Tranexamic acid by the intramuscular or intravenous route for the prevention of postpartum haemorrhage in women at increased risk: a randomised placebo-controlled trial (I'M WOMAN).

BACKGROUND: Postpartum haemorrhage (PPH) causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a life-saving treatment for women with PPH. Intravenous (IV) TXA reduces deaths due to PPH by one-third when given within 3 h of childbirth. Because TXA is more effective when given early and PPH usually occurs soon after childbirth, giving TXA just before childbirth might prevent PPH. Although several randomised trials have examined TXA for PPH prevention, the results are inconclusive. Because PPH only affects a small proportion of births, we need good evidence on the balance of benefits and harms before using TXA to prevent PPH. TXA is usually given by slow IV injection. However, recent research shows that TXA is well tolerated and rapidly absorbed after intramuscular (IM) injection, achieving therapeutic blood levels within minutes of injection. METHODS: The I'M WOMAN trial is an international, multicentre, three-arm, randomised, double-blind, placebo-controlled trial to assess the effects of IM and IV TXA for the prevention of PPH in women with one or more risk factors for PPH giving birth vaginally or by caesarean section. DISCUSSION: The trial will provide evidence of the benefits and harms of TXA for PPH prevention and the effects of the IM and IV routes of administration. The IM route should be as effective as the IV route for preventing bleeding. There may be fewer side effects with IM TXA because peak blood concentrations are lower than with the IV route. IM TXA also has practical advantages as it is quicker and simpler to administer. By avoiding the need for IV line insertion and a slow IV injection, IM administration would free up overstretched midwives and doctors to focus on looking after the mother and baby and expand access to timely TXA treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05562609. Registered on 3 October 2022. ISRCTN Registry ISRCTN12590098. Registered on 20 January 2023. Pan African Clinical Trial Registry PACTR202305473136570. Registered on 18 May 2023.

Implementing maternal and newborn health quality of care standards in healthcare facilities to improve the adoption of respectful maternity care in Bangladesh, Ghana and Tanzania: a controlled before and after study.

INTRODUCTION: Many women worldwide cannot access respectful maternity care (RMC). We assessed the effect of implementing maternal and newborn health (MNH) quality of care standards on RMC measures. METHODS: We used a facility-based controlled before and after design in 43 healthcare facilities in Bangladesh, Ghana and Tanzania. Interviews with women and health workers and observations of labour and childbirth were used for data collection. We estimated difference-in-differences to compare changes in RMC measures over time between groups. RESULTS: 1827 women and 818 health workers were interviewed, and 1512 observations were performed. In Bangladesh, MNH quality of care standards reduced physical abuse (DiD -5.2;-9.0 to -1.4). The standards increased RMC training (DiD 59.0; 33.4 to 84.6) and the availability of policies and procedures for both addressing patient concerns (DiD 46.0; 4.7 to 87.4) and identifying/reporting abuse (DiD 45.9; 19.9 to 71.8). The control facilities showed greater improvements in communicating the delivery plan (DiD -33.8; -62.9 to -4.6). Other measures improved in both groups, except for satisfaction with hygiene. In Ghana, the intervention improved women's experiences. Providers allowed women to ask questions and express concerns (DiD 37.5; 5.9 to 69.0), considered concerns (DiD 14.9; 4.9 to 24.9), reduced verbal abuse (DiD -8.0; -12.1 to -3.8) and physical abuse (DiD -5.2; -11.4 to -0.9). More women reported they would choose the facility for another delivery (DiD 17.5; 5.5 to 29.4). In Tanzania, women in the intervention facilities reported improvements in privacy (DiD 24.2; 0.2 to 48.3). No other significant differences were observed due to improvements in both groups. CONCLUSION: Institutionalising care standards and creating an enabling environment for quality MNH care is feasible in low and middle-income countries and may facilitate the adoption of RMC.

Tranexamic acid for the prevention of postpartum bleeding in women with anaemia: Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial.

