Indomethacin for Tocolysis of Preterm Labor

Sponsor

MetroHealth Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01869361

Collaborator

(none)

Enrollment

Location

Arms

15.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Indomethacin for tocolysis for 48 hours vs placebo

Condition or Disease	Intervention/Treatment	Phase
Preterm Labor	Drug: Indomethacin Drug: Placebo	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Nov 23, 2021

Actual Study Completion Date :

Nov 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Placebo Control drug
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.	Drug: Indomethacin Study drug Other Names: Indocin

Arm

Intervention/Treatment

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.

Drug: Placebo

Control drug

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.

Drug: Indomethacin

Study drug

Other Names:

Indocin

Outcome Measures

Primary Outcome Measures

delivery within 48 hours [48 hours after enrollment]
The percentage of patients remaining undelivered after 48 hours

Secondary Outcome Measures

delivery within 7 days [7 days after enrollment]
The percentage of patients remaining undelivered after 7 days
delivery before 37 weeks [participants will be followed for the duration of pregnancy through their postpartum period, an expected time of up to 20 weeks]
The percentage of patients remaining undelivered until 37 weeks gestational age
Maternal and Fetal Complications [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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Preterm labor as defined by regular uterine contractions (at least 6/hour) with cervical change of at least 1 cm or cervical shortening on transvaginal ultrasound less than 25mm of functional length
Gestational age 23w0d to 31w6d weeks
Singleton
≥ 18 years old
Able to consent in English

Exclusion Criteria:

Major congenital anomalies associated with an increased risk of newborn death
Multiple fetal gestation (2+)
Known intrauterine fetal demise
Non-reassuring fetal status requiring delivery
Preterm premature rupture of membranes (PPROM)
Suspected or known intrauterine infection
Placenta previa
Maternal allergy or contraindication to indomethacin (peptic ulcer disease, thrombocytopenia, coagulopathy, renal or hepatic dysfunction)
Inevitable delivery (cervix ≥6cm dilated)