Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery - Tabular View

Tracking Information

First Received Date ^ICMJE

September 2, 2007

Last Updated Date

June 26, 2008

Start Date ^ICMJE

December 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00525486 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

Official Title ^ICMJE

Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Preterm Labor

Intervention ^ICMJE

Drug: Nifedipine extended release

Study Arms / Comparison Groups

Experimental: The treated group of pregnant women, after having successeful treatment for PTL
No Intervention: The no treatment arm of women treated with tocolysis for PTL.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

pregnancy week 24-33
Singleton pregnancy
Ater successeful treatment to stop PTL

Exclusion Criteria:

Contraindications for Nifedipine extended release treatment.

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00525486

Responsible Party

Study ID Numbers ^ICMJE

PTL prevention Nifedipine

Study Sponsor ^ICMJE

The Baruch Padeh Medical Center, Poriya

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yuri Perlitz, MD

The Baruch Padeh Medical Center, Poria, Israel.

Information Provided By

The Baruch Padeh Medical Center, Poriya

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP