Vaginal progesterone vs cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, previous preterm birth, and singleton gestation: a systematic review and indirect comparison metaanalysis

Abstract Background Preterm birth (PTB) is the leading cause of death in children under five years. Spontaneous preterm birth (SPTB) is the major cause of preterm delivery. The key risk factors for SPTB are women who have a short cervix and women who have had previous preterm birth. Cervical cerclage has been used for several decades and has shown to decrease rates of preterm birth. The most commonly used cerclage techniques were described by Shirodkar and McDonald, with no current consensus on the preferred technique. The objective of this review is to determine and compare the effectiveness of both techniques. Methods Studies will be sourced from six electronic databases, as well as from experts in the field, reference lists, and grey literature. Eligible studies will include pregnant women, with a singleton or twin pregnancy, requiring a cervical cerclage, using either the Shirodkar or McDonald technique and run comparative analyses between the two techniques. Randomized control trials (RCT)s, non-randomized control trials, and cohort studies will be eligible. Two independent reviewers will conduct study screening at abstract and full-text level, data extraction and risk of bias assessment. Discrepancies will be resolved by a consensus third reviewer if required. Fixed-effects or random-effects models will be used where appropriate to synthesize results. Alternative synthesis methods will be investigated in instances where a meta-analysis is not appropriate, such as summarizing effect estimates, combining P values, vote counting based on direction of effect, or synthesis in narrative form. Discussion This review will synthesize the evidence on both the Shirodkar and McDonald cerclage method, and will help clinicians and health services to determine and deliver best practice antenatal care that has the potential to make an impact on preterm birth. Systematic review registration PROSPERO on 25 of May, 2020 with registration number CRD42020177386

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Effectiveness of combined vaginal progesterone and cervical cerclage in preventing preterm birth: a systematic review and meta-analysis protocol

BMJ Open ◽

10.1136/bmjopen-2021-050086 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050086

Author(s):

Rosanna C Diacci ◽

Ashad Issah ◽

Kimberley P Williams ◽

Liam McAuliffe ◽

Anne-Marie Aubin ◽

...

Keyword(s):

Preterm Birth ◽

Fixed Effects ◽

Combined Therapy ◽

Combined Treatment ◽

Cochrane Library ◽

Publication Date ◽

Singleton Pregnancy ◽

Cervical Cerclage ◽

Short Cervix ◽

Vaginal Progesterone

IntroductionPreterm birth (PTB) is the leading cause of death in children under 5 years. Preventive therapies targeted towards women with risk factors such as a prior PTB or a short cervix reduce the rate of PTB. Cervical cerclage, vaginal progesterone and a combination of the two have been used with no consensus as to whether combined treatment is more effective than any single treatment alone. The objective of this review is to determine the efficacy of combined treatment compared with cerclage alone and combined treatment compared with progesterone alone.Methods and analysisStudies will be sourced from the electronic databases Medline (Ovid), EMBASE (Ovid), PsycINFO (Ovid), Scopus, CINAHL (EBSCOhost) and Cochrane Library (Wiley) and reference lists. We will not exclude any papers due to publication date. Randomised control trials (RCTs), non-RCTs and cohort studies assessing single therapy (either progesterone or cerclage) versus combined therapy in women with a singleton pregnancy will be included. Two independent reviewers will conduct study screening (at abstract and full-text level), data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. Random or fixed effects models will be used depending on data heterogeneity and data will be presented as risk ratio for dichotomous data or mean difference for continuous data with a CI of 95% used for all outcomes.Ethics and disseminationNot applicable due to nature of the study type.PROSPERO registration numberCRD42020195975.

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Vaginal Progesterone Is as Effective as Cervical Cerclage to Prevent Preterm Birth in Women With a Singleton Gestation, Previous Spontaneous Preterm Birth, and a Short Cervix

Obstetrical & Gynecological Survey ◽

10.1097/01.ogx.0000549662.24782.f0 ◽

2018 ◽

Vol 73 (12) ◽

pp. 674-676

Author(s):

Agustin Conde-Agudelo ◽

Roberto Romero ◽

Eduardo Da Fonseca ◽

John M. OʼBrien ◽

Elcin Cetingoz ◽

...

Keyword(s):

Preterm Birth ◽

Spontaneous Preterm Birth ◽

Cervical Cerclage ◽

Short Cervix ◽

Vaginal Progesterone

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Rationale and design of SuPPoRT: a multi-centre randomised controlled trial to compare three treatments: cervical cerclage, cervical pessary and vaginal progesterone, for the prevention of preterm birth in women who develop a short cervix

BMC Pregnancy and Childbirth ◽

10.1186/s12884-016-1148-9 ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 17

Author(s):

Natasha L. Hezelgrave ◽

Helena A. Watson ◽

Alexandra Ridout ◽

Falak Diab ◽

Paul T Seed ◽

...

Keyword(s):

Preterm Birth ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cervical Cerclage ◽

Short Cervix ◽

Cervical Pessary ◽

Vaginal Progesterone ◽

Randomised Controlled

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Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial

BMJ Open ◽

10.1136/bmjopen-2019-036587 ◽

2020 ◽

Vol 10 (6) ◽

pp. e036587

Author(s):

Vinh Q Dang ◽

Yen TN He ◽

Ha NH Pham ◽

Tuyen TT Trieu ◽

Trung Q Bui ◽

...

Keyword(s):

Clinical Trial ◽

Preterm Birth ◽

Randomised Clinical Trial ◽

Cervical Cerclage ◽

Short Cervix ◽

Cervical Pessary ◽

Vaginal Progesterone ◽

Increased Risk ◽

Patient Consent ◽

Twin Pregnancies

IntroductionWomen with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB). Given the burden of prematurity and its attendant risks, the quest for effective interventions in twins has been an area of considerable research. Studies investigating the effectiveness of cervical cerclage, cervical pessary and vaginal progesterone in preventing PTB have yielded conflicting results. The aim of this study is to compare the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone to prevent PTB in women with twin pregnancies and a cervical length (CL) ≤ 28 mm.Methods and analysisThis multicentre, randomised clinical trial will be conducted at My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam. Asymptomatic women with twin pregnancies and a CL ≤28 mm, measured at 16–22 weeks’ gestation, will be randomised in a 1:1:1:1 ratio to receive a cerclage, pessary, cerclage plus progesterone or pessary plus progesterone. Primary outcome will be PTB <34 weeks. Secondary outcomes will be maternal and neonatal complications. We preplanned a subgroup analysis according to CL from all women after randomisation and divided into four quartiles. Analysis will be conducted on an intention-to-treat basis. The rate of PTB <34 weeks’ gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%. A sample size of 340 women will be required to show or refute that cervical cerclage decreases the rate of PTB <34 weeks by 50% compared with pessary (from 24.2% to 12.1%, α level 0.05, power 80%, 5% lost to follow-up and protocol deviation). This study is not to be powered to assess interactions between interventions.Ethics and disseminationEthical approval was obtained from the Institutional Ethics Committee of My Duc Hospital and informed patient consent was obtained before study enrolment. Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03863613 (date of registration: 4 March 2019).

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