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Indomethacin for Tocolysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01869361
Recruitment Status : Not yet recruiting
First Posted : June 5, 2013
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Preterm Labor Drug: Indomethacin Drug: Placebo Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis
Anticipated Study Start Date : November 1, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Indocin


Outcome Measures

Primary Outcome Measures :
  1. delivery within 48 hours [ Time Frame: 48 hours after enrollment ]
    The percentage of patients remaining undelivered after 48 hours


Secondary Outcome Measures :
  1. delivery within 7 days [ Time Frame: 7 days after enrollment ]
    The percentage of patients remaining undelivered after 7 days

  2. 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

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes 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
  • ≥ 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01869361     History of Changes
Other Study ID Numbers: IRB13-00533
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly S Gibson, MetroHealth Medical Center:
preterm labor
tocolysis
indomethacin

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