Indomethacin for Tocolysis
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:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis|
- delivery within 48 hours [ Time Frame: 48 hours after enrollment ] [ Designated as safety issue: No ]The percentage of patients remaining undelivered after 48 hours
- delivery within 7 days [ Time Frame: 7 days after enrollment ] [ Designated as safety issue: No ]The percentage of patients remaining undelivered after 7 days
- delivery before 37 weeks [ Time Frame: participants will be followed for the duration of pregnancy through their postpartum period, an expected time of up to 20 weeks ] [ Designated as safety issue: No ]The percentage of patients remaining undelivered until 37 weeks gestational age
- Maternal and Fetal Complications [ Time Frame: participants will be followed for the duration of pregnancy through their postpartum period and neonatal hospital stay, an expected time of up to 24 weeks ] [ Designated as safety issue: No ]composite of maternal intolerance of the drug, birth weight, gestational age, neonatal morbidities, changes in amniotic fluid volume, fetal cardiac assessment, or premature constriction of the ductus arteriosus.
|Study Start Date:||November 2016|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
The patient will be given a loading dose of 50mg placebo by mouth followed by 25mg by mouth every six hours for a total of eight doses over 48 hours.
Active Comparator: Indomethacin
The patient will be given a loading dose of 50mg indomethacin by mouth followed by 25mg by mouth every six hours for a total of eight doses over 48 hours.
Other Name: Indocin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869361
|Contact: Kelly S Gibson, MDfirstname.lastname@example.org|
|United States, Ohio|
|MetroHealth Medical Center||Not yet recruiting|
|Cleveland, Ohio, United States, 44109|
|Principal Investigator: Kelly S Gibson, MD|
|Principal Investigator:||Kelly S Gibson, MD||MetroHealth Medical Center|
|Study Chair:||Brian Mercer, MD||MetroHealth Medical Center|