Status:

COMPLETED

Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

Lead Sponsor:

University Hospital, Rouen

Conditions:

Placenta Previa

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2012

Estimated Enrollment :

109 Patients enrolled

Trial Details

Trial ID

NCT00620724

Start Date

January 1 2008

End Date

September 1 2012

Last Update

July 10 2014

Active Locations (1)

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1

University Hospital Rouen

Rouen, France, 76031

Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa | DecenTrialz