Incidence and risk factors for postpartum hemorrhage in Uganda.

BACKGROUND: Globally, postpartum haemorrhage (PPH) remains a leading cause of maternal deaths. However in many low and middle income countries, there is scarcity of information on magnitude of and risk factors for PPH (blood loss of 500 ml or more). It is important to understand the relative contributions of different risk factors for PPH. We assessed the incidence of, and risk factors for postpartum hemorrhage among rural women in Uganda. METHODS: Between March 2013 and March 2014, a prospective cohort study was conducted at six health facilities in Uganda. Women were administered a questionnaire to ascertain risk factors for postpartum hemorrhage, defined as a blood loss of 500 mls or more, and assessed using a calibrated under-buttocks drape at childbirth. We constructed two separate multivariable logistic regression models for the variables associated with PPH. Model 1 included all deliveries (vaginal and cesarean sections). Model 2 analysis was restricted to vaginal deliveries. In both models, we adjusted for clustering at facility level. RESULTS: Among the 1188 women, the overall incidence of postpartum hemorrhage was 9.0%, (95% confidence interval [CI]: 7.5-10.6%) and of severe postpartum hemorrhage (1000 mls or more) was 1.2%, (95% CI 0.6-2.0%). Most (1157 [97.4%]) women received a uterotonic after childbirth for postpartum hemorrhage prophylaxis. Risk factors for postpartum hemorrhage among all deliveries (model 1) were: cesarean section delivery (adjusted odds ratio [aOR] 7.54; 95% CI 4.11-13.81); multiple pregnancy (aOR 2.26; 95% CI 0.58-8.79); foetal macrosomia ≥4000 g (aOR 2.18; 95% CI 1.11-4.29); and HIV positive sero-status (aOR 1.93; 95% CI 1.06-3.50). Risk factors among vaginal deliveries only, were similar in direction and magnitude as in model 1, namely: multiple pregnancy, (aOR 7.66; 95% CI 1.81-32.34); macrosomia, (aOR 2.14; 95% CI1.02-4.47); and HIV positive sero-status (aOR 2.26; 95% CI 1.20-4.25). CONCLUSION: The incidence of postpartum hemorrhage was high in our setting despite use of uterotonics. The risk factors identified could be addressed by extra vigilance during labour and preparedness for PPH management in all women giving birth

Effectiveness and safety of misoprostol distributed to antenatal women to prevent postpartum haemorrhage after child-births: a stepped-wedge cluster-randomized trial.

BACKGROUND: Oral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH. METHODS: Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600 mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by ≥ 2 g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant. RESULTS: 97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271 (13.2%) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4% vs intervention 91.4%, mean difference = -11.0%, 95% confidence interval [CI] -25.7% to 3.6%, p = 0.11). No woman took misoprostol before their baby's birth. Shivering and fever were 14.9% in the control arm compared to 22.2% in the intervention arm (mean difference = -7.2%, 95% CI -11.1% to -3.7%), p = 0.005). There was a slight, but non-significant, reduction in the percentage of women with Hb drop ≥ 2g/dl from 18.5% in the control arm to 11.4% in the intervention arm (mean difference = 7.1%, 95% CI -3.1% to 17.3%, p = 0.14). Similarly, there was no significant difference between the groups in the primary outcome in the women who delivered at home (control 9.6% vs intervention 14.5%, mean difference -4.9; 95% CI -12.7 to 2.9), p = 0.17). CONCLUSION: This study was unable to detect a significant reduction in PPH following the antenatal distribution of misoprostol. The study was registered with Pan-African Clinical Trials Network ( PACTR201303000459148, on 19/11/2012)

Achieving community-based postpartum follow up in eastern Uganda: the field experience from the MamaMiso Study on antenatal distribution of misoprostol.