Background: Postpartum haemorrhage (PPH) is responsible for over 50,000 maternal deaths every year. Most of these deaths are in low- and middle-income countries. Tranexamic acid (TXA) reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. TXA decreases surgical bleeding and reduces deaths from bleeding after traumatic injury. When given within three hours of birth, TXA reduces deaths from bleeding in women with PPH. However, for many women, treatment of PPH is too late to prevent death. World-wide, over one-third of pregnant women are anaemic and many are severely anaemic. These women have an increased risk of PPH and are more likely to die if PPH occurs. There is an urgent need to identify ways to prevent severe postpartum bleeding in anaemic women. The WOMAN-2 trial will quantify the effects of TXA on postpartum bleeding in women with anaemia. Results: This statistical analysis plan (version 1.0; dated 22 February 2023) has been written based on information in the WOMAN-2 Trial protocol version 2.0, dated 30 June 2022. The primary outcome of the WOMAN-2 trial is the proportion of women with a clinical diagnosis of primary PPH. Secondary outcomes are maternal blood loss and its consequences (estimated blood loss, haemoglobin, haemodynamic instability, blood transfusion, signs of shock, use of interventions to control bleeding); maternal health and wellbeing (fatigue, headache, dizziness, palpitations, breathlessness, exercise tolerance, ability to care for her baby, health related quality of life, breastfeeding); and other health outcomes (deaths, vascular occlusive events, organ dysfunction, sepsis, side effects, time spent in higher level facility, length of hospital stay, and status of the baby). Conclusions: WOMAN-2 will provide reliable evidence about the effects of TXA in women with anaemia. Registration: WOMAN-2 was prospectively registered at the International Standard Randomised Controlled Trials registry ( ISRCTN62396133) on 07/12/2017 and ClinicalTrials.gov on 23/03/2018 ( NCT03475342).

Quality of life and associated factors among infertile women attending infertility clinic at Mnazi Mmoja Hospital, Zanzibar.

BACKGROUND: Worldwide, it is estimated at least 50 million couples are affected by infertility with the prevalence of infertility being 16% in Tanzania. Psychological impact of infertility in patients negatively affects women's Quality of Life (QoL) defined as a person`s perception of where they are in life in terms of culture and value in the emotional, mind-body, relational, social, environment and tolerability of treatment aspects. Poor Quality of Life is related to increased treatment discontinuation. The aim of this study was to determine the Quality of Life and associated factors among infertile women attending infertility clinic at Mnazi Mmoja Hospital, Zanzibar. METHODS: A hospital based cross-sectional study was conducted among 340 infertile women attending infertility clinic at Mnazi Mmoja Hospital, Zanzibar. Data was collected using FertiQoL tool. The factors associated with Quality of Life using FertiQoL tool in infertile women were estimated in a multivariable linear regression model at 95% confidence interval and 5% level of significance. RESULTS: Quality of life of infertile women at Mnazi Mmoja infertility clinic was 70.6 ± 10.0 on a scale of 0 to 100. It increased significantly with increase in educational level (p = 0.009). Women with female individual causes on average had 5.07 (B=- 5.07, 95%CI: -7.78, -2.35) and women with individual and respective male partner causes of infertility had on average 4.95 (B= -4.95, 95% CI: -7.77, -2.12) respective decrease in the FertiQoL scores compared to those who had their male partner with problems as reason for infertility. There was an average 4.50 (B=-4.50, 95% CI: 2.30, 6.70) decrease in quality of life in women with secondary infertility compared to women with primary infertility. Every month increase in duration of infertility led to an average of 0.04 (B=-2.57, 95%CI: -0.07, -0.01) decrease in FertiQoL scores. CONCLUSION: The overall quality of life in this population was positively associated with level of education but negatively affected with reason for infertility, type of infertility and duration of infertility.

Institutionalising maternal and newborn quality-of-care standards in Bangladesh, Ghana and Tanzania: a quasi-experimental study.

INTRODUCTION: Facility interventions to improve quality of care around childbirth are known but need to be packaged, tested and institutionalised within health systems to impact on maternal and newborn outcomes. METHODS: We conducted cross-sectional assessments at baseline (2016) and after 18 months of provider-led implementation of UNICEF/WHO's Every Mother Every Newborn Quality Improvement (EMEN-QI) standards (preceding the WHO Standards for improving quality of maternal and newborn care in health facilities). 19 hospitals and health centres (2.8M catchment population) in Bangladesh, Ghana and Tanzania were involved and 24 from adjoining districts served for 'comparison'. We interviewed 43 facility managers and 818 providers, observed 1516 client-provider interactions, reviewed 12 020 records and exit-interviewed 1826 newly delivered women. We computed a 39-criteria institutionalisation score combining clinical, patient rights and cross-cutting domains from EMEN-QI and used routine/District Health Information System V.2 data to assess the impact on perinatal and maternal mortality. RESULTS: EMEN-QI standards institutionalisation score increased from 61% to 80% during EMEN-QI implementation, exceeding 75% target. All mortality indicators showed a downward trajectory though not all reached statistical significance. Newborn case-fatality rate fell significantly by 25% in Bangladesh (RR=0·75 (95% CI=0·59 to 0·96), p=0·017) and 85% in Tanzania (RR=0.15 (95% CI=0.08 to 0.29), p<0.001), but not in Ghana. Similarly, stillbirth (RR=0.64 (95% CI=0.45 to 0.92), p<0.01) and perinatal mortality in Tanzania reduced significantly (RR=0.59 (95% CI=0.40 to 0.87), p=0.007). Institutional maternal mortality ratios generally reduced but were only significant in Ghana: 362/100 000 to 207/100 000 livebirths (RR=0.57 (95% CI=0.33 to 0.99), p=0.046). Routine mortality data from comparison facilities were limited and scarce. Systematic death audits and clinical mentorship drove these achievements but challenges still remain around human resource management and equipment maintenance systems. CONCLUSION: Institutionalisation of the UNICEF/WHO EMEN-QI standards as a package is feasible within existing health systems and may reduce mortality around childbirth. Critical gaps around sustainability must be fundamental considerations for scale-up.

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.

The health system costs of post abortion care in Tanzania.

BACKGROUND: Unsafe abortion is common in Tanzania. Currently, postabortion care (PAC) is legally provided, but there is little information on the national cost. We estimated the health system costs of offering PAC in Tanzania in 2018, at existing levels of care and when hypothetically expanded to meet all need. METHODS: We employed a bottom-up costing methodology. Between October 2018 and February 2019, face-to-face interviews were conducted with facility administrators and PAC providers in a sample of 40 health facilities located across seven mainland regions and Zanzibar. We collected data on the direct and indirect cost of care, fees charged to patients, and costs incurred by patients for PAC supplies. Sensitivity analysis was used to explore the impact of uncertainty in the analysis. RESULTS: Overall, 3850 women received PAC at the study facilities in 2018. At the national level, 77,814 women received PAC, and the cost per patient was $58. The national health system cost for PAC provision at current levels totaled nearly $4.5 million. Meeting all need for PAC would increase costs to over $11 million. Public facilities bore the majority of PAC costs, and facilities recovered just 1% of costs through charges to patients. On average PAC patients incurred $7 in costs ($6.17 for fees plus $1.35 in supplies). CONCLUSIONS: Resources for health care are limited. While working to scale up access to PAC services to meet women's needs, Tanzanian policymakers should consider increasing access to contraception to prevent unintended pregnancies.

Economic Evaluation of Provision of Postpartum Intrauterine Device Services in Bangladesh and Tanzania.

INTRODUCTION: Postpartum family planning is an effective means of achieving improved health outcomes for women and children, especially in low- and middle-income settings. We assessed the cost-effectiveness of an immediate postpartum intrauterine device (PPIUD) initiative compared with standard practice in Bangladesh and Tanzania (which is no immediate postpartum family planning counseling or service provision) to inform resource allocation decisions for governments and donors. METHODS: A decision analysis was constructed to compare the PPIUD program with standard practice. The analysis was based on the number of PPIUD insertions, which were then modeled using the Impact 2 tool to produce estimates of cost per couple-years of protection (CYP) and cost per disability-adjusted life years (DALYs) averted. A micro-costing approach was used to estimate the costs of conducting the program, and downstream cost savings were generated by the Impact 2 tool. Results are presented first for the program as evaluated, and second, based on a hypothetical national scale-up scenario. One-way sensitivity analyses were conducted. RESULTS: Compared to standard practice, the PPIUD program resulted in an incremental cost-effectiveness ratio (ICER) of US$14.60 per CYP and US$91.13 per DALY averted in Bangladesh, and US$54.57 per CYP and US$67.67 per DALY averted in Tanzania. When incorporating estimated direct health care costs saved, the results for Bangladesh were dominant (PPIUD is cheaper and more effective versus standard practice). For Tanzania, the PPIUD initiative was highly cost-effective, with the ICER (incorporating direct health care costs saved) estimated at US$15.20 per CYP and US$18.90 per DALY averted compared to standard practice. For the national scale-up model, the results were dominant in both countries.Conclusions/implications: The PPIUD initiative was highly cost-effective in Bangladesh and Tanzania, and national scale-up of PPIUD could produce long-term savings in direct health care costs in both countries. These analyses provide a compelling case for national governments and international donors to invest in PPIUD as part of their family planning strategies.

Impact of immediate postpartum insertion of TCu380A on the quantity and duration of lochia discharges in Tanzania.

BACKGROUND: The insertion of Intrauterine Contraceptive Device (PPIUD) for the purpose of contraception immediately after delivery is becoming popular in countries where the use of IUD for contraception has been extremely low. Since 2015, Tanzania implemented the initiative by the International Federation of Gynecology and Obstetrics (FIGO) to institutionalize PPIUD. As a result of capacity building and information delivery under the initiative, there have been increased uptake of the method. Working in this context, the focus of the study was to generate evidence on the effect of TCu380A IUD on amount and duration of lochia and equip service providers with evidence-based knowledge which can help them in counselling their PPIUD clients. OBJECTIVE: Establish impact of postpartum TCu380A on amount and duration of lochia. METHODS: A prospective cohort study of delivered women in two teaching hospitals in Tanzania with immediate insertion of TCu380A or without use of postpartum contraception in 2018. TCu380A models; Optima (Injeflex Co. Brazil) and Pregna (Pregna International, Chakan, India) were used. Follow-up was done by weekly calls and examination at 6th week. Lochia was estimated by Likert Scale 0-4 relative to the amount of lochia on the delivery day. An estimated 250 women sample (125 each group) would give 80% power to detect a desired 20% difference in the proportion of women with prolonged lochia discharges among the Exposed and Unexposed groups. Data analysis was by SPSS. RESULTS: Two hundred sixty women were analysed, 127 Exposed and 133 Unexposed. Medical complaints were reported by 41 (28.9%) Exposed and 37 Unexposed (27.8%), p = 0.655. Lack of dryness by end of 6th week was to 31 (23.3%) Exposed and 9 (7.1%) Unexposed, p < 0.001. Exposed had higher weekly mean lochia scores throughout with the difference most marked in 5th week (3.556 Versus 2.039, p < 0.001) and 6th week (1.44 Versus 0.449, p<0.001). CONCLUSION: PPIUD is associated with increased amount of lochia and slows progression to dryness within 6 weeks of delivery. The implications of PPIUD clients' needs to be informed about the possibility of delayed dryness of lochia at time of counseling are discussed.

A one-year cohort study of complications, continuation, and failure rates of postpartum TCu380A in Tanzania.

BACKGROUND: Less than 1% of married women in Tanzania use an Intrauterine Contraceptive Device (IUD) for contraception. An initiative by the International Federation of Gynecology and Obstetrics (FIGO) has been in progress since 2015 resulting in escalated method uptake in implementing hospitals. This study investigates failure rate, complications, and risk factors for one-year continuation of TCu380A IUD when used for immediate postpartum contraception under the initiative in Tanzania. METHODOLOGY: A prospective cohort study of women who had TCu380A insertion within 48 h of delivery in 6 hospitals in Tanzania between 1st December 2017 and 18th April 2018 was conducted. Face to face post insertion interviews were made with 1114 clients before discharge and later through phone calls up to the beginning of 13th month postpartum. Postpartum Intrauterine Device (PPIUD) continuation status, complications, duration of time they stayed with the IUD and the currently used method if PPIUD was discontinued were enquired. The outcome variable was PPIUD continuation at one year of IUD insertion. Data were analyzed using Statistical Product and Service Solutions software (SPSS) for Windows version 20 (IBM SPSS Statistics, Chicago, IL, USA). RESULTS: In total 511(45.8%)clients had consented and availed to complete the one-year follow-up. Out of these, 440 still had IUD, giving a one-year continuation rate of 86.1%. Most (63%) IUD discontinuations occurred in the period between 7th week and 6 months of insertion. One-year method expulsion rate was 2.1%. There was one reported pregnancy that gives a method failure rate of about 2 per 1000. The independent risk factors in favor of method continuation at one year were absence of medical or social problem, being a youth (16-24 years), and delivery by Cesarean section. CONCLUSIONS: The continuation rate when CuT380A is used for immediate postpartum contraception is high, with low complication and failure rates. Some medical and social factors are important for method continuation, hence the need to consider in training, counselling and advocacy.

