; 95% CI level 1++
1.15–4.01).15 Insertion of cerclage may also be associated with increased perinatal mortality,
although this was not statistically significant (RR 2.66; 95% CI 0.83–8.54).

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A prospective cohort study of 147 twin pregnancies identified 37 women with cervical length less
than 25 mm between 18 and 26 weeks of gestation, of whom 21 underwent insertion of McDonald
cerclage and 12 did not.22 Insertion of cervical cerclage was not associated with any significant
Evidence
improvement in preterm delivery at 34 weeks of gestation or less (42.9% in the cerclage group level 2++
versus 50% in the non-cerclage group). Small numbers and lack of randomised design limit the
conclusions that can be drawn from this study. Furthermore, those women who underwent
cerclage had a significantly shorter mean cervical length compared with those who did not.

There is only one RCT of history-indicated cerclage in twin pregnancies. This study examined the
effect of cerclage (n = 25) versus no cerclage (n = 23) in twins conceived following ovulation
induction, and demonstrated that cerclage was not effective in prolonging gestation or improving
fetal outcome.23

Several studies of cervical cerclage have included a subgroup of multiple pregnancies; however, Evidence
they were of insufficient number to enable conclusions to be drawn regarding the effect of cerclage level 1+

in preventing preterm birth. In an IPD meta-analysis,24 data for multiple gestations were available in
66 mothers from three randomised studies.11,25,26 The use of cervical cerclage in multiple gestations
was associated with a substantial increase in pregnancy loss or death before discharge from
hospital (OR 5.88; 95% CI 1.14–30.19); however, the results should be interpreted with caution
owing to the relatively small number of women included.

7.2 Uterine anomalies and cervical trauma

History- or ultrasound-indicated cerclage cannot be recommended in other high-risk groups such as
women with müllerian anomalies, previous cervical surgery (cone biopsy, large loop excision of the
B
transformation zone or destructive procedures such as laser ablation or diathermy) or multiple
dilatation and evacuation.

The existing published studies are either inadequately controlled or include insufficient numbers
to be able to make evidence-based recommendations in the vast majority of the groups mentioned
above. In the IPD meta-analysis of ultrasound-indicated cerclage,15 subgroup analysis of those
women with a history of cone biopsy (n = 64) or more than one dilatation and evacuation (n =
131) showed no difference in preterm birth before 35 weeks of gestation in the cerclage group
compared with the expectantly managed group (RR 1.18; 95% CI 0.57–2.45 and RR 0.91; 95% CI
0.57–1.47, respectively); however, the authors concluded that that the results should be interpreted Evidence
with caution owing to the small numbers of women. There were insufficient women with level 1+

müllerian anomalies or diethylstilbestrol exposure to perform subgroup analyses.

The Medical Research Council/RCOG study of history-indicated cerclage reported that in a

subgroup analysis of women with a history of cone biopsy or cervical amputation (n = 138), there
was no significant difference in delivery before 33+0 weeks of gestation in the cerclage group
compared with the expectant group (19% versus 22%).11

7.2.1 Radical trachelectomy

The decision to place a concomitant cerclage at radical trachelectomy should be individualised.

P
There are several case series27 reporting successful pregnancy outcomes with the use of
Evidence
concomitant cerclage placement at radical trachelectomy; however, the absence of a control group level 3
makes it impossible to provide evidence-based guidelines on the use of this technique.

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8. Transabdominal cerclage
8.1 When should a transabdominal cerclage be considered?
In women with a previous failed transvaginal cerclage, insertion of a transabdominal cerclage may be
D
considered, but this procedure may be associated with increased maternal morbidity.

Transabdominal cerclage can be performed preconceptually or in early pregnancy.

P
A transabdominal cerclage is usually inserted following a failed vaginal cerclage or extensive
cervical surgery. There are no randomised studies comparing the effectiveness of transabdominal
cerclage with that of expectant management or transvaginal cerclage. The evidence is limited to a
systematic review including 13 case series and one controlled non-randomised study of
transabdominal versus transvaginal cerclage in women with a prior failed transvaginal cerclage.This
systematic review reported a lower risk of perinatal death/delivery before 24 weeks of gestation
(6% versus 12.5%) in those women who had undergone transabdominal cerclage (n = 117) Evidence
compared with those who had a repeat insertion of transvaginal cerclage (n = 40).28 However, there level 2-/3

was a higher incidence (3.4% versus 0%) of serious operative complications (bleeding requiring
transfusion, injury to bladder/bowel/uterine artery, anaesthesia problems). Davis et al., in their
controlled non-randomised study in women with a prior failed transvaginal cerclage, reported that
the incidence of delivery before 33 weeks of gestation was lower in the 40 women with a
transabdominal suture compared with the 24 women with a transvaginal suture insertion (10%
versus 38%; P = 0.01).29

There are no studies directly comparing the insertion of a preconceptual transabdominal cerclage with
insertion in early pregnancy. However, preconceptual insertion should be considered when possible because
of the technical advantage of operating on the uterus of a woman who is not pregnant. Furthermore, there is
no evidence that preconceptual transabdominal cerclage has any detrimental impact on fertility or
management of early miscarriage. Abdominal cerclage can be safely left in place if a further pregnancy is a
possibility.

