ACTRN12623000015640
Recruiting
Phase 3
PRECeDe Trial: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes: a Randomised Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The University of Melbourne
- Enrollment
- 2200
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women with a singleton or twin pregnancy between 35\+0 and 39\+6 weeks gestation who have pre\-gestational diabetes OR gestational diabetes (diagnosed on a pregnancy 75g Oral glucose tolerance test according to the WHO criteria for gestational diabetes OR the ADIPS revised criteria during the COVID pandemic)
- •plan to give birth by planned caesarean section within the next 7 days.
Exclusion Criteria
- •Known major fetal anomaly or chromosomal anomaly.
- •Administration of intramuscular antenatal corticosteroids for the purposes of fetal lung maturation at any stage during the current pregnancy.
- •Thrombocytopaenia with a platelet count below 80x109 /litre
- •Hypersensitivity to betamethasone sodium phosphate, betamethasone acetate, or other corticosteroids
- •received any corticosteroids at any time during the pregnancy
- •Systemic fungal infection
- •Contraindication to corticosteroids
- •Previous participation in the PRECeDe trial (in a previous pregnancy). Note that participation in the PRECeDe pilot Trial is not regarded as an exclusion from participation in the current trial).
Outcomes
Primary Outcomes
Not specified
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