Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth

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. Read our disclaimer for details. Identifier: NCT00295464
Recruitment Status : Terminated
First Posted : February 23, 2006
Last Update Posted : May 3, 2006
Information provided by:
University of Oulu

Brief Summary:
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 or disease Intervention/treatment Phase
Respiratory Distress Syndrome Intraventricular Haemorrhage Drug: Betamethasone sodium phos (drug) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Trial on Efficacy and Safety of the Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth (ACG Trial)
Study Start Date : May 2001

Primary Outcome Measures :
  1. Intact survival without RDS and/or severe (gr 3-4) ICH
  2. Follow-up study at corrected age of two years

Secondary Outcome Measures :
  1. A number of diseases in preterm infants
  2. Number of mothers with premature delivery

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00295464

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
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00295464     History of Changes
Other Study ID Numbers: ACG Trial
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: February 2006

Keywords provided by University of Oulu:
Antenatal glucocorticoid
Premature birth

Additional relevant MeSH terms:
Premature Birth
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Cerebral Hemorrhage
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Anti-Asthmatic Agents
Respiratory System Agents