8.2 Should an abdominal cerclage be performed laparoscopically?

There is no evidence to support a laparoscopic approach over laparotomy in the insertion of an
abdominal cerclage.
D

One small study making a retrospective comparison in 19 women demonstrated a viable infant in
Evidence
nine of 12 women who received a laparoscopic procedure compared with five of seven who level 3
received an abdominal procedure.30

8.3 How should a delayed miscarriage or fetal death be managed in women with an abdominal cerclage?
Management decisions in cases of delayed miscarriage or fetal death in women with an abdominal
cerclage can be difficult and should be made with senior involvement. A doctor with the necessary skills P
and expertise to perform the procedure should carry out the procedure.

Successful evacuation through the stitch by suction curettage or by dilatation and evacuation (up to 18
weeks of gestation) has been described; alternatively, the suture may be cut, usually via a posterior
D
colpotomy. Failing this, a hysterotomy may be required or caesarean section may be necessary.

There are no studies evaluating the management of pregnancy termination in the event of fetal
Evidence
demise or the need to terminate a pregnancy. Success using the techniques described above has level 4
been reported by experienced clinicians.

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9. Rescue cerclage
9.1 When should a rescue cerclage be considered?
The decision to place a rescue suture should be individualised, taking into account the gestation at
presentation, as even with rescue cerclage the risks of severe preterm delivery and neonatal mortality
D
and morbidity remain high. A senior obstetrician should be involved in making the decision.

Insertion of a rescue cerclage may delay delivery by a further 5 weeks on average compared with
expectant management/bed rest alone. It may also be associated with a two-fold reduction in the
B
chance of delivery before 34 weeks of gestation. However, there are only limited data to support an
associated improvement in neonatal mortality or morbidity.

Advanced dilatation of the cervix (more than 4 cm) or membrane prolapse beyond the external os
appears to be associated with a high chance of cerclage failure.
D

There has been one RCT evaluating ‘rescue’ cerclage and bed rest against bed rest alone.31 This trial
included only 23 women (16 with singleton pregnancies and seven with twin pregnancies) who
were confirmed to have cervical dilatation and prolapse of the membranes on speculum
examination at a mean gestation of 22–23 weeks. No data are given on degree of cervical dilatation.
All women, irrespective of random allocation, were hospitalised and on bed rest until 30 weeks of
gestation and received 1 week of broad-spectrum antibiotics. In addition, those undergoing
cerclage received perioperative indometacin. Eight of 13 women in the cerclage group required
Evidence
emergency removal of the suture for maternal or fetal reasons before 36 weeks of gestation.Women level 1-
in the cerclage group delivered on average 4 weeks later than those in the bed rest group (mean
interval between randomisation and delivery 54 days versus 20 days) and there was a significant
reduction in delivery before 34 weeks of gestation (53% versus 100%; P = 0.02).There was a trend
towards improvement in neonatal survival (56% versus 28%) and a significant reduction in
compound neonatal morbidity (defined as neonatal admission to intensive care unit and/or
neonatal death: 71% versus 100%; RR 1.6; 95% CI 1.1–2.3).The authors did not provide any data on
the incidence of chorioamnionitis or neonatal morbidity.

In a prospective non-randomised study of 46 asymptomatic low-risk women found to have a dilated cervix
(mean 4 cm) with bulging membranes between 18 and 26 weeks of gestation (mean 22–23 weeks) during
routine preterm delivery screening, the insertion of a rescue cerclage was associated with a mean
prolongation of pregnancy of 8.8 weeks (range 0–17) compared with 3.1 weeks (range 0–11) in women who
received bed rest alone.32 This prolongation resulted in a three-fold reduction in the number of births before
32 weeks of gestation (31% versus 94%; RR 0.33; 95% CI 0.19–0.57), a doubling in the number of live births
(86% versus 41%) and an almost 40% improvement in neonatal survival (96% versus 57%; RR 0.59; 95% CI
0.0–0.76). No comparative data are provided regarding evidence of infection in the two groups.

