Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa - Full Text View

Sponsor:	University Hospital, Rouen
Information provided by (Responsible Party):	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

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:

Drug Information available for: Nifedipine

U.S. FDA Resources

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:	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:	October 5, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

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 February 09, 2012