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Phase 2 N=10 Randomized Quadruple-blind Treatment

Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

Obstetric Labor, Premature

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization — 2; 1 Participants — p=0.004

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Indomethacin (Drug); Nifedipine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Stanford University
Primary completion
Dec 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization
2; 1 0.004 sig
SECONDARY
Neonatal Birthweight
2830; 2240
SECONDARY
Gestational Age at Delivery
37.0; 34.0
SECONDARY
Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery
34.0; 36.0
SECONDARY
Count of Participants With Neonatal Morbidity
2; 3
SECONDARY
Count of Participants With Side-effect Due to the Medication
2; 3
SECONDARY
Time to Uterine Quiescence
2.0; 2.0

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00486824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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