'We did everything by phone': a qualitative study of mothers' experience of smartphone-aided screening of cerebral palsy in Kathmandu, Nepal.

BACKGROUND: International guidelines recommend early intervention to all children at risk of cerebral palsy, but targeted screening programs are often lacking in low- and middle-income settings with the highest burden of disease. Smartphone applications have the potential to improve access to early diagnostics by empowering parents to film their children at home followed by centralized evaluation of videos with General Movements Assessment. We explored mothers' perceptions about participating in a smartphone aided cerebral palsy screening program in Kathmandu, Nepal. METHODS: This is an explorative qualitative study that used focus group discussions (n = 2) and individual interviews (n = 4) with mothers of term-born infants surviving birth asphyxia or neonatal seizures. Parents used the NeuroMotion™ smartphone app to film their children at home and the videos were analysed using Precthl's General Movements Assessment. Sekhon et al.'s framework on the acceptability of health care interventions guided the design of the group discussions and interviews, and the deductive qualitative content analysis. RESULTS: Mothers were interested in engaging with the programme and expressed hope it would benefit their children. Most felt using the app was intuitive. They were, however, unclear about the way the analysis was performed. Support from the research team was often needed to overcome an initial lack of self-confidence in using the technology, and to reduce anxiety related to the follow-up. The intervention was overall perceived as recommendable but should be supplemented by a face-to-face consultation. CONCLUSION: Smartphone aided remote screening of cerebral palsy is acceptable in a lower middle-income population but requires additional technical support.

Armed conflict, insecurity, and attitudes toward women's and girls' reproductive autonomy in Nigeria.

BACKGROUND: Armed conflict and insecurity have been linked to deteriorations in reproductive health and rights globally. In Nigeria, armed violence has taken a significant toll on women's and girls' health and safety. However, knowledge is limited about how conflict shapes attitudes surrounding their ability to make autonomous decisions on relationships and childbearing. Drawing on a socioecological framework and terror management theory, we aimed to investigate the association between conflict, insecurity, and attitudes toward women's and girls' reproductive autonomy in Nigeria. METHODS: We conducted a cross-sectional study using data from two sources: the World Values Survey (WVS) and the Uppsala Conflict Data Program-Georeferenced Event Dataset (UCDP-GED). Nationally representative data on attitudes of 559 men and 534 women was collected by WVS in 2017-2018. Linear probability models estimated the association between attitudes toward five dimensions of women and girl's reproductive autonomy (contraception, safe abortion, marital decision-making, delayed childbearing, early marriage), respondents' perceptions of neighborhood insecurity using WVS data, and geospatial measures of conflict exposure drawn from UCDP-GED. RESULTS: Exposure to armed conflict and perceived neighborhood insecurity were associated with more supportive attitudes toward access to safe abortion among both men and women. Among women, conflict exposure was associated with higher support for contraception and the perception that early marriage can provide girls with security. Conflict-affected men were more likely to support a delay in girls' childbearing. CONCLUSION: Our findings suggest that conflict and insecurity pose a threat to, but also facilitate opportunities for, women's and girls' reproductive autonomy. Contraception, abortion, early marriage, and postponement or childbearing may be perceived as risk-aversion strategies in response to mortality threats, livelihood losses, and conflict-driven sexual violence. Our findings foreshadow changes in fertility and relationship patterns in conflict-affected Nigeria and highlight the need for health programming to ensure access to contraception and safe abortion services.

Regional lung targeting with a fluticasone/salmeterol aerosol using a bolus breath hold method of the PreciseInhale® system: A first evaluation in humans.

