Perinatal care and its association with perinatal death among women attending care in three district hospitals of western Uganda.

BACKGROUND: Provision of effective care to all women and newborns during the perinatal period is a viable strategy for achieving the Sustainable Development Goal 3 targets on reducing maternal and neonatal mortality. This study examined perinatal care (antenatal, intrapartum, postpartum) and its association with perinatal deaths at three district hospitals in Bunyoro region, Uganda. METHODS: A cross-sectional study was conducted in which a questionnaire was administered consecutively to 872 postpartum women before discharge who had attended antenatal care and given birth in the study hospitals. Data on care received during antenatal, labour, delivery, and postpartum period, and perinatal outcome were extracted from medical records of the enrolled postnatal women using a pre-tested structured tool. The care received from antenatal to 24 h postpartum period was assessed against the standard protocol of care established by World Health Organization (WHO). Poisson regression was used to assess the association between care received and perinatal death. RESULTS: The mean age of the women was 25 years (standard deviation [SD] 5.95). Few women had their blood tested for hemoglobin levels, HIV, and Syphilis (n = 53, 6.1%); had their urine tested for glucose and proteins (n = 27, 3.1%); undertook an ultrasound scan (n = 262, 30%); and had their maternal status assessed (n = 122, 14%) during antenatal care as well as had their uterus assessed for contraction and bleeding during postpartum care (n = 63, 7.2%). There were 19 perinatal deaths, giving a perinatal mortality rate of 22/1,000 births (95% Confidence interval [CI] 8.1-35.5). Of these 9 (47.4%) were stillbirths while the remaining 10 (52.6%) were early neonatal deaths. In the antenatal phase, only fetal examination was significantly associated with perinatal death (adjusted prevalence ratio [aPR] = 0.22, 95% CI 0.1-0.6). No significant association was found between perinatal deaths and care during labour, delivery, and the early postpartum period. CONCLUSION: Women did not receive all the required perinatal care during the perinatal period. Perinatal mortality rate in Bunyoro region remains high, although it's lower than the national average. The study shows a reduction in the proportion of perinatal deaths for pregnancies where the mother received fetal monitoring. Strategies focused on strengthened fetal status monitoring such as fetal movement counting methods and fetal heart rate monitoring devices during pregnancy need to be devised to reduce the incidence of perinatal deaths. Findings from the study provide valuable information that would support the strengthening of perinatal care services for improved perinatal outcomes.

Experiences of referral with an obstetric emergency: voices of women admitted at Mbarara Regional Referral Hospital, South Western Uganda.

BACKGROUND: Life-threatening obstetric complications usually lead to the need for referral and constitute the commonest direct causes of maternal deaths. Urgent management of referrals can potentially lower the maternal mortality rate. We explored the experiences of women referred with obstetric emergencies to Mbarara Regional Referral Hospital (MRRH) in Uganda, in order to identify barriers and facilitating factors. METHODS: This was an exploratory qualitative study. In-depth interviews (IDIs) were conducted with 10 postnatal women and 2 attendants as key informants. We explored health system and client related factors to understand how these could have facilitated or hindered the referral process. Data was analyzed deductively employing the constructs of the Andersen Healthcare Utilization model. RESULTS: Women experienced transport, care delays and inhumane treatment from health care providers (HCPs). The obstetric indications for referral were severe obstructed labor, ruptured uterus, and transverse lie in advanced labor, eclampsia and retained second twin with intrapartum hemorrhage. The secondary reasons for referral included; non-functional operating theatres due to power outages, unsterilized caesarian section instruments, no blood transfusion services, stock outs of emergency drugs, and absenteeism of HCPs to perform surgery. Four (4) themes emerged; enablers, barriers to referral, poor quality of care and poor health facility organization. Most referring health facilities were within a 30-50 km radius from MRRH. Delays to receive emergency obstetric care (EMOC) led to acquisition of in-hospital complications and eventual prolonged hospitalization. Enablers to referral were social support, financial preparation for birth and birth companion's knowledge of danger signs. CONCLUSION: The experience of obstetric referral for women was largely unpleasant due to delays and poor quality of care which contributed to perinatal mortality and maternal morbidities. Training HCPs in respectful maternity care (RMC) may improve quality of care and foster positive postnatal client experiences. Refresher sessions on obstetric referral procedures for HCPs are suggested. Interventions to improve the functionality of the obstetric referral pathway for rural south-western Uganda should be explored.

