Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

University Hospital, Rouen

Status and phase: Completed; Phase 2

Conditions: Placenta Previa

Treatments: Drug: Nifedipine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00620724

2005/065/HP

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Placebo three times daily

Treatment:

Drug: Placebo

B

Experimental group

Description:

20 mg of slow-release Nifedipine three times daily

Treatment:

Drug: Nifedipine