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Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa
This study is currently recruiting participants.
Verified by University Hospital, Rouen, February 2008
Sponsored by: University Hospital, Rouen
Information provided by: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00620724
  Purpose

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 Intervention Phase
Placenta Previa
Drug: Placebo
Drug: Nifedipine
Phase II

Drug Information available for: Nifedipine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Prolongation of pregnancy [ Time Frame: From allocation to the delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: January 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator
Placebo three times daily
Drug: Placebo
Placebo three times daily
B: Experimental
20 mg of slow-release Nifedipine three times daily
Drug: Nifedipine
20 mg of slow-release Nifedipine three times daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620724

Contacts
Contact: Verspyck Eric, MD, PhD 331232888745 eric.verspyck@chu-rouen.fr

Locations
France
University Hospital Rouen Recruiting
Rouen, France, 76031
Contact: Verspyck VE Eric, Pr     0232888990     eric.verspyck@chu-rouen.fr    
Sponsors and Collaborators
University Hospital, Rouen
  More Information

Responsible Party: CHU Rouen ( Verspyck Eric, MD, PhD )
Study ID Numbers: 2005/065/HP
Study First Received: January 28, 2008
Last Updated: February 8, 2008
ClinicalTrials.gov Identifier: NCT00620724  
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Calcium, Dietary
Pregnancy Complications
Obstetric Labor Complications
Placenta Previa
Nifedipine

Additional relevant MeSH terms:
Membrane Transport Modulators
Placenta Diseases
Vasodilator Agents
Tocolytic Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Calcium Channel Blockers
Reproductive Control Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009