Childbirth ProblemsPDMCNCT07357064
Professional Decision Making in Childbirth.
An observational study of Childbirth Problems, run by King's College London at 1 site in United Kingdom.
Trial summary
The study is an ethnography of clinician decision making in/during childbirth for medical interventions. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childbirth Problems
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Maternity clinicians in an NHS maternity unit
Who may be able to join
- Maternity clinicians (midwives and obstetricians, who are the clinical decision makers in childbirth)
Who cannot join
- Non maternity clinicians (neonatologists, anaesthetists, maternity support workers, who may be influential to decisions made but are not the accountable decision makers)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, London
Glen Nishku, MSc, 078473 826406, glen.nishku@nhs.net
Laura McCabe, MSc, 078473 826406, laura.mccabe10@nhs.net
About this study
Official title: Proessional Decision Making in Childbirth.
The study is an ethnography of clinician decision making in/during childbirth for medical interventions.
Read the detailed description
Medical interventions in childbirth have risen rapidly in high income countries over the last decade and this global phenomenon is reflected in the United Kingdom with, for example, caesarean section rates in England rising by 17% in the last four years to account for an average 45% of all births in 2024. Medical interventions in childbirth can be essential and have contributed to saving the lives of millions of women and children but the underpinning issues for this large rise in medical interventions in childbirth are not clear although certainly complex and multi - factorial.
The management of risk in childbirth is a central consideration as it is well documented as a key influence for professional decision making. The aim of this research study is to describe and analyse the influences on contemporary professional decisions for medical interventions in childbirth, within which risk - - how it is perceived and negotiated by clinicians and birthing parents, and the context and frameworks that support decisions to intervene or not intervene - is likely to be key.
This is a qualitative observational study with ethnography as the methodology. This approach is appropriate to explore how risk and decision making are constructed in real time contemporary frontline professional practice because it will observe what clinicians actually do (not just what they say they do) and how they create their decisions and rationales through their everyday work and professional and organisational interactions.
This research study is important because it will contribute to further understanding professional decision making for medical interventions in childbirth within a national background context of rising medical interventions, and concern about maternity care. There is not to our knowledge published qualitative research regarding this contemporary context.
This study explores professional decision making in a co - located Obstetric Unit (OU) and Alongside Midwifery Unit (AMU) in one NHS trust. A one study site is not a limitation for an in depth ethnography that will describe and analyse and the influences and complexities of contemporary clinician decision making, and from that build new insights and themes. This study as a qualitative ethnographic study will generate rich in-depth research insights that may be transferable to similar maternity settings.
- Conditions
- Childbirth Problems
- Keywords
- Childbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Midwives and obstetricians | Decision making for medical interventions in childbirth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician decisions for medical interventions in childbirth.
This is a qualitative ethnographic study collecting qualitative data from observation and interviews with clinicians about their clinical practice and decisions for (or not for) medical interventions in childbirth. Therefore there are no specific quantitative outcome measures included. However ethnographic data will collate decisions (yes/no for medical interventions in childbirth), and code the rationales underpinning these.
Measured: From enrolment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childbirth ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Claire Feeley, PhD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357064
- Sponsor's protocol ID
- 365059
- Acronym
- PDMC
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atkinson, P., Coffey, A., Delamont, S., Lofland, J., &Lofland, L. (2009). Handbook of Ethnography. Sage :London. Brocklehurst, P. & Kwee, A. (2011). Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study. BMJ 2011: 343: d7400 Coxon, K., Scammell, M.& Alaszewski, A. (2012). Risk, pregnancy and childbirth: What do we currently know and what do we need to know? An editorial. Health, Risk & Society. Vol 14, 2012, Issue 6, pages 503 - 510. https://doi.org/10.1080/13698575.2012.709486 Department of Health & Social Care. (2025). New Maternity Inquiry launched to Drive Improvements. Gov.uk Downe, S. & Kingdon, C. (2025).Caesareans are rising fast in the UK - but giving birth is getting worse for women. The Conversation, January 2025 Gulmezoglu, AM., Lawrie, TA., Hezelgrave, N., et al (2016). Interventions to Reduce Maternal and Newborn Morbidity and Mortality. In R. Black, R. Laxminarayan, & M. Temmerman (Eds) (2016) Maternal, Newborn and Child Health: Disease Control Priorities. 3rd Edition (Vol 2). https://www.ncbi.nih.gov/books/NBK361904/doi:10.1596?978-1-4648-0348-2_ch7 Hammersley, M. & Atkinson, P. (2019). Ethnography: Principles in Practice. Routledge: London and New York Healy, S., Humphreys, E., & Kennedy, C. (2016).Midwives' and obstetricians' perceptions of risk and its impact on clinical decision making in labour: An integrative review. Women and Birth Vol 29, Issue 2, April 2016, pages107 - 116 Healy, S., Humphreys, E., & Kennedy, C. (2017). A qualitative exploration of how midwives' and obstetricians' perception of risk affects care practices for low-risk women and normal birth. Women and Birth Vol 30, Issue 5, October 2017, pages 367-375 James, N.(1984). A postscript to nursing. In Bell, C. & Roberts, H. (Eds.) Social Researching: Politics, Problems, Practice. Routledge: London Kirkup, B. (2015). The Report of the Morecambe Bay Investigation. Indep
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proessional Decision Making in Childbirth.
