Increasing coverage and uptake of voluntary family planning in Uganda's emerging municipalities and secondary cities: An implementation research study protocol.

INTRODUCTION: While urban areas are often perceived to have better access to healthcare services, including modern family planning (FP) services, urban dwellers including those with better socioeconomic status are faced with multidimensional challenges that shape their access to appropriate FP services. In Uganda's urban spaces, there is currently a lack of understanding among service providers, civil society organizations, and individuals/communities regarding the implementation of interventions that promote informed choice and voluntary use of family planning services. This knowledge gap has profound implications for reproductive rights. This study seeks to enhance existing efforts towards increasing coverage and uptake of Voluntary Family Planning (VFP) in Jinja City and Iganga Municipality, central eastern Uganda. Our primary question is, "What interventions can effectively be packaged and delivered to increase the uptake of VFP among different segments of urban residents?" METHODS: We propose to use the Human-Centered Design (HCD) approach to understand the needs and challenges of users and community capabilities in ensuring access to VFP services. Co-creating with stakeholders' engagement and a data-driven-centric approach will steer design and adaptation that respond to the different population segments within the urban space. As such, the study will be implemented in three phases: formative assessment, design and implementation, and implementation monitoring and evaluation. The implementation process will incorporate robust monitoring, learning, and adaptation mechanisms. The primary focus of these mechanisms will be to utilize gathered information effectively to inform the design of the implementation and facilitate continuous learning throughout the process. The study will apply a process monitoring and evaluation approach to address questions related to what package of FP interventions work, for whom, under what circumstances and why. DISCUSSION: Guided by strong learning and implementation flexibility, we hypothesize that our implementation will provide segmentation-specific high-impact interventions in an urban context. REGISTRATION: This implementation research protocol has been registered on the Open Science Framework (OSF) repository Registries (https://osf.io/vqxu9; DOI: 10.17605/OSF.IO/VQXU9).

Using digital platforms to promote a healthcare provider community of practice for abortion care in Uganda.

BACKGROUND: A community of practice (CoP) is defined as a group of people who share a concern, set of problems, or a passion about a topic, and who deepen their knowledge and expertise by interacting on an ongoing basis. The paper presents a case study on the design, implementation and management of a CoP. The objective is to share experiences, opportunities, challenges and lessons learnt in using digital platforms for clinical mentorships to establish a CoP that promotes enhanced service provision of abortion care. METHODS: We employed competence-based training and ongoing virtual mentorship for abortion care, employing the abortion harm reduction model, and using several digital platforms to create and nurture community of practice for abortion care. Using the Capability-Opportunity-Motivation for Behavior (COM-B) model and textual data analysis, we evaluated the performance of the CoP as a tool to support abortion care, using data from in-depth interviews and information shared on the platforms. The data was analyzed by thematic analysis using text data analytical approach. RESULTS: CoPs have much unrealized potential for networking to improve abortion care, as they are more inclusive, interactive and equalizing than typical webinars, yet less expensive and can complement (though not replace) physical mentorships. CoPs' focus on sharing best practices and creating new knowledge to advance professional practice, faces challenges of maintaining regular interaction on an ongoing basis. CoP members need to share a passion for their practice and mutual trust is key to success. CONCLUSION: Though it faced initial challenges of connectivity, and limited interaction, the CoP approach using digital platforms promoted shared experiences, personal connections, communication, collaboration and application of knowledge for improved abortion care.

How a co-design process led to more contextually relevant family planning interventions in emerging urban settings in Eastern Uganda.

