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Does a stitch in time save structural differences, or iatrogenic due to previous cervical
surgery or full dilatation caesarean section.
lives? An update on the For preterm birth and mid-trimester pregnancy loss mediated
by cervical insufficiency, defined as shortening of the cervix prior
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 34:6 167 Ó 2024 Elsevier Ltd. All rights reserved.
SPOTLIGHT
Table 1
Saving Babies Lives Care Bundle (version 3) A summary of new evidence for history- and ultrasound-
Saving Babies Lives Care Bundle (SBLCB) version 2 element 5 indicated cerclage
focusses on reducing preterm birth. Version 2 standardised the
C-STICH is a UK-based RCT published in 2022 which recruited
risk factors for which preterm birth surveillance is indicated
2049 women over 6 years and randomised to either mono-
(Table 3). Version 3 of the care bundle was released in 2023 and
filament or braided suture. The trial found no difference in the
Element 5 was renamed as reducing preterm birth and optimising
primary outcome of pregnancy loss, or a composite outcome
perinatal care. The new recommendations for perinatal optimi-
including miscarriage, stillbirth, termination of pregnancy and
sation focus on antenatal actions, including place of birth, cor-
early neonatal death (adjusted risk ratio 1$05 [95% CI 0$79 to
ticosteroids, and magnesium sulphate, intrapartum antibiotics
1$40]). There was no significant difference in almost any of the
and cord management, and early post-partum interventions.
outcomes studied with the exception of maternal sepsis and
Recommended terminology and definitions from the RCOG Green Top Guideline
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 birth. A history-indicated
suture is performed as a prophylactic measure in asymptomatic women and usually inserted as
a planned procedure at 11e14 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.
Emergency cerclage (also known as physical Insertion of cerclage as a salvage measure in the case of premature cervical dilatation with
exam-indicated or rescue cerclage) 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’. It can be considered up to 27þ6 weeks
gestation.
Transvaginal cerclage (McDonald) A transvaginal purse-string suture placed at the cervical isthmus junction, without bladder
mobilization.
High transvaginal cerclage requiring bladder A transvaginal purse-string suture placed following bladder mobilization, to allow insertion
mobilization (including Shirodkar) above the level of the cardinal ligaments.
Transabdominal cerclage A suture placed laparoscopically, or at laparotomy, at the cervicoisthmic junction.
Occlusion cerclage Occlusion of the external os by placement of a continuous non-absorbable suture, the intention
being to help with retention of the mucus plug.
Table 2
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 34:6 168 Ó 2024 Elsevier Ltd. All rights reserved.
SPOTLIGHT
Saving Babies Lives: Risk assessment and management tool for pregnant women at risk of preterm birth
Surveillance and management
High risk
Previous preterm birth or mid-trimester loss 1 Referral to local or tertiary Preterm Prevention (PP) clinic by 12 weeks.
(16e34 weeks gestation).Previous preterm 2 Further risk assessment based on history examination as appropriate in secondary
prelabour rupture of membranes <34/40. care with identification of pregnant women needing referral to tertiary services.
Previous use of cervical cerclage. 3 All pregnant women to be offered transvaginal cervix scanning every 2e4 weeks
Known uterine variant (i.e., unicornuate, between 16 and 24 weeks as a secondary test to more accurately quantify the risk
bicornuate uterus or uterine septum). of preterm birth.
Intrauterine adhesions (Ashermann’s syndrome). 4 Additional use of quantitative fetal fibronectin in asymptomatic pregnant women may
History of trachelectomy (for cervical cancer). be considered where centres have this expertise.
5 Interventions should be offered to pregnant women as appropriate, based on either
history or additional risk assessment tests by clinicians able to discuss the relevant
risks and benefits according to up to date evidence and relevant guidance, for example,
UK Preterm Clinical Network guidance (www.tommys.org/our-organisation/our-research/
premature-birth-research/reducing-preterm-birth-rates) and NICE guidance. These
interventions should include cervical cerclage, pessary and progesterone as appropriate.
