NCT00525486

Brief Summary

To evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the treatment group and the control (no treatment) group. The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.

Trial Health

10
At Risk

Trial Health Score

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

Status
terminated

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
Last Updated

December 23, 2010

Status Verified

December 1, 2010

First QC Date

September 2, 2007

Last Update Submit

December 22, 2010

Conditions

Preterm Labor

Keywords

NifedipineTocolysisMaintenancePreterm deliveryextended release nifedipinePTL

Study Arms (2)

A

EXPERIMENTAL

The treated group of pregnant women, after having successful treatment for PTL

Drug: Nifedipine extended release

B

NO INTERVENTION

The no treatment arm of women treated with tocolysis for PTL.

Interventions

Nifedipine extended releaseDRUG

Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation

Also known as: Osmo-Adalat 30 mg
A

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnancy week 24-33
  • Singleton pregnancy
  • After successful treatment to stop PTL

You may not qualify if:

  • Contraindications for Nifedipine extended release treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Yuri Perlitz, MD

    The Baruch Padeh Medical Center, Poria, Israel.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 2, 2007

First Posted

September 5, 2007

Study Start

December 1, 2007

Last Updated

December 23, 2010

Record last verified: 2010-12