Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth - Full Text View

Sponsored by:	University of Oulu
Information provided by:	University of Oulu
ClinicalTrials.gov Identifier:	NCT00295464

Purpose

Administration of steroid to the mother in imminent preterm delivery is a known effective practice to decrease the risk of respiratory distress syndrome and intraventricular haemorrhage in preterm infants if given with a week of the preterm delivery. This randomized clinical trial is performed to test the possibility whether the repeat dose of steroid results in further reduction of these diseases in case the mother is in imminent preterm delivery more than a week after the first antenatal steroid treatment.

Condition	Intervention	Phase
Respiratory Distress Syndrome Intraventricular Haemorrhage	Drug: Betamethasone sodium phos (drug)	Phase IV

Drug Information available for: Betamethasone Bentelan Betamethasone dipropionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Trial on Efficacy and Safety of the Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth (ACG Trial)

Further study details as provided by University of Oulu:

Primary Outcome Measures:

Intact survival without RDS and/or severe (gr 3-4) ICH
Follow-up study at corrected age of two years

Secondary Outcome Measures:

A number of diseases in preterm infants
Number of mothers with premature delivery

Estimated Enrollment:	440
Study Start Date:	May 2001

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The pregnant women will be eligible for the trial entry if all following criteria are met:

administration of a course of antenatal corticosteroid at least 7 days before the trial entry
gestational age is less than 33.0 weeks 6 days*
very high risk of premature delivery**
none of the following therapies complications or therapies maternal long term systemic corticosteroid therapy severe clinical chorioamnionitis (maternal fever, increased CRP or another acute phase protein, uterine tenderness) lethal disease of the fetus
informed consent obtained
premature rupture of membranes is not contraindication for the trial entry

*Gestational age will be calculated from the mother’s last menstrual period and confirmed by ultrasound before 20 weeks’ gestation. In case the discrepancy in the estimates exceeds two weeks, ultrasound date is accepted.

**Very high risk of premature delivery is described as follows:
elective delivery within within 4-48 hours, as indicated by the obstetrician on the basis of the clinical status of the mother and/or the fetus
very high risk of spontaneous delivery within 4-48 hours, i.e.
cervix is open > 3 cm
contractions of the uterus at 5-10 min intervals
rupture of the membranes after the first course of ANC
fetal and/or maternal indication for elective premature delivery or cesarean section

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295464

Locations

Finland
Helsinki University Central Hospital, Finland
Helsinki, Finland, 00029 HUS
Oulu University Hospital
Oulu, Finland, 90029 OYS
Tampere University Hospital
Tampere, Finland, 33521
Kuopio University Central Hospital
Kuopio, Finland
Turku Central Hospital
Turku, Finland
Central Hospital of Pori
Pori, Finland
Joensuu Central Hospital
Joensuu, Finland
Jyväskylä Central Hospital
Jyväskylä, Finland
Lahti Central Hospital
Lahti, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland

Sponsors and Collaborators

University of Oulu

Investigators

Study Director:	Mikko N Hallman, MD	Children's Hospital, Univ. of Oulu
Principal Investigator:	Outi M Peltoniemi, MD	Children's Hospital, Univ. of Oulu
Study Director:	Pentti Jouppila, MD	Oulu Central Hospital, Dept. of Obstetrics & Gynecology

More Information

Publications indexed to this study:

Pesonen AK, Räikkönen K, Lano A, Peltoniemi O, Hallman M, Kari MA. Antenatal betamethasone and fetal growth in prematurely born children: implications for temperament traits at the age of 2 years. Pediatrics. 2009 Jan;123(1):e31-7. Epub 2008 Dec 15.

Study ID Numbers:	ACG Trial, Betamethasone
Study First Received:	February 21, 2006
Last Updated:	May 1, 2006
ClinicalTrials.gov Identifier:	NCT00295464
Health Authority:	Finland: National Agency for Medicines

Keywords provided by University of Oulu:

Antenatal glucocorticoid
Premature birth

Study placed in the following topic categories:

Betamethasone-17,21-dipropionate
Cerebral Hemorrhage
Pregnancy Complications
Betamethasone sodium phosphate
Obstetric Labor, Premature
Respiration Disorders
Respiratory Distress Syndrome, Adult
Obstetric Labor Complications
Vascular Diseases
Central Nervous System Diseases

Intracranial Hemorrhages
Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Respiratory Tract Diseases
Lung Diseases
Acute respiratory distress syndrome
Betamethasone
Premature Birth

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Disease
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009