PRECeDe Trial: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes: a Randomised Controlled Trial
- Conditions
- diabetesgestational diabetesneonatal respiratory distresstransient tachypnoea of newborncaesarean sectionpregnancyneonatal hypoglycaemiaReproductive Health and Childbirth - Childbirth and postnatal careReproductive Health and Childbirth - Antenatal careReproductive Health and Childbirth - Complications of newborn
- Registration Number
- ACTRN12623000015640
- Lead Sponsor
- The University of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 2200
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)
AND
plan to give birth by planned caesarean section within the next 7 days.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method