The findings from one further prospective non-randomised study of 37 women with cervical
dilatation of 4 cm or greater (mean 6 cm) between 20 and 27 weeks of gestation (mean 22–23
weeks) reported that the insertion of a rescue cerclage in 22 cases prolonged pregnancy for on
average 4 weeks more than the 15 pregnancies managed with bed rest alone.33 The mean age at
delivery was 33±4.4 weeks of gestation in the cerclage group and 28±4.3 weeks of gestation in the
Evidence
bed rest group.There was no significant difference in perinatal survival (73% in the cerclage group level 2++
versus 67% in the bed rest group). All women in this study received 48 hours of tocolytics
(indometacin or ritodrine) and women in the cerclage group received 5 days of antibiotics and
hospitalisation.Women in the bed rest group were hospitalised for the duration of their pregnancy.
The rate of clinical chorioamnionitis was similar in the two groups (9% versus 13%), but no data
were given on the neonatal infection rate.

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There is no clear evidence that the gestation at which the cerclage is inserted affects the magnitude
of prolongation in gestation; however, consideration should be given to the fact that, in cases
presenting before 20 weeks of gestation, insertion of a rescue cerclage is highly likely to result in a
preterm delivery before 28 weeks of gestation. Furthermore, the decision to place a rescue cerclage
Evidence
beyond 24 weeks of gestation should be individualised and take into account the local gestational level 4
age of viability. Improvements in neonatal intensive care have advanced the gestational age of
viability to 24 weeks of gestation in most developed countries and, given the potential risk of
iatrogenic membrane rupture and subsequent preterm delivery, rescue cerclage can rarely be
justified after this gestation.

The aforementioned studies have not provided an analysis of prolongation of pregnancy in relation
to cervical dilatation. However, several other uncontrolled studies have suggested that the presence
of membrane prolapse beyond the external os and/or cervical dilatation greater than 4 cm are Evidence
significant predictors of cerclage failure. In view of the absence of a control group in these studies, level 3

it is not clear whether this observation relates to treatment failure or a more advanced underlying
process that makes this group of women inherently more likely to deliver.34–36

10. What are the contraindications to cerclage insertion?

The contraindications to cerclage insertion are:
● active preterm labour
● clinical evidence of chorioamnionitis
● continuing vaginal bleeding
● PPROM
● evidence of fetal compromise
● lethal fetal defect
● fetal death.

11. What information should be given to women before cerclage insertion?

Before history- or ultrasound-indicated cerclage insertion, a woman should be given information about the
potential complications, which should include the following:

Cerclage insertion is associated with a doubling in risk of maternal pyrexia but no apparent increase in
chorioamnionitis.
B

Cerclage insertion is not associated with an increased risk of PPROM, induction of labour or caesarean
section.
B

The insertion of a cervical suture is not associated with an increased risk of preterm delivery or second-
trimester loss.
B

Before any type of cerclage insertion, women should be informed of the following:

There is a small risk of intraoperative bladder damage, cervical trauma, membrane rupture and bleeding
during insertion of cervical cerclage.
D

Shirodkar cerclage usually requires anaesthesia for removal and therefore carries the risk of an
additional anaesthetic. P

Cervical cerclage may be associated with a risk of cervical laceration/trauma if there is spontaneous
labour with the suture in place.
D

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Although women are often routinely informed of a number of potential complications associated
with cerclage insertion, including PPROM, miscarriage, preterm labour, infection, bleeding and
bladder or cervical damage, there is little published evidence to support this. None of the
randomised studies of cervical cerclage has been designed or adequately powered to assess the risk
of maternal morbidity and, to date, none of the larger studies of history- or ultrasound-indicated
cerclage has reported an increase in PPROM, preterm delivery or second-trimester loss.11,16,25
Intraoperative complications including bladder damage, cervical trauma, membrane rupture and
Evidence
bleeding are reported but are rare (<1%).11,14,16 level 1++

An IPD meta-analysis of seven randomised studies of cerclage insertion (combining data from
studies of both history-indicated and ultrasound-indicated cerclage) found that cerclage was
associated with an increased risk of maternal pyrexia (OR 2.35; 95% CI 1.37–4.05), but there was
no evidence of increase in chorioamnionitis (OR 0.73; 95% CI 0.36–1.46), PPROM (OR 0.92; 95%
CI 0.62–1.35), induction of labour or caesarean section (OR for spontaneous labour for no cerclage
0.81; 95% CI 0.65–1.02).24

In a retrospective review of 251 cerclages (including 49 rescue and 202 history-indicated sutures)
over a 7.5-year period, cervical laceration requiring suturing at the time of delivery was reported in
Evidence
11% of Shirodkar and 14% of McDonald procedures, which was higher than that reported in 55 688 level 2
other deliveries occurring during the same period (2%). Although this was statistically significant
(P < 0.025), this result is highly susceptible to reporting bias.

