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.

Baseline Assessment of Evidence-Based Intrapartum Care Practices in Medical Schools in 3 States in India: A Mixed-Methods Study.

INTRODUCTION: Implementation research with pre- and post-comparison was planned to improve the quality of evidence-based intrapartum care services in Indian medical schools. We present the baseline study results to assess the status of adherence to intrapartum evidence-based practices (IP-EBP) in study schools in 3 states in India and the perception of the faculty. METHODS: A concurrent mixed-methods approach was used to conduct the baseline assessment in 9 medical schools in Rajasthan, Gujarat, and Union Territory from October 2018 to June 2019. IP-EBP among pregnant women in uncomplicated first (n=135), second (n=120), and third stage (n=120) of labor were observed using a predesigned, pretested checklist quantitatively. We conducted in-depth interviews with 33 obstetrics and gynecology faculty to understand their perceptions of intrapartum practices. Quantitative data were analyzed using SPSS (version 22). COM-B (Capability, Opportunity, and Motivation Behavior) model was used to understand the behaviors, and thematic analysis was done for the qualitative data. FINDINGS: Unindicated augmentation of labor was done in 64.4%, fundal pressure applied in 50.8%, episiotomy done in 58.3%, and delivery in lithotomy position was performed in 86.7% of women in labor. CONCLUSIONS: Intrapartum practices that are not recommended were routinely practiced in the study medical schools due to a lack of staff awareness of evidence-based practices and incorrect beliefs about their impact.

Relative risk of postpartum maternal morbidity among cesarean-delivered women: A multisite prospective cohort study in a large district, India.

Introduction: Family doctors manage mild to moderate postpartum morbidities that do not receive attention. The morbidities are higher after cesareans, which are increasing in number. The aim was to calculate the relative risk of various maternal morbidities occurring during 6 months postpartum among cesarean-delivered women in Pune District, India. Material and Methods: This was a large multisite study, which included all 11 non-teaching government hospitals performing at least five cesarean sections per month, one teaching government hospital, and one private teaching hospital. All eligible cesarean delivered and an equal number of age and parity matched vaginally delivered women were the participants. The obstetricians interrogated women before discharge, after 4 weeks, 6 weeks, and 6 months. Results: In this study 3,112 women participated. At any visit and among any group lost to follow-up proportion was <10%. There was no major intra-operative complication among vaginally delivered women. The relative risks of acute and severe morbidity as intensive care unit admission and blood transfusion among cesarean-delivered women were 2.59 [95% confidence interval (CI) = 1.96 to 3.44], 4.33 (95% CI = 2.17 to 8.92), respectively. The adjusted relative risk of surgical site pain and infection at 4 weeks; surgical site pain at 6 weeks; and lower abdominal pain, breast engorgement/mastitis, urinary incontinence, and weakness at 6 months among cesarean-delivered women was higher (P < 0.05). Vaginally delivered women resumed family activities earlier. Conclusion: Health care workers, including family doctors, during follow-up of cesarean-delivered women, must assess for pain, induration/discharge at the surgical site, urinary incontinence, and breast engorgement/mastitis.

Violence Perpetrated by Mothers-in-Law in Northern India: Perceived Frequency, Acceptability, and Options for Survivors.

In India, physical and psychological abuse perpetrated by a mother-in-law against a daughter-in-law is well documented. However, there is a dearth of literature exploring the perceived frequency and acceptability of mother-in-law abuse or options available for survivors of this type of abuse. The goal of this qualitative study was to add to the in-law abuse literature by exploring men's and women's perspectives about physical and psychological abuse perpetrated by mothers-in-law against daughters-in-law in northern India. Forty-four women and 34 men residing in rural and urban areas of the Udaipur district in the northwest state of Rajasthan participated in semistructured interviews. Women, but not men, thought mother-in-law abuse was common in their communities. Psychological abuse was accepted in certain situations; however, few male or female participants agreed with physical mother-in-law abuse. Men were described as mediators in the context of mother-in-law abuse, and male participants thought that disrespecting a mother-in-law was a justifiable reason for a man to hit his wife. Both male and female participants described few options available for a woman experiencing mother-in-law abuse, apart from asking her husband to intervene or living as a separate, nuclear family. Grassroots initiatives and legislative policy should focus on addressing the immediate needs of women experiencing mother-in-law abuse and developing intergenerational interventions to educate men and women about the dynamics of law abuse.

Competency assessment of the medical interns and nurses and documenting prevailing practices to provide family planning services in teaching hospitals in three states of India.

OBJECTIVES: The objectives of the study were to assess the knowledge and skills of medical interns and nurses regarding family planning (FP) services, and document the prevailing FP practices in the teaching hospitals in India. STUDY DESIGN: A cross-sectional study was conducted in three states (Delhi, Rajasthan, and Maharashtra) of India, among randomly selected 163 participants, including medical interns (n = 81) and in-service nurses (n = 82), during 2017. The semi-structured, pre-tested interview schedule, was used to assess the knowledge and status of training received; and objective structured clinical examination (OSCE) based checklist was used to evaluate the skills. RESULTS: About 60% of the interns and 48% of the nurses knew more than five contraceptives that could be offered to the clients. About 22% (11.1% interns and 33.3% nurses) respondents believed that contraceptives should not be given to a married woman coming alone, and 31.9% (17.3% interns and 46.3% nurses) respondents reported that it was illegal to provide contraceptives to unmarried people. Nearly 43.3% interns and 69.5% nurses refused to demonstrate intrauterine contraceptive device (IUCD) insertion in the dummy uterus as per OSCE, and among those who did, 12.3% interns and 18.3% nurses had failed. About 63% interns and 63.4% of nurses had observed IUCD insertion, and 12.3% interns and 17.1% had performed IUCD insertion, during their training. CONCLUSIONS: Knowledge and skills of interns and nurses regarding FP services were inadequate. The medical training during graduation or internship, and during the job, was found to be inadequate to provide quality FP services as per guidelines of nursing/medical council of India and Government of India on FP.

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.

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.

Accuracy of Assessment of Eligibility for Early Medical Abortion by Community Health Workers in Ethiopia, India and South Africa.

OBJECTIVE: To assess the accuracy of assessment of eligibility for early medical abortion by community health workers using a simple checklist toolkit. DESIGN: Diagnostic accuracy study. SETTING: Ethiopia, India and South Africa. METHODS: Two hundred seventeen women in Ethiopia, 258 in India and 236 in South Africa were enrolled into the study. A checklist toolkit to determine eligibility for early medical abortion was validated by comparing results of clinician and community health worker assessment of eligibility using the checklist toolkit with the reference standard exam. RESULTS: Accuracy was over 90% and the negative likelihood ratio <0.1 at all three sites when used by clinician assessors. Positive likelihood ratios were 4.3 in Ethiopia, 5.8 in India and 6.3 in South Africa. When used by community health workers the overall accuracy of the toolkit was 92% in Ethiopia, 80% in India and 77% in South Africa negative likelihood ratios were 0.08 in Ethiopia, 0.25 in India and 0.22 in South Africa and positive likelihood ratios were 5.9 in Ethiopia and 2.0 in India and South Africa. CONCLUSION: The checklist toolkit, as used by clinicians, was excellent at ruling out participants who were not eligible, and moderately effective at ruling in participants who were eligible for medical abortion. Results were promising when used by community health workers particularly in Ethiopia where they had more prior experience with use of diagnostic aids and longer professional training. The checklist toolkit assessments resulted in some participants being wrongly assessed as eligible for medical abortion which is an area of concern. Further research is needed to streamline the components of the tool, explore optimal duration and content of training for community health workers, and test feasibility and acceptability.

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.

Perceptions of options available for victims of physical intimate partner violence in northern India.

We used qualitative methodologies to understand perceptions regarding options available for victims of physical intimate partner violence (IPV) in northern India. We interviewed male and female community members along with IPV experts. Interviews were transcribed, coded, and analyzed using grounded theory. Participants emphasized that a victim of physical IPV should bear the violence, modify her husband's behaviors, or seek help from her natal family. Accessing external resources such as the police or nongovernmental organizations was viewed as both socially inappropriate and infeasible. These results have widespread implications and lay the foundation for the development of IPV prevention initiatives in India.

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.