Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

This study has been terminated.

First Received: September 2, 2007 Last Updated: June 26, 2008 History of Changes

Sponsor:	The Baruch Padeh Medical Center, Poriya
Information provided by:	The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:	NCT00525486

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:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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
A: Experimental The treated group of pregnant women, after having successeful treatment for PTL	Drug: Nifedipine extended release Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation
B: No Intervention 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

Criteria

Inclusion Criteria:

pregnancy week 24-33
Singleton pregnancy
Ater successeful 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

Study ID Numbers:	PTL prevention Nifedipine
Study First Received:	September 2, 2007
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00525486 History of Changes
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:

Vasodilator Agents
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Obstetric Labor, Premature
Physiological Effects of Drugs
Obstetric Labor Complications
Calcium Channel Blockers
Reproductive Control Agents

Cardiovascular Agents
Nifedipine
Pharmacologic Actions
Membrane Transport Modulators
Tocolytic Agents
Therapeutic Uses
Premature Birth

ClinicalTrials.gov processed this record on November 09, 2009