Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth
This study has been terminated.
Sponsor:
University of Oulu
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00295464
First received: February 21, 2006
Last updated: May 1, 2006
Last verified: February 2006
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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:
Genetics Home Reference related topics:
COL4A1-related brain small-vessel disease
Drug Information available for:
Betamethasone sodium phosphate
Betamethasone
Betamethasone valerate
Betamethasone dipropionate
U.S. FDA Resources
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 | |
| 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 Respiratory Distress Syndrome, Adult 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 Betamethasone sodium phosphate Glucocorticoids Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013