Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery
Information source: The Baruch Padeh Medical Center, Poriya
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preterm Labor
Intervention: Nifedipine extended release (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: The Baruch Padeh Medical Center, Poriya Official(s) and/or principal investigator(s):
Yuri Perlitz, MD, Principal Investigator, Affiliation: The Baruch Padeh Medical Center, Poria, Israel.
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.
Clinical Details
Official title: Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- pregnancy week 24-33
- Singleton pregnancy
- Ater successeful treatment to stop PTL
Exclusion Criteria:
- Contraindications for Nifedipine extended release treatment.
Locations and Contacts
Additional Information
Starting date: December 2007
Last updated: September 4, 2007
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