Search

Background: The World Health Organization (WHO) Labour Care Guide (LCG) is a paper-based labour monitoring tool designed to facilitate the implementation of WHO's latest guidelines for effective, respectful care during labour and childbirth. Implementing the LCG into routine intrapartum care requires a strategy that improves healthcare provider practices during labour and childbirth. Such a strategy might optimize the use of Caesarean section (CS), along with potential benefits on the use of other obstetric interventions, maternal and perinatal health outcomes, and women's experience of care. However, the effects of a strategy to implement the LCG have not been evaluated in a randomised trial. This study aims to: (1) develop and optimise a strategy for implementing the LCG (formative phase); and (2) To evaluate the implementation of the LCG strategy compared with usual care (trial phase). Methods: In the formative phase, we will co-design the LCG strategy with key stakeholders informed by facility assessments and provider surveys, which will be field tested in one hospital. The LCG strategy includes a LCG training program, ongoing supportive supervision from senior clinical staff, and audit and feedback using the Robson Classification. We will then conduct a stepped-wedge, cluster-randomized pilot trial in four public hospitals in India, to evaluate the effect of the LCG strategy intervention compared to usual care (simplified WHO partograph). The primary outcome is the CS rate in nulliparous women with singleton, term, cephalic pregnancies in spontaneous labour (Robson Group 1). Secondary outcomes include clinical and process of care outcomes, as well as women's experience of care outcomes. We will also conduct a process evaluation during the trial, using standardized facility assessments, in-depth interviews and surveys with providers, audits of completed LCGs, labour ward observations and document reviews. An economic evaluation will consider implementation costs and cost-effectiveness. Discussion: Findings of this trial will guide clinicians, administrators and policymakers on how to effectively implement the LCG, and what (if any) effects the LCG strategy has on process of care, health and experience outcomes. The trial findings will inform the rollout of LCG internationally. Trial registration: CTRI/2021/01/030695 (Protocol version 1.4, 25 April 2022). Plain language summary: The new WHO Labour Care Guide (LCG) is an innovative partograph that emphasises women-centred, evidence-based care during labour and childbirth. Together with clinicians working at four hospitals in India, we will develop and test a strategy to implement the LCG into routine care in labour wards of these hospitals. We will use a randomised trial design where this LCG strategy is introduced sequentially in each of the four hospitals, in a random order. We will collect data on all women giving birth and their newborns during this period and analyse whether the LCG strategy has any effects on the use of Caesarean section, women's and newborn's health outcomes, and women's experiences during labour and childbirth. While the trial is being conducted, we will also collect qualitative and quantitative data from doctors, nurses and midwives working in these hospitals, to understand their perspectives and experiences of using the LCG in their day-to-day work. In addition, we will collect economic data to understand how much the LCG strategy costs, and how much money it might save if it is effective. Through this study, our international collaboration will generate critical evidence and innovative tools to support implementation of the LCG in other countries. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the nature and context of mistreatment during labour and childbirth at public and private sector maternity facilities in Uttar Pradesh, India., Methods: This study analyses mixed-methods data obtained through systematic clinical observations and open-ended comments recorded by the observers to describe care provision for 275 mothers and their newborns at 26 hospitals in three districts of Uttar Pradesh from 26 May to 8 July 2015. We conducted a bivariate descriptive analysis of the quantitative data and used a thematic approach to analyse qualitative data., Findings: All women in the study encountered at least one indicator of mistreatment. There was a high prevalence of not offering birthing position choice (92%) and routine manual exploration of the uterus (80%) in facilities in both sectors. Private sector facilities performed worse than the public sector for not allowing birth companions (p = 0.02) and for perineal shaving (p = < 0.001), whereas the public sector performed worse for not ensuring adequate privacy (p = < 0.001), not informing women prior to a vaginal examination (p = 0.01) and for physical violence (p = 0.04). Prepared comments by observers provide further contextual insights into the quantitative data, and additional themes of mistreatment, such as deficiencies in infection prevention, lack of analgesia for episiotomy, informal payments and poor hygiene standards at maternity facilities were identified., Conclusions: Mistreatment of women frequently occurs in both private and public sector facilities. This paper contributes to the literature on mistreatment of women during labour and childbirth at maternity facilities in India by articulating new constructs of overtreatment and under-treatment. There are five key implications of this study. First, a systematic and context-specific effort to measure mistreatment in public and private sector facilities in high burden states in India is required. Second, a training initiative to orient all maternity care personnel to the principles of respectful maternity care would be useful. Third, innovative mechanisms to improve accountability towards respectful maternity care are required. Fourth, participatory community and health system interventions to support respectful maternity care would be useful. Lastly, we note that there needs to be a long-term, sustained investment in health systems so that supportive and enabling work-environments are available to front- line health workers.

Background: Medical abortion with mifepristone and misoprostol can be provided up to 63 days' gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India. Methods: We applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021. Results: Medicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment. Conclusion: Opportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed. Plain language summary: Medical abortion is popular in India and benefits from a liberal legal context. It is important to understand the availability of quality abortion medicines in the country. Using the World Health Organization country assessment protocol and availability framework for medical abortion medicines we examined the availability of these medicines from supply to demand. We used this information to identify opportunities for increasing availability of quality-assured medical abortion medicines. We found that the context for medical abortion varies across states. Strengthening procurement and supply chain management, with a greater emphasis on quality-assurance and regulation of manufacturing should be instituted at the state-level. Training is also needed to increase provider knowledge of the latest national guidelines and laws to ensure respectful and person-centered services. Finally, the public should be informed about medical abortion as a safe and effective choice, especially for early abortions. [ABSTRACT FROM AUTHOR]

Background: Recognizing the need to increase access to safe abortion services to reduce maternal mortality and morbidity, the state government of Bihar, India introduced an innovative mechanism of accrediting private health care facilities. The program, Yukti Yojana ('a scheme for solution'), accredits eligible health facilities and supports them in providing abortion-related services free of charge to rural and low-income urban women. This paper describes implementation of Yukti Yojana. Methods: A descriptive analysis of abortion services provided under the Yukti Yojana program was conducted using four data sources: 1) assessment of accredited facilities over 6 months; 2) induced and incomplete abortion service registers; 3) client exit interviews and associated direct observation of client-provider interaction for a sample of accredited facilities; and 4) in-depth interviews with providers and key stakeholders responsible for providing or influencing abortion services. These analyses assessed characteristics of women receiving abortion services, quality of care and client satisfaction, and barriers and facilitating factors of a successful accreditation process. Results: Forty-nine private facilities were accredited during the first two years of the program, and 84 % had begun providing abortion services, in all 27,724 women were served. Overall, 53 % of beneficiaries reported holding a "Below Poverty Line" card, while 71 % had low living standard. The majority of women (n = 569) reported satisfaction (90 %) with their care, while 68 % perceived good quality of services. Having a government-led initiative was considered a key element of success, while stringent requirements for site approval, long waiting time for accreditation, complicated and delayed reimbursement process and low reimbursement fees for abortion services were identified as barriers to implementation. Conclusions: Yukti Yojana provides a model for successfully involving private OB/GYNs and general physicians to deliver safe abortion services to poor women on a large scale and offers additional evidence that public-private partnerships can be used to ensure availability of high-quality maternal health services to women in low-income countries. Private facility accreditation also offers a promising solution to the limited availability of safe abortion services in low resource settings such as Bihar, India. [ABSTRACT FROM AUTHOR]

Background: India launched a national conditional cash transfer program, Janani Suraksha Yojana (JSY), aimed at reducing maternal mortality by promoting institutional delivery in 2005. It provides a cash incentive to women who give birth in public health facilities. This paper studies the extent of program uptake, reasons for participation/ non participation, factors associated with non uptake of the program, and the role played by a program volunteer, accredited social health activist (ASHA), among mothers in Ujjain district in Madhya Pradesh, India. Methods: A cross-sectional study was conducted from January to May 2011 among women giving birth in 30 villages in Ujjain district. A semi-structured questionnaire was administered to 418 women who delivered in 2009. Socio-demographic and pregnancy related characteristics, role of the ASHA during delivery, receipt of the incentive, and reasons for place of delivery were collected. Multinomial regression analysis was used to identify predictors for the outcome variables; program delivery, private facility delivery, or a home delivery. Results: The majority of deliveries (318/418; 76%) took place within the JSY program; 81% of all mothers below poverty line delivered in the program. Ninety percent of the women had prior knowledge of the program. Most program mothers reported receiving the cash incentive within two weeks of delivery. The ASHA's influence on the mother's decision on where to deliver appeared limited. Women who were uneducated, multiparious or lacked prior knowledge of the JSY program were significantly more likely to deliver at home. Conclusion: In this study, a large proportion of women delivered under the program. Most mothers reporting timely receipt of the cash transfer. Nevertheless, there is still a subset of mothers delivering at home, who do not or cannot access emergency obstetric care under the program and remain at risk of maternal death. [ABSTRACT FROM AUTHOR]

Background: Person-centered care during childbirth is recognized as a critical component of quality of maternity care. But there are few validated tools to measure person-centered maternity care (PCMC). This paper aims to fill this measurement gap. We present the results of the psychometric analysis of the PCMC tool that was previously validated in Kenya using data from India. We aim to assess the validity and reliability of the PCMC scale in India, and to compare the results to those found in the Kenya validation. Methods: We use data from a cross-sectional survey conducted from August to October 2017 with recently delivered women at 40 government facilities in Uttar Pradesh, India (N = 2018). The PCMC measure used is a previously validated scale with subscales for dignity and respect, communication and autonomy, and supportive care. We performed psychometric analyses, including iterative exploratory and confirmatory factor analysis, to assess construct and criterion validity and reliability. Results: The results provide support for a 27-item PCMC scale in India with a possible score range from 0 to 81, compared to the 30-item PCMC scale in Kenya with a 0 to 90 possible score range. The overall PCMC scale has good reliability (Cronbach alpha = 0.85). Similar to Kenya, we are able to group the items in to three conceptual domains representing subscales for “Dignity and Respect,” “Communication and Autonomy,” and “Supportive Care.” The sub-scales also have relatively good reliability (Cronbach alphas range from 0.67 to 0.73). In addition, increasing scores on the scale is associated with future intentions to deliver in the same facility, suggesting good criterion validity. Conclusions: This research extends the PCMC literature by presenting results of validating the PCMC scale in a new context. The psychometric analysis using data from Uttar Pradesh, India corroborates the Kenya analysis showing the scale had good content, construct, and criterion validity, as well as high reliability. The overlap in items suggests that this scale can be used across different contexts to compare women’s experiences of care, and to inform and evaluate quality improvement efforts to promote comprehensive PCMC. [ABSTRACT FROM AUTHOR]

Objective: Access to quality, effective lifesaving uterotonics in low and middle-income countries (LMICs) remains a major barrier to reducing maternal deaths from postpartum haemorrhage (PPH). Our objective was to assess the costs of care for women who receive different preventative uterotonics, and with PPH and no-PPH so that the differences, if significant, can inform better resource allocation for maternal health care. Methods: The costs of direct hospital care of women who received oxytocin or heat-stable carbetocin for prevention of PPH in selected tertiary care facilities in India, Kenya, Nigeria, and Uganda were assessed. We collected data from all women who had PPH, as well as a random sample of women without PPH. Cost data was collected for the cost of stay, PPH interventions, transfusions and medications for 2966 women. We analyzed the difference in cost of care at a facility level between women who experienced a PPH event and those who did not. Key findings The mean cost of care of a woman experiencing PPH in the study sites in India, Kenya, Nigeria, and Uganda exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Conclusion: Our results quantify the increased cost of PPH of up to 4.1 times that for a birth without PPH. PPH cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on uterotonics for the prevention of PPH or other interventions used to treat PPH. Trial registration HRP Trial A65870; UTN U1111-1162-8519; ACTRN12614000870651; CTRI/2016/05/006969, EUDRACT 2014–004445-26. Date of registration 14 August 2014 Plain English summary: Access to quality, effective lifesaving medicines in low and middle-income countries remains a major barrier to reducing maternal deaths from bleeding after childbirth. Information on to what extent treatments for bleeding increases the cost of care of women after childbirth is important for informed resource allocation. We collected data from all women who had bleeding after childbirth, as well as a random sample of women without bleeding in selected hospitals in India, Kenya, Nigeria, and Uganda. Cost data was collected for the cost of stay and interventions to manage bleeding for 2966 women. We compared the difference in cost of care between women who experienced a bleeding event and those who did not. The mean cost of care of a woman with bleeding in the study sites exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Our results indicate an increased cost of bleeding of up to 4.1 times that for birth without bleeding. Effective prevention reduces the cost of care. Cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on medications for the prevention of bleeding after childbirth or other interventions used to treat bleeding. [ABSTRACT FROM AUTHOR]

Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention. Methods: The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5th percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth. Results: After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters. Conclusions: In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial. Trial registration: clinicaltrials.gov (NCT01084096) [ABSTRACT FROM AUTHOR]

Background: Bihar, India has higher rates of intimate partner violence (IPV) and maternal and infant mortality relative to India as a whole. This study assesses whether IPV is associated with poor reproductive and maternal health outcomes, as well as whether poverty exacerbates any observed associations, among women who gave birth in the preceding 23 months in Bihar, India. Methods: A cross-sectional analysis of data from a representative household sample of mothers of children 0–23 months old in Bihar, India (N = 13,803) was conducted. Associations between lifetime IPV (physical and/or sexual violence) and poor reproductive health outcomes ever (miscarriage, stillbirth, and abortion) as well as maternal complications for the index pregnancy (early and/or prolonged labor complications, other complications during pregnancy or delivery) were assessed using multivariable logistic regression, adjusting for demographics and fertility history of the mother. Models were then stratified by wealth index to determine whether observed associations were stronger for poorer versus wealthier women. Results: IPV was reported by 45% of women in the sample. A history of miscarriage, stillbirth, and abortion was reported by 8.7, 4.6, and 1.3% of the sample, respectively. More than one in 10 women (10.7%) reported labor complications during the last pregnancy, and 16.3% reported other complications during pregnancy or delivery. Adjusted regressions revealed significant associations between IPV and miscarriage (AOR = 1.35, 95% CI = 1.11–1.65) and stillbirth (AOR = 1.36, 95% CI = 1.02–1.82) ever, as well as with labor complications (AOR = 1.27, 95% CI = 1.04–1.54) and other pregnancy/delivery complications (AOR = 1.68, 95% CI = 1.42–1.99). Women in the poorest quartile (Quartile 1) saw no associations between IPV and miscarriage (Quartile 1 AOR = 0.98, 95% CI = 0.67–1.45) or stillbirth (Quartile 1 AOR = 1.17, 95% CI = 0.69–1.98), whereas women in the higher wealth quartile (Quartile 3) did see associations between IPV and miscarriage (Quartile 3 AOR = 1.55, 95% CI = 1.07, 2.25) and stillbirth (Quartile 3 AOR = 1.79, 95% CI = 1.04, 3.08). Discussion: IPV is highly prevalent in Bihar and is associated with increased risk for miscarriage, stillbirth, and maternal health complications. Associations between IPV and miscarriage and stillbirth do not hold true for the poorest women, possibly because other risks attached to poverty and deprivation may be greater contributors. [ABSTRACT FROM AUTHOR]