Abstract

We appreciate the comments of Dr Kaur and colleagues1Roman A. Zork N. Haeri S. et al.Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial.Am J Obstet Gynecol. 2020; ([Epub ahead of print])Abstract Full Text Full Text PDF Scopus (11) Google Scholar regarding our recent publication entitled “Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial.” I agree with Dr Kaur that the AJOG at Glance section should have included the conclusion that the combination of cerclage, indomethacin, and antibiotics was associated with a significantly different perinatal outcome compared with the control. Those 2 therapies were not included in the original protocol. However, most obstetricians adopted the findings in the study of Miller et al.2Miller E.S. Grobman W.A. Fonseca L. Robinson B.K. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial.Obstet Gynecol. 2014; 123: 1311-1316Crossref PubMed Scopus (30) Google Scholar The analysis was that “intention-to-treat” 4 patients randomized to cerclage did not receive the surgical procedure; they were included in the cerclage group analysis. The demographic characteristics were not significantly different, mostly because of the small sample size, and a regression analysis was not required. We performed further subanalysis; despite the small sample size, some outcomes were still significantly different. Cerclage decreased perinatal mortality in women randomized before 20 weeks’ gestation (5 of 10 [50%] vs 16 of 16 [100%]; P<.01) and after 20 weeks’ gestation (1 of 24 [4.1%] vs 4 of 10 [40%]; P=.02). Most women had a cervical dilation of 2 cm (cerclage [n=9] and control [n=7]); gestational age [GA] at delivery was 30.6±5.8 vs 20.9±1.8 (P=.003); and latency from diagnosis to delivery was 10.4±5.4 vs 1.7±0.7 (P=.005). There was no significant difference in the GA at delivery or latency period when comparing progesterone with no progesterone in both groups. Control and indomethacin (n=4) vs control alone (n=9) was not different (P=.58). Cerclage, indomethacin, and antibiotic (n=14) compared with control and indomethacin (n=4) or control alone (n=9) remained significantly different (P<.001). The incidences of preterm premature rupture of membranes (PPROM) at <34 weeks’ gestation and clinical chorioamnionitis were similar in both groups. However, the GA at PPROM was significantly prolonged in the cerclage group: 28.4±5.6 vs 19.3±0.5 (P=.02), with a similar interval from PPROM to delivery (1–2 weeks). After 2 to 3 weeks of cervical dilation and amniotic membrane exposure to the vaginal bacteria, it is not surprising to identify a higher incidence of histologic chorioamnionitis in the control group. The question remains if infection and inflammation are the cause or the effect of a dilated cervix and preterm birth (PTB). Only 1 woman had an intraoperative complication; the surgeon was unable to place the cerclage because of a friable cervix: 1 of 14 (7.1%) of attempted procedures. No serious adverse event was noted. The incidence of intraoperative complications is similar to previous publications in singleton pregnancies.3Ehsanipoor R.M. Seligman N.S. Saccone G. et al.Physical examination-indicated cerclage: a systematic review and meta-analysis.Obstet Gynecol. 2015; 126: 125-135Crossref PubMed Scopus (57) Google Scholar When counseling a patient, we should discuss: 10-15% of intraoperative complications, with 40% risk of preterm birth (PTB) <28 weeks, and 17.6% risk of perinatal mortality in the cerclage, indomethacin and antibiotic group vs 85% risk of PTB <28 weeks with associated neonatal complications and 77% risk of perinatal mortality in the expectant management group. Similar to the outcomes in singleton pregnancies, physical examination-indicated cerclage in twin pregnancy may not be effective on every patient.4Miller E.S. Rajan P.V. Grobman W.A. Outcomes after physical examination-indicated cerclage in twin gestations.Am J Obstet Gynecol. 2014; 211: 46.e1-46.e5Abstract Full Text Full Text PDF Scopus (30) Google Scholar The selection of the best candidate for this procedure is still difficult. More studies are needed on twin pregnancies with a dilated cervix at <24 weeks’ gestation, single or combined therapeutic options, inflammation, and infection. Physical examination–indicated cerclage in twin pregnancy: a randomized controlled trialAmerican Journal of Obstetrics & GynecologyVol. 224Issue 1PreviewWe read with great interest the study entitled “Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial” by Roman et al.1 We appreciate the authors for conducting a randomized controlled trial (RCT) on this rare yet enigmatic aspect of twin pregnancy and asymptomatic cervical dilation. However, we wish to make certain observations that will further help in comprehending the results of the study. Full-Text PDF

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