Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
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|ClinicalTrials.gov Identifier: NCT00486824|
Recruitment Status : Completed
First Posted : June 15, 2007
Results First Posted : October 1, 2018
Last Update Posted : October 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstetric Labor, Premature||Drug: Indomethacin Drug: Nifedipine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial|
|Actual Study Start Date :||April 2007|
|Actual Primary Completion Date :||December 8, 2012|
|Actual Study Completion Date :||December 8, 2012|
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 20 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.
- Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization [ Time Frame: Two weeks after enrolled and randomized, up to 37 weeks of pregnancy ]Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy.
- Neonatal Birthweight [ Time Frame: Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery ]Birthweight is presented in grams
- Gestational Age at Delivery [ Time Frame: Up to 42 weeks of pregnancy ]
- Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery [ Time Frame: Up to 42 weeks of pregnancy ]
- Count of Participants With Neonatal Morbidity [ Time Frame: Up to 42 weeks of pregnancy ]Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.
- Count of Participants With Side-effect Due to the Medication [ Time Frame: Up to 42 weeks of pregnancy ]Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash.
- Time to Uterine Quiescence [ Time Frame: Up to 42 weeks of pregnancy ]Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days.
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): NCT00486824
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Deirdre Judith Lyell||Stanford University|