Voluntary, rights-based family planning upholds women's right to determine freely the number and spacing of their children. However, low-resource settings like Uganda still face a high unmet need for family planning. And, while urban areas are often indicated to have better access to health services, emerging evidence is revealing intra-urban socio-economic differentials in family planning utilization. To address the barriers to contraceptive use in these settings, understanding community-specific challenges and involving them in tailored intervention design is crucial. This paper describes the use of co-design, a human-centred design tool, to develop context-specific interventions that promote voluntary family planning in urban settings in Eastern Uganda. A five-stage co-design approach was used: 1) Empathize: primary data was collected to understand the problem and people involved, 2) Define: findings were shared with 56 participants in a three-day in-person co-design workshop, including community members, family planning service providers and leaders, 3) Ideate: workshop participants generated potential solutions, 4) Prototype: participants prioritized prototypes, and 5) Testing: user feedback was sought about the prototypes. A package of ten interventions was developed. Five interventions targeted demand-side barriers to family planning uptake, four targeted supply-side barriers, and one addressed leadership and governance barriers. Involving a diverse group of co-creators provided varied experiences and expertise to develop the interventions. Participants expressed satisfaction with their involvement in finding solutions to challenges in their communities. However, power imbalances and language barriers were identified by the participants as potential barriers to positive group dynamics and discussion quality. To address them, participants were separated into groups, and medical terminologies were simplified during brainstorming sessions. These changes improved participation and maximized the contributions of all participants. It is therefore important to consider participant characteristics and their potential impact on the process, especially when engaging diverse participant groups, and implement measures to mitigate their effects.

Characteristics and outcomes of patients with pelvic organ prolapse: an analysis of data from Mulago National Referral Hospital from 2007-2016.

Introduction: Pelvic organ prolapse (POP) is associated with negative physical, social, psychological, and sexual experiences. There is paucity of data in low and middle income countries like Uganda. The purpose of this study was to describe clinical characteristics and outcomes of patients undergoing surgery for POP from 2007 to 2016. Methods: The study was conducted at Mulago National Referral Hospital from 2014 to 2016. We conducted a retrospective review of the urogynecology surgical records using a standardized medical record abstraction form. Data of 222 POP patients were abstracted and managed using REDCap. Analysis was performed using Stata statistical software, v14. Results: The mean participant age and parity was 57 years and 7 respectively. Ninety four percent of participants presented with a mass protruding from the vagina, 38% with uterine prolapse and 32% with cystocoele. Anaemia and hypertension were common comorbidities. Women underwent a variety of surgery types, and 35% experienced persistent pain post-operatively. At hospital discharge, 83% had achieved either complete resolution or improvement in their condition. Conclusions: Measures encouraging presentation for care as soon as symptoms are experienced and reduction of total fertility rate will be beneficial. Patients with POP should be routinely screened for anaemia and hypertension.

Contraceptive preferences and adoption following female genital fistula surgery in Uganda: a mixed-methods study.

BACKGROUND: Female genital fistula, largely caused by prolonged obstructed labour, is treated by surgical repair. Preventing pregnancy for a minimum period post-repair is recommended to ensure adequate healing and optimize post-repair outcomes. METHODS: We examined contraceptive preferences and use among Ugandan fistula patients (n = 60) in the year following genital fistula surgery using mixed-methods. Sexual activity, contraceptive use and pregnancy status were recorded quarterly for 12 months after surgery. In-depth interviews among purposively selected participants (n = 30) explored intimate relationships, sexual experiences, reproductive intentions, and contraceptive use. RESULTS: Median participant age was 28 years and almost half (48%) were married or living with partners. Counselling was provided to 97% of participants on delaying sexual intercourse, but only 59% received counselling on contraception. Sexual activity was reported by 32% after 6 months and 50% after 12 months. Eighty-three percent reported not trying for pregnancy. Among sexually active participants, contraceptive use was low at baseline (36%) but increased to 73% at 12 months. Six (10%) women became pregnant including two within 3 months post-repair. Interview participants who desired children immediately were young, had fewer children, experienced stillbirth at fistula development, and felt pressure from partners. Women adopted contraception to fully recover from fistula surgery and avoid adverse outcomes. Others simply preferred to delay childbearing. Reasons cited for not adopting contraception included misconceptions related to their fertility and to contraceptive methods and insufficient or unclear healthcare provider advice on their preferred methods. CONCLUSIONS: A high proportion of patients were not counselled by healthcare providers on contraception. Provision of comprehensive patient-centred contraceptive counselling at the time of fistula surgery and beyond is important for patients to optimize healing from fistula and minimize recurrence, as well as to meet their own reproductive preferences.

Early discontinuation of long-acting reversible contraceptives and associated factors among women discontinuing long-acting reversible contraceptives at national referral hospital, Kampala-Uganda; a cross-sectional study.