BACKGROUND: In development of inhaled drugs- and formulations the measured concentration in the systemic circulation is often used as a surrogate for local dosimetry in the lungs. To further elucidate regional differences in the fate of drugs in the lungs, different aerodynamic sizes of aerosols have been used to target major airway regions. An alternative approach to achieve regional targeting of aerosols, is to use a defined aerosol bolus together with a bolus breath hold strategy. A small volume of test aerosol is intercalated and stopped at different penetration depths, to achieve increased drug deposition at chosen lung locations. Drug permeation from the lung regions is then investigated by repeatedly sampling venous blood from the systemic circulation. The PreciseInhale® (PI) exposure platform was developed to allow generation of aerosols from different sources, including clinical inhalers, into a holding chamber, for subsequent use with alternative exposure modules in vitro and in vivo. In the current first-in-human study was investigated the feasibility of a new clinical exposure module added to the PI system. By extracting aerosol puffs from a medical inhaler for subsequent delivery to volunteers, it was possible to administer whole lung exposures, as well as regional targeting exposures. METHODS: Aerosols containing 250 µg/25 µg fluticasone propionate (FP)/salmeterol xinafoate (SMX) were automatically actuated and extracted from the pressurized Metered Dose Inhaler (pMDI) Evohaler Seretide forte into the PI system's holding chamber, then administered to the healthy volunteers using controlled flowrate and volume exposure cycles. Two main comparisons were made by measuring the systemic PK response: I. One label dose directly from the inhaler to the subject was compared to the same dose extracted from the pMDI into the PI system and then administered to the subject. II A small aerosol bolus at a penetration level in the central airways was compared to a small aerosol bolus at a penetration level in the peripheral lung. RESULTS AND CONCLUSIONS: When one inhaler dose was administered via the PI system, the absorbed dose, expressed as AUC24, was approximately twice as high and the CV was less than half, compared to direct inhalation from the same pMDI. Bolus breath hold targeting of drugs from the same aerosol mixture to the peripheral lung and the central airways showed a difference in their appearance in the systemic circulation. Normalized to the same deposited dose, SMX had a 57 % higher Cmax in the peripheral lung compared to the central airways. However, from 6 to 24 h after dosing the systemic concentrations of SMX from both regions were quite similar. FP had parallel concentrations curves with a 23 % higher AUC24 in the peripheral lung with no noticeable elevation around Cmax. The permeability of these two substances from similar sized aerosols was indeed higher in the thinner air/blood barriers of the peripheral lung compared to the central airways, but differences as measured on the venous side of the circulation were not dramatic. In conclusion, the PI system provided better control of actuation, aspiration, and dispensation of aerosols from the clinical inhaler and thereby delivered higher quality read outs of pharmacokinetic parameters such as tmax, Cmax, and AUC. Improved performance, using PI system, can likely also be employed for studying regional selectivity of other responses in the lungs, for use in drug development.

NeuroMotion smartphone application for remote General Movements Assessment: a feasibility study in Nepal.

OBJECTIVES: To evaluate the feasibility of using the NeuroMotion smartphone application for remote General Movements Assessment for screening infants for cerebral palsy in Kathmandu, Nepal. METHOD: Thirty-one term-born infants at risk of cerebral palsy due to birth asphyxia or neonatal seizures were recruited for the follow-up at Paropakar Maternity and Women's Hospital, 1 October 2021 to 7 January 2022. Parents filmed their children at home using the application at 3 months' age and the videos were assessed for technical quality using a standardised form and for fidgety movements by Prechtl's General Movements Assessment. The usability of the application was evaluated through a parental survey. RESULTS: Twenty families sent in altogether 46 videos out of which 35 had approved technical quality. Sixteen children had at least one video with approved technical quality. Three infants lacked fidgety movements. The level of agreement between assessors was acceptable (Krippendorf alpha 0.781). Parental answers to the usability survey were in general positive. INTERPRETATION: Engaging parents in screening of cerebral palsy with the help of a smartphone-aided remote General Movements Assessment is possible in the urban area of a South Asian lower middle-income country.

Association between delayed cesarean section and severe maternal and adverse newborn outcomes in the Somaliland context: a cohort study in a national referral hospital.

