PRECeDe Pilot: Prevention of neonatal respiratory distress with antenatal corticosteroids before elective caesarean section in women with diabetes - a feasibility randomised trial.
BJOG
; 130(12): 1451-1458, 2023 Nov.
Article
em En
| MEDLINE
| ID: mdl-37186126
ABSTRACT
OBJECTIVE:
The PRECeDe Pilot Trial was designed to determine the feasibility of undertaking a multicentre, randomised controlled trial (RCT) to assess the efficacy of antenatal corticosteroids administration within 7 days before elective caesarean section (CS) in women with pre-gestational diabetes (PGDM) or gestational diabetes (GDM).DESIGN:
Triple blind, parallel group, placebo-controlled, pilot RCT.SETTING:
Single-centre tertiary maternity hospital in Melbourne, Australia. POPULATION Pregnant women with PGDM (type 1 or type 2 diabetes) or GDM booked for a planned CS scheduled between 35+0 and 38+6 weeks of gestation.METHODS:
Eligible participants were randomised to receive two injections of either betamethasone 11.4 mg or normal saline placebo, 24 hours apart within 7 days before CS scheduled between 35+0 and 38+6 weeks of gestation. MAIN OUTCOMEMEASURE:
The proportion of eligible women who consented and were randomised. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry ACTRN12619001475134.RESULTS:
Of 537 women eligible, 182 were approached and 47 (26%) were recruited. Of these, 22 were allocated to the betamethasone group and 25 were allocated to the placebo group. There were no serious adverse events related to participation.CONCLUSION:
It is feasible to undertake a triple-blind, placebo-controlled RCT investigating the efficacy of antenatal corticosteroids in preventing respiratory morbidity in infants of women with PGDM or GDM who are undergoing an elective CS between 35+0 and 38+6 weeks.
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MEDLINE
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Ano de publicação:
2023
Tipo de documento:
Article