Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
Information source: Stanford University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstetric Labor, Premature
Intervention: Indomethacin and Nifedipine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Stanford University Official(s) and/or principal investigator(s):
Deirdre Judith Lyell, Principal Investigator, Affiliation: Stanford University
Overall contact:
Deirdre J Lyell, MD, Phone: (650) 736-1191, Email: dlyell@stanford.edu
Summary
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.
Clinical Details
Official title: Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial
Study design: Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: Recurrent preterm labor within two weeks of randomization
Secondary outcome: Birth weight, gestational age, delay of delivery, neonatal morbidities, maternal side effects, time to uterine quiescence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
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
Locations and Contacts
Deirdre J Lyell, MD, Phone: (650) 736-1191, Email: dlyell@stanford.edu
Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting
Deirdre J Lyell, MD, Phone: 650-736-1191, Email: dlyell@stanford.edu
Yair Blumenfeld, MD, Phone: (650) 269-4665, Email: yairb@stanford.edu
Deirdre Judith Lyell, Principal Investigator
Additional Information
Starting date: April 2007
Ending date: April 2011
Last updated: July 23, 2009
|