BACKGROUND: In a critical obstetric situation, the time interval between the decision of performing a caesarean section (CS) and delivery can influence maternal and newborn outcomes. In Somaliland, consent for surgical procedures, such as CS needs to be sought from family members. OBJECTIVE: To determine the association between a delay in performing a CS and severe maternal and newborn outcomes in a national referral hospital in Somaliland. The type of barriers leading to delayed performance of CS after a doctor's decision were also explored. METHODS: Women were followed from the time of decision to perform CS until discharge from the hospital between 15 April 2019 and 30 March 2020. No delay was defined as < 1 hour and delayed CS was defined as 1-3 hours and >3 hours from decision of CS to delivery. Information was collected on barriers leading to delayed CS and maternal and newborn outcomes. Data was analysed using binary and multivariate logistic regression. RESULTS: Overall, 1255 women were recruited from a larger cohort of 6658 women. A delay in CS >3 hours was associated with higher odds of severe maternal outcomes (aOR 1.58, 95% CI [1.13-2.21]). On the contrary, delay in performing a CS >3 hours was associated with lower odds of stillbirth (aOR 0.48, 95% CI [0.32-0.71]) compared to women without delay. Further, family decision-making for consent was the most important barrier leading to delays of >3 hours as compared to financial factors and barriers related to healthcare providers (48% vs 26% and 15%, respectively, p < 0.001). CONCLUSIONS: In this setting, delay in performing CS >3 hours was associated with higher risk of severe maternal outcomes. A standardised system of performing a CS by primarily addressing the barriers associated with family decision-making, financial aspects and healthcare providers is needed.

Improved obstetric management after implementation of a scaled-up quality improvement intervention: A nested before-after study in three public hospitals in Nepal.

BACKGROUND: We assessed the change in obstetric management after implementation of a quality improvement intervention, the Nepal Perinatal Quality Improvement Package (NePeriQIP). METHODS: The Nepal Perinatal Quality Improvement Package was a stepped-wedge cluster-randomized controlled trial conducted in 12 public hospitals in Nepal between April 2017 and October 2018. In this study, three hospitals allocated at different time points to the intervention were selected for a nested before-after analysis. We used bivariate and multivariate analyses to compare obstetric management in the control vs intervention group. RESULTS: There were 25 977 deliveries in the three hospitals during the study period: 10 207 (39%) in the control and 15 770 (61%) in the intervention group. After adjusting for maternal age, ethnicity, education, gestational age, stage of labor at admission, complications during labor, and birthweight, the intervention group had a higher proportion of fetal heart rate monitoring performed as per protocol (adjusted odds ratio [aOR] 1.19, 95% confidence interval [CI] 1.12-1.27), shorter time intervals between each fetal heart rate monitoring (aOR 2.09, 95% CI 1.96-2.23), a higher likelihood of abnormal fetal heart rate being detected (aOR 1.53, 95% CI 1.25-1.68), progress of labor more often being recorded immediately after per vaginal examination (aOR 2.73, 95% CI 2.55-2.93), and partograph filled as per standards (aOR 3.18, 95% CI 2.98-3.50). The cesarean birth rate was 2.5% in the control group and 8.2% in the intervention group (aOR 3.12, 95% CI 2.64-3.68). CONCLUSIONS: The NePeriQIP intervention has potential to improve obstetric care, especially intrapartum fetal surveillance, in similar low-resource settings.

Incidence and outcomes of intrapartum-related neonatal encephalopathy in low-income and middle-income countries: a systematic review and meta-analysis.

AIM: To examine the incidence of intrapartum-related neonatal encephalopathy, and neonatal mortality and neurodevelopmental outcomes associated with it in low-income and middle-income countries. METHODS: Reports were included when neonatal encephalopathy diagnosed clinically within 24 hours of birth in term or near-term infants born after intrapartum hypoxia-ischaemia defined as any of the following: (1) pH≤7.1 or base excess ≤-12 or lactate ≥6, (2) Apgar score ≤5 at 5 or 10 min, (3) continuing resuscitation at 5 or 10 min or (4) no cry from baby at 5 or 10 min. Peer-reviewed articles were searched from Ovid MEDLINE, Cochrane, Web of Science and WHO Global Index Medicus with date limits 1 November 2009 to 17 November 2021. Risk of bias was assessed using modified Newcastle Ottawa Scale. Inverse variance of heterogenicity was used for meta-analyses. RESULTS: There were 53 reports from 51 studies presenting data on 4181 children with intrapartum-related neonatal encephalopathy included in the review. Only five studies had data on incidence, which ranged from 1.5 to 20.3 per 1000 live births. Neonatal mortality was examined in 45 studies and in total 636 of the 3307 (19.2%) infants died. Combined outcome of death or moderate to severe neurodevelopmental disability was reported in 19 studies and occurred in 712 out of 1595 children (44.6%) with follow-up 1 to 3.5 years. CONCLUSION: Though there has been progress in some regions, incidence, case mortality and morbidity in intrapartum-related neonatal encephalopathy has been static in the last 10 years. PROSPERO REGISTRATION NUMBER: CRD42020177928.

Effects of a novel weight-loss combination product containing orlistat and acarbose on obesity: A randomized, placebo-controlled trial.

OBJECTIVE: The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. METHODS: The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI ≥30 kg/m2 or ≥28 kg/m2 with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. RESULTS: Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. CONCLUSIONS: This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.

Gender norms and women's empowerment as barriers to facility birth: A population-based cross-sectional study in 26 Nigerian states using the World Values Survey.

BACKGROUND: Central and western Africa struggle with the world's lowest regional proportion of facility birth at 57%. The aim of the current study was to compare beliefs related to maternal health care services, science/technology, gender norms, and empowerment in states with high vs. low proportions of facility birth in Nigeria. METHODS: Face-to-face interviews were performed as part of a nationally representative survey in Nigeria using a new module to measure values and beliefs related to gender and sexual and reproductive health and rights collected as part the 2018 World Values Survey. We compared beliefs related to maternal health care services, science/technology, gender norms, and empowerment between Nigerian states with facility birth proportions > 50% vs. < 25% as presented in the 2018 Nigerian Demographic Health Survey report. Pearson's chi-squared test, the independent t-test, and univariable and multivariable logistic and linear regression were used for analyses. Results were also stratified by gender. RESULTS: Among the 1,273 participants interviewed, 653 resided in states with high and 360 resided in states with low proportions of facility birth. There were no significant differences between the groups in perceived safety of facility birth (96% vs. 94%) and confidence in antenatal care (91% vs 94%). However, in states with low proportions of facility birth, participants had higher confidence in traditional birth attendants (61% vs. 39%, adjusted odds ratio [aOR] 2.1, [1.5-2.8]), men were more often perceived as the ones deciding whether a woman should give birth at a clinic (56% vs. 29%, aOR 2.4 [1.8-3.3]), and participants experienced less freedom over their own lives (56% vs. 72%, aOR 0.56 [0.41-0.76]). Most differences in responses between men and women were not statistically significant. CONCLUSIONS: In order to increase facility births in Nigeria and other similar contexts, transforming gender norms and increasing women's empowerment is key.

Incidence and causes of severe maternal outcomes in Somaliland using the sub-Saharan Africa maternal near-miss criteria: A prospective cross-sectional study in a national referral hospital.

OBJECTIVE: To describe the incidence and causes of severe maternal outcomes and the unmet need for life-saving obstetric interventions among women admitted for delivery in a referral hospital in Somaliland. METHODS: A prospective cross-sectional study was conducted from April 15, 2019 to March 31, 2020, with women admitted during pregnancy or childbirth or within 42 days after delivery. Data were collected using the World Health Organization (WHO) and sub-Saharan Africa (SSA) maternal near-miss (MNM) tools. Descriptive analysis was performed by computing frequencies, proportions, and ratios. RESULTS: The MNM ratios were 56 (SSA criteria) and 13 (WHO criteria) per 1000 live births. The mortality index was highest among women with medical complications (63%), followed by obstetric hemorrhage (13%), pregnancy-related infection (10%), and hypertensive disorders (7.9%) according to the SSA MNM criteria. Most women giving birth received prophylactic oxytocin for postpartum hemorrhage prevention (97%), and most laparotomies (60%) for ruptured uterus were conducted after 3 h. CONCLUSION: There is a need to improve the quality of maternal health services through implementation of evidence-based obstetric interventions and continuous in-service training for healthcare providers. Using the SSA MNM criteria could facilitate such preventive measures in this setting as well as similar low-resource contexts.