BACKGROUND: High levels of unmet need for contraception and unwanted pregnancies are high in developing countries despite efforts to reduce them. Long-acting reversible contraceptive (LARC) methods are more than 99% effective in preventing pregnancy. Discontinuation of LARC within the first year of initiation contributes to the high levels of unmet need. This study aimed to determine the prevalence and factors associated with the first-year discontinuation of LARC at Kawempe National Referral hospital. METHODS: A facility-based cross-sectional study was conducted from February 2020 to June 2021. We consecutively recruited 354 participants who discontinued a LARC (intrauterine device {IUD} and sub-dermal implant) during the study period after informed written consent. Data on duration of use, reasons for discontinuation, and factors associated were collected using a face-to-face interviewer-administered questionnaire and review of client records. Early LARC discontinuation was defined as the termination of the contraception within the first 12 months of use. Data were entered using SPSS version 14/0 and analyzed in STATA version 15. Prevalence was expressed as a proportion while logistic regression was used to assess factors associated with early LARC discontinuation. Variables with a p-value of < 0.05 were considered statistically significant. RESULTS: The proportion of first-year discontinuation of LARC was 29%. Women Age less than 25 years (OR = 5.07; 95% CI: 1.1-24.8) and those who desired a family size of fewer than four children (OR = 3.19; 95%CI: 1.2-8.7 ) were more likely to discontinue the LARC within 12 months of initiation after multivariate analysis. Method-related reasons for removal were painful menstrual cramps for implants, recurrent infections for IUDs, and a non-side effect reason was the desire to get pregnant. CONCLUSION: A high proportion of women discontinue LARC within 12 months following initiation. Young adults and those who desire small families are more likely to have first-year discontinuation of LARC. We recommend age-specific counseling for patients receiving the LARC and further studies looking at the depth analysis of reasons for the first-year discontinuation.

Understanding the association between informed choice and long-term reversible contraception among Ugandan women: Findings from the 2016 Demographic Health Survey.

OBJECTIVES: To understand the relationship between informed choice and long-acting reversible contraceptive (LARC) use among women aged 15-49 years in Uganda after adjusting for potential confounding. METHODS: This cross-sectional study uses data from the 2016 Uganda Standard Demographic and Health Survey. Thomas-Rao corrections to a χ2 test were used for the bivariable analysis. A design-adjusted multivariable logistic regression was used to estimate the association between informed choice and LARC use. Propensity score matching was conducted as a sensitivity analysis. RESULTS: In all, 3646 women were included in the analysis and 975 reported using a LARC. In the design-adjusted multivariable analysis, the odds of reporting LARC usage were 1.98 (95% confidence interval 1.61-2.43) times higher among women who reported informed choice compared with those who did not. The subsequent propensity score analysis reported similar findings. CONCLUSION: Providing informed choice can help to increase the number of women who use LARC in Uganda. As such, the Ugandan Ministry of Health should further expand access to family planning counseling as it could contribute to the reduction of unplanned pregnancies across Uganda with the use of LARC.

Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial.

STUDY QUESTION: Is a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWER: In terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADY: An easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. STUDY DESIGN, SIZE, DURATION: From December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. PARTICIPANTS/MATERIALS, SETTING, METHODS: We randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. MAIN RESULTS AND THE ROLE OF CHANCE: We recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique. LIMITATIONS, REASONS FOR CAUTION: We tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology. WIDER IMPLICATIONS OF THE FINDINGS: The study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique. STUDY FUNDING/COMPETING INTEREST(S): Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS. TRIAL REGISTRATION NUMBER: NCT04120337. TRIAL REGISTRATION DATE: 9 October 2019. DATE OF FIRST PATIENT'S ENROLMENT: 23 December 2019.

Comparison of the effectiveness and safety of treatment of incomplete second trimester abortion with misoprostol provided by midwives and physicians: a randomised, controlled, equivalence trial in Uganda.

