A clustered randomized control trial to assess feasibility, acceptability, and impact of implementing the birth companion intervention package in Ethiopia, Kenya, and Nigeria: study protocol.

BACKGROUND: A birth companion is a simple and low-cost intervention that can improve both maternal and newborn health outcomes. The evidence that birth companionship improves labor outcomes and experiences of care has been available for many years. Global and national policies exist in support of birth companions. Many countries including Ethiopia, Kenya, and Nigeria have not yet incorporated birth companions into routine practice in health facilities. This paper presents the protocol for a trial that aims to assess if a package of interventions that addresses known barriers can increase the coverage of birth companions. METHODS: This two parallel arm cluster randomized controlled trial will evaluate the impact of a targeted intervention package on scale-up of birth companionship at public sector health facilities in Ethiopia (five study sites encompassing 12 facilities), Kenya (two sites encompassing 12 facilities in Murang'a and 12 facilities in Machakos counties), and Nigeria (two sites encompassing 12 facilities in Kano and 12 facilities in Nasarawa states). Baseline and endline assessments at each site will include 744 women who have recently given birth in the quantitative component. We will interview a maximum of 16 birth companions, 48 health care providers, and eight unit managers quarterly for the qualitative component in each country. DISCUSSION: Ample evidence supports the contribution of birth companions to positive health outcomes for mothers and newborns. However, limited data are available on effective strategies to improve birth companion coverage and inform scale-up efforts. This trial tests a birth companion intervention package in diverse clinical settings and cultures to identify possible barriers and considerations to increasing uptake of birth companions. Findings from this study may provide valuable evidence for scaling up birth companionship in similar settings. TRIAL REGISTRATION: Trial is registered with ClinicalTrials.gov with identifier: NCT05565196, first posted 04/10/ 2022.

Effect of group versus individual antenatal care on uptake of intermittent prophylactic treatment of malaria in pregnancy and related malaria outcomes in Nigeria and Kenya: analysis of data from a pragmatic cluster randomized trial.

BACKGROUND: Every year, malaria in pregnancy contributes to approximately 20% of stillbirths in sub-Saharan Africa and 10,000 maternal deaths globally. Most eligible pregnant women do not receive the minimum three recommended doses of intermittent preventive treatment with Sulfadoxine-pyrimethamine (IPTp-SP). The objective of this analysis was to determine whether women randomized to group antenatal care (G-ANC) versus standard antenatal care (ANC) differed in IPTp uptake and insecticide-treated nets (ITN) use. METHODS: Prospective data were analysed from the G-ANC study, a pragmatic, cluster randomized, controlled trial that investigated the impact of G-ANC on various maternal newborn health-related outcomes. Data on IPTp were collected via record abstraction and difference between study arms in mean number of doses was calculated by t test for each country. Data on ITN use were collected via postpartum interview, and difference between arms calculated using two-sample test for proportions. RESULTS: Data from 1075 women and 419 women from Nigeria and Kenya, respectively, were analysed: 535 (49.8%) received G-ANC and 540 (50.2%) received individual ANC in Nigeria; 211 (50.4%) received G-ANC and 208 (49.6%) received individual ANC in Kenya. Mean number of IPTp doses received was higher for intervention versus control arm in Nigeria (3.45 versus 2.14, p < 0.001) and Kenya (3.81 versus 2.72, p < 0.001). Reported use of ITN the previous night was similarly high in both arms for mothers in Nigeria and Kenya (over 92%). Reported ITN use for infants was higher in the intervention versus control arm in Nigeria (82.7% versus 75.8%, p = 0.020). CONCLUSIONS: G-ANC may support better IPTp-SP uptake, possibly related to better ANC retention. However, further research is needed to understand impact on ITN use. Trial registration Pan African Clinical Trials Registry, May 2, 2017 (PACTR201706002254227).

Coverage, compliance, acceptability and feasibility of a program to prevent pre-eclampsia and eclampsia through calcium supplementation for pregnant women: an operations research study in one district of Nepal.

BACKGROUND: Calcium supplementation during pregnancy has been shown to reduce the incidence of pre-eclampsia/eclampsia among women with low calcium intake. Universal free calcium supplementation through government antenatal care (ANC) services was piloted in the Dailekh district of Nepal. Coverage, compliance, acceptability and feasibility of the intervention were evaluated. METHODS: Antenatal care providers were trained to distribute and counsel pregnant women about calcium use, and female community health volunteers (FCHVs) were trained to reinforce calcium-related messages. A post-intervention cluster household survey was conducted among women who had given birth in the last six months. Secondary data analysis was performed using monitoring data from health facilities and FCHVs. RESULTS: One Thousand Two hundred-forty postpartum women were interviewed. Most (94.6 %) had attended at least one ANC visit; the median gestational age at first ANC visit was 4 months. All who attended ANC were counseled about calcium and received calcium tablets to take daily until delivery.79.5 % of the women reported consuming the entire quantity of calcium they received. The full course of calcium (300 tablets for 150 days) was provided to 82.3 % of the women. Consumption of the full course of calcium was reported by 67.3 % of all calcium recipients. Significant predictors of completing a full course were gestational age at first ANC visit and number of ANC visits during their most recent pregnancy (p < 0.01). Nearly all (99.2 %) reported taking the calcium as instructed with respect to dose, timing and frequency. Among women who received both calcium and iron (n = 1,157), 98.0 % reported taking them at different times of the day, as instructed. Over 97 % reported willingness to recommend calcium to others, and said they would like to use it during a subsequent pregnancy. There were no stock-outs of calcium. CONCLUSIONS: Calcium distribution through ANC was feasible and effective, achieving 94.6 % calcium coverage of pregnant women in the district. Most women (over 80 %) attended ANC early enough in pregnancy to receive the full course of calcium supplements and benefit from the intervention. High coverage, compliance, acceptability among pregnant women and feasibility were reported, suggesting that this intervention can be scaled up in other areas of Nepal.

Uterotonic use immediately following birth: using a novel methodology to estimate population coverage in four countries.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in developing countries. While incidence of PPH can be dramatically reduced by uterotonic use immediately following birth (UUIFB) in both community and facility settings, national coverage estimates are rare. Most national health systems have no indicator to track this, and community-based measurements are even more scarce. To fill this information gap, a methodology for estimating national coverage for UUIFB was developed and piloted in four settings. METHODS: The rapid estimation methodology consisted of convening a group of national technical experts and using the Delphi method to come to consensus on key data elements that were applied to a simple algorithm, generating a non-precise national estimate of coverage of UUIFB. Data elements needed for the calculation were the distribution of births by location and estimates of UUIFB in each of those settings, adjusted to take account of stockout rates and potency of uterotonics. This exercise was conducted in 2013 in Mozambique, Tanzania, the state of Jharkhand in India, and Yemen. RESULTS: Available data showed that deliveries in public health facilities account for approximately half of births in Mozambique and Tanzania, 16% in Jharkhand and 24% of births in Yemen. Significant proportions of births occur in private facilities in Jharkhand and faith-based facilities in Tanzania. Estimated uterotonic use for facility births ranged from 70 to 100%. Uterotonics are not used routinely for PPH prevention at home births in any of the settings. National UUIFB coverage estimates of all births were 43% in Mozambique, 40% in Tanzania, 44% in Jharkhand, and 14% in Yemen. CONCLUSION: This methodology for estimating coverage of UUIFB was found to be feasible and acceptable. While the exercise produces imprecise estimates whose validity cannot be assessed objectively in the absence of a gold standard estimate, stakeholders felt they were accurate enough to be actionable. The exercise highlighted information and practice gaps and promoted discussion on ways to improve UUIFB measurement and coverage, particularly of home births. Further follow up is needed to verify actions taken. The methodology produces useful data to help accelerate efforts to reduce maternal mortality.

Antenatal care services in Benin and Tanzania 2021/2022: an equity analysis study.

Introduction: Antenatal care (ANC) interventions improve maternal and neonatal outcomes. However, access to ANC may be inequitable due to sociocultural, monetary and time factors. Examining drivers of ANC disparities may identify those amenable to policy change. Methods: We conducted an ANC services equity analysis in selected public facilities in Geita, Tanzania, where most services are free to the end-user, and Atlantique, Benin, where every visit incurs user fees. Data on total ANC contacts, quality of care (QoC) indicators and wait times were collected from representative household surveys in the catchment of 40 clinics per country and were analysed by education and wealth. We used indices of inequality, concentration indices and Oaxaca-Blinder decompositions to determine the distribution, direction and magnitude of inequalities and their contributing factors. We assessed out-of-pocket expenses and the benefit incidence of government funding. Results: ANC clients in both countries received less than the recommended minimum ANC contacts: 3.41 (95% CI 3.36 to 3.41) in Atlantique and 3.33 (95% CI 3.27 to 3.39) in Geita. Wealthier individuals had more ANC contacts than poorer ones at every education level in both countries; the wealthiest and most educated had two visits more than the poorest, least educated. In Atlantique, ANC attendees receive similar QoC regardless of socioeconomic status. In Geita, there are wide disparities in QoC received by education or wealth. In Atlantique, out-of-pocket expenses for the lowest wealth quintile are 2.7% of annual income compared with 0.8% for the highest, with user fees being the primary expense. In Geita, the values are 3.1% and 0.5%, respectively; transportation is the main expense. Conclusions: Inequalities in total ANC visits favouring wealthier, more educated individuals were apparent in both countries. In Atlantique, reduction of user-fees could improve ANC access. In Geita, training and equipping healthcare staff could improve QoC. Community health services could mitigate access barriers.

