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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 BMJ Open: first published as 10.1136/bmjopen-2019-036587 on 16 June 2020. Downloaded from PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf) and are provided with free text boxes to elaborate on their assessment. These free text comments are reproduced below. ARTICLE DETAILS TITLE (PROVISIONAL) The 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 AUTHORS Dang, Vinh; He, Yen; Pham, Ha; Trieu, Tuyen; Bui, Trung; Vuong, Nhu; Nguyen, Loc; Nguyen, Diem; Le, Thanh; Li, Wentao; Le, Cam; Mol, Ben; Vuong, Lan VERSION 1 – REVIEW REVIEWER GEORGE DASKALAKIS NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS, GREECE REVIEW RETURNED 09-Feb-2020 GENERAL COMMENTS This is a very interesting study protocol on the interventions in twin pregnancies with short cervix, for the prevention of preterm birth. In my opinion another control group without any intervention is necessary for the results to be reliable.This is the main disadvantage of the study protocol. The cut off of 28 mm may be that of the 25th centile in the local http://bmjopen.bmj.com/ population, but most of the studies so far used the cut off of 25 mm ( the same as in singletons) and this is a problem for the studies to be comparable. Recent meta-analysis by R. Romero on progesterone in twins should be included. According to newer data in singletons, cerclage is effective when it is accompanied by rigorous antibiotic treatment and/or tocolysis. The standard digital examination of the cerrvix is not necessary. It on October 1, 2021 by guest. Protected copyright. can only be performed in cases of cervical dilataion. I did not completely understand which is the lower CL limit for inclusion, and why pregnancies with a dilation of less than 2-3 cm cannot be included. This should be more clearly described. Why acute cervicitis/vaginitis/vaginal discharge are exclusion criteria. They can be easily treated and then the women can be reassessed. In the secondary outcomes, intraventricular hemorrhage stage II or above should be written. I think an external statistician should review the statistical analysis of the study. REVIEWER Amihai Rottenstreich Hadassah Medical Center, Israel REVIEW RETURNED 24-Mar-2020 1 BMJ Open: first published as 10.1136/bmjopen-2019-036587 on 16 June 2020. Downloaded from GENERAL COMMENTS I would like to thank the Editor for the opportunity to review this manuscript First, I would like to congratulate the authors for the suggested study protocol. The area of PTB prevention is a matter of ongoing debate, and even more controversial among those with twin gestation. My comments as follows- Introduction- • Line 78-brackets for PTB should be omitted. • Please mention the increasing rate of twin pregnancies due to older maternal age and increased utilization of ART • Introduction should include the reference by Romero et al. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. UOG 2017 • Regarding cervical pessary-the reference 22 by Cruz-Melguize et al should be omitted as it was performed among singleton pregnancies. I suggest instead to cite the article by Le et al. in the UOG 2019. Methods- • Why did you choose 28 mm and not 25 mm as the cut-off value? This is based on one-study of yours, while in the study aforementioned by Romero et al. which include IPD meta-analysis 25 mm was found as the better cut-off value • I suggested limiting the inclusion criteria-to DCDA twin pregnancies. This is because MCDA and MCMA twins are at significantly higher risk for adverse outcomes which may lead to indicated preterm deliveries limiting the ability to draw conclusions • I also suggest to exclude women with previous history of preterm delivery. This is due to the higher risk of recurrent preterm births in twin gestation in those with prior history of preterm births (see Schaaf et al. BJOG 2012 and Kazemier BM et al. BJOG 2014). Moreover, in this group of patients history-indicated cerclage was http://bmjopen.bmj.com/ shown to reduce the risk of preterm birth in the current twin gestation (Rottenstreich et al. UOG 2019) • Regarding the dose of vaginal progesterone-why 400 mg and not 200 mg. Again, in the study of yours indeed 400 mg were used, but is this based on any evidence-based literature? • I suggest performing vaginal and urine cultures prior to cervical cerclage in order to exclude the presence of asymptomatic infection • “ a single dose of prophylactic antibiotic”-Which antibiotics will be on October 1, 2021 by guest. Protected copyright. used perioperatively? • While blinding is obviously not possible for the