Midwives' perceptions towards the ministry of health guidelines for the provision of immediate postpartum care in rural health facilities in Uganda.

BACKGROUND: Guidelines for clinical practice have been part of the Ministry of health's efforts to improve the quality of care for over two decades. Their benefits have been documented in Uganda. However, having practice guidelines may not always result in their use in care provision. We explored the midwives' perceptions towards the ministry of health guidelines for providing immediate postpartum care. METHODS: An exploratory descriptive qualitative study was conducted in three districts in Uganda from September 2020 to January 2021. In-depth interviews with 50 midwives from 35 health centers and 2 hospitals in Mpigi, Butambala, and Gomba districts were done. Thematic analysis of data was done. RESULTS: Three themes emerged; awareness and use of the guidelines, perceived drivers, and perceived barriers to the provision of immediate postpartum care. The subthemes for theme I included; awareness of the guidelines, variations in the postpartum care practices, variations in preparedness to manage women with complications, and varied access to continuing midwifery education. Fear of complications and litigation were the perceived drivers of guideline use. On the other hand, lack of knowledge, busy maternity units, organization of the care, and the midwives' perceptions about their clients were the barriers to guideline use. Midwives felt that new guidelines and policies regarding immediate postpartum care should be disseminated widely. CONCLUSION: The midwives felt that the guidelines were good for the prevention of postpartum complications but their knowledge of the guidelines for the provision of immediate postpartum care was suboptimal. They desired on-job training and mentorship to help them bridge the knowledge gaps. Variations in patient assessment, monitoring, and pre-discharge care were acknowledged and said to be due to a poor reading culture and health facility factors like patient-midwife ratios, unit setup, and prioritization of labor.

Prediction of pre-eclampsia at St. Mary's hospital lacor, a low-resource setting in northern Uganda, a prospective cohort study.

BACKGROUND: Pre-eclampsia is the second leading cause of maternal death in Uganda. However, mothers report to the hospitals late due to health care challenges. Therefore, we developed and validated the prediction models for prenatal screening for pre-eclampsia. METHODS: This was a prospective cohort study at St. Mary's hospital lacor in Gulu city. We included 1,004 pregnant mothers screened at 16-24 weeks (using maternal history, physical examination, uterine artery Doppler indices, and blood tests), followed up, and delivered. We built models in RStudio. Because the incidence of pre-eclampsia was low (4.3%), we generated synthetic balanced data using the ROSE (Random Over and under Sampling Examples) package in RStudio by over-sampling pre-eclampsia and under-sampling non-preeclampsia. As a result, we got 383 (48.8%) and 399 (51.2%) for pre-eclampsia and non-preeclampsia, respectively. Finally, we evaluated the actual model performance against the ROSE-derived synthetic dataset using K-fold cross-validation in RStudio. RESULTS: Maternal history of pre-eclampsia (adjusted odds ratio (aOR) = 32.75, 95% confidence intervals (CI) 6.59-182.05, p = 0.000), serum alkaline phosphatase(ALP) < 98 IU/L (aOR = 7.14, 95% CI 1.76-24.45, p = 0.003), diastolic hypertension ≥ 90 mmHg (aOR = 4.90, 95% CI 1.15-18.01, p = 0.022), bilateral end diastolic notch (aOR = 4.54, 95% CI 1.65-12.20, p = 0.003) and body mass index of ≥ 26.56 kg/m2 (aOR = 3.86, 95% CI 1.25-14.15, p = 0.027) were independent risk factors for pre-eclampsia. Maternal age ≥ 35 years (aOR = 3.88, 95% CI 0.94-15.44, p = 0.056), nulliparity (aOR = 4.25, 95% CI 1.08-20.18, p = 0.051) and white blood cell count ≥ 11,000 (aOR = 8.43, 95% CI 0.92-70.62, p = 0.050) may be risk factors for pre-eclampsia, and lymphocyte count of 800 - 4000 cells/microliter (aOR = 0.29, 95% CI 0.08-1.22, p = 0.074) may be protective against pre-eclampsia. A combination of all the above variables predicted pre-eclampsia with 77.0% accuracy, 80.4% sensitivity, 73.6% specificity, and 84.9% area under the curve (AUC). CONCLUSION: The predictors of pre-eclampsia were maternal age ≥ 35 years, nulliparity, maternal history of pre-eclampsia, body mass index, diastolic pressure, white blood cell count, lymphocyte count, serum ALP and end-diastolic notch of the uterine arteries. This prediction model can predict pre-eclampsia in prenatal clinics with 77% accuracy.

