Summary Stillbirth is a major cause of mortality globally. In 2019, an estimated 1.9 million babies were stillborn, at least 84% of these babies were born in low- and middle-income countries. Recognizing maternal and newborn danger signs with timely care-seeking and attendance at the health facility could help to improve maternal and newborn outcomes and reduce the incidence of stillbirth. In high-income settings, observational studies have shown that lateral sleep position in the later stages of pregnancy can significantly reduce the risk of stillbirth. A 2019 meta-analysis found that the odds of stillbirth were greater in women who had slept in supine position during late pregnancy. An estimated 6% of stillbirths could be prevented with universal uptake of ‘sleep-on-side’ advice. As a result, “sleep on side†is now recommended for pregnant women in Australia from 28 weeks of pregnancy. In low- and middle-income settings there is limited data on women’s sleeping position during pregnancy. There has been no research on what advice antenatal care providers currently offer women in relation to sleep during pregnancy. The aims of this study are to understand maternal sleep position, patterns and behaviour among pregnant women in India; and current antenatal care practices in relation to giving sleep position advice during pregnancy. Aims and Objectives We aim to explore and measure sleep position amongst pregnant women in India, to help determine whether side sleeping advice could be an effective antenatal intervention to reduce stillbirth. We will also explore the knowledge, attitudes, and practices of antenatal care providers in India on maternal sleep position in pregnancy. This formative study will inform the development of future interventional research for evaluating safe sleeping advice during pregnancy in resource-limited-settings. The study objectives are: 1. Explore what constitutes a usual going-to-sleep position for pregnant women during their third trimester; 2. Measure the prevalence of supine usual going-to-sleep position amongst pregnant women who are attending antenatal care during the third trimester; 3. Understand current knowledge, attitudes and clinical practices of antenatal care providers in relation to women’s sleep position during pregnancy; 4. Explore knowledge, attitudes and clinical practices of antenatal care providers in relation to other stillbirth prevention interventions; 5. Explore the acceptability of a behaviour change intervention to promote side sleeping during pregnancy, from the perspective of antenatal care providers and pregnant women. 6. Review the local antenatal care guidelines and practices at national, state and facility levels. Methods Overview of study design A mixed-methods study, including: 1. In-depth interviews with pregnant women in their third trimester (15 - 20), to explore their usual sleep practices during pregnancy, and their acceptability of a sleep position intervention (Objectives #1 and #5). 2. A quantitative survey of 425 women attending antenatal care during the third trimester, to measure the proportion of pregnant women who report usually going to sleep in a supine position, and their acceptability of a sleep position intervention (Objectives #2 and #5). 3. In-depth interviews with antenatal care providers (15 - 20) to understand their views on sleep position advice for pregnant women in the third trimester, stillbirth prevention practices, and their acceptability of a sleep position intervention (Objectives #3, #4 and #5). Desk review of National, State and facility based antenatal care guidelines and/or standards of practice (Objective #6). Sites and setting Participants will be recruited from antenatal care facilities in Karnataka, India. We aim to ensure recruitment of participants across 1) public and private care facilities, 2) rural and urban areas and 3) tertiary, secondary, and primary care facilities. Recruitment will aim to balance participant characteristics (such as parity, socioeconomic status, education level and family living arrangements i.e., multigenerational or nuclear). This will ensure that participants with varying demographic characteristics are captured in the study to improve the generalizability. Study participants and eligibility criteria Pregnant women: Pregnant women at 28 to 36 weeks’ gestation attending antenatal care in participating clinics will be eligible. Gestational age reported in antenatal record and as determined by the healthcare providers (either using last menstrual period or ultrasound) will be acceptable. Women who are 18 years old and above, both primigravid and multigravida, will be eligible. Women are eligible regardless of whether they have other risk factors present. Antenatal care providers are those providing antenatal care in participating clinics (such as antenatal midwives, nurses, community health workers and doctors). All participants must be willing and able to provide informed consent. Recruitment Pregnant women will be recruited through antenatal clinics at the participating facilities. Antenatal care providers working at the participating facilities. Detailed methodology Table 1. Summary of study activity, data collection instruments and corresponding objectives | Study activity | Data collection instruments | Corresponding Study Objective | | Activity #1 – In-depth interviews with 15 - 20 pregnant women | 1. Woman demographic questionnaire 2. In-depth interview guide for pregnant women | Objectives #1 and #5 | | Activity #2 – Quantitative survey of 425 pregnant women | 3. Survey instrument | Objective #2 and #5 | | Activity #3 – In-depth interviews with 15 - 20 antenatal care providers | 4. Provider demographic questionnaire 5. In-depth interview guide for antenatal care providers | Objectives #3, #4 and #5 | | Activity #4 – Desk review of antenatal care guidelines | 6. Clinical practice guideline review tool | Objective #6 | Activity #1: In-depth interviews with pregnant women An interview guide will be developed and refined in consultation with the research team. It will be pilot tested on four pregnant women in selected study sites and then refined to ensure cultural relevance, prior to the start of the data collection. Potential participants will be given adequate information about the study to enable them to make an informed decision. Those who agree to participate will be provided with a written plain language summary and a verbal explanation in their preferred language. The research staff will include a ’teach-back’ process with all women to ensure comprehension of the consent form/plain language summary. Informed consent for participation and audio-recording will be sought from each potential participant. After