Several case series have reported high risks of membrane rupture and infection associated with rescue
cerclage; however, the lack of a control group makes it difficult to separate the procedure-related risk from
that inherent to the underlying condition.

12. Pre operative management

12.1 What investigations should be performed before insertion of cervical cerclage?
It is good practice to offer a first-trimester ultrasound scan and screening for aneuploidy before the
insertion of a history-indicated suture to ensure both viability and the absence of lethal/major fetal P
abnormality. Before ultrasound-indicated or rescue cerclage, it is good practice to ensure an anomaly
scan has been performed recently.

The use of routine maternal white cell count and C-reactive protein to detect subclinical
chorioamnionitis before insertion of a rescue cerclage is not recommended. The decision to perform P
these tests should be based on the overall clinical picture, but in the absence of clinical signs of
chorioamnionitis, the decision for rescue cerclage need not be delayed.

Although several studies have linked a raised maternal C-reactive protein level with histological
evidence of chorioamnionitis in cases of preterm labour or PPROM, the sensitivity and specificity
are considered to be too poor to be clinically useful.37,38 In an uncontrolled retrospective review of
17 cases of rescue cerclage, the authors reported that a preoperative C-reactive protein value below Evidence
4.0 mg/dl and a maternal white cell count less than 14 000/microlitre were associated with level 2

prolongation of pregnancy compared with women with values above these cut-offs. Interpretation
of these results was confounded by the degree of cervical dilatation, such that those women with
higher values also had more advanced cervical dilatation.

12.2 Should amniocentesis to detect infection be performed before rescue or ultrasound-indicated cerclage?
There is insufficient evidence to recommend routine amniocentesis before rescue or ultrasound-
indicated cerclage as there are no clear data demonstrating that it improves outcome. P

RCOG Green-top Guideline No. 60 11 of 21 © Royal College of Obstetricians and Gynaecologists

In selected cases where there is suspicion of intra-amniotic infection, amniocentesis may be performed
to aid the decision about rescue cerclage, as the presence of infection is associated with a poor
D
prognosis.

Amniocentesis before rescue cerclage does not appear to increase the risk of preterm delivery before 28
weeks of gestation.
D

Several studies have reported an association between poor pregnancy outcome and the presence
of intra-amniotic infection/inflammation, diagnosed by amniocentesis, in women presenting with a
dilated cervix, whether or not they undergo rescue cerclage.39,40 However, none of these studies was
randomised and they are hence susceptible to selection bias, with the majority of women
Evidence
undergoing amniocentesis at the discretion of the individual physician. Rates of intra-amniotic level 3
infection vary from 13% to 51% depending on the criteria used to define a ‘positive’ result and the
population selected.41–43 Furthermore, the low specificity of amniocentesis could deny women
cerclage who may have benefited from the procedure.The incidence of intra-amniotic infection in
ultrasound-indicated cerclage is about 1–2%.

Airoldi et al.41 identified 122 women between 15+0 and 25+6 weeks of gestation with a dilated cervix
(1–4 cm). Twenty-four (20%) of these had an amniocentesis performed. Following multivariate Evidence
regression analysis, the authors concluded that an amniocentesis did not independently contribute level 2+

to preterm birth before 28 weeks of gestation (P = 0.90).

12.2.1 Is amnioreduction before rescue cerclage recommended?

There is an absence of data to either refute or support the use of amnioreduction before insertion of a
rescue cerclage.
D

Several small studies have reported successful prolongation of pregnancy using amnioreduction
Evidence
before cerclage, but the absence of a valid control group makes it impossible to draw any evidence- level 3
based conclusion as to its contribution to the outcome.44–46

12.2.2 Should a latency period be observed between presentation and insertion of rescue or
ultrasound-indicated cerclage?

There are no studies to support immediate versus delayed cerclage insertion in either rescue or
ultrasound-indicated procedures, but as delay can only increase the risk of infection, immediate P
insertion is likely to supersede the benefits of waiting to see if infection manifests clinically.

The interval between presentation and suture insertion varies between studies, with some authors advocating
a period of observation to ensure that preterm labour, abruption and infection are excluded. Others argue that
delayed insertion has the potential to increase the risk of ascending infection; however, no comparative
studies of the two strategies exist.

12.2.3 Should routine genital tract screening for infection be carried out before cerclage
insertion?

There is an absence of data to support genital tract screening before cerclage insertion.
P
In the presence of a positive culture from a genital swab, a complete course of sensitive antimicrobial
eradication therapy before cerclage insertion would be recommended. P

There are no studies evaluating the benefit of screening for genital tract infection before insertion of a
cerclage.

