Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

Placenta Previa Clinical Trial

Official title:

Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620724
• Other study ID #: 2005/065/HP
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2008
• Last updated: July 9, 2014
• Start date: January 2008
• Est. completion date: September 2012

Study information

• Verified date: July 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Placenta Previa

Intervention

Drug:
• Placebo
Placebo three times daily
• Nifedipine
20 mg of slow-release Nifedipine three times daily

Locations

Country	Name	City	State
France	University Hospital Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolongation of pregnancy		From allocation to the delivery	Yes
Secondary	Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required		At the end of the study	Yes