Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review

Objectives: To evaluate uterine tamponade devices’ effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols. Search strategy: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021. Study selection: Randomised and non-randomised comparative studies. Outcomes: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy. Results: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76–7.14) and hysterectomy (RR 4.14, 95% CI 0.48–35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07–15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47–41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11–1.03) and hysterectomy (RR 0.49, 95% CI 0.04–5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32–2.81) and hysterectomy (RR 1.84, 95% CI 0.44–7.69) after the inclusion of Ebb or Bakri balloon. Conclusions: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting. Tweetable abstract: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery

Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation.

Introduction The World Health Organization’s (WHO) Labour Care Guide (LCG) is a “next-generation” partograph based on WHO’s latest intrapartum care recommendations. It aims to optimize clinical care provided to women and their experience of care. We evaluated the LCG’s usability, feasibility, and acceptability among maternity care practitioners in clinical settings. Methods Mixed-methods evaluation with doctors, midwives, and nurses in 12 health facilities across Argentina, India, Kenya, Malawi, Nigeria, and Tanzania. Purposively sampled and trained practitioners applied the LCG in low-risk women during labor and rated experiences, satisfaction, and usability. Practitioners were invited to focus group discussions (FGDs) to share experiences and perceptions of the LCG, which were subjected to framework analysis. Results One hundred and thirty-six practitioners applied the LCG in managing labor and birth of 1,226 low-risk women. The majority of women had a spontaneous vaginal birth (91.6%); two cases of intrapartum stillbirths (1.63 per 1000 births) occurred. Practitioner satisfaction with the LCG was high, and median usability score was 67.5%. Practitioners described the LCG as supporting precise and meticulous monitoring during labor, encouraging critical thinking in labor management, and improving the provision of woman-centered care. Conclusions The LCG is feasible and acceptable to use across different clinical settings and can promote woman-centered care, though some design improvements would benefit usability. Implementing the LCG needs to be accompanied by training and supportive supervision, and strategies to promote an enabling environment (including updated policies on supportive care interventions, and ensuring essential equipment is available)

Validation of a measure to assess decision-making autonomy in family planning services in three low- and middle-income countries: The Family Planning Autonomous Decision-Making scale (FP-ADM)

Background Integrating measures of respectful care is an important priority in family planning programs, aligned with maternal health efforts. Ensuring women can make autonomous reproductive health decisions is an important indicator of respectful care. While scales have been developed and validated in family planning for dimensions of person-centered care, none focus specifically on decision-making autonomy. The Mothers Autonomy in Decision-Making (MADM) scale measures autonomy in decision-making during maternity care. We adapted the MADM scale to measure autonomy surrounding a woman’s decision to use a contraceptive method within the context of contraceptive counselling. This study presents a psychometric validation of the Family Planning Autonomous Decision-Making (FP-ADM) scale using data from Argentina, Ghana, and India. Methods and findings We used cross-sectional data from women in four subnational areas in Argentina (n = 890), Ghana (n = 1,114), and India (n = 1,130). In each area, 20 primary sampling units (PSUs) were randomly selected based on probability proportional to size. Households were randomly selected in Ghana and India. In Argentina, all facilities providing reproductive and maternal health services within selected PSUs were included and women were randomly selected upon exiting the facility. Interviews were conducted with a sample of 360 women per district. In total, 890 women completed the FP-ADM in Argentina, 1,114 in Ghana and 1,130 in India. To measure autonomous decision-making within FP service delivery, we adapted the items of the MADM scale to focus on family planning. To assess the scale’s psychometric properties, we first examined the eigenvalues and conducted a parallel analysis to determine the number of factors. We then conducted exploratory factor analysis to determine which items to retain. The resulting factors were then identified based on the corresponding items. Internal consistency reliability was assessed with Cronbach’s alpha. We assessed both convergent and divergent construct validity by examining associations with expected outcomes related to the underlying construct. The Eigenvalues and parallel analysis suggested a two-factor solution. The two underlying dimensions of the construct were identified as “Bidirectional Exchange of Information” (Factor 1) and “Empowered Choice” (Factor 2). Cronbach’s alpha was calculated for the full scale and each subscale. Results suggested good internal consistency of the scale. There was a strong, significant positive association between whether a woman expressed satisfaction with quality of care received from the healthcare provider and her FP-ADM score in all three countries and a significant negative association between a woman’s FP-ADM score and her stated desire to switch contraceptive methods in the future. Conclusions Our results suggest the FP-ADM is a valid instrument to assess decision-making autonomy in contraceptive counseling and service delivery in diverse low- and middle-income countries. The scale evidenced strong construct, convergent, and divergent validity and high internal consistency reliability. Use of the FP-ADM scale could contribute to improved measurement of person-centered family planning services

