Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

July 9, 2014 updated by: University Hospital, Rouen

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rouen, France, 76031
        • University Hospital Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
EXPERIMENTAL: B
20 mg of slow-release Nifedipine three times daily
20 mg of slow-release Nifedipine three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prolongation of pregnancy
Time Frame: From allocation to the delivery
From allocation to the delivery

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
At the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (ESTIMATE)

February 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

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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