Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective.
Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial|
- Recurrent preterm labor within two weeks of randomization [ Time Frame: Two weeks after enrolled and randomized ] [ Designated as safety issue: No ]
- Birth weight, gestational age, delay of delivery, neonatal morbidities, maternal side effects, time to uterine quiescence [ Time Frame: Discharge of mother and neonate ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Indomethacin
50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.
One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs.
Active Comparator: Nifedipine
30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.
Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.
|Contact: Deirdre J Lyell, MD||(650) firstname.lastname@example.org|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Deirdre J Lyell, MD 650-736-1191 email@example.com|
|Contact: Yair Blumenfeld, MD (650) 269-4665 firstname.lastname@example.org|
|Principal Investigator: Deirdre Judith Lyell|
|Principal Investigator:||Deirdre Judith Lyell||Stanford University|