Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oulu
• Treatments: Betamethasone; Glucocorticoids

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