Indomethacin for Tocolysis of Preterm Labor

MetroHealth Medical Center

Status and phase: Withdrawn; Early Phase 1

Conditions: Preterm Labor

Treatments: Drug: Indomethacin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01869361

IRB13-00533

Details and patient eligibility

About

Indomethacin for tocolysis for 48 hours vs placebo

Full 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.

Sex: Female

Ages: 16 to 50 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Indomethacin

Active Comparator group

Description:

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.

Treatment:

Drug: Indomethacin