Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy.

BACKGROUND: The World Health Organization recommends 1500 to 2000 mg of calcium daily as supplementation, divided into three doses, for pregnant persons in populations with low dietary calcium intake in order to reduce the risk of preeclampsia. The complexity of the dosing scheme, however, has led to implementation barriers. METHODS: We conducted two independent randomized trials of calcium supplementation, in India and Tanzania, to assess the noninferiority of a 500-mg daily dose to a 1500-mg daily dose of calcium supplementation. In each trial, the two primary outcomes were preeclampsia and preterm birth, and the noninferiority margins for the relative risks were 1.54 and 1.16, respectively. RESULTS: A total of 11,000 nulliparous pregnant women were included in each trial. The cumulative incidence of preeclampsia was 3.0% in the 500-mg group and 3.6% in the 1500-mg group in the India trial (relative risk, 0.84; 95% confidence interval [CI], 0.68 to 1.03) and 3.0% and 2.7%, respectively, in the Tanzania trial (relative risk, 1.10; 95% CI, 0.88 to 1.36) - findings consistent with the noninferiority of the lower dose in both trials. The percentage of live births that were preterm was 11.4% in the 500-mg group and 12.8% in the 1500-mg group in the India trial (relative risk, 0.89; 95% CI, 0.80 to 0.98), which was within the noninferiority margin of 1.16; in the Tanzania trial, the respective percentages were 10.4% and 9.7% (relative risk, 1.07; 95% CI, 0.95 to 1.21), which exceeded the noninferiority margin. CONCLUSIONS: In these two trials, low-dose calcium supplementation was noninferior to high-dose calcium supplementation with respect to the risk of preeclampsia. It was noninferior with respect to the risk of preterm live birth in the trial in India but not in the trial in Tanzania. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT03350516; Clinical Trials Registry-India number, CTRI/2018/02/012119; and Tanzania Medicines and Medical Devices Authority Trials Registry number, TFDA0018/CTR/0010/5).

Stillbirth mortality by Robson ten-group classification system: A cross-sectional registry of 80 663 births from 16 hospital in sub-Saharan Africa.

OBJECTIVE: To assess stillbirth mortality by Robson ten-group classification and the usefulness of this approach for understanding trends. DESIGN: Cross-sectional study. SETTING: Prospectively collected perinatal e-registry data from 16 hospitals in Benin, Malawi, Tanzania and Uganda. POPULATION: All women aged 13-49 years who gave birth to a live or stillborn baby weighting >1000 g between July 2021 and December 2022. METHODS: We compared stillbirth risk by Robson ten-group classification, and across countries, and calculated proportional contributions to mortality. MAIN OUTCOME MEASURES: Stillbirth mortality, defined as antepartum and intrapartum stillbirths. RESULTS: We included 80 663 babies born to 78 085 women; 3107 were stillborn. Stillbirth mortality by country were: 7.3% (Benin), 1.9% (Malawi), 1.6% (Tanzania) and 4.9% (Uganda). The largest contributor to stillbirths was Robson group 10 (preterm birth, 28.2%) followed by Robson group 3 (multipara with cephalic term singleton in spontaneous labour, 25.0%). The risk of dying was highest in births complicated by malpresentations, such as nullipara breech (11.0%), multipara breech (16.7%) and transverse/oblique lie (17.9%). CONCLUSIONS: Our findings indicate that group 10 (preterm birth) and group 3 (multipara with cephalic term singleton in spontaneous labour) each contribute to a quarter of stillbirth mortality. High mortality risk was observed in births complicated by malpresentation, such as transverse lie or breech. The high mortality share of group 3 is unexpected, demanding case-by-case investigation. The high mortality rate observed for Robson groups 6-10 hints for a need to intensify actions to improve labour management, and the categorisation may support the regular review of labour progress.

Women's and maternity care providers' perceptions of pain management during childbirth in hospitals in Southern Tanzania.

BACKGROUND: The majority of women experience pain during childbirth. Offering and supporting women to use different methods for coping with pain is an essential competency for maternity care providers globally. Research suggests a gap between what women desire for pain management and what is available and provided in many low-and middle-income settings. The study aimed to understand how pain management is perceived by those involved: women experiencing childbirth and maternity care providers. METHODS: Individual semi-structured interviews with women (n = 23), maternity care providers (n = 17) and focus group discussions (n = 4) with both providers and women were conducted in two hospitals in Southern Tanzania in 2021. Transcribed interviews were analysed using reflexive thematic analysis. Coding and analysis were supported by the software MAXQDA. RESULTS: Three main themes were generated from the data. The first, 'pain management is multifaceted', describes how some providers and women perceived pain management as entailing various methods to manage pain. Providers perceived themselves as having a role in utilization of pain management to varying degree. The second theme 'pain management is primarily a woman's task' highlights a perception of pain management as unnecessary, which appeared to link with some providers' perceptions of pain as natural and necessary for successful childbirth. Few women explicitly shared this perception. The third theme 'practice of pain management can be improved' illustrates how women and maternity care providers perceived current practices of pain management as suboptimal. According to providers, this is primarily due to contextual factors such as shortage of staff and poor ward infrastructure. CONCLUSION: Women's and maternity care providers' perceptions ranged from perceiving pain management as involving a combination of physiological, psychological and social aspects to perceive it as related with limited to no pain relief and/or support. While some women and providers had similar perceptions about pain management, other women also reported a dissonance between what they experienced and what they would have preferred. Efforts should be made to increase women's access to respectful pain management in Tanzania.

Emerging integrase strand transfer inhibitor drug resistance mutations among children and adults on ART in Tanzania: findings from a national representative HIV drug resistance survey.

BACKGROUND: Despite the scale-up of ART and the rollout in Tanzania of dolutegravir, an integrase strand transfer inhibitor (INSTI), treatment success has not been fully realized. HIV drug resistance (HIVDR), including dolutegravir resistance, could be implicated in the notable suboptimal viral load (VL) suppression among HIV patients. OBJECTIVES: To determine the prevalence and patterns of acquired drug resistance mutations (DRMs) among children and adults in Tanzania. METHODS: A national cross-sectional HIVDR survey was conducted among 866 children and 1173 adults. Genotyping was done on dried blood spot and/or plasma of participants with high HIV VL (≥1000 copies/mL). HIV genes (reverse transcriptase, protease and integrase) were amplified by PCR and directly sequenced. The Stanford HIVDR Database was used for HIVDR interpretation. RESULTS: HIVDR genotyping was performed on blood samples from 137 participants (92 children and 45 adults) with VL ≥ 1000 copies/mL. The overall prevalence of HIV DRMs was 71.5%, with DRMs present in 78.3% of children and 57.8% of adults. Importantly, 5.8% of participants had INSTI DRMs including major DRMs: Q148K, E138K, G118R, G140A, T66A and R263K. NNRTI, NRTI and PI DRMs were also detected in 62.8%, 44.5% and 8% of participants, respectively. All the participants with major INSTI DRMs harboured DRMs targeting NRTI backbone drugs. CONCLUSIONS: More than 7 in 10 patients with high HIV viraemia in Tanzania have DRMs. The early emergence of dolutegravir resistance is of concern for the efficacy of the Tanzanian ART programme.

Quality of reporting and trends of emergency obstetric and neonatal care indicators: an analysis from Tanzania district health information system data between 2016 and 2020.

BACKGROUND: Routine health facility data provides the opportunity to monitor progress in quality and uptake of health care continuously. Our study aimed to assess the reliability and usefulness of emergency obstetric care data including temporal and regional variations over the past five years in Tanzania Mainland. METHODS: Data were compiled from the routine monthly district reports compiled as part of the health management information systems for 2016-2020. Key indicators for maternal and neonatal care coverage, emergency obstetric and neonatal complications, and interventions indicators were computed. Assessment on reliability and consistency of reports was conducted and compared with annual rates and proportions over time, across the 26 regions in of Tanzania Mainland and by institutional delivery coverage. RESULTS: Facility reporting was near complete with 98% in 2018-2020. Estimated population coverage of institutional births increased by 10% points from 71.2% to 2016 to 81.7% in 2020 in Tanzania Mainland, driven by increased use of dispensaries and health centres compared to hospitals. This trend was more pronounced in regions with lower institutional birth rates. The Caesarean section rate remained stable at around 10% of institutional births. Trends in the occurrence of complications such as antepartum haemorrhage, premature rupture of membranes, pre-eclampsia, eclampsia or post-partum bleeding were consistent over time but at low levels (1% of institutional births). Prophylactic uterotonics were provided to nearly all births while curative uterotonics were reported to be used in less than 10% of post-partum bleeding and retained placenta cases. CONCLUSION: Our results show a mixed picture in terms of usefulness of the District Health Information System(DHIS2) data. Key indicators of institutional delivery and Caesarean section rates were plausible and provide useful information on regional disparities and trends. However, obstetric complications and several interventions were underreported thus diminishing the usefulness of these data for monitoring. Further research is needed on why complications and interventions to address them are not documented reliably.

Multivitamin Supplementation Is Associated with Greater Adequacy of Gestational Weight Gain among Pregnant Women in Tanzania.

BACKGROUND: Gestational weight gain (GWG) is a modifiable risk factor associated with adverse birth outcomes. Studies have shown that the provision of multiple micronutrient supplements to pregnant women reduces the risk of low birth weight. However, the effect of multiple micronutrient supplements on GWG has been understudied. OBJECTIVES: We examined the effect of daily supplementation of pregnant women with multivitamins on GWG in relation to the GWG recommendation by the Institute of Medicine (IOM). METHODS: Pregnant women with gestational age between 12 and 27 wk were randomly assigned to receive daily multivitamins or placebo until delivery. Weight was measured at enrollment and every follow-up visit. Percentage adequacy of GWG was calculated as actual GWG divided by the recommended GWG according to the IOM recommendation. Binary outcomes included severely inadequate (<70%), inadequate (<90%), and excessive GWG (≥125%). The analysis included 7573 women with singleton pregnancies. Multiple linear regression models were used to examine the association between multivitamin supplementation and percentage adequacy of GWG, and log-binomial models were used for binary outcomes. RESULTS: The mean percentage adequacy of GWG was 96.7% in the multivitamin arm and 94.4% in the placebo arm, with a mean difference of 2.3% (95% CI: 0.3%, 4.2%; P = 0.022). Compared with women in the placebo arm, those who received multivitamins had a lower risk of severely inadequate GWG (RR: 0.90; 95% CI: 0.83, 0.97; P = 0.008) and inadequate GWG (RR: 0.95; 95% CI: 0.91, 0.99; P = 0.018). No significant difference was found in excessive GWG. CONCLUSIONS: Multivitamin supplementation increased GWG and reduced the risk of severely inadequate and inadequate GWG among pregnant women in Tanzania. Together with previously reported beneficial effects of the supplements on birth outcomes in low- and middle-income countries, our findings support scaling up the use of prenatal supplements that include multivitamins in addition to iron and folic acid.This trial was registered at clinicaltrials.gov as NCT00197548.