Intermediate risk
Previous birth by caesarean section at 1 Refer to preterm birth prevention clinic by 12 weeks.
full dilatation. 2 Further risk assessment based on history examination as appropriate in
History of significant cervical excisional event secondary care with discussion of option of additional risk assessment tests, including:
i.e., LLETZ where >15 mm depth removed, a A single transvaginal cervix scan between 18 and 22 weeks as a minimum.
or >1 LLETZ procedure carried out or cone biopsy b Additional use of quantitative fetal fibronectin in asymptomatic pregnant women
(knife or laser, typically carried out under can be considered where centres have this expertise.
general anaesthetic). 3 Interventions should be discussed with pregnant women as appropriate based on
either history or additional risk assessment tests by clinicians able to discuss the
relevant risks and benefits according to up-to-date evidence and relevant guidance.
These interventions should include cervical cerclage, pessary and progesterone as
appropriate.
4 Pregnant women at intermediate risk should be reassessed at 24 weeks for
consideration of transfer back to a low-risk pathway.
Table 3
chorioamnionitis, both unblinded and subjective clinical di- Summary of new evidence for emergency cerclage
agnoses. This evidence is consistent with previous guidance
The role of emergency cerclage (ECC), when the cervix has already
which advised the choice of suture material should be at the
dilated and the membranes are exposed, remains controversial.
discretion of the surgeon, although previously there was little
The Green Top guideline recommendations regarding emergency
evidence to support this assertion (grade 4, good practice point).
cerclage state that the decision for emergency cerclage should be
C-STICH offers a level of clinical certainty not often seen in ob-
carefully balanced, taking into account the parent’s views (grade
stetrics. Further work is awaited for secondary analyses to
2þ, strength D), and that ECC may prolong pregnancy by up to
explore the role of progesterone and suture technique particu-
34 days compared to expectant management but the impact on
larly related to the height of placement of the suture (low vs high-
neonatal morbidity and mortality is uncertain (grade 2-, strength
vaginal sutures) in preventing pregnancy loss. A recent system-
D). This is based on systematic review data, however the majority
atic review and meta-analysis of combined progesterone and
of studies are small observational studies at high risk of bias. A
cerclage found combination treatment to reduce the risk of PTB
more recent systematic review presents detailed analysis of the
before 37 and neonatal mortality compared to either cerclage or
evidence for ECC in singleton and twin pregnancies, including
progesterone alone.
analysis of demographic data of participants and frequency of use
A network meta-analysis of interventions to prevent preterm
of adjunctive treatments, however this data could not be analysed
birth in high-risk women with singleton pregnancies found that
with regards to clinical outcomes.
vaginal progesterone and Shirodkar suture (low certainty) were
C-STICH2 is a RCT of ECC compared to expectant manage-
associated with fewer preterm births at <34 weeks gestation.
ment currently recruiting in the UK. The study also includes an
Vaginal progesterone was the only intervention significantly
observational cohort for those participants that are not willing to
associated with reduction in perinatal death. McDonald suture
accept randomisation or where the responsible clinician was not
and cervical suture (unspecified) appeared to reduce the risk of
in equipoise and gave a recommendation of either emergency
perinatal death but the 95% credible interval included 1.0.
cerclage or conservative management.
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 34:6 169 Ó 2024 Elsevier Ltd. All rights reserved.
SPOTLIGHT
Cerclage in multiple pregnancies Hodgetts Morton V, Toozs-Hobson P, Moakes CA, et al. Monofilament
suture versus braided suture thread to improve pregnancy out-
The Cochrane review of 5 trials of cervical cerclage use in mul-
comes after vaginal cervical cerclage (C-STICH): a pragmatic
tiple pregnancies found no difference in perinatal deaths or
randomised, controlled, phase 3, superiority trial. Lancet 2022; 400:
neonatal morbidity. At that time there was insufficient evidence
1426e36.
to examine the role of emergency cerclage in multi-fetal preg-
Hulshoff CC, Bosgraaf RP, Spaanderman MEA, et al. The efficacy of
nancies. The RCOG guideline recommends that cervical cerclage
emergency cervical cerclage in singleton and twin pregnancies: a
is not performed in multiple pregnancies (grade 1þþ strength B)
systematic review with meta-analysis. American J Obstetrics Gy-
based on the meta-analysis results from the Cochrane systematic
necology MFM 2023; 5: 100971.
