Antenatal corticosteroids for planned birth in twins

Phase 3

• Conditions: Assessment of neonatal morbidity and need for respiratory support for twins born by planned birth (caesarean section or induction of labour) between 35+0 and 38+6 weeks gestation; Neonatal Diseases

• Registration Number: ISRCTN59959611
• Lead Sponsor: niversity of Edinburgh

Brief Summary

2024 Protocol article in https://doi.org/10.1136/bmjopen-2023-078778 (added 19/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-31
• Last Update Posted: 29 January 2024
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1552

Inclusion Criteria

1. Women aged 16 years or older and able to provide electronic or written consent
2. Women presenting with a viable twin pregnancy (monochorionic or dichorionic) with a planned birth (caesarean section or induction of labour) scheduled between 35+0 and 38+6 weeks gestation including women who have a planned birth due to logistic reasons (e.g. availability of beds or staff), parental preference or other maternal or fetal indications.
3. Women with gestation established by scan at =16 weeks according to NICE guidelines and known chorionicity
4. =24 hours and <7 days until planned birth

Exclusion Criteria

1. Women who are unable to give informed consent
2. Women who have a known or suspected major congenital fetal anomaly at the time of inclusion (defined as any structural or chromosomal anomaly that would influence management at or around birth or in the immediate postnatal period. Suspected isolated minor anomalies with lesser medical, functional or cosmetic consequences; or isolated limb abnormalities such as talipes can be included).
3. Diabetes (pre-existing or gestational)
4. Women who have received ACS within the seven days prior to randomisation
5. Women who have a sensitivity, contraindication or intolerance to any of the ACS or any of its excipients
6. Women in whom chorionicity or gestational age are unknown
7. Women with other serious pregnancy morbidities which indicate either birth before 35 weeks or urgent birth within 24 hours
8. Women involved in a clinical trial of an investigational medicinal product (CTIMP) in pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified