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

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 successeful treatment for PTL
• No Intervention: B
  • The no treatment arm of women treated with tocolysis for PTL.

Inclusion Criteria:

• pregnancy week 24-33
• Singleton pregnancy
• Ater successeful 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

Lead Sponsor: The Baruch Padeh Medical Center, Poriya

Overall Clinical Trial Officials and Contacts

Yuri Perlitz, MD Principal Investigator The Baruch Padeh Medical Center, Poria, Israel.  

Information obtained from ClinicalTrials.gov on September 05, 2008

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)