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Investigating the effects of steroids given in pregnancy on infant stress responses

Infant hypothalamic-pituitary-adrenal axis responses following antenatal corticosteroids and perinatal outcomes: a mechanism of action of health intervention study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN49188855
Enrollment
543
Registered
2022-07-20
Start date
2022-05-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of antenatal corticosteroids on infant stress responses Pregnancy and Childbirth

Interventions

The site clinical team will be asked to take the following samples at delivery of twins: • Paired maternal and cord blood samples (about 10mls) • Amniotic fluid sample • Placenta sample In a subset o

Sponsors

University of Edinburgh
Lead Sponsor
NHS Lothian
Collaborator

Eligibility

Sex/Gender
Female
Age
16 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Women with a twin pregnancy with a planned caesarean birth scheduled between 35+0 and 38+6 weeks gestation who are enrolled in STOPPIT-3 (ISRCTN59959611) 2. Women aged 16 years or older and able to provide electronic or written consent

Exclusion criteria

Exclusion criteria: 1. Women taking prescribed corticosteroid medication (orally, injected, inhaled or topical) within the last 3 months. 2. Women with planned vaginal birth.

Design outcomes

Primary

MeasureTime frame
1. Measurement of endogenous glucocorticoids, dexamethasone and its metabolites in maternal and cord blood and amniotic fluid in samples collected at birth. 2. Measurement of glucocorticoid receptor in cord blood leukocytes collected at birth. 3. Measurement of placental genes regulating glucocorticoids in placenta samples collected at birth.

Secondary

MeasureTime frame
1. Salivary cortisol pre and post heel-prick at 5 days 2. Hair cortisol at 5 days

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactDenise Cranley
STOPPIT.Trial@ed.ac.uk+44 131 651 9923

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026