Prophylactic oral nifedipine to reduce preterm delivery: a randomized controlled trial in women at high risk. (20th June 2014)

• Record Type: Journal Article
• Authors: Danti, Luana; Zonca, Marina; Barbetti, Lorena; Lojacono, Andrea; Marini, Silvia; Cappello, Nazario; Bianchi, Umberto; Benedetto, Chiara
• Is Part Of: Acta obstetricia et gynecologica Scandinavica. Volume 93:Number 8(2014)
• Page Start: 802
• Page End: 808
• Publication Date: 2014-06-20
• Subjects: Gynecology -- Periodicals; Pregnancy -- Periodicals; Obstetrics -- Periodicals; 618.05
• DOI: 10.1111/aogs.12405
• Languages: English
• ISSNs: 0001-6349

Abstract

<abstract abstract-type="main" id="aogs12405-abs-0001"> <title>Abstract</title> <sec id="aogs12405-sec-0001" sec-type="section"> <title>Objective</title> <p>To establish the efficacy of prophylactic nifedipine vs. placebo in reducing spontaneous preterm delivery in asymptomatic women at high risk for preterm delivery.</p> </sec> <sec id="aogs12405-sec-0002" sec-type="section"> <title>Design</title> <p>Prospective multicentric randomized double‐blind study.</p> </sec> <sec id="aogs12405-sec-0003" sec-type="section"> <title>Setting</title> <p>Tertiary care centre, University Hospitals of Brescia and Torino, Italy.</p> </sec> <sec id="aogs12405-sec-0004" sec-type="section"> <title>Population</title> <p>Eighty‐seven singleton pregnancies without uterine contractions and ultrasonographic cervical length of ≤25 mm at 24–32 weeks, at risk for preterm delivery, with longitudinal follow up in our Preterm Prevention Clinic.</p> </sec> <sec id="aogs12405-sec-0005" sec-type="section"> <title>Methods</title> <p>Selection was done on the basis of ultrasonographic cervical length; 43 women were randomized to receive placebo and 44 to receive nifedipine.</p> </sec> <sec id="aogs12405-sec-0006" sec-type="section"> <title>Main outcome measures</title> <p>Primary end point: spontaneous preterm delivery <37 weeks in nifedipine vs. placebo. Secondary outcomes: delivery <32 weeks, maternal side effects, neonatal complications, admissions to the Neonatal Intensive Care Unit and randomization/delivery time in nifedipine vs. placebo.</p> </sec> <sec id="aogs12405-sec-0007" sec-type="section"> <title>Results</title> <p>There was no trend towards a lower risk of spontaneous preterm delivery, neither at <37 weeks of nifedipine vs. placebo (11.4% vs. 19.0%; <italic>p</italic> = 0.320), or <32 weeks (2.3% vs. 2.4%; <italic>p</italic> = 0.973). Nifedipine reduced spontaneous preterm delivery <37 weeks (<italic>p</italic> = 0.015) in the multiparous women by stratified analysis for parity. Secondary outcomes between the groups did not differ except for a higher percentage of maternal side‐effects in the nifedipine group (31.8%) vs. placebo (11.9%) (<italic>p</italic> < 0.05). Subgroup analysis showed a borderline (<italic>p</italic> = 0.047) lower percentage of spontaneous preterm delivery in women with a ultrasonographic cervical length of <20 mm in the nifedipine group.</p> </sec> <sec id="aogs12405-sec-0008" sec-type="section"> <title>Conclusions</title> <p>Prophylactic nifedipine in asymptomatic women at high risk for preterm delivery had a positive effect on the rate of spontaneous preterm delivery <37 weeks in multiparous women.</p> </sec> </abstract>