Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

Study Overview
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Brief Summary
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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.

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

Conditions
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Placenta Previa

Intervention / Treatment
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* Drug: Placebo
* Drug: Nifedipine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Placebo three times daily | Drug: Placebo<br>* Placebo three times daily<br>|
| Experimental: B<br>20 mg of slow-release Nifedipine three times daily | Drug: Nifedipine<br>* 20 mg of slow-release Nifedipine three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolongation of pregnancy |  | From allocation to the delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required |  | At the end of the study |