Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery
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...
Brief Summary
Official Title: “Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Nifedipine extended release
- Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A
- The treated group of pregnant women, after having successful treatment for PTL
- No Intervention: B
- The no treatment arm of women treated with tocolysis for PTL.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- pregnancy week 24-33
- Singleton pregnancy
- After successful treatment to stop PTL
Exclusion Criteria:
- Contraindications for Nifedipine extended release treatment.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: The Baruch Padeh Medical Center, Poriya Other
Overall Clinical Trial Officials and Contacts
Yuri Perlitz, MD Principal Investigator The Baruch Padeh Medical Center, Poria, Israel.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00525486
Study ID Number: PTL prevention Nifedipine
ClinicalTrials.gov Identifier: NCT00525486
Health Authority: Israel:IRB Commission (local)
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00525486