Authorization of midwives to perform basic emergency obstetric and newborn care signal functions in Argentina, Ghana, and India: A multi-country validation study of a key global maternal and newborn health indicator

BACKGROUND: Midwives' authorization to deliver the seven basic emergency obstetric and newborn care (BEmONC) functions is a core policy indicator in global monitoring frameworks, yet little evidence supports whether such data are captured accurately, or whether authorization demonstrates convergence with midwives' skills and actual provision of services. In this study, we aimed to validate the data reported in global monitoring frameworks (criterion validity) and to determine whether a measure of authorization is a valid indicator for BEmONC availability (construct validity). METHODS: We conducted a validation study in Argentina, Ghana, and India. To assess accuracy of the reported data on midwives' authorization to provide BEmONC services, we reviewed national regulatory documents and compared with reported country-specific data in Countdown to 2030 and the World Health Organization Maternal, Newborn, Child and Adolescent Health Policy Survey. To assess whether authorization demonstrates convergent validity with midwives' skills, training, and performance of BEmONC signal functions, we surveyed 1257 midwives/midwifery professionals and assessed variance. RESULTS: We detected discrepancies between data reported in the global monitoring frameworks and the national regulatory framework in all three countries. We found wide variations between midwives' authorization to perform signal functions and their self-reported skills and actual performance within the past 90 days. The percentage of midwives who reported performing all signal functions for which they were authorized per country-specific regulations was 17% in Argentina, 23% in Ghana, and 31% in India. Additionally, midwives in all three countries reported performing some signal functions that the national regulations did not authorize. CONCLUSION: Our findings suggest limitations in criterion and construct validity for this indicator in Argentina, Ghana, and India. Some signal functions such as assisted vaginal delivery may be obsolete based on current practice patterns. Findings suggest the need to re-examine the emergency interventions that should be included as BEmONC signal functions

Validating the implementation of an indicator reporting policies and laws on free public maternal health-related services in the era of universal health coverage: A multi-country cross-sectional study

Background The concept of universal health coverage (UHC) encompasses both access to essential health services and freedom from financial harm. The World Health Organization’s Maternal Newborn Child and Adolescent Health (MNCAH) Policy Survey collects data on policies that have the potential to reduce maternal morbidity and mortality. The indicator, “Are the following health services provided free of charge at point-of-use in the public sector for women of reproductive age?”, captures the free provision of 13 key categories of maternal health-related services, to measure the success of UHC implementation with respect to maternal health. However, it is unknown whether it provides a valid measure of the provision of free care. Therefore, this study compared free maternal healthcare laws and policies against actual practice in three countries. Methods and findings We conducted a cross-sectional study in four districts/provinces in Argentina, Ghana, and India. We performed desk reviews to identify free care laws and policies at the country level and compared those with reports at the global level. We conducted exit interviews with women aged 15–49 years who used a component service or their accompanying persons, as well as with facility chief financial officers or billing administrators, to determine if wome

Validating indicators for monitoring availability and geographic distribution of emergency obstetric and newborn care (EmoNC) facilities: A study triangulating health system, facility, and geospatial data

Availability of emergency obstetric and newborn care (EmONC) is a strong supply side measure of essential health system capacity that is closely and causally linked to maternal mortality reduction and fundamentally to achieving universal health coverage. The World Health Organization’s indicator “Availability of EmONC facilities” was prioritized as a core indicator to prevent maternal death. The indicator focuses on whether there are sufficient emergency care facilities to meet the population need, but not all facilities designated as providing EmONC function as such. This study seeks to validate “Availability of EmONC” by comparing the value of the indicator after accounting for key aspects of facility functionality and an alternative measure of geographic distribution. This study takes place in four subnational geographic areas in Argentina, Ghana, and India using a census of all birthing facilities. Performance of EmONC in the 90 days prior to data collection was assessed by examining facility records. Data were collected on facility operating hours, staffing, and availability of essential medications. Population estimates were generated using ArcGIS software using WorldPop to estimate the total population, and the number of women of reproductive age (WRA), pregnancies and births in the study areas. In addition, we estimated the population within two-hours travel time of an EmONC facility by incorporating data on terrain from Open Street Map. Using these data sources, we calculated and compared the value of the indicator after incorporating data on facility performance and functionality while varying the reference population used. Further, we compared its value to the proportion of the population within two-hours travel time of an EmONC facility. Included in our study were 34 birthing facilities in Argentina, 51 in Ghana, and 282 in India. Facility performance of basic EmONC (BEmONC) and comprehensive EmONC (CEmONC) signal functions varied considerably. One facility (4.8%) in Ghana and no facility in India designated as BEmONC had performed all seven BEmONC signal functions. In Argentina, three (8.8%) CEmONC-designated facilities performed all nine CEmONC signal functions, all located in Buenos Aires Region V. Four CEmONC-designated facilities in Ghana (57.1%) and the three CEmONC-designated facilities in India (23.1%) evidenced full CEmONC performance. No sub-national study area in Argentina or India reached the target of 5 BEmONC-level facilities per 20,000 births after incorporating facility functionality yet 100% did in Argentina and 50% did in India when considering only facility designation. Demographic differences also accounted for important variation in the indicator’s value. In Ghana, the total population in Tolon within 2 hours travel time of a designated EmONC facility was estimated at 99.6%; however, only 91.1% of women of reproductive age were within 2 hours travel time. Comparing the value of the indicator when calculated using different definitions reveals important inconsistencies, resulting in conflicting information about whether the threshold for sufficient coverage is met. This raises important questions related to the indicator’s validity. To provide a valid measure of effective coverage of EmONC, the construct for measurement should extend beyond the most narrow definition of availability and account for functionality and geographic accessibility

Vulnerable newborn types: Analysis of population-based registries for 165 million births in 23 countries, 2000-2021.

OBJECTIVE: To examine the prevalence of novel newborn types among 165 million live births in 23 countries from 2000 to 2021. DESIGN: Population-based, multi-country analysis. SETTING: National data systems in 23 middle- and high-income countries. POPULATION: Liveborn infants. METHODS: Country teams with high-quality data were invited to be part of the Vulnerable Newborn Measurement Collaboration. We classified live births by six newborn types based on gestational age information (preterm 90th centile) for gestational age, according to INTERGROWTH-21st standards. We considered small newborn types of any combination of preterm or SGA, and term + LGA was considered large. Time trends were analysed using 3-year moving averages for small and large types. MAIN OUTCOME MEASURES: Prevalence of six newborn types. RESULTS: We analysed 165 017 419 live births and the median prevalence of small types was 11.7% - highest in Malaysia (26%) and Qatar (15.7%). Overall, 18.1% of newborns were large (term + LGA) and was highest in Estonia 28.8% and Denmark 25.9%. Time trends of small and large infants were relatively stable in most countries. CONCLUSIONS: The distribution of newborn types varies across the 23 middle- and high-income countries. Small newborn types were highest in west Asian countries and large types were highest in Europe. To better understand the global patterns of these novel newborn types, more information is needed, especially from low- and middle-income countries

Vulnerable newborn types: Analysis of population-based registries for 165 million births in 23 countries, 2000-2021.

OBJECTIVE: To examine the prevalence of novel newborn types among 165 million live births in 23 countries from 2000 to 2021. DESIGN: Population-based, multi-country analysis. SETTING: National data systems in 23 middle- and high-income countries. POPULATION: Liveborn infants. METHODS: Country teams with high-quality data were invited to be part of the Vulnerable Newborn Measurement Collaboration. We classified live births by six newborn types based on gestational age information (preterm 90th centile) for gestational age, according to INTERGROWTH-21st standards. We considered small newborn types of any combination of preterm or SGA, and term + LGA was considered large. Time trends were analysed using 3-year moving averages for small and large types. MAIN OUTCOME MEASURES: Prevalence of six newborn types. RESULTS: We analysed 165 017 419 live births and the median prevalence of small types was 11.7% - highest in Malaysia (26%) and Qatar (15.7%). Overall, 18.1% of newborns were large (term + LGA) and was highest in Estonia 28.8% and Denmark 25.9%. Time trends of small and large infants were relatively stable in most countries. CONCLUSIONS: The distribution of newborn types varies across the 23 middle- and high-income countries. Small newborn types were highest in west Asian countries and large types were highest in Europe. To better understand the global patterns of these novel newborn types, more information is needed, especially from low- and middle-income countries

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation

Objective To systematically develop evidence‐based bundles for care of postpartum hemorrhage (PPH). Methods An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated “GRADE Evidence‐to‐Decision” framework. Twenty‐three global maternal‐health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6‐month period, the expert panel met online and via teleconferences, culminating in a 2‐day in‐person meeting. Results The consultation led to the definition of two care bundles for facility implementation. The “first response to PPH bundle” comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The “response to refractory PPH bundle” comprises compressive measures (aortic or bimanual uterine compression), the non‐pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements. Conclusion For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices