Indomethacin for Tocolysis of Preterm Labor

Study Overview
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Brief Summary
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Indomethacin for tocolysis for 48 hours vs placebo

Detailed Description
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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.

Official Title
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Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis

Conditions
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Preterm Labor

Intervention / Treatment
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* Drug: Indomethacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* Control drug<br>|
| Active Comparator: Indomethacin<br>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<br>* Study drug<br>* Other names: Indocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delivery within 48 hours | The percentage of patients remaining undelivered after 48 hours | 48 hours after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delivery within 7 days | The percentage of patients remaining undelivered after 7 days | 7 days after enrollment | 
| delivery before 37 weeks | The percentage of patients remaining undelivered until 37 weeks gestational age | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm labor, tocolysis, indomethacin