Perinatal Death Clinical Trial
Official title:
Optimal Time Intervals for Vaginal Breech Births: A Multi-Site Case-Control Study
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 perinatal death following vaginal breech births. We aim to determine the predictive value of: 1) adherence/non-adherence to the Physiological Breech Birth Algorithm; and 2) premature cord clamping (<1 minute following birth) for admission to the neonatal unit and/or perinatal death following vaginal breech births. The secondary objectives are to: 1) test all variables for a single-factor association with the primary outcome; and 2) test the predictive values of associated variables using linear regression; in order to 3) explore other factors contributing to adverse outcomes in vaginal breech births.
Status | Not yet recruiting |
Enrollment | 225 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital | London | |
United Kingdom | Frimley Health NHS Foundation Trust | London | |
United Kingdom | Guy's and St Thomas' NHS Foundation Trust | London | |
United Kingdom | Kingston University Hospital NHS Trust | London | |
United Kingdom | West Middlesex Hospital | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Admission to neonatal unit | Admission to intensive care or special care neonatal unit | Immediately following a vaginal breech birth | |
Primary | Early perinatal death | Neonatal death | Within 6 days following a vaginal breech birth | |
Primary | Composite primary outcome | Neonatal death or admission | Up to 6 days following birth |
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