Indomethacin for Tocolysis of Preterm Labor

November 23, 2021 updated by: Kelly S Gibson, MetroHealth Medical Center

Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis

Indomethacin for tocolysis for 48 hours vs placebo

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delivery within 48 hours
Time Frame: 48 hours after enrollment
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
Time Frame: 7 days after enrollment
The percentage of patients remaining undelivered after 7 days
7 days after enrollment
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Investigators

  • Principal Investigator: Kelly S Gibson, MD, MetroHealth Medical Center
  • Study Chair: Brian Mercer, MD, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

November 23, 2021

Study Completion (ACTUAL)

November 23, 2021

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (ESTIMATE)

June 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB13-00533

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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