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NCT Number: NCT00620724

Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

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.

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Key information

Conditions

Placenta Previa Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Rouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo three times daily

nifedipine

Drug

20 mg of slow-release Nifedipine three times daily

Primary outcomes

  1. Prolongation of pregnancy

    Time frame: From allocation to the delivery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 21, 2008
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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