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Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obstetric Labor, Premature

Intervention: Indomethacin (Drug); 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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
Last updated: November 18, 2014

Page last updated: August 23, 2015

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