BACKGROUND: To address the knowledge gaps in the provision of post-abortion care by midwives for women in the second trimester, we investigated the effectiveness and safety of treatment for incomplete second trimester abortion with misoprostol, comparing care provision by midwives with that provided by physicians in Uganda. METHODS: Our multicentre, randomised, controlled, equivalence trial undertaken in 14 health facilities in Uganda recruited women with incomplete abortion of uterine size 13-18 weeks. We randomly assigned (1:1) women to clinical assessment and treatment by either midwife or physician. The randomisation sequence was computer generated, in blocks of four to 12, and stratified for study site. Participants received sublingual misoprostol (400 µg once every 3 h for up to five doses). The study was not concealed from the health-care providers and study participants. Primary outcome was complete abortion within 24 h that did not require surgical evacuation. Analysis was per-protocol and intention to treat; the intention-to-treat population consisted of women who were randomised, received at least one dose of misoprostol, and reported primary outcome data, and the per-protocol population excluded women with unexplained discontinuation of treatment. We used generalised mixed-effects models to obtain the risk difference. The predefined equivalence range was -5% to 5%. The trial was registered at ClinicalTrials.gov, NCT03622073. FINDINGS: Between Aug 14, 2018, and Nov 16, 2021, 1191 eligible women were randomly assigned to each group (593 women to the midwife group and 598 to the physician group). 1164 women were included in the per-protocol analysis, and 530 (92%) of 577 women in the midwife group and 553 (94%) of 587 women in the physician group had a complete abortion within 24 h. The model-based risk difference for the midwife versus physician group was -2·3% (95% CI -4·4 to -0·3), and within our predefined equivalence range (-5% to 5%). Two women in the midwife group received blood transfusion. INTERPRETATION: Clinical assessment and treatment of second trimester incomplete abortion with misoprostol provided by midwives was equally effective and safe as when provided by physicians. In low-income settings, inclusion of midwives in the medical management of uncomplicated second trimester incomplete abortion has potential to increase women's access to safe post-abortion care. FUNDING: Swedish Research Council and THRiVE-2.

Contraceptive uptake and associated factors among women in the immediate postpartum period at Kawempe Hospital.

INTRODUCTION: Within Africa, contraceptive use is low although about 214 million women who are not using contraception want to avoid pregnancy. In Uganda, modern contraceptive uptake is at 35% resulting in unwanted or unplanned pregnancies which may increase morbidity and mortality among children and mothers. Contraceptive uptake at 6 weeks postpartum is encouraged but it is not very effective since there is low attendance during this visit. Additionally, some women may have become sexually active by the visit at 6 weeks postpartum leading to early conception. OBJECTIVES: This study sought to determine contraceptive uptake in the immediate postpartum period and the associated factors among women delivering at Kawempe Hospital. METHODS: This study employed a cross-sectional study design where 397 women aged 18-49 years were recruited using systematic random sampling. The women who were discharged within 72 h after delivery were considered. Data collection was done using an interviewer-administered data collection tool. Data was double entered into EpiData version 4.2 and analyzed using STATA version 13 at univariate using descriptive statistics then at bivariate and multivariate levels using logistic regression with contraceptive uptake as the outcome. RESULTS: We enrolled 397 participants. Their mean age range was 18-45 years and a median of 25 years (IQR 22, 30). The majority of the participants, 333 (83.88%), were married and 177 (44.58%) were housewives or unemployed. Contraceptive uptake in the immediate postpartum period among these participants was 15.4% (61/397). The factors independently associated with immediate postpartum contraceptive uptake were grand multiparity (aOR = 2.57; 95% CI 1.11-5.95; p = 0.028), cesarean delivery (aOR = 2.63; 95% CI 1.24-5.57; p = 0.011), and prior contraceptive counseling during Antenatal (aOR = 9.05; 95% CI 2.65-30.93; p = < 0.001). CONCLUSION: There was a 15.4% contraceptive uptake among immediate postpartum women which is very low. The factors independently associated with immediate postpartum contraceptive uptake were grand multiparity, cesarean section, and prior contraceptive counseling during antenatal care. Efforts need to be made to improve contraceptive uptake among immediate postpartum mothers such that the high unmet need for contraception is reduced and short inter-pregnancy intervals are controlled.

Feasibility and acceptability of mobile phone data collection for longitudinal follow-up among patients treated for obstetric fistula in Uganda.