Readiness of rural health facilities to provide immediate postpartum care in Uganda.

BACKGROUND: Nearly 60% of maternal and 45% of newborn deaths occur within 24 h after delivery. Immediate postpartum monitoring could avert death from preventable causes including postpartum hemorrhage, and eclampsia among mothers, and birth asphyxia, hypothermia, and sepsis for babies. We aimed at assessing facility readiness for the provision of postpartum care within the immediate postpartum period. METHODS: A cross-sectional study involving 40 health facilities within the greater Mpigi region, Uganda, was done. An adapted health facility assessment tool was employed in data collection. Data were double-entered into Epi Data version 4.2 and analyzed using STATA version 13 and presented using descriptive statistics. RESULTS: Facility readiness for the provision of postpartum care was low (median score 24% (IQR: 18.7, 26.7). Availability, and use of up-to-date, policies, guidelines and written clinical protocols for identifying, monitoring, and managing postpartum care were inconsistent across all levels of care. Lack of or non-functional equipment poses challenges for screening, diagnosing, and treating postnatal emergencies. Frequent stock-outs of essential drugs and supplies, particularly, hydralazine, antibiotics, oxygen, and blood products for transfusions were more common at health centers compared to hospitals. Inadequate human resources and sub-optimal supplies inhibit the proper functioning of health facilities and impact the quality of postpartum care. Overall, private not-for-profit health facilities had higher facility readiness scores. CONCLUSIONS: Our findings suggest sub-optimal rural health facility readiness to assess, monitor, and manage postpartum emergencies to reduce the risk of preventable maternal/newborn morbidity and mortality. Strengthening health system inputs and supply side factors could improve facility capacity to provide quality postpartum care.

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.

Challenges and opportunities from using abortion harm reduction and value clarification and attitude transformation engagements for safe abortion advocacy in Uganda.

BACKGROUND: From 2018, the International Federation of Gynecologists and Obstetricians (FIGO) implemented the Advocating Safe Abortion project to support national obstetrics and gynecology (Obs/gyn) societies from ten member countries to become leaders of Sexual and Reproductive Health and Rights (SRHR). We share experiences and lessons learnt about using value clarification and attitude transformation (VCAT) and abortion harm reduction (AHR) as strategies for our advocacy engagements. METHODS: The advocacy goal of ending abortion-related deaths followed predefined pathways from an extensive needs assessment prior to the project. These pathways were strengthening capacity of the Obs/gyn society as safe abortion advocates; establishing a vibrant network of partners; transforming social and gender norms; raising awareness of the legal and policy environment regarding abortion, and promoting the generation and use abortion data for evidence-informed policy and practice. Our advocacy targeted multiple stakeholders including media, policy makers judicio-legal, political and religious leaders, health workers and the public. RESULTS: During each engagement, facilitators required audiences to identify what roles they can play along the continuum of strategies that can reduce maternal death from abortion complications. The audiences acknowledged abortion complications as a major problem in Uganda. Among the root causes for the abortion context, audiences noted absence of an enabling environment for abortion care, which was characterized by low awareness about the abortion laws and policy, restricted abortion laws, cultural and religious beliefs, poor quality of abortion care services and abortion stigma. CONCLUSION: VCAT and AHR were critical in enabling us to develop appropriate messages for different stakeholders. Audiences were able to recognize the abortion context, distinguish between assumptions, myths and realities surrounding unwanted pregnancy and abortion; recognize imperative to address conflict between personal and professional values, and identify different roles and values which inform empathetic attitudes and behaviors that mitigate abortion harms. The five pathways of the theory of change reinforced each other. Using the AHR model, we delineate strategies and activities which stakeholders could use to end abortion deaths. VCAT enables critical reflection of views, beliefs and values versus professional obligations and responsibilities, and promotes active attitude and behavior change and commitment to end abortion-related deaths.

Midwives' perspectives about using individualized care plans in the provision of immediate postpartum care in Uganda; an exploratory qualitative study.

INTRODUCTION: Individualized care planning has been slowly integrated into practice in Uganda with minimal documentation of how the concept is applied in providing care. This study explored the perceptions of midwives about the use of individualized care plans (ICPs) in the provision of immediate postpartum care. METHODS: An exploratory descriptive qualitative approach was used in this study. We interviewed fifty midwives from 37 health facilities in Uganda's greater Mpigi region. The midwives, who were certificate and diploma holders, were purposively enrolled in the selected facilities. Deductive content analysis was done based on the COM-B model. RESULTS: Four themes emerged from the data namely; compatibility, motivation, opportunities, and the midwives' suggested strategies and targets for improved individualized care planning. The midwives were aware of individualized care planning and they utilized it in their provision of immediate postpartum care especially when assessing clients for risks, preparing clients for referral, caring for Human Immunodeficiency virus (HIV) exposed babies and their mothers, and educating/ supporting first-time mothers (automatic motivation). Having a good nurse-patient relationship, privacy, and ample time to care for the clients were noted as motivators for individualized care plan use, while poor documentation of care, high patient load, and perceived patients' lack of understanding of the complexities of illness in the immediate postpartum period were the barriers (social opportunity) identified by midwives to the use of individualized care planning. CONCLUSION: There are still capability, motivation, and opportunity hindrances to the use of individualized care planning. Staff recruitment, training, and harmonization of the documentation forms may improve the use of care plans in the postpartum period.

Risk factors for recurrence of pelvic organ prolapse after vaginal surgery among Ugandan women: a prospective cohort study.

INTRODUCTION AND HYPOTHESIS: This study was aimed at determining the recurrence rate and risk factors for the recurrence of pelvic organ prolapse (POP), at 1 year post-vaginal reconstructive surgery in a resource-limited setting. METHODS: We enrolled women who underwent vaginal surgery for POP at the urogynecology unit of Mbarara Regional Referral Hospital (MRRH) in southwestern Uganda between December 2018 and February 2020. The surgeries that were performed include anterior colporrhaphy for cystocele, posterior colporrhaphy for rectocele, vaginal hysterectomy with vault suspension for uterine prolapse, and cervicopexy in those with uterine prolapse where uterine-sparing surgery was desired. The women were followed up for a period of 1 year after surgery. Pelvic examinations in lithotomy position under maximum strain were carried out to assess for recurrence using the Pelvic Organ Quantification (POP-Q) system. Recurrence was defined as a prolapse of ≥POP-Q stage II. Descriptive analyses and multivariate log binomial regression were performed to determine risk factors for recurrence. RESULTS: Of the 140 participants enrolled, 127 (90.7%) completed the follow-up at 1 year. The recurrence rate was 25.2% (32 out of 127). Most (56.3%) of the recurrences occurred in the anterior compartment and in the same site previously operated. Women aged <60 years (RR = 2.34; 95% CI: 1.16-4.72; p = 0.018) and those who had postoperative vaginal cuff infection (RR = 2.54; 95% CI: 1.5-4.3; p = 0.001) were at risk of recurrence. CONCLUSION: Recurrence of POP was common. Younger women, and those with postoperative vaginal cuff infection, were more likely to experience recurrent prolapse after vaginal repair.

Prediction of stillbirth low resource setting in Northern Uganda.

