Poster Presentation International Association of the Diabetes and Pregnancy Study Groups 2022 - Hosted by ADIPS

PRECeDe Pilot: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes - A Feasibility Randomised Trial (#130)

Joanne M Said 1 2 , Amalia Karahalios 3 , Lex W Doyle 2 , Christopher J Yates 4 5 , Devaang A Kevat 4 , Rosalynn Pszczola 6 , Lee-anne Lynch 1 , Elizabeth Korevaar 3 , Klea Atallah 2 , Vidanka Vasilevski 7 8 , Linda Sweet 7 8
  1. Maternal Fetal Medicine, Joan Kirner Women's & Children's at Sunshine Hospital, Western Health, St Albans, VIC, Australia
  2. Obstetrics & Gynaecology, The University of Melbourne, Parkville, Victoria, Australia
  3. Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia
  4. Diabetes and Endocrinology, Western Health, St Albans, VIC, Australia
  5. Department of Medicine, The University of Melbourne, Parkville, Victoria, Australia
  6. Newborn Services, Joan Kirner Women's & Children's at Sunshine Hospital, Western Health, St Albans, VIC, Australia
  7. School of Nursing and Midwifery, Deakin University, Burwood, Victoria, Australia
  8. Centre for Quality and Patient Safety Research, Western Health Partnership, St Albans, Victoria, Australia

Introduction: 

Babies born to women with pre-gestational diabetes (PGDM)1-4 or gestational diabetes (GDM)3,5 are more likely to be born by caesarean section (CS) and have increased rates of respiratory morbidity. Several studies have reported benefits when antenatal corticosteroids (ACS) are given to women who give birth by elective CS after 35 weeks’.6 Women with diabetes were specifically excluded from these studies, hence, whether these benefits are the same for infants born to women with diabetes is uncertain.

The PRECeDe Pilot Trial was designed to determine the feasibility of undertaking a larger multicentre, randomised, placebo-controlled trial to assess the efficacy of administration of ACS within 7 days prior to elective CS in women with PGDM or GDM on maternal and neonatal outcomes.

Methods:

We undertook a triple blind, placebo-controlled, pilot RCT at Western Health between June 2020 and May 2022 to assess the feasibility of undertaking a larger multicentre trial. The trial was registered prior to commencement of recruitment (ACTRN12619001475134) and institutional ethics approval was obtained from Melbourne Health Human Research Ethics Committee. Eligible participants with either PGDM or GDM were randomised to receive 2 injections of either betamethasone 11.4 mg or normal saline placebo in identical masked syringes, 24 hours apart within 7 days prior to planned CS scheduled between 35+0 and 38+6 weeks’ gestation.

The primary outcome for the trial was the proportion of all eligible women who consented and were randomised. The secondary outcomes included additional assessments of feasibility and the full range of primary and secondary maternal and neonatal outcomes proposed for the multicentre trial. 

Results:

Of 537 women eligible and 182 approached, 47 women were recruited to the PRECeDe Pilot Trial. Of these, 22 were allocated to the betamethasone group and 25 allocated to the placebo group, representing 8.8% of all eligible women and 25.8% of eligible women who were approached for participation in the trial.

Of 28 women who responded to a survey question regarding future participation in a similar trial, 22 women (78.5%) responded that they would be ‘likely’ or ‘very likely’ to participate in a similar trial in future.

Conclusion:

It is feasible to undertake a triple blind, placebo-controlled randomised trial investigating the efficacy of ACS in preventing neonatal respiratory morbidity in infants of women with PGDM or GDM who are undergoing an elective CS between 35+0 to 38+6 weeks.

 

 

 

  1. Abell SK, Boyle JA, de Courten B, et al. Contemporary type 1 diabetes pregnancy outcomes: impact of obesity and glycaemic control. Med J Aust 2016; 205(4): 162-7.
  2. Watson D, Rowan J, Neale L, Battin MR. Admissions to neonatal intensive care unit following pregnancies complicated by gestational or type 2 diabetes. The Australian & New Zealand journal of obstetrics & gynaecology 2003; 43(6): 429-32.
  3. Billionnet C, Mitanchez D, Weill A, et al. Gestational diabetes and adverse perinatal outcomes from 716,152 births in France in 2012. Diabetologia 2017.
  4. Abell SK, Boyle JA, de Courten B, et al. Impact of type 2 diabetes, obesity and glycaemic control on pregnancy outcomes. The Australian & New Zealand journal of obstetrics & gynaecology 2016.
  5. Fung GPG, Chan LM, Ho YC, To WK, Chan HB, Lao TT. Does gestational diabetes mellitus affect respiratory outcome in late-preterm infants? Early Human Development 2014; 90(9): 527-30.
  6. Sotiriadis A, Makrydimas G, Papatheodorou S, Ioannidis JPA, McGoldrick E. Corticosteroids for preventing neonatal respiratory morbidity after elective caesarean section at term. Cochrane Database of Systematic Reviews 2018; (8).