Optimal Time Intervals for Vaginal Breech Births: A Multi-Site Case-Control Study

Perinatal Death Clinical Trial

Official title:

Optimal Time Intervals for Vaginal Breech Births: A Multi-Site Case-Control Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05223140
• Other study ID #: IRAS 309591
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2022
• Source: King's College London
• Contact: Shawn Walker, PhD
• Phone: 07947819122
• Email: Shawn.Walker[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Intensive Care, Neonatal
• Perinatal Death

Intervention

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
• Premature cord clamping
Umbilical cord clamping <1 minute following birth

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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