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Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

This study has been terminated.
Sponsor:
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT00525486
First received: September 2, 2007
Last updated: December 22, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention
Preterm Labor
 Drug: Nifedipine extended release

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study

Resource links provided by NLM:

Drug Information available for: Nifedipine
U.S. FDA Resources

Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Study Start Date: December 2007
Arms Assigned Interventions
Experimental: A
The treated group of pregnant women, after having successful treatment for PTL
 Drug: Nifedipine extended release
Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation
Other Name: Osmo-Adalat 30 mg
No Intervention: B
The no treatment arm of women treated with tocolysis for PTL.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications for Nifedipine extended release treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525486

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
Principal Investigator: Yuri Perlitz, MD The Baruch Padeh Medical Center, Poria, Israel.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00525486     History of Changes
Other Study ID Numbers: PTL prevention Nifedipine
Study First Received: September 2, 2007
Last Updated: December 22, 2010
Health Authority: Israel:IRB Commission (local)

Keywords provided by The Baruch Padeh Medical Center, Poriya:
Nifedipine
Tocolysis
Maintenance
Preterm delivery
 extended release nifedipine
maintenance
PTL

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013