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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perinatal Death; Intensive Care, Neonatal
• Intervention / Treatment: Behavioral: Birth within 7 minutes of rumping; Behavioral: Premature cord clamping

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 neonatal death or admission to the neonatal intensive care unit (NICU) occurs following the birth, the time between the birth of the fetal pelvis and the birth of the aftercoming head will be greater than three minutes more often than it is among the controls, where no death or NICU admission has occurred. The hypothesis was developed from what is already known from previous research by Reitter, Halliday and Walker (2020). The study found that the time between the birth of the pelvis and the birth of the aftercoming head is more than three minutes in only 25% per cent of breech births with good outcomes. Spillane et al's study hypothesised that this interval would be more than three minutes in 75% of births where death or a NICU admission occurred.

Spillane et al's power calculation determined that a sample size of fifteen cases and thirty controls would be required to infer an association between a pelvis to head interval of >3 minutes and the composite neonatal outcome (death or NICU admission), with a confidence interval of 95% and a power of 80%. The results of that study confirmed that association (p=<.0005).

We have not re-calculated sample size. Our aims in this study are to confirm the results of the original study by replication in multiple different settings and to explore additional confounding variables that may only be apparent in larger data sets. We are particularly interested in the influence of immediate cord clamping on these outcomes, but it was not possible to calculate a sample size based on the original study due to none of the cases having anything other than immediate cord clamping (n=0). Therefore, we are seeking a larger sample size in the hopes of being able to identify an appropriate sample size for future research, and to confirm the results of the previous study.

All anonymised data gathered in each site will be combined and analysed as a single data set by the Co-Investigators. The complete anonymised data set, combining data from all sites, will be downloaded and stored within the KCL Sharepoint for analysis.

We will first calculate the time to event interval for all variables of interest and report descriptive statistics for all variables, including means, medians and range for continuous variables. Exposures and confounders will also be converted into binary variables, reflecting the cut-offs used in the Physiological Breech Birth Algorithm. These will then be tested against the primary outcome using the non-parametric chi-square, or Fisher's Exact tests where cell frequencies are too small for the chi-square test.

Linear and logistic regression analysis will be used to test the predictive values of meeting or exceeding the recommended time limits in the Physiological Breech Birth Algorithm, and of maintaining and intact umbilical cord until the onset of respiration or not. Further linear and logistic regression analyses will be conducted with all variables that show an association with the composite neonatal outcome to determine their predictive value, and additional variables to explore their potential as confounding factors for investigation in future studies.

• Study Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

• Study Contact: Name: Shawn Walker, PhD; Phone Number: 07947819122; Email: Shawn.Walker@kcl.ac.uk
• Study Contact Backup: Name: Emma Spillane, MSc; Phone Number: 07951291826; Email: E.Spillane@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital
    • Contact: Shawn Walker, PhD; Phone Number: 07947819122; Email: Shawn.Walker@kcl.ac.uk
  • London, United Kingdom
    • Guy's and St Thomas' NHS Foundation Trust
    • Contact: Andrew Shennan, Prof
  • London, United Kingdom, TW7 6AF
    • West Middlesex Hospital
    • Contact: Shawn Walker, PhD; Phone Number: 07947819122; Email: Shawn.Walker@kcl.ac.uk
  • London, United Kingdom
    • Frimley Health NHS Foundation Trust
    • Contact: Hannah Mullins, BSc
  • London, United Kingdom
    • Kingston University Hospital NHS Trust
    • Contact: Emma Spillane, MSc; Email: E.Spillane@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Admission to NICU or early perinatal death	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; Other Names: Adherence to physiological breech birth algorithm; Behavioral: Premature cord clamping; Umbilical cord clamping <1 minute following birth; Other Names: Immediate cord clamping
Controls; No admission to NICU or early perinatal death	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; Other Names: Adherence to physiological breech birth algorithm; Behavioral: Premature cord clamping; Umbilical cord clamping <1 minute following birth; Other Names: Immediate cord clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Shawn Walker, King's College London

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2022
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (ACTUAL): February 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: NICU; Physiological Breech Birth Algorithm; premature cord clamping; early perinatal death
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Perinatal Death
• Other Study ID Numbers: IRAS 309591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Study Protocol -- on registration Clinical Study Report -- on publication
• IPD Sharing Access Criteria: Data will be available for 10 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No