Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa
Information source: University Hospital, Rouen
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Placenta Previa
Intervention: Placebo (Drug); Nifedipine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Hospital, Rouen Overall contact:
Verspyck Eric, MD, PhD, Phone: 331232888745, Email: eric.verspyck@chu-rouen.fr
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.
Clinical Details
Official title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Prolongation of pregnancy
Secondary outcome: Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Verspyck Eric, MD, PhD, Phone: 331232888745, Email: eric.verspyck@chu-rouen.fr
University Hospital Rouen, Rouen 76031, France; Recruiting
Verspyck VE Eric, Pr, Phone: 0232888990, Email: eric.verspyck@chu-rouen.fr
Additional Information
Starting date: January 2008
Last updated: September 12, 2012
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