BACKGROUND: Women of Afro-Caribbean and Asian origin are more at risk of stillbirths. However, there are limited tools built for risk-prediction models for stillbirth within sub-Saharan Africa. Therefore, we examined the predictors for stillbirth in low resource setting in Northern Uganda. METHODS: Prospective cohort study at St. Mary's hospital Lacor in Northern Uganda. Using Yamane's 1967 formula for calculating sample size for cohort studies using finite population size, the required sample size was 379 mothers. We doubled the number (to > 758) to cater for loss to follow up, miscarriages, and clients opting out of the study during the follow-up period. Recruited 1,285 pregnant mothers at 16-24 weeks, excluded those with lethal congenital anomalies diagnosed on ultrasound. Their history, physical findings, blood tests and uterine artery Doppler indices were taken, and the mothers were encouraged to continue with routine prenatal care until the time for delivery. While in the delivery ward, they were followed up in labour until delivery by the research team. The primary outcome was stillbirth 24 + weeks with no signs of life. Built models in RStudio. Since the data was imbalanced with low stillbirth rate, used ROSE package to over-sample stillbirths and under-sample live-births to balance the data. We cross-validated the models with the ROSE-derived data using K (10)-fold cross-validation and obtained the area under curve (AUC) with accuracy, sensitivity and specificity. RESULTS: The incidence of stillbirth was 2.5%. Predictors of stillbirth were history of abortion (aOR = 3.07, 95% CI 1.11-8.05, p = 0.0243), bilateral end-diastolic notch (aOR = 3.51, 95% CI 1.13-9.92, p = 0.0209), personal history of preeclampsia (aOR = 5.18, 95% CI 0.60-30.66, p = 0.0916), and haemoglobin 9.5 - 12.1 g/dL (aOR = 0.33, 95% CI 0.11-0.93, p = 0.0375). The models' AUC was 75.0% with 68.1% accuracy, 69.1% sensitivity and 67.1% specificity. CONCLUSION: Risk factors for stillbirth include history of abortion and bilateral end-diastolic notch, while haemoglobin of 9.5-12.1 g/dL is protective.

Early contraceptive implants removal and its associated factors among women using implants at a National Referral Hospital, Kampala Uganda.

BACKGROUND: Early discontinuation of implant contraceptive methods and reasons for discontinuation remains a major concern for family planning programs. Early discontinuation is related to higher rates of the overall fertility rate, unwanted pregnancies leading to possibly induced abortion. There is paucity of data on the practice of discontinuation of contraceptives in developing countries. The objective of the study was to determine the magnitude of early implants discontinuation among women receiving implants services in the study area and the factors associated with it. METHODS: A cross-sectional study was conducted from 2nd January to 3rd March 2020. Data were collected from 207 women who had come to remove implants on socio-demographic characteristics, obstetric history, duration of implant, and reasons for wanting to remove the implant. We computed the proportion of those who removed the implant before 18 months (early discontinuation). To assess the factors associated with early discontinuation, we estimated the prevalence ratios with a generalized linear model of the poisson family with a log link and robust error variance. RESULTS: The proportion of early implant discontinuation was 87/207(42%). Factor associated with early implant discontinuation included; experience of side effects (PR = 1.1; 95% CI 1.03-1.24; P = 0.001), not having received pre-insertion counseling about the benefits and side effects of contraceptive implants (PR = 1.5; 95% CI 1.02-1.30; P = 0.019) and staying in rural areas (PR = 1.1; 95% CI 1.03-1.27; P = 0.014). CONCLUSION: Nearly one in every two mothers have early discontinuation of contraceptive implants. Factors associated with early implant removal include; experience of side effects, lack of counseling services, and staying in rural areas. There is a need for intervention to address high prevalence of early contraceptive removal through improving on counselling services about possible side effects.

Impact of surgery on quality of life of Ugandan women with symptomatic pelvic organ prolapse: a prospective cohort study.

BACKGROUND: Pelvic organ prolapse (POP) is a significant public health issue that negatively affects the Quality of Life (QOL) of women in both low and high-income countries. About 20% of women will undergo surgery for POP over their lifetime. However, there is a paucity of information on the effect of surgery on QOL especially in resource-limited settings. We therefore assessed the QOL among women with symptomatic POP living in rural southwestern Uganda and the impact of surgery on their quality of life. METHODS: We conducted a prospective cohort study among 120 women with symptomatic POP scheduled for surgery at the urogynecology unit of Mbarara Regional Referral Hospital. The QOL at baseline and at 1 year after surgery in the domains of physical performance, social interaction, emotional state, sexual life, sleep quality, personal hygiene and urinary bladder function was determined using a King's Quality of Life questionnaire. A paired t-test was used to compare the difference in mean scores at baseline and at 1-year post-surgery. RESULTS: Of the 120 participants that were enrolled at baseline, 117(98%) completed the follow-up period of 1 year. The baseline QOL was poor. The domains with the poorest QOL were physical, social, sexual, emotional and sleep quality. The mean QOL scores in all the domains and the overall QOL significantly improved 1 year after surgery (p < 0.001). The overall QOL improved by 38.9% after surgery (p < 0.001). CONCLUSIONS: The QOL was poor among women with symptomatic POP and surgery improved the QOL in all the domains of life. We recommend that surgery as an option for treatment of symptomatic POP should be scaled up to improve on the QOL of these women.

Lay persons' perception of the requirements for research in emergency obstetric and newborn care.

BACKGROUND: Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons' understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care. METHODS: This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6-8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis. RESULTS: Respondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making. CONCLUSIONS: Respondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent.

Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda.

BACKGROUND: Informed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. In low resource settings, there is limited information on the experiences of the informed consent process for randomized clinical trials in the emergency care context. The objective of this study was to explore the experiences of the informed consent process and factors that motivated participation in two obstetrics and newborn care randomized clinical trials (RCTs). METHODS: This was a qualitative study conducted among former participants of RCTs in the emergency obstetric care context, conducted at Kawempe National Referral Hospital, Uganda. It employed 30 in-depth interviews conducted from June 1, 2019 to August 30, 2019. Issues explored included attitudes about research, the purpose of the research in which they participated, motivations to take part in the study, factors that influenced enrolment decisions, and experiences of the informed consent process. RESULTS: Respondents felt that research was necessary to investigate the cause, prevention or complications of illness. The decisions to participate were influenced by hope for material or therapeutic benefit, trust in the healthcare system and influence of friends and family members. Many were satisfied with the informed consent process, though they did not understand some aspects of the research. CONCLUSION: Respondents valued participation in RCTs in emergency obstetric and newborn care. Hope for benefit, altruism, desire to further scientific knowledge and trust in the investigators featured prominently in the motivation to participate. Both intrinsic and extrinsic factors were motivators for RCT participation.

Ethical challenges of the healthcare transition to adult antiretroviral therapy (ART) clinics for adolescents and young people with HIV in Uganda.

BACKGROUND: Whereas many adolescents and young people with HIV require the transfer of care from paediatric/adolescent clinics to adult ART clinics, this transition is beset with a multitude of factors that have the potential to hinder or facilitate the process, thereby raising ethical challenges of the transition process. Decisions made regarding therapy, such as when and how to transition to adult HIV care, should consider ethical benefits and risks. Understanding and addressing ethical challenges in the healthcare transition could ensure a smooth and successful transition. The purpose of this study was to analyze the ethical challenges of transitioning HIV care for adolescents into adult HIV clinics. METHODS: Data presented were derived from 191 adolescents attending nine different health facilities in Uganda, who constituted 18 focus group discussions. In the discussions, facilitators and barriers regarding adolescents transitioning to adult HIV clinics were explored. Guided by the Silences Framework for data interpretation, thematic data analysis was used to analyze the data. The principles of bioethics and the four-boxes ethics framework for clinical care (patient autonomy, medical indications, the context of care, and quality of life) were used to analyze the ethical issues surrounding the transition from adolescent to adult HIV care. RESULTS: The key emerging ethical issues were: reduced patient autonomy; increased risk of harm from stigma and loss of privacy and confidentiality; unfriendly adult clinics induce disengagement and disruption of the care continuum; patient preference to transition as a cohort, and contextual factors are critical to a successful transition. CONCLUSION: The priority outcomes of the healthcare transition for adolescents should address ethical challenges of the healthcare transition such as loss of autonomy, stigma, loss of privacy, and discontinuity of care to ensure retention in HIV care, facilitate long-term self-care, offer ongoing all-inclusive healthcare, promote adolescent health and wellbeing and foster trust in the healthcare system. Identifying and addressing the ethical issues related to what hinders or facilitates successful transitions with targeted interventions for the transition process may ensure adolescents and young people with HIV infection remain healthy across the healthcare transition.

Factors associated with the uptake of immediate postpartum intrauterine contraceptive devices (PPIUCD) in Rwanda: a mixed methods study.

BACKGROUND: Rwanda has a high unmet need for family planning which could be reduced by improving access to postpartum intrauterine contraceptives device (PPIUCD) insertion. The objective of the study was to assess the prevalence and factors associated with the uptake of PPIUCD among postpartum women in Muhima Hospital. METHODS: A concurrent mixed-method study was used. Three hundred eight three (383) immediate postpartum mothers, and 10 health services providers were interviewed using a structured questionnaire and in-depth interviews respectively. Logistics regression was done to assess for factors associated with PPIUCD uptake and thematic analysis was used for qualitative data. RESULTS: The prevalence for PPIUCD use was 28.1%, women who had spontaneous vaginal delivery were more likely to take up PPIUCD (Adjusted Odds Ratio (AOR) 2.623, 95% CI = 2.017-6.507 compared to those who had cesarean section; women who received PPIUCD counselling during the antenatal period were more likely to use PPIUCD ((AOR 2.072, 95% CI = 1.018-4.218) as compared to those who didn't receive any form of counselling; mothers who received spouse approval were more likely to use PPIUCD (AOR 2.591,95% CI = 1.485-4.492); as compared to those who didn't receive any spousal approval; women who had more than one child were more likely to use PPIUCD (AOR =2.265, 95% CI = 1.472-3.163) as compared to prime gravida; Mothers with birth to pregnancy interval less than two years were more likely to use PPIUCD (AOR =2.123, CI =1.477-2.706) as compared to those who had birth to pregnancy interval more than 2 years. From the qualitative findings, health education of mothers and partners on PPIUCD, training of health care providers, and availability of supplies to provide PPIUCD influenced the use of PPIUCD. CONCLUSION: The acceptability to use for PPIUCD was high in this population. PPIUCD uptake was associated with normal birth, PPIUCD counselling, spousal approval, parity, birth interval, level of education. Health education of mothers and partners on PPIUCD, training of health providers, and availability of supplies to provide PPIUCD influenced uptake of PPIUCD.

Barriers and facilitators for transitioning of young people from adolescent clinics to adult ART clinics in Uganda: unintended consequences of successful adolescent ART clinics.

BACKGROUND: There is a growing number of adolescents and young adults living with HIV (YPLHIV) who require the transfer of care from pediatric/ adolescent clinics to adult Antiretroviral therapy (ART) clinics. A successful transition is critical for optimum health outcomes, yet facilities may lack infrastructure, human resources (with appropriate knowledge and skills), and a supportive environment, as only 3% of clinics in Uganda caring for YPLHIV have a process for supporting this critical transition from pediatric to adult care, and, facilitators and barriers of a successful transition are not well documented. The purpose of this study was to explore the facilitators and barriers of transitioning among adolescents from adolescent clinics to adult ART clinics. METHOD: Eighteen focus group discussions were held in nine health facilities with 174 adolescents and YPLHIV to assess barriers and facilitators regarding transitioning to adult clinics. The focus group discussions were audio-recorded and transcribed. The Silences Framework using a thematic approach guided the analysis. RESULTS: The key emerging issues were: Unfriendly adults in adult clinics, Care provided in the adolescent clinics, fear of stigma from health care providers, Congestion and long waiting time, fear to lose friends were barriers to transitioning. Transitioning preparation is key to a successful transition, moving as a cohort facilitates transition, and care in adult clinics offers new opportunities, could facilitate readiness and transition. CONCLUSION: YPLHIV expressed fear to transition to adult clinics mainly because of the perceived better care provided in the adolescent clinic, thus constituting a barrier to smooth transition A range of individual, social and health system and services-related factors hindered transitioning. The expectation of transitioning as a group, assurance of similar care as in the adolescent clinic, and guarantees of confidentiality, privacy, and autonomy in decision-making for care was perceived as facilitators. Understanding barriers and facilitators can enable the Ministry of Health to improve the quality of life of YPLHIV through linkage to care, adherence, retention, and viral suppression. There is a need to better planning and preparation for clinical providers and YPLHIV with a focus on age-appropriate and individualized case management transition as well as focus on improving both clinical and psychosocial support throughout the process.

The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care.

BACKGROUND: Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be based on best research evidence to ensure that safe, efficacious treatment or procedures are used, this seldom happens in contemporary practice. DISCUSSION: The compelling need to generate information on effectiveness and safety of procedures and medications that are already in use during neonatal care has led to increase in calls for pragmatic randomized clinical trials (PCTs). This raises ethical concerns as to whether exclusion of the vulnerable populations from research participations constitutes harm. First, neonates are denied access to both potentially beneficial research outputs and an opportunity to generate data on how interventions or medications perform in diverse clinical settings and inform clinical decision-making. Secondly, risks and harms in PCTs may differ from traditional RCTs, and can be reduced by modifications in study designs. The latter may involve assessment of effectiveness of comparable medication, devices or practices (whose safety data is available), randomization at the group level rather than at the individual level, avoidance of invasive and innovative study procedures, reliance on locally available data on relevant patient outcomes, and employment of procedures that tend to meet the criteria of minimal risk for human subject research. Thirdly, informed consent procedures should be modified from those of traditional RCTs, as neonates in traditional RCTs may be vulnerable to different extents in PCTs. Lastly, regulatory and oversight procedures designed for traditional RCT settings need modification, as they may not be translatable, feasible, appropriate or even ethical to apply in PCTs. CONCLUSION: The principle of justice, commonly interpreted as preventing an inequitable burden of research, should also allow fair access to potential benefits from PCTs for neonates and other vulnerable populations. Under certain conditions, prospective randomized trials involving neonates should be ethically permissible to allow inclusion of neonates in research. This may require modification of the research design, consent procedures or regulations for research oversight.

Ethical tensions in the informed consent process for randomized clinical trials in emergency obstetric and newborn care in low and middle-income countries.

BACKGROUND: There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated. DISCUSSION: A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation and maintenance of respect for autonomy and dignity. In emergency obstetric care research, obtaining informed consent can be problematic, leading to ethical tension between different moral considerations. Potential participants may be vulnerable due to severity of disease, powerlessness or impaired decisional capacity. Time for the consent process is limited, and some interventions have a narrow therapeutic window. These factors create ethical tension in allowing potentially beneficial research while avoiding potential harms and maintaining respect for dignity, human rights, justice and autonomy of the participants. CONCLUSION: Informed consent in emergency obstetric care in low- and middle-income countries poses numerous ethical challenges. Allowing research on vulnerable populations while maintaining respect for participant dignity and autonomy, protecting participants from potential harms and promoting justice underlie the ethical tensions in the research in emergency obstetric and newborn care. Those involved in research conduct or oversight have a duty of fair inclusion, to avoid denying participants the right to participate and to any potential research benefits.

Effect of suppressive acyclovir administered to HSV-2 positive mothers from week 28 to 36 weeks of pregnancy on adverse obstetric outcomes: a double-blind randomised placebo-controlled trial.

BACKGROUND: Acyclovir (ACV) given to HSV-2 positive women after 36 weeks reduces adverse outcomes but its benefit at lower gestation was undocumented. We determined the effect of oral acyclovir administered from 28 to 36 weeks on premature rupture of membranes (PROM) primarily and preterm delivery risk. METHODS: This was a randomized, double-blind placebo-controlled trial among 200 HSV-2 positive pregnant women at 28 weeks of gestation at Mulago Hospital, Uganda. Participants were assigned randomly (1:1) to take either acyclovir 400 mg orally twice daily (intervention) or placebo (control) from 28 to 36 weeks. Both arms received acyclovir after 36 weeks until delivery. Development of Pre-PROM by 36 weeks and preterm delivery were outcomes. RESULTS: One hundred women were randomised to acyclovir and 100 to placebo arms between January 2014 and February 2015. There was tendency towards reduction of incidence of PROM at 36 weeks but this was not statistically significant (4.0% versus 10.0%; RR 0.35; 95% 0.11-1.10) in the acyclovir and placebo arms respectively. However, there was a significant reduction in the incidence of preterm delivery (11.1% versus 23.5%; RR 0.41; 95% 0.20-0.85) in the acyclovir and placebo arms respectively. CONCLUSIONS: Oral acyclovir given to HSV-2 positive pregnant women from 28 to 36 weeks reduced incidence of preterm delivery but did not significantly reduce incidence of pre-PROM. TRIAL REGISTRATION: www.pactr.org, PACTR201311000558197 .