Indomethacin for Tocolysis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by MetroHealth Medical Center
Sponsor:
Information provided by (Responsible Party):
Kelly S Gibson, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01869361
First received: May 29, 2013
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Preterm Labor
Drug: Indomethacin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • delivery within 48 hours [ Time Frame: 48 hours after enrollment ] [ Designated as safety issue: No ]
    The percentage of patients remaining undelivered after 48 hours


Secondary Outcome Measures:
  • delivery within 7 days [ Time Frame: 7 days after enrollment ] [ Designated as safety issue: No ]
    The percentage of patients remaining undelivered after 7 days

  • 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 ] [ Designated as safety issue: No ]
    The percentage of patients remaining undelivered until 37 weeks gestational age

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 84
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other Name: Indocin

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • ≥ 16 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869361

Contacts
Contact: Kelly S Gibson, MD 2167787076 kgibson@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Kelly S Gibson, MD         
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Kelly S Gibson, MD MetroHealth Medical Center
Study Chair: Brian Mercer, MD MetroHealth Medical Center
  More Information

Publications:

Responsible Party: Kelly S Gibson, Maternal Fetal Medicine Fellow, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01869361     History of Changes
Other Study ID Numbers: IRB13-00533
Study First Received: May 29, 2013
Last Updated: May 31, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by MetroHealth Medical Center:
preterm labor
tocolysis
indomethacin

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014