Rapid dissemination of mobile technology provides substantial opportunity for overcoming challenges reaching rural and marginalized populations. We assessed feasibility and acceptability of longitudinal mobile data capture among women undergoing fistula surgery in Uganda (n = 60) in 2014-2015. Participants were followed for 12 months following surgery, with data captured quarterly, followed by interviews at 12 months. Participant retention was high (97%). Most respondents reported no difficulty with mobile data capture (range 93%-100%), and preferred mobile interview (88%-100%). Mobile data capture saved 1000 person-hours of transit and organizational time. Phone-based mobile data collection provided social support. Our results support this method for longitudinal studies among geographically and socially marginalized populations.

Determinants of modern contraceptive use among married Somali women living in Kampala; a cross sectional survey.

BACKGROUND: Low contraceptive uptake exposes women to unintended pregnancies and often the resultant obstetric complications. The immigrant communities especially from countries with low contraceptive use present a unique challenge. The main objective of the study was to describe modern contraceptive use and associated factors among married Somali women living in Kampala. METHODS: A community based cross sectional survey was conducted among Somali women living in Kampala from August to November 2016. Using consecutive sampling, 341 respondents were recruited after informed consent. Data was collected using interviewer administered questionnaires on contraceptives use and factors associated. Data was entered in Epidata 3.1 and analyzed using STATA 11.0. Logistic regression analysis was used to determine the factors associated with use of modern contraceptives. RESULTS: Majority of the participants were refugees 317/341(94%), with a mean age of 30.4 (±6.7) years and 136/341 (40%) had no formal education. More than 325/341 (95%) of respondents desired to have five or more children (Average 9 + 3) and 164/341 (45%) had five or more living children. Only 29% of women were using modern contraceptives, of which 51% used oral pills, 15% condoms and 15% injectables. Having tertiary education, one who had ever used modern contraceptives and desire for spacing of more than two years were independently associated with current of use modern contraceptives. CONCLUSIONS: The Contraceptive prevalence rate among married Somali women in Kampala was (29%). A majority of the respondents were using short acting contraceptive methods. Attaining tertiary education, ever use of modern contraceptives, those whose source of contraceptive information was health worker and desire to space for more than two years were associated with current use of modern contraceptives. There is a need for improvement of girl child education, contraceptive awareness and male involvement to increase contraceptive uptake in this community. Research looking at attitude of this community towards use of long term contraception is recommended.

Perceived Causes of Obstetric Fistula and Predictors of Treatment Seeking among Ugandan Women: Insights from Qualitative Research.

Many obstetric fistula patients remain untreated or present late to treatment despite increasing surgical availability in Uga nda. We explored women's perceptions of the cause of their obstetric fistula and their treatment seeking behaviours, including barriers and facilitators to timely care access. In-depth interviews and focus group discussions were conducted from June-August 2014 among 33 women treated for obstetric fistula at Mulago Hospital, Kampala. Data were analysed to describe dimensions and commonalities of themes identified under perceived causes and treatment seeking experiences, and their intersection. Perceived obstetric fistula causes included delays in deciding on hospital delivery, lengthy labour, injury caused by the baby, health worker incompetence, and traditional beliefs. Treatment seeking timing varied. Early treatment seeking was facilitated by awareness of treatment availability through referral, the media, community members, and support by partners and children. Barriers to early treatment seeking included inadequate financial and social support, erroneous perceptions about fistula causes and curability, incorrect diagnoses, and delayed or lack of care at health facilities. Our study supports broad educational and awareness activities, facilitation of social and financial support for accessing care, and improving the quality of emergency obstetric care and fistula treatment surgical capacity to reduce women's suffering.

Women's experiences of fistula-related stigma in Uganda: a conceptual framework to inform stigma-reduction interventions.

