Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

• Sponsor: University Hospital, Rouen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00620724
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Arms: 2
• Duration (Months): 56
• Patients Per Site Per Month: 1.9

Study Details

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
• 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: Jan 1, 2008
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Sep 1, 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 [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 [At the end of the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	University Hospital Rouen	Rouen		France	76031

Sponsors and Collaborators

• University Hospital, Rouen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT00620724
• Other Study ID Numbers: 2005/065/HP
• First Posted: Feb 21, 2008
• Last Update Posted: Jul 10, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Placenta Previa; Nifedipine

Study Results

No Results Posted as of Jul 10, 2014