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Effectiveness of Cervical Pessary Compared to Cervical Cerclage with Or Without Vaginal Progesterone for the Prevention of Prete

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Effectiveness of Cervical Pessary Compared to Cervical Cerclage with Or Without Vaginal Progesterone for the Prevention of Prete Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-036587 on 16 June 2020. Downloaded from 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 Vinh Q Dang ,1,2 Yen TN He,2,3 Ha NH Pham,1 Tuyen TT Trieu,3 Trung Q Bui,1 Nhu T Vuong,1 Loc MT Nguyen,2 Diem TN Nguyen,2 Thanh V Le,1 Wentao Li,4 Cam H Le,3 Ben W Mol,4 Lan N Vuong5 To cite: Dang VQ, He YTN, ABSTRACT Strengths and limitations of this study Pham HNH, et al. Effectiveness Introduction Women with twin pregnancies and a short of cervical pessary compared cervix are at increased risk for preterm birth (PTB). Given ► The trial has a randomised, controlled design, which to cervical cerclage with or the burden of prematurity and its attendant risks, the without vaginal progesterone should minimise bias. quest for effective interventions in twins has been an copyright. for the prevention of preterm ► A limited number of well- trained, certified staffs will area of considerable research. Studies investigating the birth in women with twin be involved in cervical length measurement, pessary effectiveness of cervical cerclage, cervical pessary and pregnancies and a short cervix: and cerclage placement which increases the validity vaginal progesterone in preventing PTB have yielded study protocol for a two- by- of the study. two factorial randomised conflicting results. The aim of this study is to compare the http://bmjopen.bmj.com/ ► An open design, which is unavoidable due to the na- clinical trial. BMJ Open effectiveness of cervical pessary and cervical cerclage ture of the interventions, could introduce bias. 2020;10:e036587. doi:10.1136/ with or without vaginal progesterone to prevent PTB in ► The majority of women with twin pregnancies in- bmjopen-2019-036587 women with twin pregnancies and a cervical length (CL) volving in the trial will conceive from assisted repro- ≤ 28 mm. ► Prepublication history and ductive technology. Therefore, the external validity of Methods and analysis This multicentre, randomised additional material for this the study might be compromised. paper are available online. To clinical trial will be conducted at My Duc Hospital and My view these files, please visit Duc Phu Nhuan Hospital, Vietnam. Asymptomatic women the journal online (http:// dx. doi. with twin pregnancies and a CL ≤28 mm, measured at 16–22 org/ 10. 1136/ bmjopen- 2019- weeks’ gestation, will be randomised in a 1:1:1:1 ratio to Trial registration number NCT03863613 (date of on September 7, 2020 at University of Aberdeen. Protected by 036587). receive a cerclage, pessary, cerclage plus progesterone or registration: 4 March 2019). pessary plus progesterone. Primary outcome will be PTB <34 Received 20 December 2019 weeks. Secondary outcomes will be maternal and neonatal Revised 10 May 2020 INTRODUCTION Accepted 13 May 2020 complications. We preplanned a subgroup analysis according to CL from all women after randomisation and divided into Preterm birth (PTB) is the most common four quartiles. Analysis will be conducted on an intention- to- cause of neonatal morbidity and mortality treat basis. The rate of PTB <34 weeks’ gestation in women worldwide1 2 and the second leading cause of with twin pregnancies and a cervix ≤28 mm and treated death in children under 5 years.3 4 Children with pessary in our previous study at My Duc Hospital was who survive may face the risk of significant © Author(s) (or their 24.2%. A sample size of 340 women will be required to show disability, including cerebral palsy, intellectual employer(s)) 2020. Re- use or refute that cervical cerclage decreases the rate of PTB impairment, chronic lung disease and vision permitted under CC BY-NC. No <34 weeks by 50% compared with pessary (from 24.2% to and hearing loss for a lifetime. They are also commercial re- use. See rights 12.1%, α level 0.05, power 80%, 5% lost to follow-up and and permissions. Published by at greater risk of developing hypertension, protocol deviation). This study is not to be powered to assess BMJ. diabetes and development problems later interactions between interventions. 