RCOG Green-top Guideline No. 60 12 of 21 © Royal College of Obstetricians and Gynaecologists

13. Operative issues
13.1 Should perioperative tocolysis be used for insertion of cerclage?
There is no evidence to support the use of routine perioperative tocolysis in women undergoing
insertion of cerclage.
D

In most of the existing randomised studies, the majority of women allocated cerclage also received
perioperative tocolysis, most commonly indometacin. Consequently, there is no control group
available for comparison. However, a retrospective cohort study involving 101 women who Evidence
underwent ultrasound-indicated cerclage reported that the rate of preterm birth before 35 weeks level 2+

of gestation was not significantly different in women who received indometacin for 48 hours
following the procedure compared with those who did not (39% versus 34%).47

13.2 Should perioperative antibiotics be given?

The decision for antibiotic prophylaxis at the time of cerclage placement should be at the discretion of
the operating team. P

There are no studies of perioperative antibiotic use in women undergoing cervical cerclage.

13.3 What method of anaesthesia should be employed for the insertion of cerclage?
The choice of anaesthesia should be at the discretion of the operating team.
P
There are no studies comparing general with regional anaesthesia for insertion of cervical cerclage and hence
the decision should be made on a case-by-case basis.

13.4 Can cerclage be performed as a day-case procedure?

Elective transvaginal cerclage can safely be performed as a day-case procedure.
C
Women undergoing ultrasound-indicated or rescue cerclage, given the higher risk of complications such
as PPROM, early preterm delivery, miscarriage and infection, may benefit from at least a 24-hour P
postoperative period of observation in hospital. Cases should be managed on an individual basis.

In women undergoing insertion of transabdominal cerclage via laparotomy, an inpatient stay of at least
48 hours is recommended. P

Golan et al. retrospectively compared 125 cases of elective outpatient cerclage with 101 cases of
inpatient cerclage, during which women received complete bed rest in hospital for 48 hours Evidence
postoperatively.48 There was no significant difference in short-term complications or pregnancy level 2+

outcome, but hospital stay was significantly shorter for those managed as planned day cases.

13.5 Which technique and material should be used?

The choice of suture material should be at the discretion of the surgeon.
P
The choice of transvaginal cerclage technique (Shirodkar versus McDonald) should be at the discretion
of the surgeon.
D

There is no current evidence to support the placement of two purse-string sutures over a single suture.
C
There is no current evidence to support the placement of a cervical occlusion suture in addition to the
primary cerclage. P

RCOG Green-top Guideline No. 60 13 of 21 © Royal College of Obstetricians and Gynaecologists

There is insufficient evidence to support any specific technique for cerclage insertion. In a
secondary analysis of singleton pregnancy data from four randomised trials of cervical cerclage in
women with a short cervix, there was no significant difference in the rate of delivery before 33
Evidence
weeks of gestation in those with a McDonald cerclage compared with those with a Shirodkar level 2-
suture, once adjusted for confounding factors (OR 0.55; 95% CI 0.2–1.3).49 These results should be
interpreted with caution since the study was not sufficiently powered to detect a statistically
significant difference in this outcome.

A retrospective analysis of 169 women having McDonald procedures and 82 women having
Shirodkar procedures did not reveal any significant differences in fetal survival or major
postoperative morbidity between the two techniques.50 In a subgroup of women with one previous Evidence
second-trimester loss, there was a significant increase in fetal survival in those with a high vaginal level 3

cerclage (100% versus 63%; P < 0.05). However, a similar effect was not observed in those with a
previous preterm birth or those with more than one previous second-trimester loss.

In a small retrospective cohort study involving 150 women who had either an ultrasound-indicated
(n = 43) or an elective (n = 107) cerclage, 112 were managed with a single purse-string suture and
Evidence
38 with a double suture.There was no significant difference in preterm delivery or pregnancy loss. level 2-
However, the study is limited by being retrospective and non-randomised and also underpowered
to detect a significant difference in the primary outcomes.51

There are no controlled studies on the use of a cervical occlusion suture in addition to the primary cerclage;
however, this is the subject of a continuing randomised trial.8

14. Adjuvant management

14.1 Bed rest
Bed rest in women who have undergone cerclage should not be routinely recommended, but the
decision should be individualised, taking into account the clinical circumstances and the potential P
adverse effects that bed rest could have on women and their families in addition to increased costs for
the healthcare system.