Fear of childbirth: validation of the Kiswahili version of Wijma delivery expectancy/experience questionnaire versions A and B in Tanzania.

BACKGROUND: Fear of childbirth is common both before and after childbirth, often leading to complications in mother and new-born. The Wijma Delivery Expectancy/Experience Questionnaires (W-DEQ) are commonly used to measure fear of childbirth among women before (version A) and after childbirth (version B). The tools are not yet validated in the Tanzanian context. This study aimed to validate the reliability, validity, and factorial structure of their Kiswahili translations. METHODS: A longitudinal study was conducted in six public health facilities in the Pwani region, Tanzania. In all, 694 pregnant and 625 postnatal women were concurrently selected and responded to W-DEQ-A and W-DEQ-B. Validation involved: translating the English questionnaires into Kiswahili; expert rating of the relevancy of the Kiswahili versions' items; computing content validity ratio; piloting the tools; data collection; statistical analysis with reliability evaluated using Cronbach's alpha and the intraclass correlation coefficient. Tool validity was assessed using factor analysis, convergent and discriminant validity. Exploratory factor analysis and confirmatory factor analysis were conducted on data collected using W-DEQ-A and W-DEQ-B, respectively. RESULTS: Exploratory factor analysis revealed seven factors contributing to 50% of the total variation. Four items did not load to any factor and were deleted. The factors identified were: fear; lack of self-efficacy; lack of positive anticipation; isolation; concerns for the baby; negative emotions; lack of positive behaviour. The factors correlated differently with each other and with the total scores. Both Kiswahili versions with 33 items had good internal consistency, with Cronbach's alphas of .83 and .85, respectively. The concerns for the baby factor showed both convergent and discriminant validity. The other six factors showed some problems with convergent validity. The final model from the confirmatory factor analysis yielded 29 items with good psychometric properties (χ2/df = 2.26, p = < .001, RMSEA = .045, CFI = .90 and TLI = .81). CONCLUSIONS: The Kiswahili W-DEQ-A-Revised and W-DEQ-B-Revised are reliable tools and measure fear of childbirth with a multifactorial structure, encompassing seven factors with 29 items. They are recommended for measuring fear of childbirth among pregnant and postnatal Tanzanian women. Further studies are needed to address the inconsistent convergent validity in the revised versions and assess the psychometric properties of W-DEQ-A among pregnant women across gestational ages.

Associations between Gestational Weight Gain Adequacy and Neonatal Outcomes in Tanzania.

INTRODUCTION: Gestational weight gain (GWG) is associated with fetal and newborn health; however, data from sub-Saharan Africa are limited. METHODS: We used data from a prenatal micronutrient supplementation trial among a cohort of human immunodeficiency virus-negative pregnant women in Dar es Salaam, Tanzania to estimate the relationships between GWG and neonatal outcomes. GWG adequacy was defined as the ratio of the total observed weight gain over the recommended weight gain based on the Institute of Medicine body mass index-specific guidelines. Neonatal outcomes assessed were stillbirth, perinatal death, preterm birth, low birthweight, macrosomia, small-for-gestational age (SGA), large-for-gestational age (LGA), stunting at birth, and microcephaly. Modified Poisson regressions with robust standard error were used to estimate the relative risk of newborn outcomes as a function of GWG adequacy. RESULTS: Of 7,561 women included in this study, 51% had severely inadequate (<70%) or inadequate GWG (70 to <90%), 31% had adequate GWG (90 to <125%), and 18% had excessive GWG (≥125%). Compared to adequate GWG, severely inadequate GWG was associated with a higher risk of low birthweight, SGA, stunting at birth, and microcephaly, whereas excessive GWG was associated with a higher risk of LGA and macrosomia. CONCLUSION: Interventions to support optimal GWG are needed and may contribute to preventing adverse neonatal outcomes.

Health workers' experiences of implementation of Helping Mothers Survive Bleeding after Birth training in Tanzania: a process evaluation using the i-PARIHS framework.