Augmentation of labor with oxytocin and its association with delivery outcomes: A large-scale cohort study in 12 public hospitals in Nepal.

INTRODUCTION: The use of oxytocin to augment labor is increasing in many low-resource settings; however, little is known about the effects of such use in contexts where resources for intrapartum monitoring are scarce. In this study, we sought to assess the association between augmentation of labor with oxytocin and delivery outcomes. MATERIAL AND METHODS: We conducted a cohort study in 12 public hospitals in Nepal, including all deliveries with and without augmentation of labor with oxytocin, but excluding elective cesarean sections, women with missing information on augmentation of labor, and women without fetal heart rate on admission. Bivariate and multivariate logistic regression calculating the crude and adjusted risk ratio (aRR) with corresponding 95% CI were performed, comparing (a) intrapartum stillbirth and first-day mortality (primary outcome); and (b) intrapartum monitoring, mode of delivery, postpartum hemorrhage, bag-and-mask ventilation of the newborn, Apgar score, and neonatal death before discharge (secondary outcomes) among women with and without oxytocin-augmented labor. RESULTS: The total cohort consisted of 78 931 women, of whom 28 915 (37%) had labor augmented with oxytocin and 50 016 (63%) did not have labor augmented with oxytocin. Women with augmentation of labor had no increased risk of intrapartum stillbirth and first-day mortality (aRR 1.24, 95% CI 0.65-2.4), but decreased risks of suboptimal partograph use (aRR 0.71, 95% CI 0.68-0.74), suboptimal fetal heart rate monitoring (aRR 0.50, 95% CI 0.48-0.53), and emergency cesarean section (aRR 0.62, 95% CI 0.59-0.66), and increased risks of bag-and-mask ventilation (aRR 2.1, 95% CI 1.8-2.5), Apgar score <7 at 5 minutes (aRR 1.65, 95% CI 1.49-1.86), and neonatal death (aRR 1.93, 95% CI 1.46-2.56). CONCLUSIONS: Although augmentation of labor with oxytocin might be associated with beneficial effects, such as improved monitoring and a decreased risk of cesarean section, its use may lead to an increased risk of adverse perinatal outcomes. We urge for a cautious use of oxytocin to augment labor in low-resource contexts, and call for evidence-based guidelines on augmentation of labor in low-resource settings.

Disclosing suboptimal indications for emergency caesarean sections due to fetal distress and prolonged labor: a multicenter cross-sectional study at 12 public hospitals in Nepal.

BACKGROUND: Global caesarean section (CS) rates have raised concern of a potential overuse of the procedure in both high- and low-resource settings. We sought to assess management and outcomes of deliveries with emergency CSs due to fetal distress and prolonged labor at 12 public hospitals in Nepal and determine factors associated with suboptimal CS indications. METHODS: We conducted a cross-sectional study on all deliveries between the 14th of April 2017 and the 17th of October 2018 at 12 public hospitals in Nepal and included all emergency CSs due to fetal distress and prolonged labor. Analysis was conducted using Pearson chi-square test and bivariate and multivariate logistic regression. RESULTS: The total cohort included 104,322 deliveries of which 18,964 (18%) were CSs (13,095 [13%] emergency CSs and 5230 [5.0%] elective CSs). We identified 1806 emergency CSs due to fetal distress and 1322 emergency CSs due to prolonged labor. Among CSs due to fetal distress, only 36% had fetal heart rate monitoring performed according to protocol, and among CSs due to prolonged labor, the partograph was completely filled in only 8.6%. Gestational age < 37 weeks and birth weight < 2500 g were associated with more suboptimal CS indications due to fetal distress (adjusted odds ratio [aOR] 1.4, 95% confidence interval [CI] 1.1-1.8 and aOR 1.7, 95% CI 1.3-2.2 respectively) than those with gestational age > 37 weeks and birth weight > 2500 g. We found no association between suboptimal CS indications and maternal ethnicity or education level. CONCLUSIONS: As fetal heart rate monitoring and partograph are fundamental to diagnose fetal distress and prolonged labor, the inappropriate monitoring proceeding CS decisions disclosed in our study indicate that CSs were performed on suboptimal indications. We call for improved quality of intrapartum monitoring, enhanced documentation in medical records, and structured auditing of CS indications in order to curb the potentially harmful CS trend.

Low use of vacuum extraction: Health care Professionals' Perspective in a University Hospital, Dar es Salaam.

BACKGROUND: Use of vacuum extraction (VE) has been declining in low and middle income countries. At the highest referral hospital Tanzania, 54% of deliveries are performed by caesarean section (CS) and only 0.8% by VE. Use of VE has the potential to reduce CS rates and improve maternal and neonatal outcomes but causes for its low use is not fully explored. METHOD: During November and December of 2017 participatory observations, semi-structured in-depth interviews (n = 29) and focus group discussions (n = 2) were held with midwives, residents and specialists working at the highest referral hospital in Tanzania. Thematic analysis was used to identify rationales for low VE use. FINDINGS: Unstructured and inconsistent clinical teaching structure, interdependent on a fear and blame culture, as well as financial incentives and a lack of structured, adhered to and updated guidelines were identified as rationales for CS instead of VE use. Although all informants showed positivity towards clinical teaching of VE, a subpar communication between clinics and academia was stated as resulting in absent clinical teachers and unaccountable students. CONCLUSION: This study draws connections between the low use of VE and the inconsistent and unstructured clinical training of VE expressed through the health care providers' points of view. However, clinical teaching in VE was highly welcomed by the informers which may serve as a good starting point for future interventions.

Vital Signs Directed Therapy for the Critically Ill: Improved Adherence to the Treatment Protocol Two Years after Implementation in an Intensive Care Unit in Tanzania.

Treating deranged vital signs is a mainstay of critical care throughout the world. In an ICU in a university hospital in Tanzania, the implementation of the Vital Signs Directed Therapy Protocol in 2014 led to an increase in acute treatments for deranged vital signs. The mortality rate for hypotensive patients decreased from 92% to 69%. In this study, the aim was to investigate the sustainability of the implementation two years later. An observational, patient-record-based study was conducted in the ICU in August 2016. Data on deranged vital signs and acute treatments were extracted from the patients' charts. Adherence to the protocol, defined as an acute treatment in the same or subsequent hour following a deranged vital sign, was calculated and compared with before and immediately after implementation. Two-hundred and eighty-nine deranged vital signs were included. Adherence was 29.8% two years after implementation, compared with 16.6% (p < 0.001) immediately after implementation and 2.9% (p < 0.001) before implementation. Consequently, the implementation of the Vital Signs Directed Therapy Protocol appears to have led to a sustainable increase in the treatment of deranged vital signs. The protocol may have potential to improve patient safety in other settings where critically ill patients are managed.

The burden of and factors associated with misclassification of intrapartum stillbirth: Evidence from a large scale multicentric observational study.

