Observational study of feasibility and acceptability of the levonorgestrel-releasing intrauterine device as a long-acting reversible contraceptive in a primary care setting in India.

Objectives: The levonorgestrel-releasing intrauterine device (LNG-IUD) is a well-accepted contraceptive across developed countries, yet there is limited experience in use and acceptance amongst women living in low-resource, developing country settings. We studied the feasibility of providing the LNG-IUD through a primary care service, and its acceptability amongst women living in a low-income, rural-tribal community in India. Study design: We conducted an observational study of feasibility and acceptability at four health facilities (three rural, and one urban) in Rajasthan, India. Women seeking contraception were offered the LNG-IUD in addition to existing contraceptive methods. We followed all those who adopted LNG-IUD from August 2015 to September 2019 (n= 1266) till discontinuation or 12 months, whichever was earlier. The primary outcome was continuation rate and acceptability, and the secondary outcome was change in hemoglobin levels, which we measured before insertion and at 12-month follow-up, using Sahli's method. Results: Most users lived in villages, were illiterate, belonged to marginalized groups, had 2 or more children, and wished to limit births when they adopted the method. The 12-month continuation rate was 87.6%. Amongst all users, 7.4% of women sought removal for side effects and 2% for change in reproductive intention, while another 2% reported spontaneous expulsion. Most continuing users reported hypomenorrhea (54%) or amenorrhea (42%) by 12 months of use. User satisfaction was high at 91.6%, with 92% of women rating their experience as equaling or exceeding expectations. Moderate and severe anemia reduced, and mean hemoglobin levels increased by 0.7 g/dL (p < 0.01). Conclusion: Primary care clinics can feasibly deliver LNG-IUD, with high acceptability amongst women living in low resource settings. Given the paucity of long-acting reversible contraceptive options and high prevalence of anemia among women in India and similar countries, the method should be piloted through the public health system. Implications: Long duration of contraceptive action, ability to reduce menstrual bleeding and reduce anemia, reversibility, and easy removal, combine to make LNG-IUD acceptable to women, especially in regions with high prevalence of anemia. This study demonstrates the feasibility and acceptability of introducing LNG-IUD in a low resource, primary care setting.

Predictors of recovery in children aged 6-59 months with uncomplicated severe acute malnutrition: a multicentre study.

OBJECTIVE: To identify predictors of recovery in children with uncomplicated severe acute malnutrition (SAM). DESIGN: This is a secondary data analysis from an individual randomised controlled trial, where children with uncomplicated SAM were randomised to three feeding regimens, namely ready-to-use therapeutic food (RUTF) sourced from Compact India, locally prepared RUTF or augmented home-prepared foods, under two age strata (6-17 months and 18-59 months) for 16 weeks or until recovery. Three sets of predictors that could influence recovery, namely child, family and nutritional predictors, were analysed. SETTING: Rural and urban slum areas of three states of India, namely Rajasthan, Delhi and Tamil Nadu. PARTICIPANTS: In total, 906 children (age: 6-59 months) were analysed to estimate the adjusted hazard ratio (AHR) using the Cox proportional hazard ratio model to identify various predictors. RESULTS: Being a female child (AHR: 1·269 (1·016, 1·584)), better employment status of the child's father (AHR: 1·53 (1·197, 1·95)) and residence in a rental house (AHR: 1·485 (1·137, 1·94)) increased the chances of recovery. No hospitalisation (AHR: 1·778 (1·055, 2·997)), no fever, (AHR: 2·748 (2·161, 3·494)) and ≤ 2 episodes of diarrhoea (AHR: 1·579 (1·035, 2·412)) during the treatment phase; availability of community-based peer support to mothers for feeding (AHR: 1·61 (1·237, 2·097)) and a better weight-for-height Z-score (WHZ) at enrolment (AHR: 1·811 (1·297, 2·529)) predicted higher chances of recovery from SAM. CONCLUSION: The probability of recovery increases in children with better WHZ and with the initiation of treatment for acute illnesses to avoid hospitalisation, availability of peer support and better employment status of the father.

Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India.

BACKGROUND: Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates. METHODS: This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters. FINDINGS: A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm. INTERPRETATION: Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births. TRIAL REGISTRATION NUMBER: The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).

Costing of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition from a randomised trial in India.