BACKGROUND: In-service training, including the competency-based Helping Mothers Survive Bleeding After Birth (HMS BAB) is widely implemented to improve the quality of maternal health services. To better understand how this specific training responds to the needs of providers and fits into the existing health systems, we explored health workers' experiences of the HMS BAB training. METHODS: Our qualitative process evaluation was done as part of an effectiveness trial and included eight focus group discussions with 51 healthcare workers in the four districts which were part of the HMS BAB trial. We employed deductive content analysis informed by the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) construct of context, recipients, innovation and facilitation. RESULTS: Overall, health workers reported positive experiences with the training content and how it was delivered. They are perceived to have improved competencies leading to improved health outcomes. Interviews proposed that peer practice coordinators require more support to sustain the weekly practices. Competing tasks within the facility in the context of limited time and human resources hindered the sustainability of weekly practices. Most health facilities had outlined the procedure for routine learning environments; however, these were not well operational. CONCLUSION: The HMS BAB training has great potential to improve health workers' competencies around the time of childbirth and maternal outcomes. Challenges to successful implementation include balancing the intervention within the routine facility setting, staff motivation and workplace cultures.

Gestational weight gain during the second and third trimesters and adverse pregnancy outcomes, results from a prospective pregnancy cohort in urban Tanzania.

BACKGROUND: Appropriate gestational weight gain (GWG) is important for optimal pregnancy outcomes. This study prospectively evaluated the associations between GWG during the second and third trimesters of pregnancy and adverse pregnancy outcomes in an urban Tanzanian pregnancy cohort. METHODS: We used data from a randomized clinical trial conducted among pregnant women recruited by 27 weeks of gestation in Dar es Salaam, Tanzania (N = 1230). Women's gestational weight was measured at baseline and at monthly antenatal visits. Weekly GWG rate during the second and third trimesters was calculated and characterized as inadequate, adequate, or excessive, in conjunction with measured or imputed early-pregnancy BMI status according to the 2009 Institute of Medicine (IOM) GWG guidelines. We used multivariable Poisson regression with a sandwich variance estimator to calculate risk ratios (RR) for associations of GWG with low birth weight, preterm birth, small for gestational age (SGA), and large for gestational age (LGA). Degree of appropriate GWG defined using additional metrics (i.e., percentage of adequacy, z-score) and potential effect modification by maternal BMI were additionally evaluated. RESULTS: According to the IOM guidelines, 517 (42.0%), 270 (22.0%), and 443 (36.0%) women were characterized as having inadequate, adequate, and excessive GWG, respectively. Overall, compared to women with adequate GWG, women with inadequate GWG had a lower risk of LGA births (RR = 0.54, 95% CI: 0.36-0.80) and a higher risk of SGA births (RR = 1.32, 95% CI: 0.95-1.81). Women with inadequate GWG as defined by percentage of GWG adequacy had a higher risk of LBW (OR = 1.93, 95% CI: 1.03-3.63). In stratified analyses by early-pregnancy BMI, excessive GWG among women with normal BMI was associated with a higher risk of preterm birth (RR = 1.59, 95% CI: 1.03-2.44). CONCLUSIONS: A comparatively high percentage of excessive GWG was observed among healthy pregnant women in Tanzania. Both inadequate and excessive GWGs were associated with elevated risks of poor pregnancy outcomes. Future studies among diverse SSA populations are warranted to confirm our findings, and clinical recommendations on optimal GWG should be developed to promote healthy GWG in SSA settings. TRIAL REGISTRATION: This trial was registered as "Prenatal Iron Supplements: Safety and Efficacy in Tanzania" (NCT01119612; http://clinicaltrials.gov/show/NCT01119612 ).

Pregnancy is a critical lifetime event for both mother and the offspring, with implications in short-term and long-term health consequences. Gestational weight gain (GWG) is an important modifiable factor for pregnancy outcomes related to infant body size and weight and prematurity. Countries in sub-Saharan Africa (SSA) have long had poor rates of insufficient GWG and pregnancy complications associated with insufficient GWG. Nevertheless, some SSA countries are experiencing economic transitions accompanied with changes in lifestyle and nutrition, which might impact pregnancy experiences, including GWG and pregnancy outcomes. This study aimed to characterize recent GWG patterns and the associations of both inadequate and excessive GWG with adverse pregnancy outcomes, using an urban pregnancy cohort in Tanzania. This study found that 42.0%. 22.0%, and 36.0% of women had insufficient, adequate, and excessive GWG, respectively. Insufficient GWG was associated with higher risks of small infant size and low infant body weight, and excessive GWG was associated with higher risk of preterm birth, particularly among women with body mass index 18.5­25.0 kg/m². Results from the present study highlight that both insufficient and excessive GWG are of potential public health concerns in urban centers of SSA, concerning upward trends in obesity and possibly obesity-related pregnancy consequences. Local public health practitioners should continue to advocate longitudinal GWG monitoring and care among African pregnant women, and optimal GWG with feasible and effective clinical guidelines should be developed to prevent both over- and under-gaining of maternal weight during pregnancy.

Advances in training of the specialized human resources for health in Tanzania: the case of Muhimbili University of Health and Allied Sciences.

