Clinical trial NCT00486824: Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
Official title: Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obstetric Labor, Premature
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-06-15
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients presenting between 24-34 weeks gestation 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. Antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor. Maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment, and/or from review of the patient's medical records.

Eligibility 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

Primary outcomes:
measure: Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization
timeFrame: Two weeks after enrolled and randomized, up to 37 weeks of pregnancy
Secondary outcomes:
measure: Neonatal Birthweight
timeFrame: Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery
measure: Gestational Age at Delivery
timeFrame: Up to 42 weeks of pregnancy
measure: Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery
timeFrame: Up to 42 weeks of pregnancy
measure: Count of Participants With Neonatal Morbidity
timeFrame: Up to 42 weeks of pregnancy
measure: Count of Participants With Side-effect Due to the Medication
timeFrame: Up to 42 weeks of pregnancy
measure: Time to Uterine Quiescence
timeFrame: Up to 42 weeks of pregnancy
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Deirdre Judith Lyell
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.