Transforming women's and providers' experience of care for improved outcomes: A theory of change for group antenatal care in Kenya and Nigeria.

BACKGROUND: Group antenatal care (G-ANC) is a promising model for improving quality of maternal care and outcomes in low- and middle-income countries (LMICs) but little has been published examining the mechanisms by which it may contribute to those improvements. Substantial interplay can be expected between pregnant women and providers' respective experiences of care, but most studies report findings separately. This study explores the experience and effects of G-ANC on both women and providers to inform an integrated theory of change for G-ANC in LMICs. METHODS: This paper reports on multiple secondary outcomes from a pragmatic cluster randomized controlled trial of group antenatal care in Kenya and Nigeria conducted from October 2016-November 2018 including 20 clusters per country. We collected qualitative data from providers and women providing or receiving group antenatal care via focus group discussions (19 with women; 4 with providers) and semi-structured interviews (42 with women; 4 with providers). Quantitative data were collected via surveys administered to 1) providers in the intervention arm at enrollment and after facilitating 4 cohorts and 2) women in both study arms at enrollment; 3-6 weeks postpartum; and 1 year postpartum. Through an iterative approach with framework analysis, we explored the interactions of voiced experience and perceived effects of care and placed them relationally within a theory of change. Selected variables from baseline and final surveys were analyzed to examine applicability of the theory to all study participants. RESULTS: Findings support seven inter-related themes. Three themes relate to the shared experience of care of women and providers: forming supportive relationships and open communication; becoming empowered partners in learning and care; and providing and receiving meaningful clinical services and information. Four themes relate to effects of that experience, which are not universally shared: self-reinforcing cycles of more and better care; linked improvements in health knowledge, confidence, and healthy behaviors; improved communication, support, and care beyond G-ANC meetings; and motivation to continue providing G-ANC. Together these themes map to a theory of change which centers the shared experience of care for women and providers among multiple pathways to improved outcomes. DISCUSSION: The reported experience and effects of G-ANC on women and providers are consistent with other studies in LMICs. This study is novel because it uses the themes to present a theory of change for G-ANC in low-resource settings. It is useful for G-ANC implementation to inform model development, test adaptations, and continue exploring mechanisms of action in future research.

Building a Global Evidence Base to Guide Policy and Implementation for Group Antenatal Care in Low- and Middle-Income Countries: Key Principles and Research Framework Recommendations from the Global Group Antenatal Care Collaborative.

Evidence from high-income countries suggests that group antenatal care, an alternative service delivery model, may be an effective strategy for improving both the provision and experience of care. Until recently, published research about group antenatal care did not represent findings from low- and middle-income countries, which have health priorities, system challenges, and opportunities that are different than those in high-income countries. Because high-quality evidence is limited, the World Health Organization recommends group antenatal care be implemented only in the context of rigorous research. In 2016 the Global Group Antenatal Care Collaborative was formed as a platform for group antenatal care researchers working in low- and middle-income countries to share experiences and shape future research to accelerate development of a robust global evidence base reflecting implementation and outcomes specific to low- and middle-income countries. This article presents a brief history of the Collaborative's work to date, proposes a common definition and key principles for group antenatal care, and recommends an evaluation and reporting framework for group antenatal care research.

Maternal death reviews: A retrospective case series of 90 hospital-based maternal deaths in 11 hospitals in Indonesia.

OBJECTIVE: To determine the factors contributing to hospital-based maternal deaths in Indonesia, given most women deliver with skilled birth attendants and in health facilities. METHODS: A retrospective review of case records examined quality of care issues related to maternal mortality in hospital settings. The review abstracted information from blinded medical records of 90 women who died in 11 hospitals from January to June 2014. Specialists from the Indonesian Society of Obstetrics and Gynecology reviewed abstracted records to determine causes of death and identify contextual factors for these deaths. RESULTS: Seventy-five of the 90 maternal deaths (83%) reviewed were due to direct obstetric causes. Severe pre-eclampsia and eclampsia combined were the leading direct cause of death (42%). Human resource/health worker factors were more frequently identified than supply, facility, or infrastructure factors. Ninety percent of maternal deaths were classified as preventable. CONCLUSION: The review exercise yielded useful information on factors contributing to preventable maternal mortality in hospitals in Indonesia. Results helped focus quality improvement efforts and increased awareness of the value of routine, in-depth facility-based maternal death reviews.

Presence of doctors and obstetrician/gynecologists for patients with maternal complications in hospitals in six provinces of Indonesia.

OBJECTIVE: To describe doctors' and specialist physicians' availability to manage obstetric complications in hospitals in six provinces of Indonesia. METHODS: Data from a nonrandomized, quasi-experimental pre-post evaluation study were used to describe the distribution of providers by each cadre of worker and assess the availability of doctors and obstetrician/gynecologists (ob/gyns) for consultations for women experiencing postpartum hemorrhage or pre-eclampsia/eclampsia, disaggregated by hospital type, province, referral status, and by time of day of provider consultation. RESULTS: Among hospitals that should have comprehensive emergency obstetric and newborn care (CEmONC) services available 24 hours a day, 7 days a week, many did not have a doctor available to manage obstetric complications as they presented, despite there being an average of seven ob/gyns and four doctors registered for service across all facilities. Slightly over 50% of obstetric emergency cases admitted with postpartum hemorrhage and severe pre-eclampsia/eclampsia did not receive a consultation from an ob/gyn. Among the patients who received consultations, about 70% received consultations by phone or SMS. CONCLUSION: Findings from this study indicate that persistent issues of maldistribution of maternal and newborn specialists and high absence rates of both doctors and ob/gyns at CEmONC hospitals during obstetric emergencies undermines Indonesia's efforts to reduce high maternal mortality rates.

Impact of group antenatal care (G-ANC) versus individual antenatal care (ANC) on quality of care, ANC attendance and facility-based delivery: A pragmatic cluster-randomized controlled trial in Kenya and Nigeria.

BACKGROUND: Low quality and frequency of antenatal care (ANC) are associated with lower uptake of facility-based deliveries-a key intervention to reduce maternal and neonatal mortality. We implemented group ANC (G-ANC), an alternative service delivery model, in Kenya and Nigeria, to assess its impact on quality and attendance at ANC and uptake of facility-based delivery. METHODS: From October 2016‒January 2018, we conducted a facility-based, pragmatic, cluster-randomized controlled trial with 20 clusters per country. We recruited women <24 weeks gestation during their first ANC visit and enrolled women at intervention facilities who agreed to attend G-ANC in lieu of routine individual ANC. The G-ANC model consisted of five monthly 2-hour meetings with clinical assessments alongside structured gestationally specific group discussions and activities. Quality of care was defined as receipt of eight specific ANC interventions. Data were obtained through facility records and self-report during a home-based postpartum survey. Analysis was by intention to treat. FINDINGS: All women who completed follow up are included in the analysis (Nigeria: 1018/1075 enrolled women [94.7%], Kenya: 826/1013 [81.5%]). In Nigeria women in the intervention arm were more likely to have a facility-based delivery compared to those in the control arm (Nigeria: 76.7% [391/510] versus 54.1% [275/508]; aOR 2.30, CI 1.51-3.49). In both countries women in the intervention arm were more likely than those in the control arm to receive quality ANC (Nigeria: aOR 5.8, CI 1.98-17.21, p<0.001; Kenya: aOR 5.08, CI 2.31-11.16, p<0.001) and to attend at least four ANC visits (Nigeria: aOR 13.30, CI 7.69-22.99, p<0.001; Kenya: aOR 7.12, CI 3.91-12.97, p<0.001). CONCLUSIONS: G-ANC was associated with higher facility-based delivery rates in Nigeria, where those rates associated with individual ANC were low. In both Kenya and Nigeria it was associated with a higher proportion of women receiving quality ANC and higher frequency of ANC visits.

Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria.

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017.

Case Study: Clinical Governance as an Approach to Improve Maternal and Newborn Health in 22 Hospitals in Indonesia.

Clinical governance is a concept used to improve management, accountability and the provision of quality healthcare. An approach to strengthen clinical governance as a means to improve the quality of maternal and newborn care in Indonesia was developed by the Expanding Maternal and Neonatal Survival (EMAS) Program. This case study presents findings and lessons learned from EMAS program experience in 22 hospitals where peer-to-peer mentoring supported staff in strengthening clinical governance from 2012-2015. Efforts resulted in improved hospital preparedness and significantly increased the odds of facility-level coverage for three evidence-based maternal and newborn healthcare interventions.