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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223140 on ClinicalTrials.gov