review. A recent systematic review and meta-analysis including
Medley N, Vogel JP, Care A, et al. Interventions during pregnancy to
26 studies again found no benefit of vaginal progesterone pessary
prevent preterm birth: an overview of Cochrane systematic reviews.
or cervical cerclage in the prevention of PTB <34 weeks in an
Cochrane Database Syst Rev 2018; 11: CD012505.
unselected population of twin pregnancies, nor in those with a
NICE. Preterm labour and birth NICE Guideline 25. National Institute
short (<25 mm) cervical length.
for Health and Care Excellence (NICE), 2015.
Only recently in 2020 was the first RCT of emergency cerclage
Norman JE, Marlow N, Messow CM, et al. Vaginal progesterone pro-
in twins published. The trial reported a significant reduction in
phylaxis for preterm birth (the OPPTIMUM study): a multicentre,
PTB <34 weeks and perinatal morbidity. Of note the trial was
randomised, double-blind trial. Lancet 2016; 387: 2106e16.
closed prematurely by the data monitoring committee after
Rafael TJ, Berghella V, Alfirevic Z. Cervical stitch (cerclage) for pre-
recruiting only 34 participants. The Twin-Cerclage trial of
venting preterm birth in multiple pregnancy. Cochrane Database
emergency cerclage for exposed membranes or ultrasound-
Syst Rev 2014; 2014: CD009166.
indicated cerclage for a very short cervix (<15 mm) in twin
Shennan AH, Story L. Cervical cerclage: green-top guideline No. 75.
pregnancies is currently recruiting. A Bjog 2022; 129: 1178e210.
Shennan A, Chandiramani M, Bennett P, et al. MAVRIC: a multicenter
FURTHER READING randomized controlled trial of transabdominal vs transvaginal cer-
Alfirevic Z, Stampalija T, Medley N. Cervical stitch (cerclage) for pre- vical cerclage. Am J Obstet Gynecol 2020; 222: 261.e1e9.
venting preterm birth in singleton pregnancy. Cochrane Database
Syst Rev 2017; 6: CD008991.
Aubin AM, Mcauliffe L, Williams K, et al. Combined vaginal proges- Practice points
terone and cervical cerclage in the prevention of preterm birth: a C Cervical cerclage is an important intervention for preventing
systematic review and meta-analysis. Am J Obstet Gynecol MFM
pregnancy loss in certain populations, such as women who have
2023; 5: 101024.
experienced multiple mid-trimester losses or early preterm births
Care A, Nevitt SJ, Medley N, et al. Interventions to prevent sponta-
and high-risk women with a short cervix identified by transvaginal
neous preterm birth in women with singleton pregnancy who are at
ultrasound scan
high risk: systematic review and network meta-analysis. Bmj 2022; C The potential benefit in other populations, such as those with an
376: e064547.
incidental finding of a short cervix or twin pregnancy, is uncertain
Ehsanipoor RM, Seligman NS, Saccone G, et al. Physical examination- C Suture thread and suture technique do not appear to make a
indicated cerclage: a systematic review and meta-analysis. Obstet
difference, although a transabdominal approach may be of benefit
Gynecol 2015; 126: 125e35.
if previous stitches have failed
Hezelgrave NL, Watson HA, Ridout A, et al. Rationale and design of C Further research is needed to understand the role of adjunctive
SuPPoRT: a multi-centre randomised controlled trial to compare
treatments such as progesterone alongside cerclage, surgical
three treatments: cervical cerclage, cervical pessary and vaginal
technique and whether emergency cerclage is a safe and effective
progesterone, for the prevention of preterm birth in women who
intervention when the membranes are exposed
develop a short cervix. BMC Pregnancy Childbirth 2016; 16: 358.
OBSTETRICS, GYNAECOLOGY AND REPRODUCTIVE MEDICINE 34:6 170 Ó 2024 Elsevier Ltd. All rights reserved.