NCT00620724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

4.4 years

First QC Date

January 28, 2008

Last Update Submit

July 9, 2014

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

  • Prolongation of pregnancy

    From allocation to the delivery

Secondary Outcomes (1)

  • Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required

    At the end of the study

Study Arms (2)

A

PLACEBO COMPARATOR

Placebo three times daily

Drug: Placebo

B

EXPERIMENTAL

20 mg of slow-release Nifedipine three times daily

Drug: Nifedipine

Interventions

PlaceboDRUG

Placebo three times daily

A
NifedipineDRUG

20 mg of slow-release Nifedipine three times daily

B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rouen

Rouen, 76031, France

Location

Related Publications (3)

  • Verspyck E, Thill C, Ego A, Machevin E, Brasseur-Daudruy M, Ickowicz V, Blondel C, Degre S, Lefebure A, Braund S, Benichou J. Screening for small for gestational age infants in early vs late third-trimester ultrasonography: a randomized trial. Am J Obstet Gynecol MFM. 2023 Nov;5(11):101162. doi: 10.1016/j.ajogmf.2023.101162. Epub 2023 Sep 15.

    PMID: 37717697DERIVED

  • Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

    PMID: 35947046DERIVED

  • Verspyck E, de Vienne C, Muszynski C, Bubenheim M, Chanavaz-Lacheray I, Dreyfus M, Deruelle P, Benichou J. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial. PLoS One. 2017 Mar 23;12(3):e0173717. doi: 10.1371/journal.pone.0173717. eCollection 2017.

    PMID: 28333939DERIVED

MeSH Terms

Conditions

Placenta Previa

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 21, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

FR(1)