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RCOG World Congress 2025

June 23 - 25, 2025 | ExCeL London, UK

EP.1204

BEAD Feasibility Study: Baby head ElevAtion Device at Full Dilatation Caesarean Section

Part of Topic

Hot topics (emerging research/issues) in obstetrics

BEAD Feasibility Study: Baby head ElevAtion Device at Full Dilatation Caesarean Section

Jordon Wimsett1,2, Charlotte Oyston2,3, Meghan Hill2,3,Robin Cronin2,3, Erena Browne4, Jane Alwseiler1,5, John Thompson5, Karaponi Okesene-Gafa3,6, Matthew Drake1, Lynn Sadler1

1Te Toka Tumai Auckland Hospital, Health New Zealand, Auckland, New Zealand; 2Department of Obstetrics, Gynaecology, and Reproductive Sciences, University of Auckland, Auckland, New Zealand; 3Te Whatu Ora Counties Manukau, Health New Zealand, Auckland, New Zealand; 4Te Whatu Ora Waikato, Health New Zealand, Hamilton, New Zealand; 5Dept of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand  6Pacific Health, University of Auckland

 

Objectives

1.To assess the feasibility of undertaking an industry-independent, randomised trial of the impact of inflated versus non-inflated Fetal Pillow® on uterine incision extensions.
2.To gain feedback on abbreviated consent and trial processes from patients and clinicians.

Design

Double-blinded, randomised placebo-controlled feasibility study at two New Zealand hospitals.

Qualitative studies within the trial were used to understand patient and clinician experience.

Method

Mixed method survey with patients and semi-structured interviews with clinicians.

RCT process:

- Approached in labour if age ≥16 years, singleton, cephalic, live, term (≥37 weeks’) pregnancy, confirmed 10cm cervical dilatation, requiring CS

- Abbreviated consent to be randomised to BEAD Study

- Randomised to inflation or non-inflation of Fetal Pillow® at time of CS at full dilatation

- Full postpartum consent +/- survey

Key findings

Feasibility

- 60 patients recruited in second six months, exceeding progression criteria

- Randomisation was equitable by ethnicity

Patient feedback

- Most of those consenting (111/129, 86%) and declining the RCT (38/57, 67%) consented to postpartum survey
- Patients were supportive of the consenting approach although 33% of consenting, and 69% of declining, participants would have preferred more information pre-labour

Clinician feedback

Enablers to trial participation:

- 24/7 availability of research team
- Usefulness of study-specific resources such as script for intrapartum consent

Barriers:

- Lack of equipoise among some current device users
- Competing clinical demands

Clinicians were supportive of the 2-stage consent process (abbreviated intrapartum consent and full post-partum consent).

Conclusion

- Recruitment for a larger trial (n=400) is feasible in this context.
- Abbreviated consent at decision for emergency CS is acceptable to patients and clinicians but providing information prior to labour may support broader patient participation.
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