Danielle Wilson

and 4 more

Reply to the Letter to the Editor by Kember et al, Regarding Wilson et al., “A Position Modification Device for the Prevention of Supine Sleep During Pregnancy: A Randomised Crossover Trial” Published in the British Journal of Obstetrics & Gynaecology on 16 September 2024.Danielle L. Wilson, MSc., PhD1,2,3; Carley Whenn1; Maree Barnes, MBBS1,4; Susan P. Walker, MBBS, MD, FRANZCOG, DDU, CMFM2,5; Mark E Howard, MBBS, FRACP, GDEB, PhD1,41Institute for Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia;2Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia.3School of Electrical Engineering and Computer Science, The University of Queensland, St Lucia, Queensland, Australia.4Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.5Mercy Perinatal, Mercy Hospital for Women, Heidelberg, Victoria, Australia.Address correspondence to: Danielle L. Wilson, Institute for Breathing and Sleep, Level 5 Harold Stokes Building, Austin Health, Heidelberg, Victoria, Australia. Tel: 613 9496 3517; Fax: 613 9496 5124; e-mail: [email protected] Prof. Aris Papageorghiou,We thank Dr. Kember and his colleagues1 for their interest in our recently published article2. Firstly, we acknowledge the recent publication by Coleman et al3 regarding the benefits of the Prenabelt on foetal growth, as revealed through re-analysis of their data using Bayesian methods. Unfortunately, this paper3 was published after our initial submission. Interestingly, while the frequentist analysis approach just fell short of significance, a Bayesian approach shows promise for supine sleep position interventions, by throwing an interesting light on the likelihood of a benefit depending on prior clinical beliefs. It remains that the mechanisms of action need further exploration however, given that supplemental data from the original publication4 suggests that objectively measured supine sleep in a subset of women did not differ between those using Prenabelt v sham.Secondly, we recognise our study was constrained by the measurement device used. The Night Shift Sleep Positioner (Night Shift) with neck placement was initially chosen, however, during our study a chest belt was introduced by the manufacturer. We performed a sub-study with N=20 of the participants wearing the device at both neck and abdominal placements for one night. An epoch-by-epoch comparison revealed substantial agreement between the two devices for all sleep positions with 88% concordance overall (unweighted κ = .797 [SE .006], p<.001). Regrettably, we neglected to include these data within the original publication.Despite the limitations of our measurement device, we believe that distinguishing between neck and pelvic position would not have substantially impacted our conclusions, given the high concordance between neck and abdominal devices revealed above, and particularly given that the intervention showed a nonsignificant increase in the proportion of supine sleep overnight. As Dr. Kember’s team have demonstrated, sleep positions where the thorax and pelvis are discordant (e.g., supine thorax with left pelvis tilt) are infrequent, occurring in less than 6% of “real-world” sleeping positions during pregnancy.5We agree that the Night Shift lacked sufficient resolution to fully appreciate the complex interplay between maternal positioning and foetal haemodynamics, as mentioned in the limitations section of our paper. Indeed, measurement limitations persist with all position sensing methodologies including infra-red video monitoring, with Dr. Kember’s recent paper5 demonstrating that while the most commonly occurring sleeping positions (left-lateral, right-lateral and supine) were well-recognised by modelling, the twisted/hybrid positions had intermediate performance, with the modelling particularly challenged by left or right tilted positions. To address the limitations of the Night Shift, we have recently completed data collection on a subsequent study using tri-axial accelerometry at abdominal level to characterise maternal sleep position in degrees of roll around the axial plane, with an aim to capture the subtleties of maternal position on uteroplacental haemodynamics and foetal growth.As mentioned, this is an understudied area. Dr. Kember and his team share our drive to gather objective evidence of a causal pathway between supine sleep position and foetal wellbeing, which we believe is particularly important given current guidelines regarding safe sleeping position in late pregnancy are based on retrospective cohort studies of self-reported “going-to-sleep” position. Our team congratulates Dr. Kember and his colleagues for their excellent work in the sleep position during pregnancy space, and we look forward to the outcomes from their upcoming DOSAGE Study.Disclosure of Interests:The authors have no financial disclosures or conflicts of interest.Contributions of Authorship:Dr. Wilson, Prof. Walker and Prof. Howard drafted and revised the manuscript, Ms. Whenn and Dr. Barnes critically revised the manuscript.Details of Ethics Approval:Additional analyses comparing device location were approved under an amendment to the original approval by the Mercy Hospital for Women Human Research Ethics Committee project number 2020-015, on 3rd June 2021.References:https://doi.org/10.1111/1471-0528.179521. Kember A. Placeholder for Letter to the Editor for BJOG.2. Wilson Danielle L, Whenn C, Barnes M, Walker Susan P, Howard Mark E. A position modification device for the prevention of supine sleep during pregnancy: A randomised crossover trial. BJOG: An International Journal of Obstetrics & Gynaecology. 2024; .3. Coleman J, Grewal S, Warland J, Hobson S, Liu K, Kember A. Maternal positional therapy for fetal growth and customised birth weight centile benefit in a Bayesian reanalysis of a double-blind, sham-controlled, randomised clinical trial. BMJ Open. 2024; 14 (4): e078315.4. Coleman J, Okere M, Seffah J, et al. The Ghana PrenaBelt trial: a double-blind, sham-controlled, randomised clinical trial to evaluate the effect of maternal positional therapy during third-trimester sleep on birth weight. BMJ Open. 2019; 9 (4): e022981.5. Kember AJ, Zia H, Elangainesan P, et al. Transitioning sleeping position detection in late pregnancy using computer vision from controlled to real-world settings: an observational study. Sci Rep. 2024; 14 (1): 17380.

Danielle Wilson

and 4 more

Objective: to assess the effectiveness and acceptability of a pillow-like position modification device to reduce supine sleep during late pregnancy, and to determine the impacts on the severity of sleep-disordered breathing (SDB) and fetal wellbeing. Design: Randomised cross-over study Setting and population: Individuals in the third trimester of pregnancy receiving antenatal care at a tertiary maternity hospital in Australia. Methods: Participants used their own pillow for a control week and an intervention pillow for a week overnight, in randomized order. Sleep position and total sleep time for each night of both weeks was objectively monitored, with a sleep study and fetal heart rate monitoring performed on the last night of each week. Main Outcome Measures: Percentage of sleep time in the supine position, apnoea-hypopnoea index, fetal heart rate decelerations and birthweight. Results: Forty-one individuals were randomized with data collected on 35 participants over 469 nights. There was no difference in percentage of total sleep time in the supine position overnight between the control or intervention pillow week (13.0% [6.1, 25.5] v 16.0% [5.6, 27.2], p = .81), and no difference in the severity of SDB or fetal heart rate decelerations across weeks. However, increased supine sleep was significantly related to a higher apnea-hypopnea index (r s = .37, p = .003), lower birthweight (r s = -.45, p = .007) and lower customised birthweight centile (r s = -.45, p = .006). The proportion of supine sleep each night of the week varied widely both within and across participants, despite awareness of side-sleeping recommendations. Conclusions: The adoption of a pillow designed to discourage supine sleep was not effective in late pregnancy, with women spending an average of one hour per night supine. Supine sleep was associated with SDB and lower birthweight. Alternative devices should be investigated, incorporating lessons learnt from this study to inform trials of supine sleep minimisation in pregnancy. Clinical Trial Registration Number – ACTRN12620000371998 (Australia New Zealand Clinical Trials Registry)