pessary vs cerclage, but one about blinding regarding the progesterone and using a placebo as well? • “In case the CL shortens, further intervention, if any, will be based on the clinician’s decision after a full discussion with the participant”-can you be more specific after cervical shortening are you planning to suggest cervical cerclage or pessary or vaginal progesterone for those who are not using them already based on their original allocation?. This is an important issue. • While for those with PPROM, I agree that the cervical cerclage, pessary and progesterone should not be used. However, in an episode of preterm labor this may not hold true. This is particularly true for pessary for which a recent article in AJOG showed that following an episode of preterm labor it was more beneficial than vaginal progesterone. 2 BMJ Open: first published as 10.1136/bmjopen-2019-036587 on 16 June 2020. Downloaded from Outcomes- • Please also record the time lapsed from ACS administration to delivery as optimal timing of ACS (delivery within 24 hours up to 1 week following the first dose) is significantly associated with better neonatal outcomes. VERSION 1 – AUTHOR RESPONSE Reviewer 1: 1. This is a very interesting study protocol on the interventions in twin pregnancies with short cervix, for the prevention of preterm birth. In my opinion another control group without any intervention is necessary for the results to be reliable. This is the main disadvantage of the study protocol. RESPONSE: Thank you for your comment. While we appreciate that when interventions are introduced, they should be compared to no intervention or placebo, this has already been done in twins for both cervical pessary (Liem et al, 2013, Nicolaides et al 2016, Goya et al, 2016, n=2130 twins) and progesterone (Schuit et al, 2015, n=3768 twins). Our recent trial showed that pessary, in women with twin pregnancies and a short cervix, resulted in more favorable results compared to progesterone (Dang et al, 2019, n=300). In addition, recent small retrospective studies showed that cerclage could lower PTB rates and could improve neonatal outcomes (Adams et al, 2018 in J Matern Fetal Neonatal Med 31(8):1092-1098; Houlihan et al, 2016 in Ultrasound Obstet Gynecol 48(6):752-756; Fichera et al, 2019 in Acta Obstet Gynecol Scand 98(4):487-493). Thus, we choose to compare the two interventions directly to each other, with the idea that any of the two would be better than no intervention/placebo. The text has been updated in Discussion section to clarify this. It now reads “In this study, we choose to compare two interventions directly to each other. While we appreciate that when interventions are introduced, they should be compared to expectant management or placebo, this has already been done http://bmjopen.bmj.com/ in a large number of twins, for both cervical pessary (20, 21, 23) and progesterone (15). Our recent trial showed that compared to vaginal progesterone, the use of pessary in women with twin pregnancies and a short cervix improved neonatal outcomes. Moreover, in women with a CL ≤28mm (25th percentile of CL distribution), the rate of PTB <34 weeks reduced from 54.5% in the progesterone group to 24.2% in the pessary group (24). In addition, recent small retrospective studies showed that cerclage could lower PTB rates and could improve neonatal outcomes (30-32). These data suggest that any of the two treatments could reduce the risk of PTB and subsequent poor neonatal outcome. The aim of clinical research is not to directly prove in a purely scientific setting whether a treatment works over no on October 1, 2021 by guest. Protected copyright. treatment, but to show which is the best for patients. In view of the large differences that we found for pessary versus progesterone (24) and others found for pessary and progesterone against no treatment (15, 20, 21), we render it from an ethical point challenging to compare these treatments to expectant management or placebo. This approach can also be found in other ongoing trials (33, 34).”. Please see line 420-437, page 18-19 of the revised manuscript. 2. The cut off of 28 mm may be that of the 25th centile in the local population, but most of the studies so far used the cut off of 25 mm (the same as in singletons) and this is a problem for the studies to be comparable. RESPONSE: A cut off of 28 mm was chosen based on a pre-planned subgroup analysis of our previous RCT that reported that in patients with a CL 25th percentile (28 mm), the use of pessary was 3 BMJ Open: first published as 10.1136/bmjopen-2019-036587 on 16 June 2020.
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