Effect of a postpartum family planning intervention on postpartum intrauterine device counseling and choice: evidence from a cluster-randomized trial in Tanzania.

BACKGROUND: The World Health Organization recommends postpartum family planning (PPFP) for healthy birth spacing. This study is an evaluation of an intervention that sought to improve women's access to PPFP in Tanzania. The intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services for women electing PPIUD in the immediate postpartum period. METHODS: This cluster-randomized controlled trial recruited 15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016. We present the effectiveness of the intervention using a difference-in-differences approach to compare outcomes, receipt of PPIUD counseling and choice of PPIUD after delivery, between the pre- and post-intervention period in the treatment and control group. We also present an intervention adherence-adjusted analysis using an instrumental variables estimation. RESULTS: We estimate linear probability models to obtain effect sizes in percentage points (pp). The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp). The adherence-adjusted estimates demonstrate that if all women had been counseled, we would have observed a 31.6 pp increase in choice of PPIUD (95% CI: 24.3 - 35.8 pp). Among women counseled, determinants of choosing PPIUD included receiving an informational leaflet during counseling and being counseled after admission for delivery services. CONCLUSIONS: The intervention modestly increased the rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling among women delivering in study facilities. With universal PPIUD counseling, large increases in choice of PPIUD would have been observed. Giving women informational materials on PPIUD and counseling after admission for delivery are likely to increase the proportion of women choosing PPIUD. TRIAL REGISTRATION: Registered with clinicaltrials.gov (NCT02718222) on March 24, 2016, retrospectively registered.

Practice of emergency obstetric care signal functions and reasons for non-provision among health centers and hospitals in Lake and Western zones of Tanzania.

BACKGROUND: The Lake and Western Zones of Tanzania that encompass eight regions namely; Kagera, Geita, Simiyu, Shinyanga, Mwanza, Mara Tabora and Kigoma have consistently been reported with the poorest Maternal Newborn and Child Health (MNCH) indicators in the country. This study sought to establish the provision of Emergency Obstetric Care (EmOC) signal functions and reasons for the failure to do so among health centers and hospitals in the two zones. METHODS: All the 261 public and private hospitals and health centers providing Obstetric Care services in Lake and Western Zones were surveyed in 2014. Data were collected using questionnaires adapted from the Averting Maternal Deaths and Disabilities (AMDD) tool to assess EmOC indicators. Managers in all facilities were interviewed and services, medicines and equipment were observed. Spatial Mapping was done using a calibrated Global Positioning System (GPS) Essential Software for Android and coordinates represented on digitalized map with Arc Geographical Information System (GIS) software. Population data were according to the 2012 Housing and Population National Census. RESULTS: In total 261 health facilities were identified as providers of Obstetric care services, including 69 hospitals and 192 health centres which constitute an overall facility density of 8 per 500,000 population. The three most common EmOC signal functions available in the 3 months preceding the survey were oxytocics (95.7%), injectable antibiotics (88.9%) and basic newborn resuscitation (83.4%). The lowest proportions of facilities performed Cesarean section (25.7%) and blood transfusion (34.6%). Policy restrictions were the most frequent reasons given in relation to nonperformance of blood transfusion and Cesarean section when needed. Lack of training and supplies were the most common reasons for non availability of assisted vaginal delivery and uterine evacuation. Overall the Direct Case fatality Rate for direct obstetric causes was 3%. The referral system highly depended on hired or shared ambulance. CONCLUSION: The provision of EmOC signal functions in Lake and Western zones of Tanzania is inconsistent, being mainly compromised by policy restrictions, lack of supplies and professional development, and by operating under lowly developed referral services.

Clinical outcomes of postpartum intrauterine devices inserted by midwives in Tanzania.

OBJECTIVE: To assess the rate of complications following immediate postpartum insertion of intrauterine devices (IUDs) by trained midwives in Tanzania. METHODS: A prospective cohort study of women who underwent immediate postpartum IUD (PPIUD) insertions provided by midwives between December 31, 2016 and October 15, 2017. Midwives received standardized training via the FIGO initiative. Women who returned 6 weeks after delivery were evaluated for complications. Outcomes of interest were uterine infection, IUD expulsion, medical removal of IUD, and method discontinuation. RESULTS: There were 40 470 deliveries, 2347 (5.8%) PPIUD insertions, and 1013 (43.2%) women with a PPIUD who returned for a follow-up visit in the program-affiliated clinics. Midwives were providers in 596 (58.8%) of these follow-up cases and clinicians in 417 (41.2%) cases. All PPIUD insertions by midwives were transvaginal and among them 43 (7.2%) had PPIUD-related complications by the end of sixth week. These complications included 16 (2.7%) cases of uterine infection, 14 (2.3%) IUD expulsions, 26 (4.4%) IUD removals, and 33 (5.5%) with overall method discontinuation. Only one case had uterine infection severe enough to warrant hospitalization. CONCLUSION: PPIUD insertion by trained midwives in Tanzania compares favorably with results reported from other settings.

Migration for obstetric care: the impact of regional Obstetric Care Facility Density disparities in Tanzania.

OBJECTIVE: This is an extended analysis of the previously published data to demonstrate the relationship between high Obstetric Care Facility Density (OCFD) and migration for obstetric services in Tanzania. RESULTS: Overall, regions with excess institutional deliveries had significantly higher OCFD compared to other regions. A consistent pattern was observed whereby regions with excess Institutional deliveries also exhibited the most outstanding OCFD of all the neighbouring regions. The observed patterns of Institutional deliveries and OCFD affirm the hypothesis of immigration for obstetric care services from low to high OCFD regions. Further research is suggested to prove this hypothesis in the field.

Safety of Tubal Occlusion by Minilaparotomy Provided by Trained Clinical Officers Versus Assistant Medical Officers in Tanzania: A Randomized, Controlled, Noninferiority Trial.

BACKGROUND: Tubal occlusion by minilaparotomy is a safe, highly effective, and permanent way to limit childbearing. We aimed to establish whether the safety of the procedure provided by trained clinical officers (COs) was not inferior to the safety when provided by trained assistant medical officers (AMOs), as measured by major adverse event (AE) rates. METHODS: In this randomized, controlled, open-label noninferiority trial, we enrolled participants at 7 health facilities in Arusha region, Tanzania, as well as during outreach activities conducted in Arusha and neighboring regions. Consenting, eligible participants were randomly allocated by a research assistant at each site to minilaparotomy performed by a trained CO or by a trained AMO, in a 1:1 ratio. We asked participants to return at 3, 7, and 42 days postsurgery. The primary outcome was the rate of major AEs following minilaparotomy performed by COs versus AMOs, during the procedure and through 42 days follow-up. The noninferiority margin was 2%. The trial is registered with ClinicalTrials.gov, Identifier NCT02944149. RESULTS: We randomly allocated 1,970 participants between December 2016 and June 2017, 984 to the CO group and 986 to the AMO group. Most (87%) minilaparotomies were conducted during outreach services. In the intent-to-treat analysis, 0 of 978 participants had a major AE in the CO group compared with 1 (0.1%) of 984 in the AMO group (risk difference: -0.1% [95% confidence interval: -0.3% to 0.1%]), meeting the criteria for noninferiority. We saw no evidence of differences in measures of procedure performance, participant satisfaction, or provider self-efficacy between the groups. CONCLUSIONS: Tubal occlusion by minilaparotomy performed by trained COs is safe, effective, and acceptable to women, and the procedure can be safely and effectively provided in outreach settings. Our results provide evidence to support policy change in resource-limited settings to allow task shifting of minilaparotomy to properly trained and supported COs, increasing access to female sterilization and helping to meet the rising demand for the procedure among women wanting to avoid pregnancy. They also suggest high demand for these services in Tanzania, given the large number of women recruited in a relatively short time period.

Safety of tubal ligation by minilaparotomy provided by clinical officers versus assistant medical officers: study protocol for a noninferiority randomized controlled trial in Tanzanian women.

BACKGROUND: Female sterilization by tubal ligation is a safe, extremely effective, and permanent way to limit childbearing. It is the most popular modern contraceptive method worldwide. The simplest way to provide tubal ligation is by a procedure called minilaparotomy, generally performed with the client under local anesthesia with systemic sedation and analgesia. In Tanzania, unmet need for family planning is high and has declined little in the past decade. Access to tubal ligation is limited throughout the country, in large part because of a lack of trained providers. Clinical officers (COs) are midlevel health workers who provide diagnosis, treatment, and minor surgeries. They are more prevalent than physicians in poorer and rural communities. Task shifting-the delegation of some tasks to less-specialized health workers, including task shifting of surgical procedures to midlevel cadres-has improved access to lifesaving interventions in resource-limited settings. It is a cost-effective way to address shortages of physicians, increasing access to services. The primary objective of this trial is to establish whether the safety of tubal ligation by minilaparotomy provided by COs is noninferior to the safety of tubal ligation by minilaparotomy provided by physicians (assistant medical officers [AMOs]), as measured by rates of major adverse events (AEs) during the procedure and through 42 days of follow-up. METHODS/DESIGN: In this facility-based, multicenter, noninferiority randomized controlled trial, we are comparing the safety of tubal ligation by minilaparotomy performed by trained COs versus by trained AMOs. The primary outcome is safety, defined by the overall rate of major AEs occurring during the minilaparotomy procedure and through 42 days of follow-up. The trial will be conducted among 1970 women 18 years of age or older presenting for tubal ligation at 7 study sites in northern Tanzania. DISCUSSION: If no major safety issues are identified, the data from this trial may facilitate changes in the Tanzanian government's regulations, allowing appropriately trained COs to provide tubal ligation by minilaparotomy. Positive findings may have broader implications. Task shifting to provide long-acting contraceptives, if proven safe, may be an effective approach to increasing contraceptive access in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02944149 . Registered on 14 October 2016.

Evaluation of a training program for health care workers to improve the quality of care for rape survivors: a quasi-experimental design study in Morogoro, Tanzania.

BACKGROUND: Sexual violence against women and children in Tanzania and globally is a human rights violation and a developmental challenge. OBJECTIVE: The aim of this study was to assess the impact of training health professionals on rape management. The specific objectives were to evaluate the changes of knowledge and attitudes toward sexual violence among a selected population of health professionals at primary health care level. DESIGN: A quasi-experimental design using cross-sectional surveys was conducted to evaluate health care workers' knowledge, attitude, and clinical practice toward sexual violence before and after the training program. The study involved the Kilombero (intervention) and Ulanga (comparison) districts in Morogoro region. A total of 151 health professionals at baseline (2012) and 169 in the final assessment (2014) participated in the survey. Data were collected using the same structured questionnaire. The amount of change in key indicators from baseline to final assessment in the two areas was compared using composite scores in the pre- and post-interventions, and the net intervention effect was calculated by the difference in difference method. RESULTS: Overall, there was improved knowledge in the intervention district from 55% at baseline to 86% and a decreased knowledge from 58.5 to 36.2% in the comparison area with a net effect of 53.7% and a p-value less than 0.0001. The proportion of participants who exhibited an accepting attitude toward violence declined from 15.3 to 11.2% in the intervention area but increased from 13.2 to 20.0% in the comparison area. CONCLUSIONS: Training on the management of sexual violence is feasible and the results indicate improvement in healthcare workers' knowledge and practice but not attitudes. Lessons learned from this study for successful replication of such an intervention in similar settings require commitment from those at strategic level within the health service to ensure that adequate resources are made available.

Incidence of Induced Abortion and Post-Abortion Care in Tanzania.

