Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
The objective of our study is to determine the clinical utility related to the maintenance
oral nifedipine therapy in patients with symptomatic placenta previa. This study is a
prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of
hospitalized patients with symptomatic placenta praevia. All patients may initially receive
oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are
randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one
every 8 hours) until 37 weeks of gestation.
The primary outcome for the trial is the length of pregnancy in days after the enrollment. A
sample size calculation is designed to detect at least a 14 -day difference in time gained in
patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per
group would have a 80 % chance of detecting this difference at the 5 % level of significance.