Optimal Time Intervals for Vaginal Breech Births: A Multi-Site Case-Control Study
1 other identifier
observational
225
1 country
5
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 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.
Trial Health
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participants targeted
Target at P75+ for all trials
Started Feb 2022
5 active sites
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2022
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedFebruary 3, 2022
January 1, 2022
1.7 years
January 24, 2022
January 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Admission to neonatal unit
Admission to intensive care or special care neonatal unit
Immediately following a vaginal breech birth
Early perinatal death
Neonatal death
Within 6 days following a vaginal breech birth
Composite primary outcome
Neonatal death or admission
Up to 6 days following birth
Study Arms (2)
Cases
Admission to NICU or early perinatal death
Controls
No admission to NICU or early perinatal death
Interventions
Birth within 7 minutes of rumping (+3 station), within 5 minutes of birth of pelvis, within 3 minutes of birth of umbilicus
Umbilical cord clamping \<1 minute following birth
Eligibility Criteria
Vaginal breech births will be identified by the local PI, who is a member of the clinical care team, through a search of routine electronic healthcare records. Once vaginal breech births have been identified, the primary outcome will be identified for each record in time-descending order, beginning with the most recent vaginal breech birth. When a case (NICU admission or neonatal death) is identified, then two controls will be identified in time-descending order and matched for parity with the case. Only the medical records which have been identified as cases and controls for the study will be accessed for data collection.
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- Guy's and St Thomas' NHS Foundation Trustcollaborator
Study Sites (5)
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
West Middlesex Hospital
London, TW7 6AF, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shawn Walker
King's College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2022
First Posted
February 3, 2022
Study Start
February 1, 2022
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
February 3, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Study Protocol -- on registration Clinical Study Report -- on publication
- Access Criteria
- Data will be available for 10 years
Fully anonymised data will also be uploaded onto an online open access repository as part of the publication process, to ensure sufficient peer review and public scrutiny. Published results will not contain any personal data that could allow identification of individual participants or the location of the births included in the analysis.