INTRODUCTION: Global estimates suggest 2.6 million stillbirths and 2.5 million neonatal deaths occur annually worldwide. The majority of these deaths occur in low resource settings where analysis of health metrics and outcomes measurements may be challenging. We examined the misclassification of documented intrapartum stillbirth and factors associated with misclassification. MATERIAL AND METHODS: A prospective observational study was performed in 12 public hospitals in Nepal. Data were extracted from the medical records of all births that occurred during the 6-month period of the study. For the study purpose, we classified birth outcome based on the presence of fetal heart sound (FHS) at admission and use of neonatal resuscitation. The health worker-documented intrapartum stillbirths were considered potentially misclassified when there were FHS present at admission and no resuscitation initiated after birth. The association between potentially misclassified intrapartum stillbirth and complications during labor, birthweight and gestational age was assessed using Pearson's chi-square test, bivariate and multivariate logistic regression. RESULTS: A total of 39 562 mother-infant dyads were enrolled in the study, all of whom had FHS at admission. Among the 391 intrapartum stillbirths recorded during the study, 180 (46.0%) of them had FHS at admission with no resuscitation initiated after birth and were considered potentially misclassified intrapartum stillbirths. Among these potentially misclassified intrapartum stillbirths, 170 (43.5%) had FHS present 15 minutes before birth and 10 had no FHS 15 minutes before birth Among the potentially misclassified intrapartum stillbirths, 23.3% had complications during labor, 93.3% had birthweight less than 2500 g and 90.0% were born preterm. The risk of intrapartum misclassification was nearly four times higher among low birthweight babies (adjusted odds ratio [aOR] 3.5, 95% confidence interval [CI] 1.8 to 7.0, P < 0.001) and five times higher among preterm babies (aOR 5.3, 95% CI 3.0 to 9.3, P < 0.001). CONCLUSIONS: We estimate that 46% of intrapartum stillbirths were potentially misclassified intrapartum stillbirths. Improving quality of both FHS monitoring and neonatal resuscitation as well as measurement of the care will reduce the risk of potentially misclassified intrapartum stillbirth and consequently intrapartum stillbirth.

Coverage, associated factors, and impact of companionship during labor: A large-scale observational study in six hospitals in Nepal.

BACKGROUND: Companionship at the time of birth is a nonclinical intervention that has been proven to improve the quality of intrapartum care. This study aims to evaluate the coverage, associated factors, and impact of companionship during labor at public hospitals in Nepal. METHODS: We conducted a cross-sectional observational study in six public hospitals in Nepal. The study was conducted from July 2018 to August 2018. Data were collected on sociodemographic, maternal, obstetric, and neonatal characteristics from patient case notes and through predischarge interviews. Coverage of companionship during labor and its association with intrapartum care was analyzed. Bivariate and multivariate analyses were done to assess the association between companionship during labor and demographic, obstetric, and neonatal characteristics. RESULTS: A total of 63 077 women participated in the study with 19% of them having a companion during labor. Women aged 19-24 years had 65% higher odds of having a companion during labor compared with women aged 35 years and older (aOR 1.65 [95% CI, 1.40-1.94]). Women who were from an advantaged ethnic group (Chhetri/Brahmin) had fourfold higher odds of having a companion than women from a disadvantaged group (aOR 3.84; [95% CI, 3.24-4.52]). Women who had companions during labor had fewer unnecessary cesarean births than those who had no companions (5.2% vs 6.8%, P < .001). CONCLUSIONS: In Nepal, sociodemographic factors affect women's likelihood of having a companion during labor. As companionship during labor is associated with improved quality of care, health facilities should encourage women's access to birth companions.

Effect of a scaled-up neonatal resuscitation quality improvement package on intrapartum-related mortality in Nepal: A stepped-wedge cluster randomized controlled trial.

BACKGROUND: Improving quality of intrapartum care will reduce intrapartum stillbirth and neonatal mortality, especially in resource-poor settings. Basic neonatal resuscitation can reduce intrapartum stillbirth and early neonatal mortality, if delivered in a high-quality health system, but there is a dearth of evidence on how to scale up such evidence-based interventions. We evaluated the scaling up of a quality improvement (QI) package for neonatal resuscitation on intrapartum-related mortality (intrapartum stillbirth and first day mortality) at hospitals in Nepal. METHODS AND FINDINGS: We conducted a stepped-wedge cluster randomized controlled trial in 12 hospitals over a period of 18 months from April 14, 2017, to October 17, 2018. The hospitals were assigned to one of four wedges through random allocation. The QI package was implemented in a stepped-wedge manner with a delay of three months for each step. The QI package included improving hospital leadership on intrapartum care, building health workers' competency on neonatal resuscitation, and continuous facilitated QI processes in clinical units. An independent data collection system was set up at each hospital to gather data on mortality through patient case note review and demographic characteristics of women using semi-structured exit interviews. The generalized linear mixed model (GLMM) and multivariate logistic regression were used for analyses. During this study period, a total of 89,014 women-infant pairs were enrolled. The mean age of the mother in the study period was 24.0 ± 4.3 years, with 54.9% from disadvantaged ethnic groups and 4.0% of them illiterate. Of the total birth cohort, 54.4% were boys, 16.7% had gestational age less than 37 weeks, and 17.1% had birth weight less than 2,500 grams. The incidence of intrapartum-related mortality was 11.0 per 1,000 births during the control period and 8.0 per 1,000 births during the intervention period (adjusted odds ratio [aOR], 0.79; 95% CI, 0.69-0.92; p = 0.002; intra-cluster correlation coefficient [ICC], 0.0286). The incidence of early neonatal mortality was 12.7 per 1,000 live births during the control period and 10.1 per 1,000 live births during the intervention period (aOR, 0.89; 95% CI, 0.78-1.02; p = 0.09; ICC, 0.1538). The use of bag-and-mask ventilation for babies with low Apgar score (<7 at 1 minute) increased from 3.2% in the control period to 4.0% in the intervention period (aOR, 1.52; 95% CI, 1.32-1.77, p = 0.003). There were two major limitations to the study; although a large sample of women-infant pairs were enrolled in the study, the clustering reduced the power of the study. Secondly, the study was not sufficiently powered to detect reduction in early neonatal mortality with the number of clusters provided. CONCLUSION: These results suggest scaled-up implementation of a QI package for neonatal resuscitation can reduce intrapartum-related mortality and improve clinical care. The QI intervention package is likely to be effective in similar settings. More implementation research is required to assess the sustainability of QI interventions and quality of care. TRIAL REGISTRATION: ISRCTN30829654.

Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a stepped wedge cluster randomized controlled trial in public hospitals.

BACKGROUND: Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement package-Scaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)-on intrapartum care and intrapartum-related mortality in public hospitals of Nepal. METHODS: We will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2 months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19 months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo®) and neonatal heart rate monitors (Neobeat®) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations. DISCUSSION: With the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings. TRIAL REGISTRATION NUMBER: ISRCTN16741720 . Registered on 2 March 2019.

The burden of misclassification of antepartum stillbirth in Nepal.

BACKGROUND: Globally, every year 1.1 million antepartum stillbirths occur with 98% of these deaths taking place in countries where the health system is poor. In this paper we examine the burden of misclassification of antepartum stillbirth in hospitals of Nepal and factors associated with misclassification. METHOD: A prospective observational study was conducted in 12 hospitals of Nepal for a period of 6 months. If fetal heart sounds (FHS) were detected at admission and during the intrapartum period, the antepartum stillbirth (fetal death ≥22 weeks prior labour) recorded in patient's case note was recategorised as misclassified antepartum stillbirth. We further compared sociodemographic, obstetric and neonatal characteristics of misclassified and correctly classified antepartum stillbirths using bivariate and multivariate analysis. RESULT: A total of 41 061 women were enrolled in the study and 39 562 of the participants' FHS were taken at admission. Of the total participants whose FHS were taken at admission, 94.8% had normal FHS, 4.7% had abnormal FHS and 0.6% had no FHS at admission. Of the total 119 recorded antepartum stillbirths, 29 (24.4%) had FHS at admission and during labour and therefore categorised as misclassified antepartum stillbirths. Multivariate analysis performed to adjust the risk of association revealed that complications during pregnancy resulted in a threefold risk of misclassification (adjusted OR-3.35, 95% CI 1.95 to 5.76). CONCLUSION: Almost 25% of the recorded antepartum stillbirths were misclassified. Improving quality of data is crucial to improving accountability and quality of care. As the interventions to reduce antepartum stillbirth differ, accurate measurement of antepartum stillbirth is critical. TRIAL REGISTRATION NUMBER: ISRCTN30829654.