Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length

Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35249-7333, USA.
American journal of obstetrics and gynecology (Impact Factor: 4.7). 10/2009; 201(4):375.e1-8. DOI: 10.1016/j.ajog.2009.08.015
Source: PubMed


The objective of the study was to assess cerclage to prevent recurrent preterm birth in women with short cervix.
Women with prior spontaneous preterm birth less than 34 weeks were screened for short cervix and randomly assigned to cerclage if cervical length was less than 25 mm.
Of 1014 women screened, 302 were randomized; 42% of women not assigned and 32% of those assigned to cerclage delivered less than 35 weeks (P = .09). In planned analyses, birth less than 24 weeks (P = .03) and perinatal mortality (P = .046) were less frequent in the cerclage group. There was a significant interaction between cervical length and cerclage. Birth less than 35 weeks (P = .006) was reduced in the less than 15 mm stratum with a null effect in the 15-24 mm stratum.
In women with a prior spontaneous preterm birth less than 34 weeks and cervical length less than 25 mm, cerclage reduced previable birth and perinatal mortality but did not prevent birth less than 35 weeks, unless cervical length was less than 15 mm.

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Available from: Vincenzo Berghella, Nov 21, 2014
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    • "This international multicenter trial was performed at 12 centers and did not describe the specific surgical technique but stated that a video recording of the technique was made available to all participating centers and the obstetrician with the relevant expertise at each site performed the cerclage. Owen et al. [4] performed a randomized trial of McDonald cerclage for short cervix < 25 mm in patients with a history of prior spontaneous preterm birth and found that cerclage prevented preterm birth < 35 weeks of gestation in patients with cervical length < 15 mm. Cerclage heights were not measured in these randomized trials. "
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    ABSTRACT: Objective: The objective of this study was to compare modified Shirodkar cerclage to bed rest for treatment of the midtrimester extremely short cervix. Methods: This study used a concurrent retrospective cohort design at two institutions over the same period, 2000-2010. Patients were included at both institutions when midtrimester endovaginal ultrasound cervical length was ≤ 15 mm and had modified Shirodkar cerclage (cerclage group) at New York Hospital Queens and bed rest (control group) at Weill Cornell Medical Center. Cerclage was placed as high on the cervix as possible. Indomethacin and antibiotics were used perioperatively. Results: The cerclage group included 112 patients and the control group included 55 patients. Median postoperative cervical length in the cerclage group was 3.3 cm (interquartile range 3.0-3.6). Cerclage patients were less likely to deliver preterm at 37, 35, 32, and 28 weeks (P=0.0066, 0.0004, 0.0023, and 0.03 respectively) and had longer latency (median 120 vs. 94 days P<0.0001). Kaplan-Meier survival curve showed a significant benefit in favor of cerclage (P=0.0043). Conclusions: Our data suggest that modified Shirodkar cerclage as high as possible on the cervix with perioperative indomethacin and antibiotics is superior to bed rest for treatment of the midtrimester extremely short cervix (≤15 mm). We propose a randomized trial of this specific technique.
    Journal of Perinatal Medicine 08/2013; 42(1):1-5. DOI:10.1515/jpm-2013-0092 · 1.36 Impact Factor
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    • "This evidence is derived from a meta-analysis of randomized clinical trials of women with a short cervix determined by transvaginal sonography (performed before 24 weeks of gestation). Patients from fi ve trials, which compared cerclage with expectant management, contributed to this meta-analysis [2] [14] [124] [149] [163] . "
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    ABSTRACT: Abstract Preterm birth is the leading cause of perinatal morbidity and mortality worldwide, and is the most important challenge to modern obstetrics. A major obstacle has been that preterm birth is treated (implicitly or explicitly) as a single condition. Two thirds of preterm births occur after the spontaneous onset of labor, and the remaining one third after "indicated" preterm birth; however, the causes of spontaneous preterm labor and "indicated" preterm birth are different. Spontaneous preterm birth is a syndrome caused by multiple etiologies, one of which is a decline in progesterone action, which induces cervical ripening. A sonographic short cervix (identified in the midtrimester) is a powerful predictor of spontaneous preterm delivery. Randomized clinical trials and individual patient meta-analyses have shown that vaginal progesterone reduces the rate of preterm delivery at <33 weeks of gestation by 44%, along with the rate of admission to the neonatal intensive care unit, respiratory distress syndrome, requirement for mechanical ventilation, and composite neonatal morbidity/mortality score. There is no evidence that 17-α-hydroxyprogesterone caproate can reduce the rate of preterm delivery in women with a short cervix, and therefore, the compound of choice is natural progesterone (not the synthetic progestin). Routine assessment of the risk of preterm birth with cervical ultrasound coupled with vaginal progesterone for women with a short cervix is cost-effective, and the implementation of such a policy is urgently needed. Vaginal progesterone is as effective as cervical cerclage in reducing the rate of preterm delivery in women with a singleton gestation, history of preterm birth, and a short cervix (<25 mm).
    Journal of Perinatal Medicine 01/2013; 41(1):27-44. DOI:10.1515/jpm-2012-0272 · 1.36 Impact Factor
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    • "A recent multicenter randomized trial included 302 women with at least one prior PTB ≤32 weeks and TVU CL < 25 mm between 16 and 226/7 weeks randomized to either cerclage or no cerclage. PTB <35 weeks was similar in both groups, but the benefit was most pronounced when CL was <15 mm, suggesting the presence of a more significant, and treatable, component of cervical insufficiency [82]. The systematic meta-analysis by Berghella et al. has shown that Cerclage, when performed in women with a singleton gestation, previous preterm birth, and cervical length <25 mm, seems to have a similar effect regardless of the degree of cervical shortening, including CL 16–24 mm, as well as CL ≤ 5.9 mm [83]. "
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    ABSTRACT: Preterm delivery (PTD), defined as birth before 37 completed weeks of gestation, is the leading cause of perinatal morbidity and mortality. Evaluation of the cervical morphology and biometry with transvaginal ultrasonography at 16-24 weeks of gestation is a useful tool to predict the risk of preterm birth in low- and high-risk singleton pregnancies. For instance, a sonographic cervical length (CL) > 30 mm and present cervical gland area have a 96-97% negative predictive value for preterm delivery at <37 weeks. Available evidence supports the use of progesterone to women with cervical length ≤25 mm, irrespective of other risk factors. In women with prior spontaneous PTD with asymptomatic cervical shortening (CL ≤ 25 mm), prophylactic cerclage procedure must be performed and weekly to every two weeks follow-up is essential. This article reviews the evidence in support of the clinical introduction of transvaginal sonography for both the prediction and management of spontaneous preterm labour.
    Journal of pregnancy 02/2012; 2012(4):201628. DOI:10.1155/2012/201628
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