Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

Not Applicable

Terminated

• Conditions: Preterm Labor
• Interventions: Drug: Nifedipine extended release

• Registration Number: NCT00525486
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-02
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Study Start: 2007-12
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-22
• Last Update Posted: 2010-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Contraindications for Nifedipine extended release treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Nifedipine extended release	The treated group of pregnant women, after having successful treatment for PTL