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Not yet recruiting 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

Observational General Anaesthesia During Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: General Anaesthesia During Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed 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.

Primary outcome measures

  • Postnatal depression [Time frame: 1-15 months post birth]
  • Newborn bonding [Time frame: 1-15 months post birth]
Secondary outcome measures (3)
  • Anxiety [Time frame: 1-15 months post birth]
  • PTSD symptoms [Time frame: 1-15 months post birth.]
  • Self-harm [Time frame: 1-15 months post birth]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Faculty of Life Science and Medicine — London

Publications

  • Wittkowski A, Vatter S, Muhinyi A, Garrett C, Henderson M. Measuring bonding or attachment in the parent-infant-relationship: A systematic review of parent-report assessment measures, their psychometric properties and clinical utility. Clin Psychol Rev. 2020 Dec;82:101906. doi: 10.1016/j.cpr.2020.101906. Epub 2020 Sep 3. PMID 32977111
  • Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 2002 Jul 18;347(3):194-9. doi: 10.1056/NEJMcp011542. No abstract available. PMID 12124409
  • Widstrom AM, Brimdyr K, Svensson K, Cadwell K, Nissen E. Skin-to-skin contact the first hour after birth, underlying implications and clinical practice. Acta Paediatr. 2019 Jul;108(7):1192-1204. doi: 10.1111/apa.14754. Epub 2019 Mar 13. PMID 30762247
  • Reck C, Hunt A, Fuchs T, Weiss R, Noon A, Moehler E, Downing G, Tronick EZ, Mundt C. Interactive regulation of affect in postpartum depressed mothers and their infants: an overview. Psychopathology. 2004 Nov-Dec;37(6):272-80. doi: 10.1159/000081983. Epub 2004 Nov 9. PMID 15539778
  • Pownall M, Hutter RRC, Rockliffe L, Conner M. Memory and mood changes in pregnancy: a qualitative content analysis of women's first-hand accounts. J Reprod Infant Psychol. 2023 Nov;41(5):516-527. doi: 10.1080/02646838.2022.2052827. Epub 2022 Mar 20. PMID 35306947
  • Powell DN, Leonhardt ND. A Longitudinal Examination of Mothers' Early Postnatal Adaptation: Relative Stability Across the First Eight Weeks. Matern Child Health J. 2023 Dec;27(12):2175-2184. doi: 10.1007/s10995-023-03776-4. Epub 2023 Sep 28. PMID 37768532
  • NMPA Project Team. National maternity and perinatal audit: clinical report (2019) Based on births in NHS maternity services between 1st April 2016 and 31st March 2017. Royal College of Obstetrics and Gynaecology, London 2019. NMPA Clinical Report 2019.pdf (maternityaudit.org.uk)
  • NMPA Project Team. National maternity and perinatal audit: clinical report (2021) Based on births in NHS maternity services between 1st April 2017 and 31st March 2018. Royal College of Obstetrics and Gynaecology, London 2019. NMPA Clinical Report 2019.pdf (maternityaudit.org.uk).

Identifiers

NCT: NCT07115823 · 359600 · RTF1201 · RTF1201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