BackgroundAdvance provision of misoprostol to women during antenatal care aims to achieve broader access to uterotonics for the prevention of postpartum hemorrhage. Studies of this community-based approach usually involve antenatal education as well as timely postpartum follow-up visits to confirm maternal and neonatal outcomes. The MamaMiso study in Mbale, Uganda sought to assess the feasibility of conducting follow-up visits in the postpartum period following advance provision of misoprostol for postpartum hemorrhage prevention. MamaMiso recruited women during antenatal care visits. Participants were asked to contact the research team within 48 h of giving birth so that postpartum follow-up visits could be carried out at their homes. Women's baseline and delivery characteristics were collected and analyzed with respect to follow-up time ('on time' ≤ 7 days, 'late' > 7 days, and 'lost to follow up'). Every woman who was followed up late due to a failure to report the delivery was asked for the underlying reasons for the delay. When attempts at following up participants were unsuccessful, a file note was generated explaining the details of the failure. We abstracted data and identified themes from these notes.ResultsOf 748 recruited women, 700 (94%) were successfully followed up during the study period, 465 (62%) within the first week postpartum. The median time to follow up was 4 days and was similar for women who delivered at home or in facilities and for women who had attended or unattended births. Women recruited at the urban hospital site (as opposed to rural health clinics) were more likely to be lost to follow up or followed up late. Of the women followed up late, 202 provided a reason. File notes explaining failed attempts at follow up were generated for 164 participants. Several themes emerged from qualitative analysis of these notes including phone difficulties, inaccurate baseline information, misperceptions, postpartum travel, and the condition of the mother and neonate.ConclusionsKeeping women connected to the health system in the postpartum period is feasible, though reaching them within the first week of their delivery is challenging. Understanding characteristics of women who are harder to reach can help tailor follow-up efforts and elucidate possible biases in postpartum study data. Trial Registration Number ISRCTN70408620 December 28, 2011

Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014.

BACKGROUND: In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design's perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design. METHODS: We searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy. RESULTS: Our review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being 'instruction on how to perform a behaviour' (n = 32) and 'persuasive source' (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size. CONCLUSIONS: The popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis

Critical signs and symptoms for self-assessment in the immediate postnatal period: an international Systematic Scoping Review and Delphi consensus study

Background Every two minutes a woman dies from complications of pregnancy and childbirth. Most maternal deaths occur within the first 24 hours following birth, highlighting the importance of immediate postnatal care (iPNC). Self-care strategies are increasingly being employed to promote women-centred, continuous care provision. Despite international calls for development of strategies promoting self-care, none have been developed for self-monitoring in the immediate postnatal period. Fundamental to the development of a self-monitoring strategy, is an understanding of which signs and symptoms are predictive of maternal morbidity and mortality and can be easily assessed by mothers and birth companions, in health facilities, without the need for equipment. The objective of this study was to develop and achieve international consensus on the key signs and symptoms. Methods A multi-step approach involving a systematic scoping review, two- round Delphi Survey, and expert consensus was employed to identify key signs and symptoms that can be self- assessed and predict morbidity and mortality in the immediate postnatal period. Results A comprehensive list of 351 key signs and symptoms was identified from 44 clinical practice guidelines. Subsequently, 134 signs and symptoms were reviewed by Delphi respondents and international expert consensus was achieved for 19 key signs and symptoms across seven condition categories. The signs that were considered both important and able to be self-assessed by mothers and birth companions in the first 24 hours following birth included change in consciousness, seizure, severe headache, persistent visual impairment, urinary incontinence, chest pain, shortness of breath, severe pallor, fast heartbeat, rejection of baby, suicidal/infanticidal, fever, heavy blood loss, soft flabby uterus, unable to urinate easily, foul smelling discharge, rigors, syncope/dizziness, abnormal coloured urine. Conclusion This study identified key signs and symptoms which can be easily assessed by mothers and birth companions in the immediate postnatal period to identify those most at risk of morbidity and mortality. Further work is needed to validate this screening tool, and adapt it regionally and nationally

Systems and processes for regulation of investigational medical devices in Uganda

BackgroundIn many parts of the world, medical devices and the processes of their development are tightly regulated. However, the current regulatory landscape in Uganda like other developing countries is weak and poorly defined, which creates significant barriers to innovation, clinical evaluation, and translation of medical devices.AimTo evaluate current knowledge, systems and infrastructure for medical devices regulation and innovation in Uganda.MethodsA mixed methods study design using the methods triangulation strategy was employed in this study. Data of equal weight were collected sequentially. First, a digital structured questionnaire was sent out to innovators to establish individual knowledge and experience with medical device innovation and regulation. Then, a single focus group discussion involving both medical device innovators and regulators to collect data about the current regulatory practices for medical devices in Uganda. Univariate and bivariate analysis was done for the quantitative data to summarize results in graphs and tables. Qualitative data was analyzed using thematic analysis. Ethical review and approval were obtained from the Makerere University School of Biomedical Sciences, Research and Ethics Committee, and the Uganda National Council for Science and Technology.ResultsA total of 47 innovators responded to the questionnaire. 14 respondents were excluded since they were not medical device innovators. Majority (76%) of individuals had been innovators for more than a year, held a bachelor's degree with a background in Engineering and applied sciences, and worked in an academic research institute. 22 of the 33 medical device innovators had stopped working on their innovations and had stalled at the proof-of-concept stage. Insufficient funding, inadequate technical expertise and confusing regulatory landscape were major challenges to innovation. The two themes that emerged from the discussion were “developing standards for medical devices regulation” and “implementation of regulations in practical processes”. Legal limitations, lengthy processes, and low demand were identified as challenges to developing medical device regulations.ConclusionsEfforts have been taken by government to create a pathway for medical device innovations to be translated to the market. More work needs to be done to coordinate efforts among stakeholders to build effective medical device regulations in Uganda

Let's Do Audit!

