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Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

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ClinicalTrials.gov Identifier: NCT00620724
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : July 10, 2014
Information provided by (Responsible Party):
University Hospital, Rouen

Brief 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.

Condition or disease Intervention/treatment Phase
Placenta Previa Drug: Placebo Drug: Nifedipine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial
Study Start Date : January 2008
Primary Completion Date : June 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: A
Placebo three times daily
Drug: Placebo
Placebo three times daily
Experimental: B
20 mg of slow-release Nifedipine three times daily
Drug: Nifedipine
20 mg of slow-release Nifedipine three times daily

Primary Outcome Measures :
  1. Prolongation of pregnancy [ Time Frame: From allocation to the delivery ]

Secondary Outcome Measures :
  1. Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required [ Time Frame: At the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620724

University Hospital Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00620724     History of Changes
Other Study ID Numbers: 2005/065/HP
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs