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- W2887232008 abstract "Free AccessPositional TherapyModifying Maternal Sleep Position in Late Pregnancy Through Positional Therapy: A Feasibility Study Jane Warland, PhD, Jillian Dorrian, PhD, Allan J. Kember, BSc, Craig Phillips, PhD, Ali Borazjani, PhD, Janna L. Morrison, PhD, Louise M. O'Brien, PhD Jane Warland, PhD Address correspondence to: Jane Warland, University of South Australia, GPO Box 2471, Adelaide, South Australia 5001 E-mail Address: [email protected] Mother's Babies and Families Research Group, School of Nursing and Midwifery, University of South Australia, Adelaide, South Australia, Australia Search for more papers by this author , Jillian Dorrian, PhD Behaviour-Brain-Body Research Centre, Sleep and Chronobiology Laboratory, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, South Australia, Australia Search for more papers by this author , Allan J. Kember, BSc Dalhousie Medical School, Dalhousie University, Halifax, Nova Scotia, Canada Global Innovations for Reproductive Health and Life (GIRHL) Cleveland, Ohio Search for more papers by this author , Craig Phillips, PhD School of Nursing and Midwifery, University of South Australia, Adelaide, South Australia, Australia; Global Innovations for Reproductive Health and Life (GIRHL) Cleveland, Ohio Search for more papers by this author , Ali Borazjani, PhD Global Innovations for Reproductive Health and Life (GIRHL) Cleveland, Ohio Search for more papers by this author , Janna L. Morrison, PhD Early Origins of Adult Health Research Group, School of Pharmacy and Medical Sciences, Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia Search for more papers by this author , Louise M. O'Brien, PhD Sleep Disorders Center and Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan Search for more papers by this author Published Online:August 15, 2018https://doi.org/10.5664/jcsm.7280Cited by:11SectionsAbstractPDF ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutABSTRACTStudy Objectives:To test whether a customized positional therapy device, PrenaBelt, would reduce time spent sleeping supine and evaluate any change in maternal or fetal parameters, in a group of healthy pregnant women in the third trimester of pregnancy.Methods:Participants underwent an in-home, overnight sleep study during late pregnancy (32–38 weeks). Participants were observed over 2 nights: 1 night when the PrenaBelt was not worn (nonintervention or control) and 1 night when it was (intervention). The intervention night was randomly allocated, and the study nights were consecutive. On the control night, participants were filmed using a night-capable (infrared) video camera, maternal sleep was measured by the Watch-PAT200, and the fetus was continuously monitored using the Monica AN24. On the intervention night, video, maternal, and fetal monitoring were repeated with the addition of the mother wearing the PrenaBelt.Results:A total of 25 healthy pregnant women were studied. Four had missing data for the Watch-PAT or Monica, and eight had missing or disrupted video data. Video-determined time in bed was not significantly different during intervention and control nights (P = .196, r = −.23). Median time spent supine during the intervention night was reduced from 48.3 minutes, to 28.5 minutes during the control night (P = .064, r = −.33). The difference in the proportion of time spent supine was significant (P = .039). There was no significant difference in objectively estimated sleep time (P = .651, r = −.07). Improvement was observed in both maternal and fetal parameters during the intervention night with an increase in median minimum maternal oxygen saturations (control = 91.6%, intervention = 92.4%, P = .006, r = −.42), fewer maternal oxygen desaturations (control = 7.1, intervention = 5.9, P = .095, r = −.26), and fewer fetal heart rate decelerations (control = 14.0, intervention = 10.4, P = .045, r = −.31) compared to the control night.Conclusions:Results provide preliminary evidence that an intervention to reduce supine sleep in late pregnancy may provide maternal and fetal health benefits, with minimal effect on maternal perception of sleep quality and objectively estimated sleep time. Further research to explore relationships between objectively determined maternal sleep position, maternal respiratory indices, and fetal well-being is warranted.Citation:Warland J, Dorrian J, Kember AJ, Phillips C, Borazjani A, Morrison JL, O'Brien LM. Modifying maternal sleep position in late pregnancy through positional therapy: a feasibility study. J Clin Sleep Med. 2018;14(8):1387–1397.BRIEF SUMMARYCurrent Knowledge/Study Rationale: Research suggests that modifying maternal sleep position, especially the position in which pregnant women go to sleep, may be one way to reduce stillbirth. Positional therapy is a well-accepted means to reduce supine sleep time in the adult (nonpregnant) population with sleep-disordered breathing. However, it is not known whether positional therapy is similarly effective in the pregnant population.Study Impact: The current study shows that wearing a customized positional therapy device significantly reduces time spent sleeping supine in late pregnancy, without significant effect on length and quality of sleep and with beneficial physiological effects for both the pregnant mother and her fetus. Future research is therefore needed to further explore the most effective means of promoting lengthy non-supine sleep in late pregnancy.INTRODUCTIONIn obstetrics, it is well known that when a pregnant woman assumes the supine position, whether during the day, during labor, or on the operating table, maternal cardiovascular parameters1–13 and/or fetal oxygenation4,11,12 are altered, occasionally causing substantial fetal heart rate changes.12,13 However, until recently, there has been little evidence on the effect of the supine position during sleep in pregnancy. Several epidemio-logical studies now suggest that maternal supine sleep position may be a risk factor for stillbirth14–19 and/or low birth weight/ fetal growth restriction (FGR); birth weight less than 2.5 kg or < 10th centile for gestational age.16,19 One suggested mechanism for the effect of supine sleep in late pregnancy focuses on occlusion of the inferior vena cava (running down the right side of the mother's body), and subsequent deprivation of oxygen to the fetus.9 It has also been suggested that supine sleep may influence maternal and fetal health via exacerbating symptoms of sleep-disordered breathing (SDB), including snoring, apnea, and hypopnea.20This research is of interest because supine sleeping position is potentially modifiable. There have been many and varied methods proposed to avoid supine sleep in the general population. For example, in the late 18th century and early 20th century, soldiers in the American War of Independence and World War I were told to sleep with their rucksacks filled and strapped to their back in order to avoid supine-related snoring and thereby disclose their position to the enemy.21 In 1984, in a letter to the editor of Chest, a patient's wife explained how she cured her husband's snoring/apnea problem by sewing “a pocket into the back of a T-shirt” and inserting “a hollow, lightweight plastic ball (about the size of a tennis ball)” in order to prevent him from sleeping on his back.22 This form of intervention—preventing individuals from assuming the supine position during sleep—is now known as positional therapy (PT). PT is a noninvasive, inexpensive, long-established, safe, and effective treatment option for individuals with position-dependent snoring and mild to moderate obstructive sleep apnea (OSA).23–28 There are several ways PT may be used to alert the supine individual to change position, including pressure points, auditory alarms, and vibratory alarms. PT may also be used to restrict the individual's position on the sleeping surface and thus prevent him/her from adopting the supine position in the first place.Given the emerging research indicating that supine sleep may have a negative effect on fetal well-being in late pregnancy and that this position may be relatively easy to modify in pregnancy, we conducted a study to determine the effect, on maternal and fetal parameters, of a PT device. In 2014, members of our team (AK, AB) developed a PT device specifically for use in pregnancy, called “PrenaBelt” (Global Innovations for Reproductive Health and Life, Cleveland, Ohio, United States) (Figure 1). The PrenaBelt is designed to cause subtle pressure points on the pregnant user's lower back and buttocks when she lies in the supine position and thereby activate her body's natural mechanism to spontaneously reposition to maintain comfort. We aimed to test the effectiveness of this device to reduce time spent sleeping supine in a group of healthy pregnant women in the third trimester of pregnancy, without negative effects on sleep duration or quality, and also to determine whether maternal and fetal indices of sleep quality and health improved as a result.Figure 1: PrenaBelt: a positional therapy device designed specifically for pregnant women.PrenaBelt (Global Innovations for Reproductive Health & Life, Cleveland, Ohio, USA Patent #WO2016176632A1). Device for investigational use only. BPS = body position sensor.Download FigureSpecifically, we hypothesized that wearing a customized PT device during late pregnancy would be associated with: A reduction in the amount of time spent sleeping supine;No differences in sleep duration or sleep efficiency;Lower maternal apnea-hypopnea index, and higher maternal oxygen saturations; andFewer fetal heart rate (FHR) decelerations. In order to explore the effect of supine position-related SDB on these relationships, participants were also classified according to whether they met criteria for SDB (while not wearing the device). Analyses explored differences with and without the device as well as by SDB status.METHODSSample and ProcedureHealthy pregnant women were recruited to the study via convenience29 and snowball sampling.30 Study flyers, with study details and eligibility information, were placed around the participating university's campuses and community notice boards. Potential participants who saw the flyer and expressed interest by contacting the researchers were sent the information sheet; if they were still interested, they were booked into the 2-night study. All women who expressed their interest in participating in the study were eligible and participated. Women who participated in the study were asked to share the study flyer with their pregnant friends. In this manner, we recruited healthy pregnant women (n = 25) for an in-home sleep study in late pregnancy (32–38 weeks).The study was conducted over 2 nights—1 night with no intervention and 1 night with intervention—using participants as their own control. The intervention night was randomly allocated and the study nights were consecutive. On the control (nonintervention) night, participants were filmed using a nightcapable (infrared) video camera, maternal sleep was monitored using the Watch-PAT200 (Itamar Medical Ltd., Cesarea, Israel) (Watch-PAT), and the fetus was continuously monitored using the Monica AN24 (Monica Healthcare Ltd., Nottingham, United Kingdom). On the intervention night, video, maternal, and fetal monitoring were repeated with the addition of the PrenaBelt. On the intervention night, a body position sensor (BPS) (HOBO Pendant G Data Logger, UA-004-64, Onset Computer Corporation, Cape Cod, Massachusetts, United States), was also placed in a pocket on the posterior aspect of the belt.A research assistant attended the home of the participant on the evening of both nights. She first gained written consent from the woman (and her bed partner) and then set up all equipment (as described in the next paragraphs). She returned the evening of the second night to collect the used equipment and replace with recharged equipment. Finally, she returned to the participant's home the morning after the second night of the study to collect all the equipment including the completed questionnaire. Participants were instructed to sleep as normal with regard to hours in bed, number of pillows used, and room lighting.QuestionnaireAll participants completed a short questionnaire regarding their usual sleep practices. We had used these questions previously.32 Questions included what position they usually slept in when not pregnant, and what position they had been sleeping in during the previous month. We also asked participants to estimate the time they spent sleeping supine on both study nights as well as a scaled question to determine potential effect of the study on sleep quality; this was “on a scale of 1–10 (1 restless and 10 sound) I would describe my quality of sleep last night as…” Finally, participants were asked to comment on the acceptability of wearing the PrenaBelt.Infrared Video CameraAn infrared-capable handheld video camera was positioned on a tripod at the end of the participant's side of the bed. The participant was asked to turn it on at lights out and off at lights on. The camera was in the participant's complete control. A research assistant was employed to view and score sleep position from the video tape. Sleep position was scored as supine, left, or right in 1-minute epochs from the video camera recordings. This was conducted using the same protocol as a previous published study.32 Thus, time spent sleeping supine was calculated.Watch-PATThe Watch-PAT is a portable diagnostic device that uses finger-based plethysmography to record the peripheral arterial tonometry (PAT) signal, maternal heart rate, blood oxygen saturation (SpO2), and actigraphy from a built-in actigraph. The Watch-PAT proprietary software algorithm analyzes the PAT signal amplitude along with the heart rate and SpO2 to estimate the apnea-hypopnea index (AHI). O'Brien and colleagues reported that in a pregnant population, the Watch-PAT demonstrates excellent sensitivity and specificity for identification of obstructive sleep apnea, defined as AHI ≥ 5 events/h on polysomnography.33 However, they also found that the Watch-PAT may overestimate the respiratory disturbance index (RDI) somewhat, especially at high RDI values, and has poor correlation with sleep stages33; these indices were therefore not included in this study. The Watch-PAT measures that were analyzed for this study included total sleep time during the sleep period (minutes), maternal AHI, minimum SpO2 (%), and maternal SpO2 desaturation count. For analysis, participants were also classified into a group as being likely to have SDB if they exhibited an AHI ≥ 5 events/h33,34 during their control night—SDB versus no SDB.Monica AN24Overnight fetal and maternal heart rate were recorded using the Monica AN24 (Monica Healthcare, Nottingham, United Kingdom). The research assistant applied the monitor each evening following