TRIAL DESIGN: Three feeding regimens-centrally produced ready-to-use therapeutic food, locally produced ready-to-use therapeutic food, and augmented, energy-dense, home-prepared food-were provided in a community setting for children with severe acute malnutrition (SAM) in the age group of 6-59 months in an individually randomised multicentre trial that enrolled 906 children. Foods, counselling, feeding support and treatment for mild illnesses were provided until recovery or 16 weeks. METHODS: Costs were estimated for 371 children enrolled in Delhi in a semiurban location after active survey and identification, enrolment, diagnosis and treatment for mild illnesses, and finally treatment with one of the three regimens, both under the research and government setting. Direct costs were estimated for human resources using a price times quantity approach, based on their salaries and average time taken for each activity. The cost per week per child for food, medicines and other consumables was estimated based on the total expenditure over the period and children covered. Indirect costs for programme management including training, transport, non-consumables, infrastructure and equipment were estimated per week per child based on total expenditures for research study and making suitable adjustments for estimations under government setting. RESULTS: No significant difference in costs was found across the three regimens per covered or per treated child. The average cost per treated child in the government setting was estimated at US$56 (<3500 rupees). CONCLUSION: Home-based management of SAM with a locally produced ready-to-use therapeutic food is feasible, acceptable, affordable and very cost-effective in terms of the disability-adjusted life years saved and gross national income per capita of the country. The treatment of SAM at home needs serious attention and integration into the existing health system, along with actions to prevent SAM. TRIAL REGISTRATION NUMBER: NCT01705769; Pre-results.

Can community health workers play a greater role in increasing access to medical abortion services? A qualitative study.

BACKGROUND: Despite being legally available in India since 1971, barriers to safe and legal abortion remain, and unsafe and/or illegal abortion continues to be a problem. Community health workers have been involved in improving access to health information and care for maternal and child health in resource poor settings, but their role in facilitating accurate information about and access to safe abortion has been relatively unexplored. A qualitative study was conducted in Rajasthan, India to study acceptability, perspectives and preferences of women and community health workers, regarding the involvement of community health workers in medical abortion referrals. METHODS: In-depth interviews were conducted with 24 women seeking early medical abortion at legal abortion facilities or presenting at these facilities for a follow-up assessment after medical abortion. Ten community health workers who were trained to assess eligibility for early medical abortion and/or to assess whether women needed a follow-up visit after early medical abortion were also interviewed. The transcripts were coded using ATLAS-ti 7 (version 7.1.4) in the local language and reports were generated for all the codes, emerging themes were identified and the findings were analysed. RESULTS: Community health workers (CHWs) were willing to play a role in assessing eligibility for medical abortion and in identifying women who are in need of follow-up care after early medical abortion, when provided with appropriate training, regular supplies and job aids. Women however had apprehensions about contacting CHWs in relation to abortions. Important barriers that prevented women from seeking information and assistance from community health workers were fear of breach of confidentiality and a perception that they would be pressurised to undergo sterilisation. CONCLUSIONS: Our findings support a potential for greater role of CHWs in making safe abortion information and services accessible to women, while highlighting the need to address women's concerns about approaching CHWs in case of unwanted pregnancy. Further intervention research would be needed to shed light on the effectiveness of role of CHWs in facilitating access to safe abortion and to outline specific components in a programme setting. TRIAL REGISTRATION: Not applicable.

Negotiating Collective and Individual Agency: A Qualitative Study of Young Women's Reproductive Health in Rural India.

The societal changes in India and the available variety of reproductive health services call for evidence to inform health systems how to satisfy young women's reproductive health needs. Inspired by Foucault's power idiom and Bandura's agency framework, we explore young women's opportunities to practice reproductive agency in the context of collective social expectations. We carried out in-depth interviews with 19 young women in rural Rajasthan. Our findings highlight how changes in notions of agency across generations enable young women's reproductive intentions and desires, and call for effective means of reproductive control. However, the taboo around sex without the intention to reproduce made contraceptive use unfeasible. Instead, abortions were the preferred method for reproductive control. In conclusion, safe abortion is key, along with the need to address the taboo around sex to enable use of "modern" contraception. This approach could prevent unintended pregnancies and expand young women's agency.

Does mode of follow-up influence contraceptive use after medical abortion in a low-resource setting? Secondary outcome analysis of a non-inferiority randomized controlled trial.

BACKGROUND: Post-abortion contraceptive use in India is low and the use of modern methods of contraception is rare, especially in rural areas. This study primarily compares contraceptive use among women whose abortion outcome was assessed in-clinic with women who assessed their abortion outcome at home, in a low-resource, primary health care setting. Moreover, it investigates how background characteristics and abortion service provision influences contraceptive use post-abortion. METHODS: A randomized controlled, non-inferiority, trial (RCT) compared clinic follow-up with home-assessment of abortion outcome at 2 weeks post-abortion. Additionally, contraceptive-use at 3 months post-abortion was investigated through a cross-sectional follow-up interview with a largely urban sub-sample of women from the RCT. Women seeking abortion with a gestational age of up to 9 weeks and who agreed to a 2-week follow-up were included (n = 731). Women with known contraindications to medical abortions, Hb < 85 mg/l and aged below 18 were excluded. Data were collected between April 2013 and August 2014 in six primary health-care clinics in Rajasthan. A computerised random number generator created the randomisation sequence (1:1) in blocks of six. Contraceptive use was measured at 2 weeks among women successfully followed-up (n = 623) and 3 months in the sub-set of women who were included if they were recruited at one of the urban study sites, owned a phone and agreed to a 3-month follow-up (n = 114). RESULTS: There were no differences between contraceptive use and continuation between study groups at 3 months (76 % clinic follow-up, 77 % home-assessment), however women in the clinic follow-up group were most likely to adopt a contraceptive method at 2 weeks (62 ± 12 %), while women in the home-assessment group were most likely to adopt a method after next menstruation (60 ± 13 %). Fifty-two per cent of women who initiated a method at 2 weeks chose the 3-month injection or the copper intrauterine device. Only 4 % of women preferred sterilization. Caste, educational attainment, or type of residence did not influence contraceptive use. CONCLUSIONS: Simplified follow-up after early medical abortion will not change women's opportunities to access contraception in a low-resource setting, if contraceptive services are provided as intra-abortion services as early as on day one. Women's postabortion contraceptive use at 3 months is unlikely to be affected by mode of followup after medical abortion, also in a low-resource setting. Clinical guidelines need to encourage intra-abortion contraception, offering the full spectrum of evidence-based methods, especially long-acting reversible methods. TRIAL REGISTRATION: Clinicaltrials.gov NCT01827995.

Improving access to safe abortion in a rural primary care setting in India: experience of a service delivery intervention.

BACKGROUND: Abortion services were legalized in India in 1972, however, the access to safe abortion services is restricted, especially in rural areas. In 2002, medical abortion using mifepristone- misoprostol was approved for termination of pregnancy, however, its use has been limited in primary care settings. METHODS: This paper describes a service delivery intervention for women attending with unwanted pregnancies over 14 years in four primary care clinics of Rajasthan, India. Prospective data was collected to document the profile of women, method of abortion provided, contraceptive use and follow-up rates after abortion. This analysis includes data collected during August 2001-March 2015. RESULTS: A total of 9076 women with unwanted pregnancies sought care from these clinics, and abortion services were provided to 70 % of these. Most abortion seekers were married, had one or more children. After 2003, the use of medical abortion increased over the years and ultimately accounted for 99 % of all abortions in 2014. About half the women returned for a follow-up visit, while the proportion using contraceptives declined from 74 % to 52 % from 2001 to 2014. CONCLUSIONS: The results of our intervention indicate that integrating medical abortion into primary care settings is feasible and has a potential to improve access to safe abortion services in rural areas. Our experience can be used to guide program managers and service providers about reducing barriers and making abortion services more accessible to women.

Huwa Rog, Parhej, and Desi Dawai: Women's Perceptions of Postpartum Maternal Morbidity and Care in Rajasthan, India.

Although more maternal deaths occur in the postpartum period, this period receives far less attention from the program managers. To understand how the women and their families perceive postpartum health problems, the culturally derived restrictions, and precautions controlling diets and behavior patterns, we conducted a mixed-method study in Rajasthan, India. The study methods included free listing of maternal morbidity conditions, interviews with 81 recently delivered women, case interviews with eight cases of huwa rog (postpartum illness), and interviews with nine key informants. The study showed that huwa rog refers to a broad category of serious postpartum illness, thought to affect women a few weeks to several months after delivery. Prevention of the illness involves a system of precautions referred to as parhej, which includes a distinctive set of "medicinal dietary items" referred to as desi dawai, or "country medicine," and restrictions about mobility and work patterns of a postpartum woman. This cultural framework around the concept of huwa rog and peoples' beliefs about it are of central importance for planning postpartum health interventions, including place of contact and communication messages.

Home use of misoprostol for early medical abortion in a low resource setting: secondary analysis of a randomized controlled trial.

INTRODUCTION: Although home use of misoprostol for early medical abortion is considered to be safe, effective and feasible, it has not become standard service delivery practice. The aim of this study was to compare the efficacy, safety, and acceptability of home use of misoprostol with clinic misoprostol in a low-resource setting. MATERIAL AND METHODS: This was a secondary analysis of a randomized controlled trial conducted in six primary care clinics in India. Women seeking medical abortion within up to nine gestational weeks (n = 731) received mifepristone in the clinic and were allocated either to home or clinic administration of misoprostol. Follow-up contact was after 10-15 days. RESULTS: Of 731 participants, 73% were from rural areas and 55% had no formal education. Complete abortion rates in the home and clinic misoprostol groups were 94.2 and 94.4%, respectively. The rate of adverse events was similar in both groups (0.3%). A greater proportion of home users (90.2%) said that they would opt for misoprostol at home in the event of a future abortion compared with clinic users (79.7%) who would opt for misoprostol at the clinic in a similar situation (p = 0.0002). Ninety-six percent women using misoprostol at home or in the clinic were satisfied with their abortion experience. CONCLUSIONS: Home-use of misoprostol for early medical abortion is as effective and acceptable as clinic use, in low resource settings. Women should be offered a choice of this option regardless of distance of their residence from the clinic and communication facilities.

Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India.

OBJECTIVE: To assess the efficacy of ready-to-use therapeutic food (RUTF), centrally produced RUTF (RUTF-C) or locally prepared RUTF (RUTF-L) for home-based management of uncomplicated severe acute malnutrition (SAM) compared with micronutrient-enriched (augmented) energy-dense home-prepared foods (A-HPF, the comparison group). METHODS: In an individually randomised multicentre trial, we enrolled 906 children aged 6-59 months with uncomplicated SAM. The children enrolled were randomised to receive RUTF-C, RUTF-L or A-HPF. We provided foods, counselling and feeding support until recovery or 16 weeks, whichever was earlier and measured outcomes weekly (treatment phase). We subsequently facilitated access to government nutrition services and measured outcomes once 16 weeks later (sustenance phase). The primary outcome was recovery during treatment phase (weight-for-height ≥-2 SD and absence of oedema of feet). RESULTS: Recovery rates with RUTF-L, RUTF-C and A-HPF were 56.9%, 47.5% and 42.8%, respectively. The adjusted OR was 1.71 (95% CI 1.20 to 2.43; p=0.003) for RUTF-L and 1.28 (95% CI 0.90 to 1.82; p=0.164) for RUTF-C compared with A-HPF. Weight gain in the RUTF-L group was higher than in the A-HPF group (adjusted difference 0.90 g/kg/day, 95% CI 0.30 to 1.50; p=0.003). Time to recovery was shorter in both RUTF groups. Morbidity was high and similar across groups. At the end of the study, the proportion of children with weight-for-height Z-score (WHZ) >-2 was similar (adjusted OR 1.12, 95% CI 0.74 to 1.95; p=0.464), higher for moderate malnutrition (WHZ<-2 and ≥-3; adjusted OR 1.46, 95% CI 1.02 to 2.08; p=0.039), and lower for those with SAM (adjusted OR 0.58, 95% CI 0.40 to 0.85; p=0.005) in the RUTF-L when compared with the A-HPF group. CONCLUSIONS: This first randomised trial comparing options for home management of uncomplicated SAM confirms that RUTF-L is more efficacious than A-HPF at home. Recovery rates were lower than in African studies, despite longer treatment and greater support for feeding. TRIAL REGISTRATION NUMBER: NCT01705769; Pre-results.

"Who Wants to Go Repeatedly to the Hospital?" Perceptions and Experiences of Simplified Medical Abortion in Rajasthan, India.

The aim of this study is to explore women's experiences and perceptions of home use of misoprostol and of the self-assessment of the outcome of early medical abortion in a low-resource setting in India. In-depth interviews were conducted with 20 women seeking early medical abortion, who administered misoprostol at home and assessed their own outcome of abortion using a low-sensitivity pregnancy test. With home use of misoprostol, women were able to avoid inconvenience of travel, child care, and housework, and maintain confidentiality. The use of a low-sensitivity pregnancy test alleviated women's anxieties about retained products. Majority said they would prefer medical abortion involving a single visit in future. This study provides nuanced understanding of how women manage a simplified medical abortion in the context of low literacy and limited communication facilities. Service delivery guidelines should be revised to allow women to have medical abortion with fewer visits.

Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial.

BACKGROUND: Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education. OBJECTIVE: To investigate women's acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India. DESIGN: Secondary outcome of a randomised, controlled, non-inferiority trial. SETTING: Outpatient primary health care clinics in rural and urban Rajasthan, India. POPULATION: Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85 mg/l and were below 18 years. METHODS: Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible. MAIN OUTCOME MEASURES: Women's acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups. RESULTS: 731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%), in the home-assessment group preferred home-assessment in the future, as compared with 188 (70%) of women in the clinic follow-up group, who preferred clinic follow-up in the future (p < 0.001). CONCLUSION: Home-assessment is highly acceptable among women in low-resource, and rural, settings. The choice to follow-up an early medical abortion according to women's preference should be offered to foster women's reproductive autonomy. TRIAL REGISTRATION: ClinicalTrials.gov NCT01827995.

Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial.

BACKGROUND: The need for multiple clinical visits remains a barrier to women accessing safe legal medical abortion services. Alternatives to routine clinic follow-up visits have not been assessed in rural low-resource settings. We compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting. METHODS: This randomised, controlled, non-inferiority trial was done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of gestation were randomly assigned (1:1) to either routine clinic follow-up or self-assessment at home. Randomisation was done with a computer-generated randomisation sequence, with a block size of six. The study was not blinded. Women in the home-assessment group were advised to use a pictorial instruction sheet and take a low-sensitivity urine pregnancy test at home, 10-14 days after intake of mifepristone, and were contacted by a home visit or telephone call to record the outcome of the abortion. The primary (non-inferiority) outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone and misoprostol. The non-inferiority margin for the risk difference was 5%. All participants with a reported primary outcome and who followed the clinical protocol were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01827995. FINDINGS: Between April 23, 2013, and May 15, 2014, 731 women were recruited and assigned to clinic follow-up (n=366) or home assessment (n=365), of whom 700 were analysed for the main outcomes (n=336 and n=364, respectively). Complete abortion without continuing pregnancy, surgical intervention, or additional mifepristone and misoprostol was reported in 313 (93%) of 336 women in the clinic follow-up group and 347 (95%) of 364 women in the home-assessment group (difference -2·2%, 95% CI -5·9 to 1·6). One case of haemorrhage occurred in each group (rate of adverse events 0·3% in each group); no other adverse events were noted. INTERPRETATION: Home assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting.

Adherence to evidence based care practices for childbirth before and after a quality improvement intervention in health facilities of Rajasthan, India.

BACKGROUND: After the launch of Janani Suraksha Yojana, a conditional cash transfer scheme in India, the proportion of women giving birth in institutions has rapidly increased. However, there are important gaps in quality of childbirth services during institutional deliveries. The aim of this intervention was to improve the quality of childbirth services in selected high caseload public health facilities of 10 districts of Rajasthan. This intervention titled "Parijaat" was designed by Action Research & Training for Health, in partnership with the state government and United Nations Population Fund. METHODS: The intervention was carried out in 44 public health facilities in 10 districts of Rajasthan, India. These included district hospitals (9), community health centres (32) and primary health centres (3). The main intervention was orientation training of doctors and program managers and regular visits to facilities involving assessment, feedback, training and action. The adherence to evidence based practices before, during and after this intervention were measured using structured checklists and scoring sheets. Main outcome measures included changes in practices during labour, delivery or immediate postpartum period. RESULTS: Use of several unnecessary or harmful practices reduced significantly. Most importantly, proportion of facilities using routine augmentation of labour reduced (p = 0), episiotomy for primigravidas (p = 0.0003), fundal pressure (p = 0.0003), and routine suction of newborns (0 = 0.0005). Among the beneficial practices, use of oxytocin after delivery increased (p = 0.0001) and the practice of listening foetal heart sounds during labour (p = 0.0001). Some practices did not show any improvements, such as dorsal position for delivery, use of partograph, and hand-washing. CONCLUSIONS: An intervention based on repeated facility visits combined with actions at the level of decision makers can lead to substantial improvements in quality of childbirth practices at health facilities.

Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India--study protocol and intervention adaptation of a randomised control trial.

BACKGROUND: The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic. METHODS/DESIGN: This study protocol describes a study that is a randomised, controlled, non-superiority trial. Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. The randomisation list will be generated using a computerized random number generator and opaque sealed envelopes with group allocation will be prepared. Randomization of the study participants will occur after the first clinical encounter with the doctor. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study this study protocol describes is to evaluate the efficacy of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This resulted in an optimized, tailor-made intervention and in the development of the pictorial instruction sheet with a guide on how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion. DISCUSSION: In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor. TRIAL REGISTRATION: Clinicaltrials.gov NCT01827995. Registered 04 May 2013.

Understanding care and feeding practices: building blocks for a sustainable intervention in India and Pakistan.

Undernutrition and inadequate stimulation both negatively influence child health and development and have a long-term impact on school attainment and income. This paper reports data from India and Pakistan looking at how families interact, play with, and feed children; their expectations of growth and development; and the perceived benefits, consequences, opportunities, and barriers of adopting recommended feeding and developmental behaviors. These data were collected as part of formative research for the Sustainable Program Incorporating Nutrition and Games (SPRING) trial. This trial aims to deliver an innovative, feasible, affordable, and sustainable intervention that can achieve delivery at a scale of known effective interventions that maximize child development, growth, and survival and improve maternal psychosocial well-being in rural India and Pakistan.

Setting research priorities to reduce global mortality from preterm birth and low birth weight by 2015.

AIM: This paper aims to identify health research priorities that could improve the rate of progress in reducing global neonatal mortality from preterm birth and low birth weight (PB/LBW), as set out in the UN's Millennium Development Goal 4. METHODS: We applied the Child Health and Nutrition Research Initiative (CHNRI) methodology for setting priorities in health research investments. In the process coordinated by the World Health Organization in 2007-2008, 21 researchers with interest in child, maternal and newborn health suggested 82 research ideas that spanned across the broad spectrum of epidemiological research, health policy and systems research, improvement of existing interventions and development of new interventions. The 82 research questions were then assessed for answerability, effectiveness, deliverability, maximum potential for mortality reduction and the effect on equity using the CHNRI method. RESULTS: The top 10 identified research priorities were dominated by health systems and policy research questions (eg, identification of LBW infants born at home within 24-48 hours of birth for additional care; approaches to improve quality of care of LBW infants in health facilities; identification of barriers to optimal home care practices including care seeking; and approaches to increase the use of antenatal corticosteriods in preterm labor and to improve access to hospital care for LBW infants). These were followed by priorities for improvement of the existing interventions (eg, early initiation of breastfeeding, including feeding mode and techniques for those unable to suckle directly from the breast; improved cord care, such as chlorhexidine application; and alternative methods to Kangaroo Mother Care (KMC) to keep LBW infants warm in community settings). The highest-ranked epidemiological question suggested improving criteria for identifying LBW infants who need to be cared for in a hospital. Among the new interventions, the greatest support was shown for the development of new simple and effective interventions for providing thermal care to LBW infants, if KMC is not acceptable to the mother. CONCLUSION: The context for this exercise was set within the MDG4, requiring an urgent and rapid progress in mortality reduction from low birth weight, rather than identifying long-term strategic solutions of the greatest potential. In a short-term context, the health policy and systems research to improve access and coverage by the existing interventions, coupled with further research to improve effectiveness, deliverability and acceptance of existing interventions, and epidemiological research to address the key gaps in knowledge, were all highlighted as research priorities.