Randomised trial of cervical cerclage, with and without occlusion, for the prevention of preterm birth in women suspected for cervical insufficiency
ABSTRACT OBJECTIVE: To evaluate the effect of cerclage, with and without cervical occlusion. DESIGN: Multicentre, stratified, randomised controlled trial. SETTING: Hospital-based multicentre study with 18 tertiary centres from nine countries. POPULATION: Women with a history of cervical insufficiency (prophylactic trial) and women with a short cervix (therapeutic trial) were recruited from August 2006 to August 2011. METHODS: A centralised telephone randomisation service with a computer system was used to randomise women to cervical cerclage with or without cervical occlusion. Only the analyst performing the interim analyses was blinded. MAIN OUTCOME MEASURES: The take-home baby rate (number of infants discharged alive from the hospital), gestational age at delivery, and the number of days in the neonatal intensive care unit (NICU). RESULTS: Women (n = 309) were stratified into the prophylactic trial (n = 213) or the therapeutic trial (n = 96). The trial stopped early due to slow recruitment and an interim analysis showing no benefit of occlusion. Final analysis comprised 197 women in the prophylactic trial and 87 women in the therapeutic trial. No added effect of cervical occlusion was found in terms of the take-home baby rate in the prophylactic trial (92 versus 90%, RR 1.03, 95% CI 0.94-1.12) or in the therapeutic trial (81 versus 85%, RR 0.96, 95% CI 0.79-1.16). No effect of cervical occlusion was found in terms of gestational age at delivery and number of days the neonate spent in the NICU. Cervical occlusion was associated with no harm. CONCLUSIONS: Cervical occlusion with cerclage had no significant additional effect.
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ABSTRACT: Cervical cerclage is a common obstetric procedure, performed in an attempt to reduce the likelihood of late miscarriage and preterm delivery. Many questions still remain unanswered, however, regarding its efficacy and the populations most likely to benefit. Existing studies often use endpoints such as preterm delivery, but associations between preterm birth and more long-term health effects such as neurodevelopmental sequelae are well reported. Such endpoints have often not been addressed in many of the studies to date. This article reviews and appraises the literature and evidence regarding cervical cerclage as well as addressing the questions that, as yet, remain unanswered.European journal of obstetrics, gynecology, and reproductive biology 05/2014; 176. DOI:10.1016/j.ejogrb.2014.01.013 · 1.63 Impact Factor
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ABSTRACT: In spite of the continuous progress in prenatal care, 1 out of 10 babies is born too early - tendency rising worldwide. As a consequence of the heterogeneous aetiology of preterm birth, there is still no single and efficient interventional therapy. Cerclage is one option for pregnancies with cervical insufficiency, whereas the clinical benefit is discussed controversially. We analyzed in a retrospective study with 120 patients the effect of a cerclage intervention regarding pregnancy prolongation. Patients with cervical incompetence and Shirodkar cerclage were compared to those undergoing conservative treatment. As expected, gestational age at delivery was significantly lower after emergency cerclage (31 weeks) compared to prophylactic (36 weeks) and therapeutic cerclage (35 weeks). Prolongation differs significantly between the prophylactic (18 weeks), therapeutic (14 weeks) and emergency cerclage (10 weeks) groups. Conservative management achieved 8 weeks prolongation. Of note, particularly emergency cerclage in cases with advanced cervical incompetence resulted in a substantially higher pregnancy prolonga-tion (10 weeks) compared to no intervention (one week). The efficiency of cerclage operations has to be assessed in a differentiated manner based on the clinical situation and indication. The clinical benefit depends strongly on proper patient selection.Zeitschrift für Geburtshilfe und Neonatologie 08/2014; 218(4):165-70. DOI:10.1055/s-0034-1382070 · 0.46 Impact Factor
- BJOG An International Journal of Obstetrics & Gynaecology 08/2014; 121(9). DOI:10.1111/1471-0528.12582 · 3.86 Impact Factor