Prophylactic oral nifedipine to reduce preterm delivery: a randomized controlled trial in women at high risk.
OBJECTIVE
To establish the efficacy of prophylactic nifedipine vs. placebo in reducing spontaneous preterm delivery in asymptomatic women at high risk for preterm delivery.


METHODS
Prospective multicentric randomized double-blind study.


METHODS
Tertiary care centre, University Hospitals of Brescia and Torino, Italy.


METHODS
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.


METHODS
Primary end point: spontaneous preterm delivery <37 weeks in nifedipine vs. placebo.


RESULTS
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.
Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
Luana
L
Danti
Marina
M
Zonca
Lorena
L
Barbetti
Andrea
A
Lojacono
Silvia
S
Marini
Nazario
N
Cappello
Umberto
U
Bianchi
Chiara
C
Benedetto
D000284:Administration, Oral; D000328:Adult; D058070:Asymptomatic Diseases; D054791:Cervical Length Measurement; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D009543:Nifedipine / Q000627:therapeutic use*; D011247:Pregnancy; D018566:Pregnancy, High-Risk; D047928:Premature Birth / Q000000981:diagnostic imaging / Q000517:prevention & control*; D011446:Prospective Studies; D018570:Risk Assessment; D015149:Tocolytic Agents / Q000627:therapeutic use*; D016896:Treatment Outcome
D015149:Tocolytic Agents; D009543:Nifedipine
Prophylactic nifedipine; asymptomatic pregnant women; high-risk pregnancy; preterm delivery; ultrasonographic cervical length