Status:
TERMINATED
Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth
Lead Sponsor:
University of Oulu
Conditions:
Respiratory Distress Syndrome
Intraventricular Haemorrhage
Eligibility:
All Genders
Phase:
PHASE4
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 inf...
Detailed Description
RANDOMIZED TRIAL ON EFFICACY AND SAFETY OF THE ANTENATAL RESCUE COURSE OF GLUCOCORTCOID IN THREATENED PREMATURE BIRTH (ACG trial) Introduction Prematurity is the main cause of neonatal mortality and...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00295464
Start Date
May 1 2001
Last Update
May 3 2006
Active Locations (10)
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1
Helsinki University Central Hospital, Finland
Helsinki, Finland, 00029 HUS
2
Joensuu Central Hospital
Joensuu, Finland
3
Jyväskylä Central Hospital
Jyväskylä, Finland
4
Kuopio University Central Hospital
Kuopio, Finland