Dataset Information

The Collaborative IPD of Sleep and Stillbirth (Cribss): is maternal going-to-sleep position a risk factor for late stillbirth and does maternal sleep position interact with fetal vulnerability? An individual participant data meta-analysis study protocol.

ABSTRACT: INTRODUCTION:Accumulating evidence has shown an association between maternal supine going-to-sleep position and stillbirth in late pregnancy. Advising women not to go-to-sleep on their back can potentially reduce late stillbirth rate by 9%. However, the association between maternal right-sided going-to-sleep position and stillbirth is inconsistent across studies. Furthermore, individual studies are underpowered to investigate interactions between maternal going-to-sleep position and fetal vulnerability, which is potentially important for producing clear and tailored public health messages on safe going-to-sleep position. We will use individual participant data (IPD) from existing studies to assess whether right-side and supine going-to-sleep positions are independent risk factors for late stillbirth and to test the interaction between going-to-sleep position and fetal vulnerability. METHODS AND ANALYSIS:An IPD meta-analysis approach will be used using the Cochrane Collaboration-endorsed methodology. We will identify case-control and prospective cohort studies and randomised trials which collected maternal going-to-sleep position data and pregnancy outcome data that included stillbirth. The primary outcome is stillbirth. A one stage procedure meta-analysis, stratified by study with adjustment of a priori confounders will be carried out. ETHICS AND DISSEMINATION:The IPD meta-analysis has obtained central ethics approval from the New Zealand Health and Disability Ethics Committee, ref: NTX/06/05/054/AM06. Individual studies should also have ethical approval from relevant local ethics committees. Interpretation of the results will be discussed with consumer representatives. Results of the study will be published in peer-reviewed journals and presented at international conferences. PROSPERO REGISTRATION NUMBER:CRD42017047703.

SUBMITTER: Li M

PROVIDER: S-EPMC5898330 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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The Collaborative IPD of Sleep and Stillbirth (Cribss): is maternal going-to-sleep position a risk factor for late stillbirth and does maternal sleep position interact with fetal vulnerability? An individual participant data meta-analysis study protocol.

Li Minglan M Thompson John M D JMD Cronin Robin S RS Gordon Adrienne A Raynes-Greenow Camille C Heazell Alexander E P AEP Stacey Tomasina T Culling Vicki V Bowring Victoria V Mitchell Edwin A EA McCowan Lesley M E LME Askie Lisa L

BMJ open 20180410 4

<h4>Introduction</h4>Accumulating evidence has shown an association between maternal supine going-to-sleep position and stillbirth in late pregnancy. Advising women not to go-to-sleep on their back can potentially reduce late stillbirth rate by 9%. However, the association between maternal right-sided going-to-sleep position and stillbirth is inconsistent across studies. Furthermore, individual studies are underpowered to investigate interactions between maternal going-to-sleep position and feta ...[more]

PMID: 29643161

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Project description:BackgroundMaternal supine going-to-sleep position has been associated with increased risk of late stillbirth (≥ 28 weeks), but it is unknown if the risk differs between right and left side, and if some pregnancies are more vulnerable.MethodsSystematic searches were undertaken for an individual-level participant data (IPD) meta-analysis of case-control studies, prospective cohort studies and randomised trials undertaken up until 26 Jan, 2018, that reported data on maternal going-to-sleep position and stillbirth. Participant inclusion criteria included gestation ≥ 28 weeks', non-anomalous, singleton pregnancies. The primary outcome was stillbirth. A one-stage approach stratified by study and site was used for the meta-analysis. The interaction between supine going-to-sleep position and fetal vulnerability was assessed by bi-variable regression. The multivariable model was adjusted for a priori confounders. Registration number: PROSPERO, CRD42017047703.FindingsSix case-control studies were identified, with data obtained from five (cases, n = 851; controls, n = 2257). No data was provided by a sixth study (cases, n = 100; controls, n = 200). Supine going-to-sleep position was associated with increased odds of late stillbirth (adjusted odds ratio [aOR] 2.63, 95% CI 1.72-4.04, p < 0.0001) compared with left side. Right side had similar odds to left (aOR 1.04, 95% CI 0.83-1.31, p = 0.75). There were no significant interactions between supine going-to-sleep position and assessed indicators of fetal vulnerability, including small-for-gestational-age infants (p = 0.32), maternal obesity (p = 0.08), and smoking (p = 0.86). The population attributable risk for supine going-to-sleep position was 5.8% (3.2-9.2).InterpretationThis IPD meta-analysis confirms that supine going-to-sleep position is independently associated with late stillbirth. Going-to-sleep on left or right side appears equally safe. No significant interactions with our assessed indicators of fetal vulnerability were identified, therefore, supine going-to-sleep position can be considered a contributing factor for late stillbirth in all pregnancies. This finding could reduce late stillbirth by 5.8% if every pregnant woman ≥ 28 weeks' gestation settled to sleep on her side.

Project description:Background and objectivesSleep-disordered breathing (SDB) affects up to one third of women during late pregnancy and is associated with adverse pregnancy outcomes, including hypertension, diabetes, impaired fetal growth, and preterm birth. However, it is unclear if SDB is associated with late stillbirth (≥28 weeks' gestation). The aim of this study was to investigate the relationship between self-reported symptoms of SDB and late stillbirth.MethodsData were obtained from five case-control studies (cases 851, controls 2257) from New Zealand (2 studies), Australia, the United Kingdom, and an international study. This was a secondary analysis of an individual participant data meta-analysis that investigated maternal going-to-sleep position and late stillbirth, with a one-stage approach stratified by study and site. Inclusion criteria: singleton, non-anomalous pregnancy, ≥28 weeks' gestation. Sleep data ('any' snoring, habitual snoring ≥3 nights per week, the Berlin Questionnaire [BQ], sleep quality, sleep duration, restless sleep, daytime sleepiness, and daytime naps) were collected by self-report for the month before stillbirth. Multivariable analysis adjusted for known major risk factors for stillbirth, including maternal age, body mass index (BMI kg/m2), ethnicity, parity, education, marital status, pre-existing hypertension and diabetes, smoking, recreational drug use, baby birthweight centile, fetal movement, supine going-to-sleep position, getting up to use the toilet, measures of SDB and maternal sleep patterns significant in univariable analysis (habitual snoring, the BQ, sleep duration, restless sleep, and daytime naps). Registration number: PROSPERO, CRD42017047703.ResultsIn the last month, a positive BQ (adjusted odds ratio [aOR] 1.44, 95% confidence interval [CI] 1.02-2.04), sleep duration >9 hours (aOR 1.82, 95% CI 1.14-2.90), daily daytime naps (aOR 1.52, 95% CI 1.02-2.28) and restless sleep greater than average (aOR 0.62, 95% CI 0.44-0.88) were independently related to the odds of late stillbirth. 'Any' snoring, habitual snoring, sleep quality, daytime sleepiness, and a positive BQ excluding the BMI criterion, were not associated.ConclusionA positive BQ, long sleep duration >9 hours, and daily daytime naps last month were associated with increased odds of late stillbirth, while sleep that is more restless than average was associated with reduced odds. Pregnant women may be reassured that the commonly reported restless sleep of late pregnancy may be physiological and associated with a reduced risk of late stillbirth.

Project description:OBJECTIVE:To report maternal sleep practices in women who experienced a stillbirth compared with controls with ongoing live pregnancies at similar gestation. DESIGN:Prospective case-control study. SETTING:Forty-one maternity units in the United Kingdom. POPULATION:Women who had a stillbirth after ? 28 weeks' gestation (n = 291) and women with an ongoing pregnancy at the time of interview (n = 733). METHODS:Data were collected using an interviewer-administered questionnaire that included questions on maternal sleep practices before pregnancy, in the four weeks prior to, and on the night before the interview/stillbirth. MAIN OUTCOME MEASURES:Maternal sleep practices during pregnancy. RESULTS:In multivariable analysis, supine going-to-sleep position the night before stillbirth had a 2.3-fold increased risk of late stillbirth [adjusted Odds Ratio (aOR) 2.31, 95% CI 1.04-5.11] compared with the left side. In addition, women who had a stillbirth were more likely to report sleep duration less than 5.5 hours on the night before stillbirth (aOR 1.83, 95% CI 1.24-2.68), getting up to the toilet once or less (aOR 2.81, 95% CI 1.85-4.26), and a daytime nap every day (aOR 2.22, 95% CI 1.26-3.94). No interaction was detected between supine going-to-sleep position and a small-for-gestational-age infant, maternal body mass index, or gestational age. The population-attributable risk for supine going-to-sleep position was 3.7% (95% CI 0.5-9.2). CONCLUSIONS:This study confirms that supine going-to-sleep position is associated with late stillbirth. Further work is required to determine whether intervention(s) can decrease the frequency of supine going-to-sleep position and the incidence of late stillbirth. TWEETABLE ABSTRACT:Supine going-to-sleep position is associated with 2.3× increased risk of stillbirth after 28 weeks' gestation. PLAIN LANGUAGE SUMMARY:Stillbirth, the death of a baby before birth, is a tragedy for mothers and families. One approach to reduce stillbirths is to identify factors that are associated with stillbirth. There are few risk factors for stillbirth that can be easily changed, but this study is looking at identifying how mothers may be able to reduce their risk. In this study, we interviewed 291 women who had a stillbirth and 733 women who had a live-born baby from 41 maternity units throughout the UK. The mothers who had a stillbirth were interviewed as soon as practical after their baby died. Mothers who had a live birth were interviewed during their pregnancies at the same times in pregnancy as when the stillbirths occurred. We did not interview mothers who had twins or who had a baby with a major abnormality. Mothers who went to sleep on their back had at least twice the risk of stillbirth compared with mothers who went to sleep on their left-hand side. This study suggests that 3.7% of stillbirths after 28 weeks of pregnancy were linked with going to sleep lying on the back. This study also shows that the link between going-to-sleep position and late stillbirth was not affected by the duration of pregnancy after 28 weeks, the size of the baby, or the mother's weight. Women who got up to the toilet once or more at night had a reduced risk of stillbirth. This is the largest of four similar studies that have all shown the same link between the position in which a mother goes to sleep and stillbirth after 28 weeks of pregnancy. Further studies are needed to see whether women can easily change their sleep position in late pregnancy and whether changing the position a mother goes to sleep in reduces stillbirth.

