Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

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

Study Description

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 Design

• 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
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: September 2012

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

France

University Hospital Rouen

Rouen, France, 76031

Sponsors and Collaborators

University Hospital, Rouen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Verspyck E, de Vienne C, Muszynski C, Bubenheim M, Chanavaz-Lacheray I, Dreyfus M, Deruelle P, Benichou J. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial. PLoS One. 2017 Mar 23;12(3):e0173717. doi: 10.1371/journal.pone.0173717. eCollection 2017.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT00620724
• Other Study ID Numbers: 2005/065/HP
• First Posted: February 21, 2008
• Last Update Posted: July 10, 2014
• Last Verified: July 2014

Additional relevant MeSH terms:

Nifedipine; Placenta Previa; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Tocolytic Agents; Reproductive Control Agents