Fistula-related stigma is common. The absence of a unifying conceptual framework prevents a nuanced understanding of the nature of fistula-related stigma, comparison across contexts and the ability to contrast with other stigmas. It also hinders intervention development. We conducted in-depth interviews or focus groups with 60 women who had undergone fistula surgery 6-24 months prior at Mulago Hospital in Kampala, Uganda in 2014. Transcripts were analysed for experiences and consequences of enacted, anticipated and internalised stigma. Narratives revealed experiences with enacted stigma, including gossip, verbal abuse and social exclusion. Women also anticipated and feared stigma in the future. Internalised stigma reports revealed shame and low self-esteem: self-worth reduction, feeling disgraced and envisioning no future. Consequences included social isolation, changes to normal activities, non-disclosure and poor mental health. Refining stigma theory to specific conditions has resulted in a more nuanced understanding of stigma dimensions, manifestations, mechanisms and consequences, permitting comparison across contexts and populations and the development of stigma-reduction interventions. These lessons should be applied to fistula, acknowledging unique features: concealability, the potential for treatment, lack of community awareness and the social consequences of stillbirth. Reducing fistula-related stigma requires timely surgery and supportive care, stigma-reduction interventions and addressing the complex societal structures that perpetuate fistula.

Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial.

BACKGROUND: A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians. METHODS: A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size > 12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 µg misoprostol administered sublingually every 3 h up to five doses within 24 h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14 days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of - 5% and + 5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ≤ 0.05 will be considered statistically significant. DISCUSSION: Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.

Trajectories of women's physical and psychosocial health following obstetric fistula repair in Uganda: a longitudinal study.

OBJECTIVES: To explore trajectories of physical and psychosocial health, and their interrelationship, among women completing fistula repair in Uganda for 1 year post-surgery. METHODS: We recruited a 60-woman longitudinal cohort at surgical hospitalisation from Mulago Hospital in Kampala Uganda (Dec 2014-June 2015) and followed them for 1 year. We collected survey data on physical and psychosocial health at surgery and at 3, 6, 9 and 12 months via mobile phone. Fistula characteristics were abstracted from medical records. All participants provided written informed consent. We present univariate analysis and linear regression results. RESULTS: Across post-surgical follow-up, most women reported improvements in physical and psychosocial health, largely within the first 6 months. By 12 months, urinary incontinence had declined from 98% to 33% and general weakness from 33% to 17%, while excellent to good general health rose from 0% to 60%. Reintegration, self-esteem and quality of life all increased through 6 months and remained stable thereafter. Reported stigma reduced, yet some negative self-perception remained at 12 months (mean 17.8). Psychosocial health was significantly impacted by the report of physical symptoms; at 12 months, physical symptoms were associated with a 21.9 lower mean reintegration score (95% CI -30.1, -12.4). CONCLUSIONS: Our longitudinal cohort experienced dramatic improvements in physical and psychosocial health after surgery. Continuing fistula-related symptoms and the substantial differences in psychosocial health by physical symptoms support additional intervention to support women's recovery or more targeted psychosocial support and reintegration services to ensure that those coping with physical or psychosocial challenges are appropriately supported.

The effect of immediate postpartum levonorgestrel contraceptive implant use on breastfeeding and infant growth: a randomized controlled trial.

OBJECTIVE: This study assessed whether immediate postpartum insertion of levonorgestrel contraceptive implants is associated with a difference in infant growth from birth to 6 months, onset of lactogenesis, or breastfeeding continuation at 3 and 6 months postpartum compared to delayed insertion at 6 to 8 weeks postpartum. STUDY DESIGN: We conducted a randomized trial of women in Uganda who desired contraceptive implants postpartum. We randomly assigned participants to receive either immediate (within 5 days of delivery) or delayed (6 to 8 weeks postpartum) insertion of a two-rod levonorgestrel contraceptive implant system. This is a prespecified secondary analysis evaluating breastfeeding outcomes. The primary outcome of this secondary analysis was change in infant weight; infants were weighed and measured at birth and 6 months. We used a validated questionnaire to assess onset of lactogenesis daily in person while participants were in the hospital, and then daily by phone after they left the hospital, until lactogenesis was documented. We used interviewer-administered questionnaires to assess breastfeeding continuation and concerns at 3 months and 6 months postpartum. RESULTS: Among the 96 women randomized to the immediate group and the 87 women to the delayed group, the mean change in infant weight from birth to 6 months was similar between groups: 4632 g in the immediate group and 4407 g in the delayed group (p=.26). Among the 97 women who had not experienced lactogenesis prior to randomization, the median time to onset of lactogenesis did not differ significantly between the immediate and delayed groups (65 h versus 63 h; p=.84). Similar proportions of women in the immediate and delayed groups reported exclusive breastfeeding at 3 months (74% versus 71%; p=.74) and 6 months (48% versus 52%; p=.58). CONCLUSION: We found no association between the timing of postpartum initiation of levonorgestrel contraceptive implants and change in infant growth from birth to 6 months, onset of lactogenesis, or breastfeeding continuation at 3 or 6 months postpartum. IMPLICATIONS: This study provides evidence that immediate postpartum initiation of contraception implants does not have a deleterious effect on infant growth or initiation or continuation of breastfeeding.

