Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth

This study has been terminated.
Sponsor:
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00295464
First received: February 21, 2006
Last updated: May 1, 2006
Last verified: February 2006
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized Trial on Efficacy and Safety of the Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth (ACG Trial)

Resource links provided by NLM:


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
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: NCT00295464

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

No publications provided by University of Oulu

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00295464     History of Changes
Other Study ID Numbers: ACG Trial, Betamethasone
Study First Received: February 21, 2006
Last Updated: May 1, 2006
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
Antenatal glucocorticoid
Premature birth

Additional relevant MeSH terms:
Hemorrhage
Respiratory Distress Syndrome, Newborn
Premature Birth
Cerebral Hemorrhage
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Glucocorticoids
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Hormones

ClinicalTrials.gov processed this record on August 27, 2014