This book is aimed at everyone who wants to improve the quality of the medical care they provide: nurses, doctors, managers, healthcare assistants, students, laboratory clinicians and so on. The book demonstrates how to examine the quality of the care you provide using simple steps: decide what you should be doing in any circumstance, examine whether or not you are doing it and then look for ways of improving your care until you are doing it correctly. The book contains six lessons, each designed to take around one hour, with exercises to complete. The lessons can be used by individuals or in a group setting. The book will be of interest to anyone working in healthcare practice who is keen to find a better way of working.</jats:p

Excessive bleeding is a normal cleansing process: a qualitative study of postpartum haemorrhage among rural Uganda women

BACKGROUND: Postpartum haemorrhage (PPH) remains the leading cause of maternal morbidity and mortality worldwide. The main strategy for preventing PPH is the use of uterotonic drugs given prophylactically by skilled health workers. However, in settings where many women still deliver at home without skilled attendants, uterotonics are often inaccessible. In such cases, women and their caregivers need to recognize PPH promptly so, as to seek expert care. For this reason, it is important to understand how women and their caregivers recognize PPH, as well as the actions they undertake to prevent and treat PPH in home births. Such knowledge can also inform programs aiming to make uterotonics accessible at the community level. METHODS: Between April and June 2012, a phenomenological study was carried out in a rural Ugandan district involving 15 in-depth interviews. Respondents were purposively sampled and included six women who had delivered at home in the past year and nine traditional birth attendants (TBAs). The interviews explored how PPH was recognized, its perceived causes, and the practices that respondents used in order to prevent or treat it. Phenomenological descriptive methodology was used to analyse the data. RESULTS: Bleeding after childbirth was considered to be a normal cleansing process, which if stopped or inhibited would lead to negative health consequences to the mother. Respondents used a range of criteria to recognize PPH: rate of blood flow, amount of blood (equivalent to two clenched fists), fainting, feeling thirsty, collapsing or losing consciousness immediately after birth. As a group, respondents seemed to correctly identify women at risk of PPH (those with twin pregnancies, high parity or prolonged labour), but many individuals did not know all the reasons. Respondents used cold drink, uterine massage and traditional medicine to treat PPH. CONCLUSION: The community viewed bleeding after childbirth as a normal process and their methods of determining excessive bleeding are imprecise and varied. This opens the door for intervention for reducing delays in the home diagnosis of PPH. This includes increasing awareness among TBAs, women and their families about the risk of death due to excessive bleeding in the immediate postpartum period

Prevalence And Factors Associated With Psychological Distress Among Pregnant Women Attending The Antenatal Clinic At A National Referral Hospital In Uganda.

Abstract Background: Psychological distress (PD) among pregnant women has a bearing both on the mother and the outcome of the pregnancy and is thus a public health problem. It is a precursor for other severe mental health conditions that include anxiety, depression, bipolar disorder and so if screened and diagnosed early it can prevent progress to severe mental illness. PD has however not been screened among pregnant women and thus no available data in Uganda. The objective of this study was to determine the prevalence and factors associated with PD among pregnant women at Kawempe hospital Uganda.Methods: A cross sectional study was conducted among 530 pregnant women attending antenatal care at Kawempe hospital Uganda. The SRQ-20 tool was used to screen for PD and data on socio-demographic and clinical factors was collected using a. socio-demographic questionnaire and medical records respectively. Descriptive statistics were applied to determine the prevalence of PD and multivariable logistic regression analysis was used to assess for factors associated with PD among pregnant women.Results: The prevalence of PD was 19.1% , while having a fair/bad relationship with the spouse (P-value =0.007), a low monthly income (p-value = 0.013), and having less than two meals a day (P-value =0.022). were independently associated with PDConclusion: Approximately one in five pregnant women receiving ANC at Kawempe hospital has PD. This study therefore supports the need for integration of mental health assessment into the antenatal care package of women at Kawempe hospital and Uganda at large</jats:p