There are no studies comparing bed rest with no bed rest in women undergoing cervical cerclage.A Cochrane
review of bed rest in women at high risk of preterm delivery identified only one randomised cluster study of
uncertain methodological quality. A comparison was made between 432 women prescribed bed rest and 834
women prescribed no intervention/placebo. Preterm birth before 37 weeks of gestation was similar in both
groups (7.9% in the intervention group versus 8.5% in the control group: RR 0.92; 95% CI 0.62–1.37).52

14.2 Sexual intercourse

Abstinence from sexual intercourse following cerclage insertion should not be routinely recommended.
P
There are no studies evaluating the effect of sexual intercourse on the risk of second-trimester loss or preterm
delivery in women with cervical cerclage. Furthermore, there is no evidence that sexual intercourse in early
pregnancy increases the risk of preterm delivery in women with a previous preterm birth. In a secondary
analysis of an observational study of transvaginal sonographic examinations performed at 16–18 weeks of
gestation on 187 women with singleton gestations with a prior spontaneous preterm birth before 32 weeks
of gestation, women who reported infrequent sexual intercourse during early pregnancy had an incidence of
recurrent spontaneous preterm birth of 28% compared with 38% in those women who reported some
intercourse (P = 0.35).53

RCOG Green-top Guideline No. 60 14 of 21 © Royal College of Obstetricians and Gynaecologists

14.3 Is there a role for post-cerclage serial sonographic surveillance of cervical length?
While routine serial sonographic measurement of the cervix is not recommended, it may be useful in
individual cases following ultrasound-indicated cerclage to offer timely administration of steroids or in
D
utero transfer.

Several studies have shown a significant increase in cervical length following the insertion of elective,
ultrasound-indicated and rescue cerclage.54–57 A postoperative upper cervical length (closed cervix above the
cerclage) of less than 10 mm before 28 weeks of gestation appears to provide the best prediction of
subsequent preterm delivery before 36 weeks of gestation following the placement of an ultrasound-indicated
cerclage.55,58

14.4 Is there a role for repeat cerclage when cervical shortening is seen post-cerclage?
Placement of an ultrasound-indicated cerclage in the presence of cervical length shortening cannot be
D
recommended as, compared with expectant management, it may be associated with an increase in both
pregnancy loss and delivery before 35 weeks of gestation.

The decision to place a rescue cerclage following an elective or ultrasound-indicated cerclage should be
made on an individual basis, taking into account the clinical circumstances. P

In a retrospective cohort study involving 24 women with a history-indicated cerclage and

subsequent cervical length shortening to less than 25 mm on ultrasound, 19 women were managed
expectantly and five women underwent insertion of a reinforcing cerclage.59 Repeat suture
Evidence
insertion was associated with a significantly earlier gestational age at delivery (21 versus 33 weeks level 2-
of gestation; P = 0.002) and an increased miscarriage rate (80% versus 16%; P = 0.01). However, the
selection criteria for choosing expectant management over repeat suture insertion were not
defined and hence these results may be subject to bias.

In a further retrospective cohort, Fox et al. followed 12 women with an elective cerclage who had
cervical length shortening of more than 2 cm or prolapse of the membranes below the suture
Evidence
before 28 weeks of gestation, and who underwent between one and four repeat cerclage level 3
procedures.60 The median gestation at delivery was 34 weeks (range 22–39), with 75% of women
delivering before 37 weeks of gestation.

14.5 Is fetal fibronectin testing useful following insertion of a cervical cerclage?

Routine fetal fibronectin testing is not recommended post-cerclage. However, the high negative
predictive value of fetal fibronectin testing for subsequent delivery at less than 30 weeks of gestation
C
in asymptomatic high-risk women with a cerclage in place may provide reassurance to women and
clinicians in individual cases. However, the increased false-positive rate of fetal fibronectin testing in
such women makes the finding of a positive result less useful.

In a retrospective observational study involving 910 asymptomatic women at high risk of preterm
birth, including 159 with a cervical cerclage in place, fetal fibronectin testing for the prediction of
Evidence
delivery before 30 weeks of gestation was shown to have a similar negative predictive value in both level 2+
groups (over 98%) but a significantly lower specificity (77% versus 90%; P < 0.001) in those with a
suture.61

14.6 Should women receive supplemental progesterone following cerclage?

Routine use of progesterone supplementation following cerclage is not recommended.
P

RCOG Green-top Guideline No. 60 15 of 21 © Royal College of Obstetricians and Gynaecologists

The RCOG guidance currently recommends that in women at high risk of preterm delivery, progesterone
administration be restricted to clinical trials which aim to determine whether its use is associated with
improved fetal, neonatal and/or infant outcome.62

There are no comparative studies on the use of progesterone in woman who have undergone cerclage. In an
RCT of ultrasound-indicated cerclage involving 302 women with singleton pregnancies and a history of
spontaneous preterm birth between 17+0 and 33+6 weeks of gestation, an analysis of the woman’s recorded
intention to use supplemental progesterone did not appear to have any effect on delivery before 35+0 weeks
of gestation (OR 0.97; 95% CI 0.6–1.6).16

15. When should the cerclage be removed?

A transvaginal cervical cerclage should be removed before labour, usually between 36+1 and 37+0 weeks
of gestation, unless delivery is by elective caesarean section, in which case suture removal could be P
delayed until this time.

