Completed

Intravenous Thyrotropin-Releasing Hormone and Betamethasone/Dexamethasone for Threatened Premature Delivery

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What is being tested

betamethasone

+ dexamethasone

+ thyrotropin-releasing hormone

Drug
Who is being recruted

Lung Diseases+7

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

+ Pathologic Processes

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 1993
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1993

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Participants are stratified by participating institution. Participants are randomly assigned to 1 of 2 treatment groups. The first group is treated with intravenous thyrotropin-releasing hormone (TRH) and intramuscular injections of betamethasone or dexamethasone. The second group receives a placebo in place of TRH. Postnatal therapy with surfactants, prophylactic steroids, and indomethacin is allowed.

NCT00004778
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

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

1090 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesRespiration DisordersPathological Conditions, Signs and SymptomsDisease AttributesInfant, Newborn, DiseasesRespiratory Distress SyndromeRespiratory Tract DiseasesRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Threatened premature delivery at 24 to 30 weeks gestation, i.e.: Premature labor Premature rupture of membranes Elective premature delivery medically indicated Fetal lung maturity immature or unknown --Prior/Concurrent Therapy-- No more than 72 hours since any initial corticosteroids --Patient Characteristics-- The following complications exclude: Fetal distress Amnionitis Severe maternal bleeding uncontrolled with transfusion or volume replacement Fetal or maternal heart disease Significant fetal blood loss Maternal blood pressure 140/90 mm Hg or higher with or without treatment Maternal hyperthyroidism Maternal hyperprolactinemic condition Significant fetal anomaly Multiple gestation with demise of 1 or more fetuses Nonimmune hydrops No participation in other clinical research projects

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers
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