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NCT Number: NCT07115823

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Life Science and Medicine

London, SE1 7EH, United Kingdom

Location contact

Dr Hannah Rayment-Jones

PRINCIPAL_INVESTIGATOR

Michelle Anderson, PhD Candidate

CONTACT

[email protected]

07957955462

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postnatal depression

    Time frame: 1-15 months post birth

    Depression scores (DASS-21)

  2. Newborn bonding

    Time frame: 1-15 months post birth

    PBQ scores

Secondary outcomes

  1. Anxiety

    Time frame: 1-15 months post birth

    Anxiety scores (DASS-21)

  2. PTSD symptoms

    Time frame: 1-15 months post birth.

    City Birth Trauma Scale scores

  3. Self-harm

    Time frame: 1-15 months post birth

    Scores from self-harm question on Edinburgh Postnatal Depression Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Anderson, PhD Candidate

CONTACT

[email protected]

+447957955462

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Burdett Trust for Nursing
  • Wellbeing of Women

Registry information

Acronym: GABI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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