BACKGROUND: Increasing the number of specialized human resources for health is paramount to attainment of the United Nations sustainable development goals. Higher learning institutions in low-and middle-income countries must address this necessity. Here, we describe the 5-years trends in accreditation of the clinical and non-clinical postgraduate (PG) programmes, student admission and graduation at the Muhimbili University of Health and Allied Sciences (MUHAS) in Tanzania, highlighting successes, challenges and opportunities for improvement. METHODS: This was a retrospective longitudinal study describing trends in PG training at MUHAS between 2015 and 2016 and 2019-2020. Major interventions in the reporting period included university-wide short course training programme to faculty on curricula development and initiation of online application system. Data were collected through a review of secondary data from various university records and was analyzed descriptively. Primary outcomes were the number of accredited PG programmes, number of PG applicants as well as proportions of applicants selected, applicants registered (enrolled) and students graduated, with a focus on gender and internationalization (students who are not from Tanzania). RESULTS: The number of PG programmes increased from 60 in 2015-2016 to 77 in 2019-2020, including programmes in rare fields such as cardiothoracic surgery, cardiothoracic anesthesia and critical care. The number of PG applications, selected applicants, registered applicants and PG students graduating at the university over the past five academic years had steadily increased by 79, 81, 50 and 79%, respectively. The average proportions of PG students who applied, were selected and registered as well as graduated at the university over the past five years by gender and internationalization has remained stably at 60% vs. 40% (male vs. female) and 90% vs. 10% (Tanzanian vs. international), respectively. In total, the university graduated 1348 specialized healthcare workers in the five years period, including 45 super-specialists in critical fields, through a steady increase from 200 graduates in 2015-2016 to 357 graduates in 2019-2020. Major challenges encountered include inadequate sponsorship, limited number of academic staff and limited physical infrastructure for teaching. CONCLUSION: Despite challenges encountered, MUHAS has made significant advances over the past five years in training of specialized and super-specialized healthcare workforce by increasing the number of programmes, enrollment and graduates whilst maintaining a narrow gender gap and international relevance. MUHAS will continue to be the pillar in training of the specialized human resources for health and is thus poised to contribute to timely attainment of the health-related United Nations sustainable development goals in Tanzania and beyond, particularly within the Sub-Saharan Africa region.

Predictors of fear of childbirth and depressive symptoms among pregnant women: a cross-sectional survey in Pwani region, Tanzania.

BACKGROUND: Many women experience fear of childbirth (FoB) and depressive symptoms (DS) during pregnancy, but little is known about FoB among Tanzanian women. The current study aimed to assess the prevalence of FoB and DS among pregnant women and determine predictors of each and both, focusing on sociodemographic and obstetric predictors. METHODS: A cross-sectional study was conducted at six health facilities in two districts in Tanzania between 2018 and 2019. In total, 694 pregnant women with gestational age between 32 and 40 weeks and expecting vaginal delivery were consecutively recruited and assessed for FoB and DS. We collected data through interviews using 6 and 4-points Likert Scale of the Wijma Delivery Expectancy Questionnaire Version A and Edinburgh Postnatal Depression Scale, respectively. Women who scored ≥66 and ≥ 10 were categorised as having FoB and DS, respectively. We performed multivariable logistic regression to investigate the predictors of FoB and DS. RESULTS: The prevalence rates of FoB and DS among pregnant women were 15.1 and 17.7%, respectively. FoB and DS were more likely in women aged above 30 years [Adjusted Odds Ratio (AOR) 6.29, 95%CI 1.43-27.84] and in single mothers (AOR 2.57, 95%CI 1.14-5.78). Women with secondary education and above (AOR 0.22, 95%CI 0.05-0.99) and those who had given birth previously (AOR 0.27, 95% CI 0.09-0.87) were less likely to have FoB in combination with DS Women who had previous obstetric complications, and those who did not receive any social support from male partners in previous childbirth were more likely to have FoB and DS. FoB was strongly associated with DS (AOR 3.42, 95%CI 2.12-5.53). DS only was more common in women who had inadequate income (AOR 2.35, 95%CI 1.38-3.99) or had previously experienced a perineal tear (AOR 2.32, 95%CI 1.31-4.08). CONCLUSIONS: Not having a formal education, having only primary education, being aged above 30 years, being single, being nulliparous, having experienced obstetric complications, and having a lack of social support from a male partner during previous pregnancy and childbirth were predictors of FoB and DS during pregnancy. FoB and DS were strongly associated with each other. It is vital to identify at-risk women early, to offer support during pregnancy and childbirth.

Agreement between careHPV and hybrid capture 2 in detecting high-risk HPV in women in Tanzania.

