![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
University of Oulu |
---|---|
Information provided by: | University of Oulu |
ClinicalTrials.gov Identifier: | NCT00295464 |
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 |
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) |
Estimated Enrollment: | 440 |
Study Start Date: | May 2001 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The pregnant women will be eligible for the trial entry if all following criteria are met:
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:
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 |
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 |
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 |
Antenatal glucocorticoid Premature birth |
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 |
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 |