Effect of caesarean birth on perinatal mortality for singleton breech presentation in spontaneous preterm labour - a target trial emulation using Scottish health record data.

Abstract

Background The effects of mode of birth for women in preterm breech labour could not be successfully determined in randomised trials. We aimed to explore the effect of caesarean birth on perinatal mortality for women in spontaneous-onset preterm labour with a singleton baby presenting breech through target trial emulation.

Methods A target trial emulation of a parallel group randomised controlled trial using routinely collected Scottish electronic health record data was performed. Participants were pregnant women at 24- 36 gestational weeks with a singleton breech baby, no prior caesarean birth, in spontaneous labour with a live baby at labour onset (1 January 1997 to 31 December 2019). We compared caesarean birth (intervention) to vaginal breech birth (control) in a per-protocol analysis (actual mode of birth). The primary outcome was extended perinatal mortality (intrapartum stillbirths and neonatal deaths). A multiple logistic regression model with inverse probability weight was used to adjust for measured confounders.

There were 2,092 caesarean births and 967 vaginal breech births. In the emulated trial, caesarean birth reduced extended perinatal mortality compared to vaginal breech birth (odds ratio [OR] 0.31, 95% confidence interval [CI] 0.25 to 0.39). At 24 weeks’ gestation, caesarean birth decreased the odds of perinatal death by 47.7% (OR: 0.53, 95% CI: 0.35 to 0.78). At 36 gestational weeks it was associated with an 82.1% reduction in the odds of perinatal death (OR: 0.18, 95% CI: 0.10 to 0.32). As the risk of perinatal mortality is inversely correlated with gestational age at birth, seven and 88 caesarean births were needed to prevent one perinatal death at 24 weeks and 36 weeks’ gestation, respectively.

Conclusions Caesarean birth reduces the risk of extended perinatal mortality in spontaneous preterm singleton breech labour in a per-protocol trial emulation. Observational data that accurately captures planned mode of birth is required to emulate an intention-to-treat analysis.

Competing Interest Statement

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/. SJS declares she is the Program Director of the Wellcome Leap In Utero Program. She has received grant funding (paid to her institution) from Wellcome, MRC, CSO Scotland and Tommy?s. She has received consultancy fees from Natera and Norgine and honoraria for educational lectures from Hologic. All other authors declare no support from any organisation for the submitted work other than that described above no financial relationships with any organisations that might have an interest in the submitted work in the previous three years no other relationships or activities that could appear to have influenced the submitted work.

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Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval for usage of anonymised routinely collected data to enable this trial emulation was granted by the National Health Service Scotland Public Benefit and Privacy Panel for Health and Social Care (1819-0119) and the University of St Andrews Teaching and Research Ethics Committee (MD15778). Ethical approval included a waiver of informed written consent for individuals included within the study. Access to the datasets by the authorised researchers was exclusively within a Safe Haven environment after deidentification of the records.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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