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. 2023 Nov;130(12):1451-1458.
doi: 10.1111/1471-0528.17513. Epub 2023 Apr 25.

PRECeDe Pilot: Prevention of neonatal respiratory distress with antenatal corticosteroids before elective caesarean section in women with diabetes - a feasibility randomised trial

Joanne M Said  1   2 , Amalia Karahalios  3 , Christopher J Yates  4   5 , Devaang A Kevat  4 , Rosalynn Pszczola  6 , Lee-Anne Lynch  1   2 , Elizabeth Korevaar  3 , Klea Atallah  2 , Vidanka Vasilevski  7   8 , Linda Sweet  7   8 , Lex W Doyle  2   9
Affiliations

PRECeDe Pilot: Prevention of neonatal respiratory distress with antenatal corticosteroids before elective caesarean section in women with diabetes - a feasibility randomised trial

Joanne M Said et al. BJOG. 2023 Nov.

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 outcome measure: 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.

Keywords: antenatal corticosteroids; betamethasone; caesarean section; diabetes; gestational diabetes; neonatal hypoglycaemia; respiratory distress syndrome.

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References

REFERENCES

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