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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)

Time-to-Transition Caesarean Birth Study: A study investigating the feasibility of a “Time-to-Transition Caesarean Birth”

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15774307
Enrollment
34
Registered
2026-01-16
Start date
2024-03-08
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Planned (elective) caesarean section Pregnancy and Childbirth

Interventions

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 •

Sponsors

North Bristol NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
1. Maternal Outcomes 1. Indication for caesarean birth is recorded from clinical records at time of delivery 2. Antenatal corticosteroid administration for fetal lung maturity is recorded from clinical records including gestational age at time of administration 3. Length of surgery is measured using operative time from knife-to-skin to wound closure recorded in theatre records at time of surgery 4. Weighed blood loss is measured using gravimetric method recorded in theatre records at time of surgery 5. Use of cell salvage and volume of blood re-infused is recorded from anaesthetic chart at time of surgery 6. Pre-operative haemoglobin is measured using full blood count from laboratory results within 24 hours prior to surgery 7. Post-operative Day 1 haemoglobin is measured using full blood count from laboratory results on Day 1 post-surgery 8. Blood pressure on admission is measured using automated sphygmomanometer and recorded in clinical notes at time of hospital admission 9. Lowest blood pressure pre-delivery in theatre is measured using anaesthetic monitoring and recorded in theatre records during surgery 10. Maternal febrile morbidity is measured using maximum recorded maternal temperature and duration of temperature =38°C from clinical records during hospital stay 11. Post-natal antibiotic treatment is recorded from medication administration records during postnatal hospital stay 12. Maternal length of stay is measured using admission and discharge dates from hospital records 13. Maternal readmission to hospital is recorded from hospital administrative data within 28 days post-discharge 2. Neonatal Outcomes 14. CTG classification post-regional anaesthetic is assessed using clinical interpretation of cardiotocography and recorded in clinical notes immediately following anaesthetic administration 15. Apgar scores at 1, 5 and 10 minutes are measured using standard Apgar scoring system recorded in neonatal records after complete delivery

Countries

England, United Kingdom

Contacts

Public ContactJoanna;Abi Crofts;Loose

;

joanna.crofts@nbt.nhs.uk;Abi.Loose@nbt.nhs.uk+44 117 4149330;-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026