Indomethacin for Tocolysis of Preterm Labor

Early Phase 1WithdrawnNCT01869361

MetroHealth Medical Center

Overview

Indomethacin for tocolysis for 48 hours vs placebo

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Preterm Labor

Interventions

IndomethacinDRUG

Study drug

PlaceboDRUG

Control drug

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 50 Years

Medical Language ↔ Plain English

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)

Locations (1)

MetroHealth Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

delivery within 48 hours

The percentage of patients remaining undelivered after 48 hours

Time frame: 48 hours after enrollment

Secondary Outcomes

delivery within 7 days

The percentage of patients remaining undelivered after 7 days

Time frame: 7 days after enrollment

delivery before 37 weeks

The percentage of patients remaining undelivered until 37 weeks gestational age

Time frame: participants will be followed for the duration of pregnancy through their postpartum period, an expected time of up to 20 weeks

Maternal and Fetal Complications

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.

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

Data from ClinicalTrials.gov

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