Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
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Purpose
OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery.
II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease.
III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Distress Syndrome |
Drug: betamethasone Drug: dexamethasone Drug: thyrotropin-releasing hormone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 1090 |
| Study Start Date: | August 1993 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004778 History of Changes |
| Other Study ID Numbers: | 199/11826, CHP-92536 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Office of Rare Diseases (ORD):
|
cardiovascular and respiratory diseases neonatal disorders rare disease respiratory distress syndrome |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Betamethasone-17,21-dipropionate Dexamethasone acetate Betamethasone Dexamethasone Betamethasone sodium phosphate Dexamethasone 21-phosphate Hormones Thyrotropin-Releasing Hormone |
BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 22, 2013