In women presenting in established preterm labour, the cerclage should be removed to minimise
potential trauma to the cervix. P

There are no studies comparing elective removal of transvaginal cerclage with removal in labour. However, in
the absence of preterm labour, elective removal at 36–37 weeks of gestation is advisable owing to the
potential risk of cervical injury in labour and the minimal risk to a neonate born at this gestation.

A Shirodkar suture will usually require anaesthesia for removal.

P
There are no studies regarding the use of anaesthesia in the removal of a Shirodkar suture but, given that the
technique involves burial of the suture, an anaesthetic is likely to be necessary for removal.

All women with a transabdominal cerclage require delivery by caesarean section, and the abdominal
suture may be left in place following delivery. P

There are no published studies on long-term outcome comparing a policy of removing a transabdominal
cerclage to it remaining in place. However, if further pregnancies are contemplated, it is reasonable to
recommend leaving the cerclage in place.

15.1 Should the cerclage be removed following PPROM?

In women with PPROM between 24 and 34 weeks of gestation and without evidence of infection or
D
preterm labour, delayed removal of the cerclage for 48 hours can be considered, as it may result in
sufficient latency that a course of prophylactic steroids for fetal lung maturation is completed and/or in
utero transfer arranged.

Delayed suture removal until labour ensues or delivery is indicated is associated with an increased risk
C
of maternal/fetal sepsis and is not recommended.

Given the risk of neonatal and/or maternal sepsis and the minimal benefit of 48 hours of latency in
pregnancies with PPROM before 23 and after 34 weeks of gestation, delayed suture removal is unlikely P
to be advantageous in this situation.

Jenkins et al. retrospectively studied 62 women, approximately 50% of whom had an elective
Evidence
cerclage in place and the remainder a rescue cerclage in place, who had PPROM between 24 and level 2+
34 weeks of gestation but no signs of preterm labour or infection.63 In 37 women there was

RCOG Green-top Guideline No. 60 16 of 21 © Royal College of Obstetricians and Gynaecologists

immediate removal (less than 24 hours) of the suture and in 25 women removal was delayed (over
24 hours) based on clinician preference. The duration of latency from PPROM to delivery was
significantly longer in the delayed-removal group (10.1 days versus 5.0 days; P < 0.001), but there
was no significant difference in gestational age at delivery. Delayed removal was associated with
significantly more women delivering more than 48 hours after presentation (96% versus 54%;
P < 0.001) compared with immediate removal, accompanied by a trend towards lower neonatal Evidence
mortality (4% versus 11%).There was no significant trend towards a higher rate of maternal infection level 2+

(44% versus 22%) and neonatal sepsis (16% versus 5%) in the delayed-removal group. Prolongation
of time to removal of cerclage to more than 48 hours in the delayed-removal group compared with
the immediate group (206.8±7.4 hours versus 5.4±0.2 hours) may have contributed to the observed
trend towards an increase in infectious complications.There was no obvious difference in outcome
in those with a history-indicated, ultrasound-indicated or rescue cerclage.

Ludmir et al. retrospectively studied 30 women with an elective cerclage in place and PPROM between 24
and 32 weeks of gestation where all cases were managed expectantly but in 20 cases there was immediate
removal of the suture and in 10 cases there was retention of the cerclage until delivery.64 Significantly more
women with retained cerclage had delivery delayed for at least 48 hours compared with women who had
immediate cerclage removal (90% versus 50%), but there was no overall difference in gestation at delivery.
Although there was no difference in the reported rate of chorioamnionitis prompting delivery in the retained
cerclage versus the removed cerclage groups, there was a significantly higher neonatal mortality rate in the
retained cerclage group (70% versus 10%), the majority of deaths in the former group being attributed to
neonatal sepsis.

Both of these studies lack a randomised approach to the allocated management strategy and are hence subject
to selection bias. Furthermore, there may be significant differences between the effects and complications
associated with delayed removal in women with rescue, ultrasound-indicated and elective cerclage.

16. Suggested audit topics

● Number of women referred to a consultant obstetrician (or a specialist prematurity clinic) before 12 weeks
of gestation as a proportion of those eligible for history-indicated cerclage.
● Review of the indications for cerclage in women having undergone a procedure in line with local protocol.
● Proportion of women receiving aneuploidy screening before history-indicated cerclage insertion.
● Pregnancy loss rate at less than 24 weeks of gestation and preterm delivery at 24–32 weeks of gestation
following cervical cerclage insertion.

