A Longitudinal, Cohort Study Investigating the Impact of General Anaesthetic Caesarean Birth, With or Without ICU Admission, on Maternal Mental Health and Mother/Infant Bonding (GABI)

King's College London

Status: Not yet enrolling

Conditions: General Anaesthesia During Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT07115823

RTF1201 (Other Grant/Funding Number)

359600

Details and patient eligibility

About

In the UK, approximately 6000 women every year undergo caesarean sections with general anaesthetic. Additionally, around 1300 women are admitted to Intensive Care Units (ICU) annually, typically due to pregnancy or childbirth complications. Some of these women are admitted to ICU for critical care immediately following a general anaesthetic caesarean section. However, there is little research on the impact of these experiences on women/birthing people and their families.

This project aims to explore the impact of general anaesthetic caesarean section, with or without subsequent ICU admission, on a mother's mental health and bonding with her newborn. Women and birthing people who have undergone a caesarean section with an epidural or spinal anaesthesia can also take part in this study, so that outcomes can be compared for different types of caesarean birth.

Full description

Birth is a dynamic and transformative event, both on an individual and societal level and a key phase in the transition to motherhood. Many women or birthing people remain conscious during childbirth, allowing for immediate interaction and bonding activities with their newborns. However, those who undergo a General Anaesthetic Caesarean Section (GACS) are in a state of controlled unconsciousness due the effects of the general anaesthetic and therefore, will not experience their infant being born or early post-birth interactions.

Additionally, a small proportion of women or birthing people require admission to Intensive Care Units (ICU) following GACS. This can result in more prolonged periods where the mother is unable to emotionally connect or interact with her newborn. Consequently, this may increase the risk of mental health issues and affect bonding experiences for the mother postnatally. Yet, the impact of these events on women and their families remains largely underexplored.

This study Involves a longitudinal survey to collect prospective data on the experience of GACS compared to caesarean sections with neuraxial anaesthesia (NACS), focusing on mental health outcomes and maternal-infant bonding. The survey will include the Depression, Anxiety & Stress Scale (DASS-21), the City Birth Trauma Scale (CBTS) and the Postpartum Bonding Questionnaire (PBQ) and one question on self-harm from the Edinburgh Postnatal Depression Scale (EPDS). These measures will be collected upon completion of the initial survey and again 3 months later.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age and over
• Gave birth by caesarean section (CS) in a UK hospital within the last 12 months
• Able and willing to access the internet
• ICU admission following CS

Exclusion criteria

• Under 18 years of age.
• Vaginal birth (including instrumental) that did not lead to GACS or NACS
• CS that has not taken place in a UK hospital
• CS more than 12 months ago
• ICU admission immediately following CS outside of the UK.
• Unable to access the internet

Trial design

500 participants in 2 patient groups

Women or birthing people who have given birth by GACS

Description:

Women or birthing people aged 18 or older who have given birth by GACS in a UK hospital, within 12 months postpartum.

Women or birthing people who have given birth by NACS

Description:

Women or birthing people aged 18 or older who have given birth by NACS in a UK hospital, within 12 months postpartum.