Development and preliminary validation of a post-fistula repair reintegration instrument among Ugandan women.

BACKGROUND: Obstetric fistula is a debilitating and traumatic birth injury affecting 2-3 million women globally, mostly in sub-Saharan Africa and Asia. Affected women suffer physically, psychologically and socioeconomically. International efforts have increased access to surgical treatment, yet attention to a holistic outcome of post-surgical rehabilitation is nascent. We sought to develop and pilot test a measurement instrument to assess post-surgical family and community reintegration. METHODS: We conducted an exploratory sequential mixed-methods study, beginning with 16 in-depth interviews and four focus group discussions with 17 women who underwent fistula surgery within two previous years to inform measure development. The draft instrument was validated in a longitudinal cohort of 60 women recovering from fistula surgery. Qualitative data were analyzed through thematic analysis. Socio-demographic characteristics were described using one-way frequency tables. We used exploratory factor analysis to determine the latent structure of the scale, then tested the fit of a single higher-order latent factor. We evaluated internal consistency and temporal stability reliability through Raykov's ρ and Pearson's correlation coefficient, respectively. We estimated a series of linear regression models to explore associations between the standardized reintegration measure and validated scales representing theoretically related constructs. RESULTS: Themes central to women's experiences following surgery included resuming mobility, increasing social interaction, improved self-esteem, reduction of internalized stigma, resuming work, meeting their own needs and the needs of dependents, meeting other expected and desired roles, and negotiating larger life issues. We expanded the Return to Normal Living Index to reflect these themes. Exploratory factor analysis suggested a four-factor structure, titled 'Mobility and social engagement', 'Meeting family needs', 'Comfort with relationships', and 'General life satisfaction', and goodness of fit statistics supported a higher-order latent variable of 'Reintegration.' Reintegration score correlated significantly with quality of life, depression, self-esteem, stigma, and social support in theoretically expected directions. CONCLUSION: As more women undergo surgical treatment for obstetric fistula, attention to the post-repair period is imperative. This preliminary validation of a reintegration instrument represents a first step toward improving measurement of post-surgical reintegration and has important implications for the evidence base of post-surgical reintegration epidemiology and the development and evaluation of fistula programming.

Effect of Efavirenz on Endogenous Progesterone Concentrations and Contraceptive Outcomes among Ugandan HIV Infected Women Coadministering Ethinylestradiol/Levonorgestrel.

This study assessed the effect of efavirenz mid-dose plasma concentrations on mid-luteal endogenous progesterone concentrations and contraceptive outcomes among 49 HIV infected women coadministering ethinylestradiol/levonorgestrel, including 34 HIV positive women on Highly Active Antiretroviral Therapy (HAART) and 15 HAART naïve HIV infected women, purposively selected from Mulago Hospital, Uganda. A blood sample was collected once between days 20 and 22 of each woman's menstrual cycle for measuring endogenous progesterone and efavirenz concentrations by electrochemiluminescence technology and High Performance Liquid Chromatography (HPLC), respectively. Descriptive statistical analysis and correlation and logistic regression analysis were done using SPSS v.21 and R3.1. Efavirenz showed a weak positive linear relationship with endogenous progesterone at efavirenz concentrations below 12 µg/ml. Based on serum endogenous progesterone, the observed hormonal contraceptives failure rate (24.5%) was higher than expected (maximum 8%). A higher proportion of HIV positive women on efavirenz based HAART (26.5%) was at risk of contraceptive failure than their HIV infected HAART naïve counterparts (20%) though it was not statistically significant (p = 0.63). Efavirenz mid-dose plasma concentrations seem to have no significant effect on mid-luteal endogenous progesterone concentrations and contraceptive outcomes among HIV infected Ugandan women coadministering ethinylestradiol/levonorgestrel oral pills.