informed consent has been given, basic demographic information about participants will be collected by the research team via REDCap surveys on tablets. The questionnaire will include questions about age, parity, level of education, occupation and family living arrangements. Refreshments will be provided prior to the interviews. Interviews will be conducted in a private setting at the health facility by a trained research staff in the participant’s preferred language. Interviews will be conducted with about 15 – 20 women, or until data saturation is achieved. It is anticipated that each interview will take between 30 - 45 minutes to complete. Field notes will also be taken by the research staff. Activity #2: A quantitative survey of pregnant women attending antenatal care services The quantitative survey will be developed by the research team using the REDCap software. The questionnaire will include questions pertaining to current sleep position, sleep position advice received and willingness to participate if there is an intervention to promote sleeping on the side in late pregnancy. The surveys will be pilot tested for reliability by administering and re-administering the survey (test-retest) to the same group of four pregnant women two weeks apart. Reliability will be measured using Cohen’s kappa measure of agreement for categorical variables and correlation test for continuous variables. The surveys will be electronic and will be administered by trained research staffs using tablets. In terms of sample size, the likely prevalence of the outcome of interest (proportion of pregnant women who usually go to sleep in a supine position during third trimester) is not known. We have therefore calculated sample size using a conservative estimate of 50% of women who report this outcome. With a Type 1 error rate (α) of 0.05 and precision of 0.05 (+/-5%), a sample size of 385 is required. We will therefore survey at least 425 women (allowing for an extra 10% in whom survey responses may not be complete) across the participating facilities. The survey is anticipated to take about 15 – 20 minutes to complete. Activity #3: In-depth interviews with antenatal care providers An interview guide will be developed and refined in consultation with the research team. It will include questions relating to the antenatal provider’s current knowledge, attitudes, and practices regarding 1) giving sleep advice during pregnancy; and 2) stillbirth prevention practices (such as detection and management of risk factors for fetal growth restriction and small-for-gestational age; symphysis fundal height measurements; discussions with women about monitoring movements, what to do if fetal movement is reduced, and timing of birth). We will also explore providers’ perspectives on the acceptability of sleep position interventions to women and the provider’s willingness to participate if there was an interventional trial on giving sleep advice during pregnancy in their setting. We will also ask questions to understand the current practices and protocols of the antenatal care facility in relation to sleep advice during pregnancy. Potential participants will be given adequate information about the study to enable them to make an informed decision. Those who agree to participate will be provided with a written plain language summary and a verbal explanation in their preferred language. The research staff will include a ’teach-back’ process with all participants to ensure comprehension of the consent form/plain language summary. Informed consent for participation and audio-recording will be sought from each potential participant. Following informed consent, basic demographic information will be collected through an electronic survey using tablets. The questionnaire will include questions pertaining to the number of years of practice and professional role (e.g., midwife, doctor etc). Refreshments will be provided prior to the interviews. Interviews will be conducted in a private setting at the health facility by a trained research staff in the participant’s preferred language. Interviews will be conducted with about 15 – 20 antenatal care providers, or until data saturation is achieved. It is anticipated that each interview will take between 30 - 45 minutes to complete. Field notes will also be taken by the research staffs. Activity #4: Desk review of antenatal care guidelines The National, State and facility-based antenatal care guidelines and standards of practice will be obtained from the relevant authorities and reviewed. The guidelines will be reviewed to obtain a comprehensive overview of the current practices and recommendations in relation to sleep position advice during late pregnancy. Consistency and completeness of guidelines across National, State and facility levels will be evaluated. The review findings will be narratively summarized and will provide context and understanding of the findings of the qualitative and quantitative findings. Data analysis Qualitative data All recordings will be transcribed verbatim initially into the language in which it was conducted and then translated into English by trained and experienced members of the research team. Thematic analysis will be conducted by the team using participatory and reflexive analysis practices to develop consensus and improve reliability. Throughout the data collection and analysis, we will practice critical reflexivity both as individuals and as the study team (Indian and Australian researchers). This will enable us to consider, acknowledge and reflect on how our own lived experiences, training, and perspectives on sleep and stillbirth shape and influence how we conduct the study and interpret the data. Themes will be derived through inductive hand-coding supported by qualitative analysis software (NVivo®). Quantitative data The primary outcomes include: 1. the prevalence of supine going-to-sleep position which will be reported as the proportion of women who report going to sleep in a supine position in the past week (Objective #2) 2. participant’s willingness to participate if there was an intervention to promote sleeping on the side in late pregnancy (Objective #5) The secondary outcomes include participant’s reasons for choice of sleeping position, proportion of participants who changed sleep position during pregnancy, and presence of personal beliefs around going-to-sleep position during pregnancy. Quantitative data will be summarized using descriptive statistics. Categorical data will be reported as frequencies and percentages while continuous data will be reported as means and standard deviations or medians and interquartile ranges as appropriate. Data analysis will be performed using Stata software. |