Official Title: “Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Ramdomized Double-Blinded Clinical Trial”

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 indomethatcin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then recieve 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 Type: Interventional

Study Design: Randomized, Double-Blind, Active Control, Parallel Assignment

Primary:

• Recurrent preterm labor within two weeks of randomization

Secondary:

• Birth weight, gestational age, delay of delivery, neonatal morbidities, maternal side effects, time to uterine quiescence

Inclusion Criteria::

• Singleton and twin gestations
• Intact amniotic membranes
• No contra-indications to tocolysis
• 24-34 weeks gestation by last menstrual period and/or ultrasound
• Documented cervical change, and regular painful uterine contactions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement Exclusion Criteria:-
• Ruptured amniotic membranes
• Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness)
• Non-reassuring fetal heart rate tracings
• Contra-indications to indomethacin or nifedipine
• Contra-indications to tocolysis

Lead Sponsor: Stanford University

Stanford University School of Medicine

Stanford California 94305 United States

Overall Clinical Trial Officials and Contacts

Deirdre Judith Lyell Principal Investigator Stanford University  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00486824

Study ID Number: 97873

ClinicalTrials.gov Identifier: NCT00486824

Health Authority: United States: Institutional Review Board