Official Title: “Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Placebo three times daily
• Drug: Nifedipine
  • 20 mg of slow-release Nifedipine three times daily

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
  • Placebo three times daily
• Experimental: B
  • 20 mg of slow-release Nifedipine three times daily

Primary Measures

• Prolongation of pregnancy
  • Time Frame: From allocation to the delivery
    Safety Issue?: Yes

Secondary Measures

• Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required
  • Time Frame: At the end of the study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital, Rouen

Overall Clinical Trial Officials and Contacts

Overall Contact: Verspyck Eric, MD, PhD 331232888745 eric.verspyck@chu-rouen.fr

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620724

Study ID Number: 2005/065/HP

ClinicalTrials.gov Identifier: NCT00620724

Health Authority: France: Afssaps - French Health Products Safety Agency