INTRODUCTION: Visual inspection of the cervix with acetic acid is used to control the burden of cervical cancer in low- and middle-income countries. This method has some limitations and HPV DNA testing may be an alternative, but it is expensive and requires a laboratory setup. Cheaper and faster HPV tests have been developed. This study describe the agreement between a fast HPV test (careHPV) and hybrid capture 2 (HC2) in detection of high-risk HPV among Tanzanian women. MATERIAL AND METHODS: The study involved women attending routine cervical cancer screening at the Ocean Road Cancer Institute and Kilimanjaro Christian Medical Centre in Tanzania. The women were offered HIV testing. Two cervical samples were subsequently obtained; the first sample was processed at the clinics using careHPV and the second sample was transported to Denmark and Germany for cytology and HC2 analysis. Kappa statistic was calculated to assess the agreement between careHPV and HC2. The sensitivity, specificity and predictive values of careHPV were calculated using HC2 as reference. The analyses were done for the overall study population and stratified by testing site and HIV status. RESULTS: A total of 4080 women were enrolled, with 437 being excluded due to invalid information, lack of careHPV or HC2 results. Overall agreement between the tests was substantial with a kappa value of 0.69 (95% confidence interval [CI] 0.66-0.72). The sensitivity and specificity of careHPV was 90.7% (95% CI 89.6-91.8) and 84.2% (95% CI 81.2-86.8), respectively. The agreement was similar in the stratified analyses where the kappa values were 0.75 (95% CI 0.70-0.79) in women aged 25-34, 0.66 (95% CI 0.62-0.70) in women aged 35-60, 0.73 (95% CI 0.70-0.77) at the Ocean Road Cancer Institute, 0.64 (95% CI 0.60-0.69) at the Kilimanjaro Christian Medical Center, 0.73 (95% CI 0.68-0.79) in HIV-positive and 0.66 (95% CI 0.63-0.70) in HIV-negative women. The kappa value of 0.64 (95% CI 0.39-0.88) for cervical high-grade lesions indicates a substantial agreement between careHPV and HC2 in detecting HPV among women with cervical high-grade lesions. CONCLUSIONS: A substantial agreement was found between careHPV and HC2 in detecting HPV overall as well as detecting HPV among women with cervical high-grade lesions. However, given the limited resources available in low and middle-income countries, the HPV testing assay should be weighed against the cost-effectiveness of the test.

Uterotonics for prevention of postpartum haemorrhage: EN-BIRTH multi-country validation study.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of preventable maternal mortality worldwide. The World Health Organization (WHO) recommends uterotonic administration for every woman after birth to prevent PPH. There are no standardised data collected in large-scale measurement platforms. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) is an observational study to assess the validity of measurement of maternal and newborn indicators, and this paper reports findings regarding measurement of coverage and quality for uterotonics. METHODS: The EN-BIRTH study took place in five hospitals in Bangladesh, Nepal and Tanzania, from July 2017 to July 2018. Clinical observers collected tablet-based, time-stamped data. We compared observation data for uterotonics to routine hospital register-records and women's report at exit-interview survey. We analysed the coverage and quality gap for timing and dose of administration. The register design was evaluated against gap analyses and qualitative interview data assessing the barriers and enablers to data recording and use. RESULTS: Observed uterotonic coverage was high in all five hospitals (> 99%, 95% CI 98.7-99.8%). Survey-report underestimated coverage (79.5 to 91.7%). "Don't know" replies varied (2.1 to 14.4%) and were higher after caesarean (3.7 to 59.3%). Overall, there was low accuracy in survey data for details of uterotonic administration (type and timing). Register-recorded coverage varied in four hospitals capturing uterotonics in a specific column (21.6, 64.5, 97.6, 99.4%). The average coverage measurement gap was 18.1% for register-recorded and 6.0% for survey-reported coverage. Uterotonics were given to 15.9% of women within the "right time" (1 min) and 69.8% within 3 min. Women's report of knowing the purpose of uterotonics after birth ranged from 0.4 to 64.9% between hospitals. Enabling register design and adequate staffing were reported to improve routine recording. CONCLUSIONS: Routine registers have potential to track uterotonic coverage - register data were highly accurate in two EN-BIRTH hospitals, compared to consistently underestimated coverage by survey-report. Although uterotonic coverage was high, there were gaps in observed quality for timing and dose. Standardisation of register design and implementation could improve data quality and data flow from registers into health management information reporting systems, and requires further assessment.

Maternal death surveillance and response in Tanzania: comprehensiveness of narrative summaries and action points from maternal death reviews.

BACKGROUND: Maternal deaths reviews are proposed as one strategy to address high maternal mortality in low and middle-income countries, including Tanzania. Review of maternal deaths relies on comprehensive documentation of medical records that can reveal the sequence of events leading to death. The World Health Organization's and the Tanzanian Maternal Death and Surveillance (MDSR) system propose the use of narrative summaries during maternal death reviews for discussing the case to categorize causes of death, identify gaps in care and recommend action plans to prevent deaths. Suggested action plans are recommended to be Specific, Measurable, Attainable, Relevant and Time bound (SMART). To identify gaps in documenting information and developing recommendations, comprehensiveness of written narrative summaries and action plans were assessed. METHODS: A total of 76 facility maternal deaths that occurred in two regions in Southern Tanzania in 2018 were included for analysis. Using a prepared checklist from Tanzania 2015 MDSR guideline, we assessed comprehensiveness by presence or absence of items in four domains, each with several attributes. These were socio-demographic characteristics, antenatal care, referral information and events that occurred after admission. Less than 75% completeness of attributes in all domains was considered poor while 95% and above were good/comprehensive. Action plans were assessed by application of SMART criteria and according to the place of planned implementation (community, facility or higher level of health system). RESULTS: Almost half of narrative summaries (49%) scored poor, and only1% scored good/comprehensive. Summaries missed key information such as demographic characteristics, time between diagnosis of complication and commencing treatment (65%), investigation results (47%), summary of case evolution (51%) and referral information (47%). A total of 285 action points were analysed. Most action points, 242(85%), recommended strategies to be implemented at health facilities and were mostly about service delivery, 120(42%). Only 42% (32/76) of the action points were deemed to be SMART. CONCLUSIONS: Abstraction of information to prepare narrative summaries used in the MDSR system is inadequately done. Most recommendations were unspecific with a focus on improving quality of care in health facilities.

Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda.

BACKGROUND: Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period. METHODS: This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial's primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention. DISCUSSION: There is evidence that each of the ALERT intervention components improves health providers' practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. TRIAL REGISTRATION: Pan African Clinical Trial Registry ( www.pactr.org ): PACTR202006793783148. Registered on 17th June 2020.

Causes of maternal deaths and delays in care: comparison between routine maternal death surveillance and response system and an obstetrician expert panel in Tanzania.

BACKGROUND: To reduce maternal mortality Tanzania introduced Maternal Death Surveillance and Response (MDSR) system in 2015 as recommended by World Health Organization (WHO). All health facilities are to notify and review all maternal deaths inorder to recommend quality improvement actions to reduce deaths in future. The system relies on consistent and correct categorization of causes of maternal deaths and three phases of delays. To assess its adequacy we compared the routine MDSR categorization of causes of death and three phases of delays to those assigned by an independent expert panel with additional information from Verbal Autopsy (VA). METHODS: Our cross-sectional study included 109 reviewed maternal deaths from two regions in Tanzania for the year 2018. We abstracted the underlying medical causes of death and the three phases of delays from MDSR system records. We interviewed bereaved families using the standard WHO VA questionnaire. The obstetrician expert panel assigned underlying causes of death based on information from medical files and VA according to International Classification of Disease to Death in Pregnancy Childbirth and Puerperium (ICD-MM). They assigned causes to nine ICD-MM groups and identified the three phases of delays. We used Cohen's K statistic to compare causes of deaths and delays categorization. RESULTS: Comparison of underlying causes was done for 99 deaths. While 109 and 84 deaths for expert panel and MDSR respectively were analyzed for delays because of missing data in MDSR system. Expert panel and MDSR system assigned the same underlying causes in 64(64.6%) deaths (K statistic 0.60). Agreement increased in 80 (80.8%) when causes were assigned by ICD-MM groups (K statistic 0.76). The obstetrician expert panel identified phase one delays in 74 (67.9%), phase two in 24 (22.0%) and phase three delays in all 101 (100%) deaths that were assessed for this delay while MDSR system identified delays in 42 (50.0%), 10 (11.9%) and 78 (92.9%).The expert panel found human errors in management in 94 (93.1%) while MDSR system reported in 53 (67.9%) deaths. CONCLUSIONS: MDSR committees performed reasonably well in assigning underlying causes of death. The obstetrician expert panel found more delays than reported in MDSR system indicating difficulties within MDSR teams to critically review deaths.

National policies and care provision in pregnancy and childbirth for twins in Eastern and Southern Africa: A mixed-methods multi-country study.

BACKGROUND: High-risk pregnancies, such as twin pregnancies, deserve particular attention as mortality is very high in this group. With a view to inform policy and national guidelines development for the Sustainable Development Goals, we reviewed national training materials, guidelines, and policies underpinning the provision of care in relation to twin pregnancies and assessed care provided to twins in 8 Eastern and Southern African countries: Kenya, Malawi, Mozambique, Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe. METHODS AND FINDINGS: We located policies and guidelines by reviewing national repositories and by contacting experts to systematically map country-level maternal and newborn training materials, guidelines, and policies. We extracted recommendations for care for twins spanning ante-, intra-, and postpartum care that typically should be offered during twin pregnancies and childbirth. We compared care provided for mothers of twins to that provided for mothers of singletons during the ante-, intra-, and postpartum period and computed neonatal mortality rates using the most recent Demographic and Health Surveys (DHS) data for each country. There was a paucity of guidance on care specifically for twin or multiple pregnancies: None of the countries provided clear guidance on additional number of antenatal care visits or specific antenatal content, while 7 of the 8 countries recommended twins to be delivered in a comprehensive emergency obstetric and neonatal care facility. These results were mirrored by DHS results of 73,462 live births (of which 1,360 were twin) indicating that twin pregnancies did not receive more frequent or intensified antenatal care. The percentage of twin deliveries in hospitals varied from 25.3% in Mozambique to 63.0% in Kenya, and women with twin deliveries were between 5 and 27 percentage points more likely to deliver in hospitals compared to women with singleton live births; this difference was significant in 5 of the 8 countries (t test p < 0.05). The percentage of twin deliveries by cesarean section varied from 9% in Mozambique to 36% in Rwanda. The newborn mortality rate among twins, adjusted for maternal age and parity, was 4.6 to 7.2 times higher for twins compared to singletons in all 8 countries. CONCLUSIONS: Despite the limited sample size and the limited number of clinically relevant services evaluated, our study provided evidence that mothers of twins receive insufficient care and that mortality in twin newborns is very high in Eastern and Southern Africa. Most countries have insufficient guidelines for the care of twins. While our data do not allow us to make a causal link between insufficient guidelines and insufficient care, they call for an assessment and reconceptualisation of policies to reduce the unacceptably high mortality in twins in Eastern and Southern Africa.

