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 secondary outcome will be the side effects of the medication and the newborn/mother health variables.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study|
|Study Start Date:||December 2007|
The treated group of pregnant women, after having successful treatment for PTL
Drug: Nifedipine extended release
Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation
Other Name: Osmo-Adalat 30 mg
No Intervention: B
The no treatment arm of women treated with tocolysis for PTL.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525486
|Principal Investigator:||Yuri Perlitz, MD||The Baruch Padeh Medical Center, Poria, Israel.|