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

BMJ Open ◽  
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.

Safety and efficacy of the cervical pessary combined with vaginal progesterone for the prevention of spontaneous preterm birth

2018 ◽  
Vol 46 (5) ◽  
pp. 531-537 ◽  
Author(s):  
Georgios Daskalakis ◽  
Dimitrios Zacharakis ◽  
Marianna Theodora ◽  
Panagiotis Antsaklis ◽  
Nikolaos Papantoniou ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Combined Treatment ◽  
Primary Outcome Measure ◽  
Perinatal Complications ◽  
Spontaneous Preterm Birth ◽  
Singleton Pregnancy ◽  
Short Cervix ◽  
Safety And Efficacy ◽  
Cervical Pessary ◽  
Vaginal Progesterone

AbstractIntroduction:The aim of this study was to evaluate the safety and efficacy of the combined treatment of cervical pessary and endovaginal progesterone for the prevention of spontaneous preterm birth (SPB) in women with a short cervical length (CL) between 20 and 24 weeks of gestation.Materials and methods:This is a prospective study of women with a singleton pregnancy and a sonographically detected mid-trimester CL ≤25 mm. The primary outcome measure was spontaneous delivery before 34 weeks (238 days) of gestation.Results:The study sample consisted of 90 women with a mean CL of 14.2 mm (SD=6.5 mm). Of the women, 34.4% had at least one risk factor for SPB; 7.8% delivered preterm before 34 weeks of gestation, and 25.6%, before 37 weeks. Neonatal death occurred in two (2.2%) cases due to respiratory distress syndrome. Lower body mass index values, history of preterm delivery and number of second trimester miscarriages were independently associated with delivery before 34 weeks.Conclusion:The combination of vaginal progesterone and cervical pessary for the prevention of SPB in women with a short cervix is safe and well tolerated. This therapy was associated with pregnancy prolongation, reduced prematurity rate and a low rate of perinatal complications.

scholarly journals Vaginal progesterone in risk reduction of preterm birth in women with short cervix

2019 ◽  
Vol 8 (7) ◽  
pp. 2695
Author(s):  
Shubhi Srivastava ◽  
D. Borgohain
Keyword(s):  
Preterm Birth ◽  
Transvaginal Ultrasound ◽  
Perinatal Outcomes ◽  
Cervical Length ◽  
Singleton Pregnancy ◽  
Short Cervix ◽  
Mortality And Morbidity ◽  
Medical College ◽  
Vaginal Progesterone ◽  
Adverse Neonatal Outcomes

Background: Preterm birth is a global health problem affecting the neonate, family and country in general. It is the leading cause of perinatal mortality and morbidity. Short cervical length detected on transvaginal ultrasound is the most practical risk factor for prediction of preterm birth. The aim of this study was to determine the efficacy and safety of vaginal progesterone in reducing the rate of preterm birth in women with a short cervix and to determine its effect on neonatal mortality and morbidity.Methods: The study was carried out in the Department of Obstetrics and Gynaecology at Assam Medical College, Dibrugarh for a period of one year. It included 128 asymptomatic women with a singleton pregnancy and a sonographic short cervix. Women were randomly divided into two groups, one of which was given placebo and the other was given vaginal progesterone and a comparative study was conducted.Results: It was observed that delivery before 37 weeks of gestation was less frequent in the progesterone group than in the placebo group (60.94% vs. 90.63%). Vaginal progesterone was also associated with a significant reduction in adverse neonatal outcomes like the rate of sepsis (6.25% vs. 18.75%), requirement of ventilator (12.5% vs. 26.56%), admission to NICU (10.94% vs. 26.56%) and birth weight ≤1.5kg (7.81% vs. 21.88%).Conclusions: Vaginal progesterone reduces the risk of preterm birth and adverse perinatal outcomes in pregnant women without any deleterious effects on the foetus or mother.

scholarly journals McDonald versus Shirodkar cerclage technique in women requiring a prophylactic cerclage: a systematic review and meta-analysis protocol

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Ashad Issah ◽  
Rosanna Diacci ◽  
Kimberley P. Williams ◽  
Anne-Marie Aubin ◽  
Liam McAuliffe ◽  
...  
Keyword(s):  
Systematic Review ◽  
Preterm Birth ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Grey Literature ◽  
Synthesis Methods ◽  
Randomized Control Trials ◽  
Cervical Cerclage ◽  
Short Cervix ◽  
Randomized Control

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

scholarly journals Vaginal progesterone for prevention of preterm birth in asymptomatic high-risk women with a normal cervical length: a systematic review and meta-analysis protocol

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Kimberley P. Williams ◽  
Liam McAuliffe ◽  
Rosanna Diacci ◽  
Anne-Marie Aubin ◽  
Ashad Issah ◽  
...  
Keyword(s):  
Preterm Birth ◽  
High Risk ◽  
Meta Analysis ◽  
Cervical Length ◽  
Analysis Model ◽  
Spontaneous Preterm Birth ◽  
Singleton Pregnancy ◽  
Short Cervix ◽  
High Risk Women ◽  
Vaginal Progesterone

Abstract Background Preterm birth (PTB) is estimated to affect 14.9 million babies globally every year. Global rates of PTB continue to increase from 9.8 to 10.6% over a 15-year period from 2000 to 2014. Vaginal progesterone is commonly used by clinicians as a prevention strategy, with recent evidence affirming the benefit of vaginal (micronised) progesterone to prevent PTB in women with a shortened cervix (< 25 mm). Given the low incidence of a short cervix at mid-gestation in high-risk populations further evidence is required. The objective of this review is to determine if vaginal progesterone reduces spontaneous preterm birth (sPTB) before 37 weeks in asymptomatic high-risk women with a singleton pregnancy with a normal mid-gestation cervical length. Methods Studies will be sourced from MEDLINE, Embase and Cochrane Register of Trials (CENTRAL) from their inception onwards with the search terms ‘progesterone’ and ‘preterm birth’. Studies will be screened and included if they assess vaginal progesterone compared to placebo in women with a normal cervical length. The primary outcome will be sPTB < 37 weeks, with secondary outcomes of sPTB < 34 weeks. 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. The Mantel-Haenszel statistical method and random effects analysis model will be used to produce treatment effect odds ratios and corresponding 95% confidence intervals. Discussion This review will assess the current body of evidence and provide clarity regarding the potential benefits and best practice of use of vaginal progesterone in asymptomatic women with high-risk singleton pregnancies and normal cervical length. Trial registration PROSPERO CRD42020152051

scholarly journals 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 ◽  
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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