Effectiveness of the Home Based Life Saving Skills training by community health workers on knowledge of danger signs, birth preparedness, complication readiness and facility delivery, among women in Rural Tanzania.

BACKGROUND: In spite of government efforts, maternal mortality in Tanzania is currently at more than 400 per 100,000 live births. Community-based interventions that encourage safe motherhood and improved health-seeking behaviour through acquiring knowledge on the danger signs and improving birth preparedness, and, ultimately, reduce maternal mortality, have been initiated in different parts of low-income countries. Our aim was to evaluate if the Home Based Life Saving Skills education by community health workers would improve knowledge of danger signs, birth preparedness and complication readiness and facility-based deliveries in a rural community in Tanzania. METHODS: A quasi-experimental study design was used to evaluate the effectiveness of Home Based Life Saving Skills education to pregnant women and their families through a community intervention. An intervention district received training with routine care. A comparison district continued to receive routine antenatal care. A structured household questionnaire was used in order to gather information from women who had delivered a child within the last two years before the intervention. This questionnaire was used in both the intervention and comparison districts before and after the intervention. The net intervention effect was estimated using the difference between the differences in the intervention and control districts at baseline and endline. RESULTS: A total of 1,584 and 1,486 women were interviewed at pre-intervention and post intervention, respectively. We observed significant improvement of knowledge of three or more danger signs during pregnancy (15.2 % vs. 48.1 %) with a net intervention effect of 29.0 % (95 % CI: 12.8-36.2; p < .0001) compared to the comparison district. There was significant effect on the knowledge of three or more danger signs during childbirth (15.3 % vs. 43.1 %) with a net intervention effect of 18.3 % (95 % CI: 11.4-25.2; p < .0001) and postpartum for those mentioning three or more of the signs (8.8 % vs. 19.8 %) with net effect of 9.4 % (95 % CI: 6.4-15.7; p < .0001). Birth preparedness practice improved for those who made more than three actions (20.8 vs. 35.3 %) with a net intervention effect of 10.3 % (95 % CI: 10.3-20.3; p < .0001) between the intervention and control district at pre-intervention and post intervention. Utilisation of antenatal care with four visits improved significantly (43.4 vs. 67.8 %) with net effect of 25.3 % (95 % CI: 16.9-33.2; p < .0001), use of facility delivery improved in the intervention area (75.6 vs. 90.2 %; p = 0.0002) but there was no significant net effect 11.5 % (95 % CI: -5.1-39.6; p = 0.123) compared to comparison district. CONCLUSION: This study shows that a community-based intervention employing community health workers as teachers in delivering Home Based Life Saving Skills program to pregnant women and their families improved their knowledge of danger signs during pregnancy, childbirth and postpartum, preparedness for childbirth and increased deliveries at health facilities which employ skilled health workers in this rural community.

Maternal mortality at Muhimbili National Hospital in Dar-es-Salaam, Tanzania in the year 2011.

BACKGROUND: Improving maternal health is one of the eight millennium development goals adopted at the millennium summit in the year 2000. Within this frame work, the international community is committed to reduce the maternal mortality ratio by 75% between 1990 and 2015. The objective of this study was to determine the maternal mortality ratio, classify causes of maternal deaths and assess substandard care factors at Muhimbili National Hospital (MNH), Dar-es-Salaam in Tanzania. METHODS: A retrospective review of all maternal death records of cases that occurred from 1st January to 31st December 2011 was done. RESULTS: There were 10,057 live births, 155 maternal deaths and hence MMR of 1,541 per 100,000 live births. Direct causes of maternal deaths were classified in 69.5% of the maternal deaths. Of the direct causes, preeclampsia/eclampsia was the major cause (19.9% of all deaths), followed by post partum haemorrhage (14.9%), abortion complications (9.9%) and sepsis (9.2%). Among the indirect causes anaemia was the leading cause (11.3%) of all deaths, followed by HIV/AIDS (9.9%). Substandard care factors contributing to deaths were identified in 116 (82.3%) of all cases. Among these 28 had patient factors only, 71 medical service factors while 17 had both patient and medical service substandard care factors. The common factors from the woman's side included delay in seeking care (73.3%) and complete lack of antenatal care (11.1%). Of the medical service factors, inadequate (26.1%) or no blood for transfusion (19.3%), delay in receiving treatment (18.3%) and mismanagement (17%) were the common factors. CONCLUSION: There is a high maternal mortality ratio at MNH. Hypertensive disorders of pregnancy, post partum haemorrhage and anaemia are the leading causes of maternal deaths in this institution. Multiple substandard care factors identified both at individual and health care service levels that contributed to maternal deaths. There is a need for increasing efforts in the fight to reduce maternal deaths at the institution. A more pro-active role from the referring facilities in the region is needed.