Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: A secondary analysis from a randomized, double-blind, placebo-controlled trial

Department of Obstetrics and Gynaecology (2. LF), Charles University in Prague, Praha, Praha, Czech Republic
Ultrasound in Obstetrics and Gynecology (Impact Factor: 3.85). 10/2007; 30(5):697-705. DOI: 10.1002/uog.5159
Source: PubMed


To investigate the efficacy of vaginal progesterone to prevent early preterm birth in women with sonographic evidence of a short cervical length in the midtrimester.
This was a planned, but modified, secondary analysis of our multinational, multicenter, randomized, placebo-controlled trial, in which women were randomized between 18 + 0 and 22 + 6 weeks of gestation to receive daily treatment with 90 mg of vaginal progesterone gel or placebo. Cervical length was measured with transvaginal ultrasound at enrollment and at 28 weeks of gestation. Treatment continued until either delivery, 37 weeks of gestation or development of preterm rupture of membranes. Maternal and neonatal outcomes were evaluated for the subset of all randomized women with cervical length < 28 mm at enrollment. The primary outcome was preterm birth at </= 32 weeks.
A cervical length < 28 mm was identified in 46 randomized women: 19 of 313 who received progesterone and 27 of 307 who received the placebo. Baseline characteristics of the two groups were similar. In women with a cervical length < 28 mm, the rate of preterm birth at </= 32 weeks was significantly lower for those receiving progesterone than it was for those receiving the placebo (0% vs. 29.6%, P = 0.014). With progesterone, there were fewer admissions into the neonatal intensive care unit (NICU; 15.8% vs. 51.9%, P = 0.016) and shorter NICU stays (1.1 vs. 16.5 days, P = 0.013). There was also a trend toward a decreased rate of neonatal respiratory distress syndrome (5.3% vs. 29.6%, P = 0.060).
Vaginal progesterone may reduce the rate of early preterm birth and improve neonatal outcome in women with a short sonographic cervical length.

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Available from: Pavel Calda
    • "Ultrasonic cervical length has been the standard measure used to identify cervical insufficiency and to identify women who should receive preventive progestogen therapy to prevent preterm birth (Cahill et al. 2010; Campbell 2011; Romero et al. 2013; Werner et al. 2011). Progestogen therapy has been promising in preventing preterm birth in women with cervical shortening or a history of preterm birth (DeFranco et al. 2007; Fonseca et al. 2007), although the mechanisms underlying its prevention of preterm birth are poorly understood (Nold et al. 2013). Cervical length assessment has become a widely used clinical measure for identifying women at high risk for preterm birth; however, it has low positive predictive value in low-risk women because the majority of individuals identified with a short cervix still deliver at term (Berghella et al. 2009; Romero et al. 2013). "
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    ABSTRACT: The purpose of this study was to determine whether cervical ultrasonic attenuation could identify women at risk of spontaneous preterm birth. During pregnancy, women (n = 67) underwent from one to five transvaginal ultrasonic examinations to estimate cervical ultrasonic attenuation and cervical length. Ultrasonic data were obtained with a Zonare ultrasound system with a 5- to 9-MHz endovaginal transducer and processed offline. Cervical ultrasonic attenuation was lower at 17-21 wk of gestation in the SPTB group (1.02 dB/cm-MHz) than in the full-term birth groups (1.34 dB/cm-MHz) (p = 0.04). Cervical length was shorter (3.16 cm) at 22-26 wk in the SPTB group than in the women delivering full term (3.68 cm) (p = 0.004); cervical attenuation was not significantly different at this time point. These findings suggest that low attenuation may be an additional early cervical marker to identify women at risk for SPTB. Copyright © 2015 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.
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    • "Progestational agents such as progesterone and 17-hydroxyprogesterone caproate (17P) have been shown to reduce the rate of PTB in women with certain risk factors for PTB, including women with a history of a prior PTB [10-12], women with a short cervix [13-15], or women who have had an acute episode of preterm labor successfully suppressed after tocolysis [16,17]. It is unknown whether 17P or other progestins might be beneficial after PROM. "
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    ABSTRACT: Progestational agents may reduce the risk of preterm birth in women with various risk factors. We sought to test the hypothesis that a weekly dose of 17-hydroxyprogesterone caproate (17P) given to women with preterm rupture of the membranes (PROM) will prolong pregnancy and thereby reduce neonatal morbidity. Double-blind, placebo-controlled randomized clinical trial. Women with PROM at 23.0 to 31.9 weeks of gestation were randomly assigned to receive a weekly intramuscular injection of 17P (250 mg in 1 mL castor oil) or placebo (1 mL castor oil). The primary outcome was the rate of continuing the pregnancy until 34.0 weeks of gestation or until documentation of fetal lung maturity at 32.0 to 33.9 weeks of gestation. Planned secondary outcomes were duration of latency period and rate of composite neonatal morbidity. Enrollment of 111 participants per group, 222 total, was planned to yield 80% power to detect an increase in the primary outcome from 30% with placebo to 50% with 17P. Twelve women were enrolled of whom 4 were randomly assigned to receive 17P and 8 to receive placebo. The trial was terminated prematurely because of two separate issues related to the supply of 17P. No adverse events attributable to 17P were identified. Because of premature termination, the trial does not have adequate statistical power to evaluate efficacy or safety of 17P in women with PROM. Nonetheless, ethical principles dictate that we report the results, which may contribute to possible future metaanalyses and systematic reviews. NCT01119963Supported by a research grant from the Center for Research, Education, and Quality, Pediatrix Medical Group, Sunrise, FL.
    Full-text · Article · Dec 2011 · BMC Research Notes
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