Randomised trial of cervical cerclage, with and without occlusion, for the prevention of preterm birth in women suspected for cervical insufficiency

Department of Paediatrics, Aarhus University Hospital, Skejby, Denmark.
BJOG An International Journal of Obstetrics & Gynaecology (Impact Factor: 3.45). 01/2013; 120(5). DOI: 10.1111/1471-0528.12119
Source: PubMed


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.

1 Follower
12 Reads
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The objective was to review the evidence supporting various perioperative technical and management strategies for transvaginal cervical cerclage. We performed MEDLINE, PubMed, EMBASE, and COCHRANE searches with the terms, cerclage, cervical cerclage, cervical insufficiency, and randomized trials, plus each technical aspect (eg, suture, amniocentesis, etc) considered. The search spanned 1966 through September 2012 and was not restricted by language. Each retrieved manuscript was carefully evaluated, and any pertinent references from the reports were also obtained and reviewed. All randomized trials covering surgical and selected perioperative, nonsurgical aspects of cerclage were included in the review. The evidence was assessed separately for history-, ultrasound-, and physical examination-indicated cerclage. Evidence levels according to the new method outlined by the US Preventive Services Task Force were assigned based on the evidence. There are no grade A high-certainty recommendations regarding technical aspects of transvaginal cervical cerclage. Grade B moderate-certainty recommendations include performing a fetal ultrasound before cerclage to ensure fetal viability, confirm gestational age, and assess fetal anatomy to rule out clinically significant structural abnormalities; administering spinal, and not general, anesthesia; performing a McDonald cerclage, with 1 stitch, placed as high as possible; and outpatient setting. Unfortunately, no other recommendations can be made regarding the other technical aspects of cerclage.
    Full-text · Article · Feb 2013 · American journal of obstetrics and gynecology
  • [Show abstract] [Hide abstract]
    ABSTRACT: Mid-trimester pregnancy loss (MTL) occurs between 12 and 24 weeks' gestation. The true incidence of this pregnancy complication is unknown, because research into MTL in isolation is scarce, although the estimated incidence has been noted to be 2% to 3% of pregnancies. A comprehensive preconceptual screening protocol is recommended, because the cause for an MTL may be present in isolation or combined (dual pathology), and is often heterogeneous. Patients with a history of MTL are at an increased risk of future miscarriage and preterm delivery. This risk is increased further depending on the number of associative factors diagnosed.
    No preview · Article · Mar 2014 · Obstetrics and Gynecology Clinics of North America
  • [Show abstract] [Hide abstract]
    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.
    No preview · Article · May 2014 · European journal of obstetrics, gynecology, and reproductive biology
Show more