NCT07115823

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2025Jun 2026

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

August 11, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

August 4, 2025

Last Update Submit

August 8, 2025

Conditions

Keywords

General anaesthetic caesarean birthMaternal mental healthNewborn bondingObstetric ICU admission

Outcome Measures

Primary Outcomes (2)

  • Postnatal depression

    Depression scores (DASS-21)

    1-15 months post birth

  • Newborn bonding

    PBQ scores

    1-15 months post birth

Secondary Outcomes (3)

  • Anxiety

    1-15 months post birth

  • PTSD symptoms

    1-15 months post birth.

  • Self-harm

    1-15 months post birth

Study Arms (2)

Women or birthing people who have given birth by GACS

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

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any woman or birthing person who has undergone a caesarean section with general or neuraxial anaesthesia in a UK based hospital within 12 months postpartum.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Life Science and Medicine

London, SE1 7EH, United Kingdom

Location

Related Publications (35)

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    BACKGROUND
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    BACKGROUND
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    PMID: 30279671BACKGROUND
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    PMID: 3651732BACKGROUND
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Related Links

Study Officials

  • Dr Hannah Rayment-Jones

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Anderson, PhD Candidate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

November 1, 2025

Primary Completion

March 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

August 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared as participants do not provide consent for the sharing of their data outside the research team, even in anonymised form.

Locations