Open AccessProphylactic oral nifedipine to reduce preterm delivery: a randomized controlled trial in women at high risk
Author(s) -
Danti Luana,
Zonca Marina,
Barbetti Lorena,
Lojacono Andrea,
Marini Silvia,
Cappello Nazario,
Bianchi Umberto,
Benedetto Chiara
Publication year - 2014
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1111/aogs.12405
Subject(s) - medicine , nifedipine , placebo , randomization , randomized controlled trial , population , neonatal intensive care unit , relative risk , anesthesia , obstetrics , pediatrics , surgery , confidence interval , alternative medicine , environmental health , pathology , calcium
Objective To establish the efficacy of prophylactic nifedipine vs. placebo in reducing spontaneous preterm delivery in asymptomatic women at high risk for preterm delivery. Design Prospective multicentric randomized double‐blind study. Setting Tertiary care centre, University Hospitals of Brescia and Torino, Italy. Population 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. Methods Selection was done on the basis of ultrasonographic cervical length; 43 women were randomized to receive placebo and 44 to receive nifedipine. Main outcome measures 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. Results 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%; p = 0.320), or <32 weeks (2.3% vs. 2.4%; p = 0.973). Nifedipine reduced spontaneous preterm delivery <37 weeks ( p = 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%) ( p < 0.05). Subgroup analysis showed a borderline ( p = 0.047) lower percentage of spontaneous preterm delivery in women with a ultrasonographic cervical length of <20 mm in the nifedipine group. Conclusions 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.