Standardisation, acceptability and outcomes of elective (planned) caesarean births where the baby's head is delivered first, and the baby is not fully delivered until after they have taken their first cry or 2 minutes have passed (whichever is sooner)
| ISRCTN | ISRCTN15774307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15774307 |
| Integrated Research Application System (IRAS) | 325202 |
| Protocol serial number | R&D 5238 |
| Sponsor | North Bristol NHS Trust |
| Funder | Southmead Hospital Charity Research Fund |
- Submission date
- 22/05/2025
- Registration date
- 16/01/2026
- Last edited
- 15/01/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Whilst in the womb, a baby’s lungs are filled with fluid, which helps them grow and develop. During labour and birth, most of this fluid goes away, as the baby transitions from life in the womb to breathing air. Some babies might take longer to clear this fluid after they are born, so the lungs can remain “wet” for longer, making it harder to breathe until the fluid clears. When this happens, babies breathe faster and shallower, a condition known as Transient Tachypnea of the Newborn (TTN) and they often need some additional help with breathing, antibiotics to prevent or clear infection, and sometimes a stay in a Neonatal Intensive Care Unit.
The condition TTN is twice as common in babies born by planned caesarean than those born vaginally. Babies born via Caesarean are typically born very quickly which may not give them enough time to clear this fluid, and transition well to breathing air.
In this world-first study, we aim to assess a new way to perform a planned CB: a ‘Time-to-Transition- Caesarean Birth’. Rather than being born rapidly after opening the womb, the doctor will deliver the baby’s head and keep the body inside the womb until the baby starts to cry: a process designed to mimic the transition time which happens in vaginal births. This extra time may help the baby to transition to breathing air and has the potential to reduce the risk of TTN. As with any CB, the mother and baby will be closely monitored and if there are any concerns the baby will be immediately delivered. Everything else about the CB and recovery afterwards will remain unchanged.
Reducing “wet lungs” (and TTN) at birth could improve the experience for many families in the first few weeks after their planned caesarean birth and could result in cost-savings for the NHS.
The aim of the study is to investigate if it is possible (feasible) to conduct a larger study to determine if a “Time-to-Transition caesarean birth (CB)” improves the health of newborn babies.
Who can participate?
We will recruit 34 women at Southmead Maternity Unit.
Women will be able take part if they are:
• pregnant with one baby
• planning to have Caesarean birth
• and if baby’s position is “head-down”
What does the study involve?
This study will investigate the possibility of performing a “Time-to-Transition Caesarean Birth”. We will video the births, so we are able to learn from each of them. We will ensure we can accurately collect health information about both mother and baby from the Hospital records and in the first four weeks after birth. We will ask women and their birth partner their views on their birth experience and ask healthcare professionals their views on the births too.
What are the possible benefits and risks of participating?
We don’t know if this new method is better than a routine caesarean birth. We hope that the Time-to-Transition birth will reduce the chance your baby will have wet lungs and are less likely to need help breathing, antibiotics, or a stay in NICU. But we can’t be sure. This study will help us find out. For that reason, we don’t know if there will be any direct benefit to you or your baby, but you may be helping families in the future once the results of this study are known.
We don’t expect the Time-to-Transition birth will be riskier to you or your baby. During all caesarean births, including a Time-to-Transition caesarean birth, the mother is monitored closely for blood loss and the baby is monitored for colour, tone, heart rate and breathing. Your baby will be birthed immediately if there are any concerns about you or your baby.
Where is the study run from?
This study is being carried out by staff at North Bristol NHS Trust and the University of the West of England. Pregnant women who are having a planned caesarean section at Southmead Maternity Unit will be approached and offered study participation by a member of their care team.
When is the study starting and how long will it run for?
March 2024 to September 2024.
Who is funding the study?
This study is funded by donations made to the Southmead Hospital Charity, Bristol (UK)
Who is the main contact?
Dr Joanna Crofts at Southmead Hospital (North Bristol NHS Trust), Joanna.Crofts@nbt.nhs.uk.
