Deirdre J. Lyell, M.D.
Indomethacin versus Nifedipine for Preterm Labor Tocolysis
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Indomethacin and Nifedipine
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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 contractions
at least every 5 minutes, or at least 2 cm cervical dilation and 80%
effacement
Key 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
Additional Study Details
Official Title:
Indocin versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical TrialAnticipated start date:
4/10/2007Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
UnspecifiedAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
UnspecifiedPrimary Outcomes:
- Recurrent preterm labor within two weeks of randomization
Secondary Outcomes:
- Birth weight, gestational age, delay of delivery, neonatal morbidities, maternal side effects, time to uterine quiescence
Total Number to be Enrolled:
110Total Number to be Enrolled at Stanford:
110More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/21/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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