Indomethacin for Tocolysis of Preterm Labor

Status Withdrawn

Clinical Trial Summary

Indomethacin for tocolysis for 48 hours vs placebo

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01869361
Study type	Interventional
Source	MetroHealth Medical Center
Contact
Status	Withdrawn
Phase	Early Phase 1
Start date	August 1, 2020
Completion date	November 23, 2021

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