Contact information
Public, Scientific, Principal investigator
R&D
Level 3 Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0009-0000-8452-7595 |
|---|---|
| Phone | +44 117 4149330 |
| joanna.crofts@nbt.nhs.uk |
Public, Scientific, Principal investigator
R&D
Level 3 Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| ORCID ID |
0000-0002-9178-102X |
|---|---|
| Abi.Loose@nbt.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre observational feasibility study |
| Secondary study design | Feasibility study |
| Participant information sheet | 47386_PIS_Birth Partner_v1.2_18Jul2023.pdf |
| Scientific title | Time-to-Transition Caesarean Birth Study: A study investigating the feasibility of a “Time-to-Transition Caesarean Birth” |
| Study acronym | Time-to-Transition Caesarean Birth Study |
| Study objectives | During an uncomplicated CB there are seconds between opening the uterus and birth. This rapidity relates to historic concerns regarding maternal blood loss (in general the longer the uterus remains open, the greater the maternal blood loss) however, a rapid birth provides the neonate with very little time to adapt to the ex-utero environment. This contrasts with babies born through the birth canal when the body is usually born several minutes after the head, during which time breathing and fluid drainage from the mouth frequently occurs. These natural events may be fundamental to a successful neonatal transition; their lack during CB may contribute to the higher incidence of TTN. Slowing the birth of babies born by CB has the potential to reduce the incidence of TTN. The intervention to be studied is novel: a ‘Time-to-Transition Caesarean Birth’ during which the birth of the baby from the uterus will be slowed with the intention of providing the baby with more time to transition from in-utero to ex-utero life. The CB will be conducted as per routine practice until the birth of the baby’s head. Once the baby’s head has been delivered from the uterine cavity onto the maternal abdomen, the body of the baby will be left inside the uterus to allow the baby to commence spontaneous respiration whilst remaining attached to the placental circulation. The body will be delivered 30 seconds after the first cry (approximately 20 neonatal breaths) or at 120 seconds, whichever is sooner. Neonatal and maternal condition will be monitored throughout, as per routine care, and the birth will be expedited and the intervention ceased if any concerns arise. The uterine incision will be under tension (stretched and compressed by the fetal trunk) and therefore maternal bleeding during the delayed delivery is expected to be minimal. |
| Ethics approval(s) |
Approved 01/08/2023, South Central - Berkshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048276; berkshireb.rec@hra.nhs.uk), ref: 23/SC/0228 |
| Health condition(s) or problem(s) studied | Planned (elective) caesarean section |
| Intervention | Novel intervention called "time-to-transition caesarean birth". Fetal head delivered first, and fetal body remains in the uterine cavity until either: • 30 seconds have passed since first cry OR • 120 seconds have passed – whichever is soonest Delivery will be expedited if there are concerns about either neonatal or maternal condition. In a routine caesarean birth, the fetal head is delivered first, followed immediately by body (usually over a duration of two to 10 seconds). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Proportion of births in which the fetal body remained in the uterine cavity after the delivery of the fetal head and shoulders until either (i) 30 seconds passed since first cry, or (ii) 120 seconds have passed (whichever is sooner) was achieved measured using patient records |
| Key secondary outcome measure(s) |
1. Maternal Outcomes |
| Completion date | 18/09/2024 |
Eligibility
| Participant type(s) | Patient, Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 34 |
| Total final enrolment | 34 |
| Key inclusion criteria | Women will be included if they are having a planned Caesarean Birth and are: 1. Aged ≥16 years 2. Singleton pregnancy 3. Cephalic presentation 4. Gestational age* at birth between 37+0 and 42+0 weeks (*determined by early ultrasound scan) 5. Willingness for caesarean birth to be filmed using Hospital cameras Birth partners will be included if they: 1. Aged ≥16 years 2. Are present during the birth of a woman recruited into the clinical study |
| Key exclusion criteria | Women will be excluded if they: 1. Are unable to provide informed consent 2. Multiple pregnancy 3. Ruptured membranes 4. Non-cephalic presentation (e.g. breech, oblique or transverse presentations) 5. Suspected abnormally invasive placenta 6. Anterior low-lying placenta 7. Known or suspected significant fetal abnormality 8. Caesarean birth under general anaesthetic 9. Declines consent to filming Birth partners will be excluded if they are unable to provide informed consent |
| Date of first enrolment | 08/03/2024 |
| Date of final enrolment | 20/06/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 18/07/2023 | 14/01/2026 | No | Yes |
| Participant information sheet | version 1.3 | 18/07/2023 | 14/01/2026 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 47386_PIS_Birth Partner_v1.2_18Jul2023.pdf
- Participant information sheet
- 47386_PIS_Feasibility_v1.3_18Jul2023.pdf
- Participant information sheet
Editorial Notes
23/05/2025: Trial's existence confirmed by South Central - Berkshire B Research Ethics Committee.