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preterm birth in women with a short cervix found on trans- cerclage. Is there a role for amnioreduction? Aust N Z J
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26. Rust OA, Atlas RO, Reed J, van Gaalen J, Balducci J. Revisiting Amnioreduction in patients with bulging prolapsed
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APPENDIX
Clinical guidelines are ‘systematically developed statements which assist clinicians and women in making
decisions about appropriate treatment for specific conditions’. Each guideline is systematically developed
using a standardised methodology. Exact details of this process can be found in Clinical Governance
Advice No.1: Development of RCOG Green-top Guidelines (available on the RCOG website at
http://www.rcog.org.uk/guidelines). These recommendations are not intended to dictate an exclusive
course of management or treatment. They must be evaluated with reference to individual patient needs,
resources and limitations unique to the institution and variations in local populations. It is hoped that this
process of local ownership will help to incorporate these guidelines into routine practice. Attention is
drawn to areas of clinical uncertainty where further research might be indicated.

The evidence used in this guideline was graded using the scheme below and the recommendations
formulated in a similar fashion with a standardised grading scheme.

Classification of evidence levels Grades of recommendations

1++ High-quality meta-analyses, systematic
At least one meta-analysis, systematic review or
reviews of randomised controlled trials A
randomised controlled trial rated as 1++ and
or randomised controlled trials with a
directly applicable to the target population; or
very low risk of bias
A systematic review of randomised controlled
1+ Well-conducted meta-analyses, systematic
trials or a body of evidence consisting
reviews of randomised controlled trials
principally of studies rated as 1+ directly
or randomised controlled trials with a
applicable to the target population and
low risk of bias
demonstrating overall consistency of results
1– Meta-analyses, systematic reviews of
A body of evidence including studies rated as
randomised controlled trials or B
2++ directly applicable to the target
randomised controlled trials with a high
population, and demonstrating overall
risk of bias
consistency of results; or
2++ High-quality systematic reviews of
Extrapolated evidence from studies rated as
case–control or cohort studies or high-
1++ or 1+
quality case–control or cohort studies
with a very low risk of confounding, bias A body of evidence including studies rated as
C
or chance and a high probability that the 2+ directly applicable to the target population
relationship is causal and demonstrating overall consistency of
results; or
2+ Well-conducted case–control or cohort
studies with a low risk of confounding, Extrapolated evidence from studies rated as
bias or chance and a moderate 2++
probability that the relationship is causal Evidence level 3 or 4; or
D
2- Case–control or cohort studies with a Extrapolated evidence from studies rated as 2+
high risk of confounding, bias or chance
and a significant risk that the
relationship is not causal Good practice point
3 Non-analytical studies, e.g. case reports,
Recommended best practice based on the
case series P clinical experience of the guideline
4 Expert opinion development group

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 This guideline was produced on behalf of the Guidelines Committee of the Royal College of Obstetricians and
Gynaecologists by:
Professor AH Shennan FRCOG, London and Ms MS To MRCOG, London
and peer-reviewed by: BLISS (Babies Born too Soon, too Small, too Sick); RCOG Consumers’ Forum; Royal College of
Midwives; Mrs A Diyaf MRCOG, Nottingham; Ms LMM Duley FRCOG, Leeds; Mr RG Farquharson FRCOG, Liverpool;
Ms SK Flint FRCOG, Tunbridge Wells; Mr KT Moriarty MRCOG, Warwickshire; Dr NC Smith FRCOG, Aberdeen.

The Guidelines Committee lead reviewers were: Mr M Griffiths FRCOG, Luton and Dr K Langford FRCOG, London.

Conflicts of interest: none declared.

The final version is the responsibility of the Guidelines Committee of the RCOG.

The guidelines review process will commence in 2014 unless evidence requires earlier review.

DISCLAIMER

The Royal College of Obstetricians and Gynaecologists produces guidelines as an educational aid to good clinical
practice. They present recognised methods and techniques of clinical practice, based on published evidence, for
consideration by obstetricians and gynaecologists and other relevant health professionals. The ultimate judgement
regarding a particular clinical procedure or treatment plan must be made by the doctor or other attendant in the light
of clinical data presented by the patient and the diagnostic and treatment options available within the appropriate
health services.

This means that RCOG Guidelines are unlike protocols or guidelines issued by employers, as they are not intended to
be prescriptive directions defining a single course of management. Departure from the local prescriptive protocols or
guidelines should be fully documented in the patient’s case notes at the time the relevant decision is taken.

RCOG Green-top Guideline No. 60 21 of 21 © Royal College of Obstetricians and Gynaecologists