5 For numbered affiliations see Ethics and dissemination Ethical approval was obtained in their lives. Therefore, prevention of PTB end of article. from the Institutional Ethics Committee of My Duc Hospital has been considered a priority worldwide to Correspondence to and informed patient consent was obtained before study promote the well- being of mothers and chil- 6 Dr Vinh Q Dang; enrolment. Results of the study will be submitted for dren. Due to an increased use of assisted bsvinh. dq@ myduchospital. vn publication in a peer- reviewed journal. reproductive technologies (ARTs) and an Dang VQ, et al. BMJ Open 2020;10:e036587. doi:10.1136/bmjopen-2019-036587 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-036587 on 16 June 2020. Downloaded from older maternal age, the incidence of twin pregnancies weeks, was comparable between the two groups. However, has increased, in the recent three decades, by almost 70% other secondary outcomes, including neonatal outcomes, worldwide.7 8 were significantly improved in women treated with pessary. Women with twin pregnancies are at increased risk for Moreover, in women with a CL ≤28 mm (25th percentile of PTB. In the USA, data in 2016 showed that more than 60% randomised women), the rate of PTB <34 weeks significantly women with twin pregnancies gave birth before 37 weeks, reduced from 54.5% in the progesterone group to 24.2% in of whom 21.2% did so before 34 weeks.9 Corresponding the pessary group.24 A recent cost-effective analysis showed figures in women with singleton pregnancies were 8% and that pessary significantly improves the rate of morbidity- free 2.1%, respectively.9 In addition, short cervical length (CL) survival neonate while reducing costs as compared with in the second trimester of pregnancy is well known to be an vaginal progesterone.25 As these data showed that cervical independent risk factor for PTB.10 11 In women with twin pessary might be superior to vaginal progesterone in the pregnancies, the risk of spontaneous PTB also increases prevention of PTB in women with twin pregnancies and with decreasing CL.12 Therefore, women with twin preg- a CL ≤28 mm, the question that arises now is how cervical nancies and a short cervix are at extremely high risk for pessary compares to cervical cerclage. We therefore propose PTB.13 the Pessary versus Cerclage with or without Progesterone Although vaginal progesterone, cervical cerclage and in Twins (PCP- Twins) study, in which we will compare the cervical pessary have been used in clinical practice to effectiveness of cervical pessary and cervical cerclage with prevent PTB, evidence regarding the effectiveness of or without vaginal progesterone to prevent PTB in women these interventions is still inconclusive.14 A meta- analysis with twin pregnancies and a CL ≤28 mm. of randomised clinical trials (RCTs) suggested that proges- terone potentially reduced PTB and neonatal complica- tions in women with twin pregnancies and a short cervix.15 However, a recent meta-analysis showed that progesterone METHODS AND ANALYSIS could only improve some secondary outcomes, regardless Study design and ethical considerations of CL.16 The PCP-T wins study is a randomised controlled trial and For cervical cerclage, a meta- analysis of three trials in will be conducted at My Duc Hospital and My Duc Phu 49 women with twin pregnancies and a CL <25 mm could Nhuan Hospital, Ho Chi Minh City, Vietnam, according not demonstrate a benefit of cerclage in this popula- to the principles outlined in the Declaration of Helsinki copyright. tion.17 Moreover, cerclage group had higher rates of very and its amendments, in accordance with the Medical low birth weight and of respiratory distress syndrome Research Involving Human Subjects Act (WMO) and than control group. In contrast, a recent systematic using Good Clinical Practice. The trial has been approved http://bmjopen.bmj.com/ review and meta- analysis, which includes RCTs and by the Institutional Ethics Committee (IEC) of My Duc cohort studies, indicate that cerclage placement is bene- Hospital (02/2019/MÐ-HÐÐÐ). ficial for the reduction of PTB only in twin pregnancies It is our daily practice that all pregnant women will with a CL <15 mm or dilated cervix of >10 mm.18 In this undergo urine culture for screening of asymptomatic study, authors stated that further high- quality studies are bacteriuria in the first prenatal visit. If they have asymp- needed to confirm the findings, due to the insufficiency tomatic bacteriuria, they will be treated with antibiotics.26 of strong supporting evidence.18 At 16–22 weeks of gestation, asymptomatic women with Among types of cervical pessaries, the Arabin is the most twin pregnancies will undergo CL measurement and digital on September 7, 2020 at University of Aberdeen. Protected by common used in the prevention of PTB.19 This pessary examination as part of routine clinical care. In case where has shown encouraging results in women with twin preg- vaginitis is suspected, vaginal culture could be performed. nancies. A large open-label RCT was conducted at 40 For women who conceived after ART, gestational age will be Dutch centres from 2009 to 2012 among 813 women with determined by the date of embryo transfer or intrauterine a twin pregnancy.20 While there was no significant effect insemination. For those who conceived naturally, gesta- in the overall population, pessary significantly reduced tional age will be determined from the menstrual history PTB <28 weeks and <32 weeks, median of time to delivery and confirmed by the fetal crown-rump length of the larger and adverse neonatal outcomes in women with a short twin at the first-trimester ultrasound examination.
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