Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

This study is currently recruiting participants.
Verified September 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00620724
First received: January 28, 2008
Last updated: September 12, 2012
Last verified: September 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial

Resource links provided by NLM:


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 Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00620724     History of Changes
Other Study ID Numbers: 2005/065/HP
Study First Received: January 28, 2008
Last Updated: September 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on April 15, 2014