Status:
UNKNOWN
Optimal Time Intervals for Vaginal Breech Births: A Multi-Site Case-Control Study
Lead Sponsor:
King's College London
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Intensive Care, Neonatal
Perinatal Death
Eligibility:
FEMALE
Brief Summary
This study uses a case-control design to test the hypotheses that avoidable delay in late second stage and premature cord clamping are associated with admission to the neonatal unit and/or early perin...
Detailed Description
This study replicates a previous successful pilot study (Spillane et al 2021). The sample size calculation for the original study was based on the hypothesis that among those breech births where a neo...
Eligibility Criteria
Inclusion
- CASES
- INCLUSION CRITERIA:
- Singleton pregnancy \> 37+0 weeks with a breech-presenting fetus born vaginally;
- Alive on admission to intrapartum care
- Admission to the neonatal unit or early neonatal death (within 6 days of birth);
- Healthcare professional in attendance.
- EXCLUSION CRITERIA
- Births which took place prior to the arrival of a trained health care professional;
- Major congenital anomaly, identified prior to or after birth, likely to have compromised neonatal condition.
- CONTROLS
- INCLUSION CRITERIA:
- Singleton pregnancy \> 37+0 weeks with a longitudinal breech-presenting fetus born vaginally;
- No admission to the neonatal unit or early neonatal death (within 6 days of birth);
- Healthcare professional in attendance;
- Occurring immediately prior to the matched case; and
- Matched for parity with that case (nullip/multip).
Exclusion
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT05223140
Start Date
February 1 2022
End Date
September 30 2023
Last Update
February 3 2022
Active Locations (5)
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1
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
2
West Middlesex Hospital
London, United Kingdom, TW7 6AF
3
Frimley Health NHS Foundation Trust
London, United Kingdom
4
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom