Clinical trial NCT00620724: Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa
Official title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Placenta Previa
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasonography
* Placenta previa may be symptomatic with at least one episode of bleeding
* Estimated gestational age within 24 to 34 weeks
* Maternal age \> 18 years
* Informed consent after received an explanation of the study and an information sheet
* Social affiliation

Exclusion Criteria:

* Premature rupture of membranes
* Severe bleeding requiring an immediate termination of pregnancy
* Abnormal fetal heart rates requiring an immediate termination of pregnancy
* Intrauterine fetal death
* Pre-eclampsia, chorioamnionitis, liver disease, severe chronic renal disease, heart disease
* Abruptio placentae
* Nifedipine sensibility
* Drugs interaction with nifedipine

Primary outcomes:
measure: Prolongation of pregnancy
timeFrame: From allocation to the delivery
Secondary outcomes:
measure: Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital Rouen
Study officials:
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
citation: Verspyck E, de Vienne C, Muszynski C, Bubenheim M, Chanavaz-Lacheray I, Dreyfus M, Deruelle P, Benichou J. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial. PLoS One. 2017 Mar 23;12(3):e0173717. doi: 10.1371/journal.pone.0173717. eCollection 2017.