Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00525486|
Recruitment Status : Terminated
First Posted : September 5, 2007
Last Update Posted : December 23, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Preterm Labor||Drug: Nifedipine extended release||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525486
|Principal Investigator:||Yuri Perlitz, MD||The Baruch Padeh Medical Center, Poria, Israel.|