Optimal Time Intervals for Vaginal Breech Births: A Multi-Site Case-Control Study
NCT05223140 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 225
Last updated 2022-02-03
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 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.
Conditions
- Intensive Care, Neonatal
- Perinatal Death
Interventions
- BEHAVIORAL
-
Birth within 7 minutes of rumping
Birth within 7 minutes of rumping (+3 station), within 5 minutes of birth of pelvis, within 3 minutes of birth of umbilicus
- BEHAVIORAL
-
Premature cord clamping
Umbilical cord clamping \<1 minute following birth
Sponsors & Collaborators
-
Guy's and St Thomas' NHS Foundation Trust
collaborator OTHER - lead OTHER
Principal Investigators
-
Shawn Walker · King's College London
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2023-09-30
- Completion
- 2023-09-30
Countries
- United Kingdom
Study Locations
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