- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00620724
Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Rouen, France, 76031
- University Hospital Rouen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: A
Placebo three times daily
|
Placebo three times daily
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EXPERIMENTAL: B
20 mg of slow-release Nifedipine three times daily
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20 mg of slow-release Nifedipine three times daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prolongation of pregnancy
Time Frame: From allocation to the delivery
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From allocation to the delivery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required
Time Frame: At the end of the study
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At the end of the study
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Obstetric Labor Complications
- Placenta Diseases
- Placenta Previa
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Nifedipine
Other Study ID Numbers
- 2005/065/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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