NCT01869361

Indomethacin for Tocolysis of Preterm Labor

Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Indomethacin for tocolysis for 48 hours vs placebo

Detailed description

Background: Indomethacin is frequently used as a tocolytic, however there is currently only scant evidence to support its efficacy. Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48 hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously administered, and magnesium sulfate for neuroprotection. Ultrasound performed before initiation of study drug and after completion of study medication for amniotic fluid index and fetal cardiac assessment.

Conditions

• Preterm Labor

Interventions

Type	Name	Description
DRUG	Indomethacin	Study drug
DRUG	Placebo	Control drug

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2013-06-05
• Last updated: 2021-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study