the manufacturer's instructions for skin preparation, electrode placement, and impedance testing. The device records a fetal electrocardiography with true beat-to-beat intervals being recorded in 1-minute epochs without autocorrelation as used in commercial cardiotocography machines. The software provides hourly numerical values of accelerations and decelerations, extracted from an automated Dawes-Redman analysis35 and then provides summary statistics including large (> 15 bpm) and small (> 10 bpm) deceleration counts. Monica AN24 and Watch-PAT records were aligned and data collected during the measured sleep period were isolated for analysis.Body Position SensorThe BPS is a battery-powered, commercially-available, three-axis accelerometer for measuring three-dimensional motion during sports or medical therapy (HOBO Pendant G Data Logger). The PrenaBelt contains a pocket on the posterior aspect of the belt that allows for placement of sensors or other electronic components. On the intervention night, the BPS was placed in this pocket as an additional measure to validate the device's recording of body position against the video recording. The BPS data were downloaded to a computer using HOBOware software (Onset Computer Corporation, Cape Cod, Massachusetts, United States). The participants' body position (left, right, supine, prone) throughout the intervention night (BPS-determined body position) was resolved by analyzing the data via a custom Java code.Inclusion CriteriaSelf-declared healthy pregnancy (ie, no current medical or obstetric complications); self-declared gestational age between 32–38 weeks; singleton.Exclusion CriteriaBody mass index of ≥ 35 kg/m2 at the beginning of the pregnancy; multiple pregnancy; and known fetal abnormality.Ethics ApprovalEthics approval was gained from the UniSA Human Research Ethics committee, approval number 0000033795. All participants (and their bed partners) signed a consent form that included all the usual assurances of privacy and confidentiality and participant anonymity.AnalysesTwenty-five participants were recruited into the study, agreeing to be recorded for 2 nights each (Figure 2).Figure 2: CONSORT diagram.There were 25 participants enrolled into this repeated-measures study. Participants were randomized to completed either the intervention or the control night first. Equipment failures for Monica AN24, Watch-PAT, and video recordings are shown, leading to final complete datasets for both intervention and control nights of n = 18 for the primary video analyses, and n = 21 for the primary Monica AN24 and Watch-PAT analyses.Download FigureVideo-Determined Time in Bed and Sleep PositionThere were errors in the video recording for 7 participants, leaving 16 with video data for both nights (Figure 2). Wilcoxon Signed Rank Tests (and associated effect sizes) were used to examine within-subject differences in video-determined time in bed (TIB), time spent supine (minutes), and percentage of TIB spent supine on control compared to intervention nights. To visualize the effect of the intervention on position, lateral/supine position was plotted across elapsed TIB for 16 participants, who spent at least 5 hours in bed on both control and intervention nights. The number of participants on their back across elapsed TIB was also plotted on control compared to intervention nights. For proportion of time in bed spent supine, a generalized estimating equations (GEE) model for binomial distributions with a logit link function (appropriate for proportions) was also conducted, specifying a predictor of condition (control/intervention).Sleep Length, Quality, Sleep Position, Respiration and Heart RateOn 2 of the nights, the Monica AN24 failed to record, and on 1 night, because of dropout, the recording was not sufficient for analysis. Data for these two participants was excluded. Data from a third participant was excluded because on 1 night their Watch-PAT recording failed, and on the other night they withdrew partway through the night because of false labor pains. This left full Watch-PAT and Monica AN24 datasets for analysis (both nights) for 21 participants (Figure 2). Of these, 1 participant did not complete their sleep quality ratings. Wilcoxon signed-rank tests (and associated effect sizes) were used to examine within-subject differences between control and intervention nights in total sleep time (TST), TIB, sleep quality ratings, maternal respiratory indicators, and FHR.In order to explore the potential influence of SDB status on the control night (yes/no), a series of models were conducted. For continuous dependent variables maternal AHI, minimum and mean maternal blood oxygen saturation: minimum SPO2, average FHR, mixed-effects regression specified fixed effects of condition (control/intervention), SDB group (SDB/no SDB) and the condition × SDB group interaction, with a random effect of subject on the intercept. For parsimony, nonsignificant interaction effects were dropped in final reported models. To control for night (order) effects, order was entered as an additional predictor variable. However, it was not significant, nor did it influence the effect of the other predictors on the dependent variable, and therefore it was dropped from final models. This type of model allows for appropriate treatment of within-and between-subject variance.36 For count variables (maternal oxygen desaturation count, FHR deceleration count), GEE for Poisson distributions with a log link function (appropriate for count variables) specified a repeated effect of study night with an exchangeable covariance structure, and predictors of condition (control/intervention), SDB group (SDB/no SDB), and the condition × SDB group interaction. Nonsignificant interaction effects were dropped in final reported models.Body Position SensorOf the available 25 BPS/PrenaBelt nights total, we had 6 BPS/PrenaBelt nights with no video, leaving 19 for analysis. The ability of the BPS to correctly classify the participant's position (supine versus lateral) in comparison with the gold standard (infrared video) was evaluated via 2 × 2 contingency table and the sensitivity and specificity for the supine position classification were calculated.RESULTSParticipantsTable 1 shows the age and parity distribution for study participants. Although approximately 50% (n = 10) reported typically sleeping supine, self-reported frequency reduced to 30% during the month immediately before the study nights. Thirty percent (n = 7) met the cutoff for SDB during the control night.Table 1 Participant demographic and descriptive information (n = 21).Table 1 Participant demographic and descriptive information (n = 21).Video-Determined Sleep Position (n = 16)The effect size for differences in video-determined TIB on control and intervention nights was small to medium (r = .23, P = .196, Table 2). Effect sizes for differences in time spent supine (P = .064) and percentage of TIB spent supine (P = .074) were medium (Table 2). GEE (for proportions) yielded a significant difference in video-determined proportion of sleep time spent supine, indicating that it was significantly lower on the intervention night (B = 1.38, χ12 = 4.24, P = .039). Figure 3 shows the patterns in lateral/supine sleep by elapsed time in bed on control and intervention nights for each participant. Most participants showed reduced or eliminated supine sleep during the intervention night; however, 2 participants spent no time in the supine position during the first 5 hours of their TIB, and 1 participant did sleep in the supine position for more than 1 hour during the intervention night. Figure 4 provides a summary of number of participants on their back across elapsed TIB on the control compared to intervention nights.Table 2 Video-determined maternal sleep measures (n = 16) during the control night and the intervention (PrenaBelt) nights.Table 2 Video-determined maternal sleep measures (n = 16) during the control night and the intervention (PrenaBelt) nights.Figure 3: Sleep position for each participant (lines) on control (left) and intervention (right) nights by elapsed time in bed.n = 16 participants are shown. These participants have complete video records for both nights. The first 5 hours are shown, because these participants were in bed for at least 5 hours on both nights.Download FigureFigure 4: Number of participants on their back on control (dotted line) and intervention (solid line) nights by elapsed time in bed.n = 16 participants are shown. These participants have complete video records for at least 5 hours on both nights.Download FigureSleep Length and Self-Rated Sleep QualityTST was not significantly different on control and intervention nights (P = .651), with a very small effect size (Table 3). The effect size for the difference in sleep quality ratings between control and intervention nights (P = .118) was small to medium (Table 3). We also asked all our participants to comment on the acceptability of wearing the PrenaBelt, and 22 (88%) agreed that they would participate in such a study again.Table 3 Maternal sleep and respiratory measures (from the Watch-PAT) and fetal heart rate measures (from the Monica AN24) during the control night and the intervention (PrenaBelt) nights (n = 21).Table 3 Maternal sleep and respiratory measures (from the Watch-PAT) and fetal heart rate measures (from the Monica AN24) during the control night and the intervention (PrenaBelt) nights (n = 21).Maternal Respiratory Indicators and Fetal Heart RateInitial nonparametric comparisons between control and intervention nights revealed a small, nonsignificant effect for AHI (P = .276), small to medium effects for mean maternal oxygen desaturation (P = .190) and desaturation count (P = .095), and medium to large effects for minimum maternal oxygen desatu-ration (P = .006) and FHR deceleration count (P = .045).Analyses exploring the potential influence of SDB at baseline suggested that for those in the SDB group, there was a reduction in maternal AHI on the intervention, compared to control nights, whereas for others, maternal AHI was stable across both conditions (Figure 5). There was a significant main effect of SDB group for maternal AHI (F1,19.0 = 9.11, P = .007), with the effect of condition (F1,19.0 = 4.03, P = .059) and the SDB group × condition interaction effect (F1,19.0 = 3.95, P = .061) approaching significance (Figure 5). Maternal oxygen desaturation count was significantly lower during the intervention night (B = 0.18, χ12 = 5.28, P = .022), and for those without SDB (B = −1.56, χ12 = 4.58, P = .032). Minimum maternal oxygen saturation was significantly higher during the intervention night (F1,20.0 = 10.90, P = .004), but was not significantly different between SDB groups (F1,19.0 = 0.469, P = .502; Figure 2). There were no significant differences in mean maternal oxygen saturation by condition (F1,20.0 = 1.72, P = .204) or SDB group (F1,19.0 = 1.28, P = .271). FHR decelerations > 10 bpm were significantly lower during the intervention night (B = 0.296, χ12 = 5.24, P = .022), but were not significantly different between SDB groups (B = −0.073, χ12 = 0.12, P = .734).Figure 5: Maternal AHI, maternal oxygen desaturations, minimum maternal oxygen saturation, and FHR decelerations during the control and intervention nights by SDB group.n = 21 participants are shown (no SDB = 14, SDB = 7). AHI = apnea-hypopnea index, FHR = fetal heart rate, SDB = sleep-disordered breathing.Download FigureIllustrative Case ExampleResults from a single case, participant number 20, are shown in Figure 6 for the control (left) and intervention (right) nights. This case was chosen because there were noticeably more large (> 15 bpm) fetal heart rate decelerations (dark red) and small (10–15 bpm) decelerations (light red) relative to supine sleep position (lower section) on the control night relative to the intervention night. Maternal AHI and SPO2 desaturation count were also improved on the intervention night. Following the study, the patient was advised by the midwife on the research team (JW) to avoid supine sleep position for the remaining weeks of the pregnancy (she reported to us that her infant was born alive and well 2 weeks after the study nights).Figure 6: Example results from individual number 20 during the control (left) and intervention (right) nights.Large (>15 bpm, dark red) and small (>10 bpm, light red) FHR decelerations are shown (upper) relative to maternal sleep position (lower). Proportion of sleep time spent on back (red), left (green) and right (black) is shown across clock time. Maternal AHI and desaturation count for each night are also indicated. AHI = apnea-hypopnea index, FHR = fetal heart rate.Download FigureBody Position SensorThe video recording was not available for 6 participants; therefore, these participants were excluded from the sensitivity and specificity analysis. From the remaining 19 participants, we analyzed 14,838 30-second epochs of BPS-determined body position in comparison to the reference body position as determined by infrared video. The BPS identified supine sleeping position with a sensitivity of 48% and specificity of 93%. As would be expected in late pregnancy, no prone position was detected by either the video or BPS.DISCUSSIONOur findings indicate that reducing time spent in the supine maternal sleep position may confer benefits to the mother-baby dyad during late pregnancy. Although the exact mechanism for why the supine sleeping position is detrimental to the fetus is still not known, this study indicates that maternal oxygen desaturations and increased symptoms of SDB and FHR decelerations are more common when the mother is sleeping supine. The fetal response may be an adaptive response to either inferior vena cava (IVC) compression or maternal deoxygenation, or both.Our findings are supported by the earlier epidemiological studies14–19 with support from recent physiological work by Stone et al. who demonstrated that when women lie supine, whether that is during the day37 or during sleep,38 that the fetus is more likely to enter fetal behavioral state “1F.” This is a quiescent state, demonstrated by stable HR with little FHR variability (less than 5 bpm), and is thought to be oxygen/energy conserving.39 Interestingly, Stone et al. did not describe observing FHR decelerations when their pregnant participants assumed the supine position in either their daytime or overnight study. However, as reduction in FHR variability often occurs prior to any noticeable change in the HR itself,40 we surmise that most fetuses cope with the supine stressor by entering 1F, and only certain fetuses respond with significantly more FHR decelerations when the mothe" @default.
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- W2887232008 title "Modifying Maternal Sleep Position in Late Pregnancy Through Positional Therapy: A Feasibility Study" @default.
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