Placenta Previa Clinical Trial
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.
Status | Completed |
Enrollment | 109 |
Est. completion date | September 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | University Hospital Rouen | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prolongation of pregnancy | From allocation to the delivery | Yes | |
Secondary | Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required | At the end of the study | Yes |
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