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Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

Information source: University Hospital, Rouen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Placenta Previa

Intervention: Placebo (Drug); Nifedipine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University Hospital, Rouen

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Prolongation of pregnancy

Secondary outcome: Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

University Hospital Rouen, Rouen 76031, France
Additional Information

Starting date: January 2008
Last updated: July 9, 2014

Page last updated: August 23, 2015

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