STOPPIT-M: a mechanism of action of health intervention study
Research type
Research Study
Full title
Infant hypothalamic-pituitary-adrenal axis responses following antenatal corticosteroids and perinatal outcomes: a mechanism of action of health intervention study (STOPPIT-M)
IRAS ID
309594
Contact name
Rebecca Reynolds
Contact email
Sponsor organisation
University of Edinburgh
ISRCTN Number
49188855
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
The use of ACS in late preterm (35-36 weeks gestation) and early term (37 weeks gestation) is an area of substantial controversy in obstetrics. There is evidence that ACS reduce serious breathing difficulties and neonatal unit admission but there is potential for both short (e.g. low blood sugar levels) and long-term harms (e.g. brain development) in some exposed babies. Practice is highly variable regarding ACS administration at later preterm and early term gestations.
STOPPIT-3 is a multicentre placebo-controlled trial to evaluate the effectiveness of ACS (dexamethasone phosphate) prior to planned birth of twins in an NHS setting. The primary outcome is respiratory support within 72 hours of birth. STOPPIT-M is a linked study to explore the mechanisms underlying ACS effects on the infant’s endogenous HPA axis responses, and resultant effects on neonatal outcomes.
STOPPIT-M will aim to recruit 543 women pregnant with twins enrolled in the STOPPIT-3 trial across 50 sites. Women who have agreed to take part will have the following samples collected at delivery of twins: paired maternal and cord blood samples, amniotic fluid sample and a placenta sample. In a subset of infants in Edinburgh the following samples will be taken: a saliva sample and a hair sample.
We will use these samples to compare the stress axis in infants with
i) early adverse health (need for respiratory support; low APGAR score; low blood sugar; jaundice), in babies exposed and non-exposed to ACS
ii) developmental delay aged 2 years (from the main STOPPIT-3 trial)A secondary aim is to explore whether these outcomes differ in boys and girls.
Gaining a better understanding of the mechanisms of action of ACS is essential to improve targeted delivery of ACS – ensuring administration to mothers and babies who will benefit from ACS, but avoiding harm in those who will not benefit.REC name
North of Scotland Research Ethics Committee 2
REC reference
22/NS/0017
Date of REC Opinion
28 Feb 2022
REC opinion
Further Information Favourable Opinion