Project description:BackgroundPublic health and clinical recommendations are established from systematic reviews and retrospective meta-analyses combining effect sizes, traditionally, from aggregate data and more recently, using individual participant data (IPD) of published studies. However, trials often have outcomes and other meta-data that are not defined and collected in a standardized way, making meta-analysis problematic. IPD meta-analysis can only partially fix the limitations of traditional, retrospective, aggregate meta-analysis; prospective meta-analysis further reduces the problems.MethodsWe developed an initiative including seven clinical intervention studies of balanced energy-protein (BEP) supplementation during pregnancy and/or lactation that are being conducted (or recently concluded) in Burkina Faso, Ethiopia, India, Nepal, and Pakistan to test the effect of BEP on infant and maternal outcomes. These studies were commissioned after an expert consultation that designed recommendations for a BEP product for use among pregnant and lactating women in low- and middle-income countries. The initiative goal is to harmonize variables across studies to facilitate IPD meta-analyses on closely aligned data, commonly called prospective meta-analysis. Our objective here is to describe the process of harmonizing variable definitions and prioritizing research questions. A two-day workshop of investigators, content experts, and advisors was held in February 2020 and harmonization activities continued thereafter. Efforts included a range of activities from examining protocols and data collection plans to discussing best practices within field constraints. Prior to harmonization, there were many similar outcomes and variables across studies, such as newborn anthropometry, gestational age, and stillbirth, however, definitions and protocols differed. As well, some measurements were being conducted in several but not all studies, such as food insecurity. Through the harmonization process, we came to consensus on important shared variables, particularly outcomes, added new measurements, and improved protocols across studies.DiscussionWe have fostered extensive communication between investigators from different studies, and importantly, created a large set of harmonized variable definitions within a prospective meta-analysis framework. We expect this initiative will improve reporting within each study in addition to providing opportunities for a series of IPD meta-analyses.

Project description:BackgroundLate stillbirth continues to affect 3-4/1000 pregnancies in high-resource settings, with even higher rates in low-resource settings. Reduced foetal movements are frequently reported by women prior to foetal death, but there remains a poor understanding of the reasons and how to deal with this symptom clinically, particularly during the preterm phase of gestation. We aimed to determine which women are at the greatest odds of stillbirth in relation to the maternal report of foetal movements in late pregnancy (≥ 28 weeks' gestation).MethodsThis is an individual participant data meta-analysis of all identified case-control studies of late stillbirth. Studies included in the IPD were two from New Zealand, one from Australia, one from the UK and an internet-based study based out of the USA. There were a total of 851 late stillbirths, and 2257 controls with ongoing pregnancies.ResultsIncreasing strength of foetal movements was the most commonly reported (> 60%) pattern by women in late pregnancy, which were associated with a decreased odds of late stillbirth (adjusted odds ratio (aOR) = 0.20, 95% CI 0.15 to 0.27). Compared to no change in strength or frequency women reporting decreased frequency of movements in the last 2 weeks had increased odds of late stillbirth (aOR = 2.33, 95% CI 1.73 to 3.14). Interaction analysis showed increased strength of movements had a greater protective effect and decreased frequency of movements greater odds of late stillbirth at preterm gestations (28-36 weeks' gestation). Foetal hiccups (aOR = 0.45, 95% CI 0.36 to 0.58) and regular episodes of vigorous movement (aOR = 0.67, 95% CI 0.52 to 0.87) were associated with decreased odds of late stillbirth. A single episode of unusually vigorous movement was associated with increased odds (aOR = 2.86, 95% CI 2.01 to 4.07), which was higher in women at term.ConclusionsReduced foetal movements are associated with late stillbirth, with the association strongest at preterm gestations. Foetal hiccups and multiple episodes of vigorous movements are reassuring at all gestations after 28 weeks' gestation, whereas a single episode of vigorous movement is associated with stillbirth at term.

Dataset Information

The Collaborative IPD of Sleep and Stillbirth (Cribss): is maternal going-to-sleep position a risk factor for late stillbirth and does maternal sleep position interact with fetal vulnerability? An individual participant data meta-analysis study protocol.

Publications

The Collaborative IPD of Sleep and Stillbirth (Cribss): is maternal going-to-sleep position a risk factor for late stillbirth and does maternal sleep position interact with fetal vulnerability? An individual participant data meta-analysis study protocol.

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