- ClinicalTrials.gov ID
- NCT07357064
- Acronym / sponsor ID
- PDMC / 365059
- Conditions
- Childbirth Problems
- Keywords
- Childbirth
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is an ethnography of clinician decision making in/during childbirth for medical interventions.
Detailed description
Medical interventions in childbirth have risen rapidly in high income countries over the last decade and this global phenomenon is reflected in the United Kingdom with, for example, caesarean section rates in England rising by 17% in the last four years to account for an average 45% of all births in 2024. Medical interventions in childbirth can be essential and have contributed to saving the lives of millions of women and children but the underpinning issues for this large rise in medical interventions in childbirth are not clear although certainly complex and multi - factorial.
The management of risk in childbirth is a central consideration as it is well documented as a key influence for professional decision making. The aim of this research study is to describe and analyse the influences on contemporary professional decisions for medical interventions in childbirth, within which risk - - how it is perceived and negotiated by clinicians and birthing parents, and the context and frameworks that support decisions to intervene or not intervene - is likely to be key.
This is a qualitative observational study with ethnography as the methodology. This approach is appropriate to explore how risk and decision making are constructed in real time contemporary frontline professional practice because it will observe what clinicians actually do (not just what they say they do) and how they create their decisions and rationales through their everyday work and professional and organisational interactions.
This research study is important because it will contribute to further understanding professional decision making for medical interventions in childbirth within a national background context of rising medical interventions, and concern about maternity care. There is not to our knowledge published qualitative research regarding this contemporary context.
This study explores professional decision making in a co - located Obstetric Unit (OU) and Alongside Midwifery Unit (AMU) in one NHS trust. A one study site is not a limitation for an in depth ethnography that will describe and analyse and the influences and complexities of contemporary clinician decision making, and from that build new insights and themes. This study as a qualitative ethnographic study will generate rich in-depth research insights that may be transferable to similar maternity settings.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midwives and obstetricians | – | –Decision making for medical interventions in childbirth |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Maternity clinicians in an NHS maternity unit
Key inclusion criteria (1 listed)
- Maternity clinicians (midwives and obstetricians, who are the clinical decision makers in childbirth)
Key exclusion criteria (1 listed)
- Non maternity clinicians (neonatologists, anaesthetists, maternity support workers, who may be influential to decisions made but are not the accountable decision makers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinician decisions for medical interventions in childbirth.
Time frame: From enrolment to 6 months
This is a qualitative ethnographic study collecting qualitative data from observation and interviews with clinicians about their clinical practice and decisions for (or not for) medical interventions in childbirth. Therefore there are no specific quantitative outcome measures included. However ethnographic data will collate decisions (yes/no for medical interventions in childbirth), and code the rationales underpinning these.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- BackgroundAtkinson, P., Coffey, A., Delamont, S., Lofland, J., &Lofland, L. (2009). Handbook of Ethnography. Sage :London. Brocklehurst, P. & Kwee, A. (2011). Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study. BMJ 2011: 343: d7400 Coxon, K., Scammell, M.& Alaszewski, A. (2012). Risk, pregnancy and childbirth: What do we currently know and what do we need to know? An editorial. Health, Risk & Society. Vol 14, 2012, Issue 6, pages 503 - 510. https://doi.org/10.1080/13698575.2012.709486 Department of Health & Social Care. (2025). New Maternity Inquiry launched to Drive Improvements. Gov.uk Downe, S. & Kingdon, C. (2025).Caesareans are rising fast in the UK - but giving birth is getting worse for women. The Conversation, January 2025 Gulmezoglu, AM., Lawrie, TA., Hezelgrave, N., et al (2016). Interventions to Reduce Maternal and Newborn Morbidity and Mortality. In R. Black, R. Laxminarayan, & M. Temmerman (Eds) (2016) Maternal, Newborn and Child Health: Disease Control Priorities. 3rd Edition (Vol 2). https://www.ncbi.nih.gov/books/NBK361904/doi:10.1596?978-1-4648-0348-2_ch7 Hammersley, M. & Atkinson, P. (2019). Ethnography: Principles in Practice. Routledge: London and New York Healy, S., Humphreys, E., & Kennedy, C. (2016).Midwives' and obstetricians' perceptions of risk and its impact on clinical decision making in labour: An integrative review. Women and Birth Vol 29, Issue 2, April 2016, pages107 - 116 Healy, S., Humphreys, E., & Kennedy, C. (2017). A qualitative exploration of how midwives' and obstetricians' perception of risk affects care practices for low-risk women and normal birth. Women and Birth Vol 30, Issue 5, October 2017, pages 367-375 James, N.(1984). A postscript to nursing. In Bell, C. & Roberts, H. (Eds.) Social Researching: Politics, Problems, Practice. Routledge: London Kirkup, B. (2015). The Report of the Morecambe Bay Investigation. Indep
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Feeley, PhD study director
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childbirth Problems, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Naish, MA, MSc (07494028198, deborah.naish@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician decisions for medical interventions in childbirth. (time frame: From enrolment to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07357064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.