BACKGROUND: Tanzania has one of the highest maternal mortality ratios in the world, and unsafe abortion is one of its leading causes. Yet little is known about its incidence. OBJECTIVES: To provide the first ever estimates of the incidence of unsafe abortion in Tanzania, at the national level and for each of the 8 geopolitical zones (7 in Mainland plus Zanzibar). METHODS: A nationally representative survey of health facilities was conducted to determine the number of induced abortion complications treated in facilities. A survey of experts on abortion was conducted to estimate the likelihood of women experiencing complications and obtaining treatment. These surveys were complemented with population and fertility data to obtain abortion numbers, rates and ratios, using the Abortion Incidence Complications Methodology. RESULTS: In Tanzania, women obtained just over 405,000 induced abortions in 2013, for a national rate of 36 abortions per 1,000 women age 15-49 and a ratio of 21 abortions per 100 live births. For each woman treated in a facility for induced abortion complications, 6 times as many women had an abortion but did not receive care. Abortion rates vary widely by zone, from 10.7 in Zanzibar to 50.7 in the Lake zone. CONCLUSIONS: The abortion rate is similar to that of other countries in the region. Variations by zone are explained mainly by differences in fertility and contraceptive prevalence. Measures to reduce the incidence of unsafe abortion and associated maternal mortality include expanding access to post-abortion care and contraceptive services to prevent unintended pregnancies.

A community-based intervention for improving health-seeking behavior among sexual violence survivors: a controlled before and after design study in rural Tanzania.

BACKGROUND: Despite global recognition that sexual violence is a violation of human rights, evidence still shows it is a pervasive problem across all societies. Promising community intervention studies in the low- and middle-income countries are limited. OBJECTIVE: This study assessed the impact of a community-based intervention, focusing on improving the community's knowledge and reducing social acceptability of violence against women norms with the goal to prevent and respond to sexual violence. DESIGN: The strategies used to create awareness included radio programs, information, education communication materials, and advocacy meetings with local leaders. The intervention took place in Morogoro region in Tanzania. The evaluation used a quasi-experimental design including cross-sectional surveys at baseline (2012) and endline (2014) with men and women aged 18-49 years. Main outcome measures were number of reported rape cases at health facilities and the community's knowledge and attitudes toward sexual violence. RESULTS: The number of reported rape events increased by more than 50% at health facilities during the intervention. Knowledge on sexual violence increased significantly in both areas over the study period (from 57.3 to 80.6% in the intervention area and from 55.5 to 71.9% in the comparison area; p<0.001), and the net effect of the intervention between the two areas was statistically significant (6.9, 95% CI 0.2-13.5, p=0.03). There was significant improvement in most of the attitude indicators in the intervention area, but not in the comparison area. However, the intervention had no significant effect on the overall scores of acceptance attitudes in the final assessment when comparing the two areas (-2.4, 95% CI: -8.4 to 3.6, p=0.42). CONCLUSIONS: The intervention had an effect on some indicators on knowledge and attitudes toward sexual violence even after a short period of intervention. This finding informs the public health practitioners of the importance of combined strategies in achieving changes.

Knowledge and attitude towards rape and child sexual abuse--a community-based cross-sectional study in rural Tanzania.

BACKGROUND: Violence against women and children is globally recognized as a social and human rights concern. In Tanzania, sexual violence towards women and children is a public health problem. The aim of this study was to determine community knowledge of and attitudes towards rape and child sexual abuse, and assess associations between knowledge and attitudes and socio-demographic characteristics. METHODS: A cross-sectional study was undertaken between May and June 2012. The study was conducted in the Kilombero and Ulanga rural districts in the Morogoro Region of Tanzania. Men and women aged 18-49 years were eligible for the study. Through a three-stage cluster sampling strategy, a household survey was conducted using a structured questionnaire. The questionnaire included socio-demographic characteristics, attitudes about gender roles and violence, and knowledge on health consequences of rape. Data were analyzed using the Statistical Package for Social Sciences (SPSS) software, version 21. Main outcome measures were knowledge of and attitudes towards sexual violence. Multivariate analyses were used to assess associations between socio-demographic characteristics and knowledge of and attitudes towards sexual violence. RESULTS: A total of 1,568 participants were interviewed. The majority (58.4%) of participants were women. Most (58.3%) of the women respondents had poor knowledge on sexual violence and 63.8% had accepting attitudes towards sexual violence. Those who were married were significantly more likely to have good knowledge on sexual violence compared to the divorced/separated group (AOR = 1.6 (95% CI: 1.1-2.2)) but less likely to have non-accepting attitudes towards sexual violence compared to the single group (AOR = 1.8 (95%CI: 1.4-2.3)). Sex of respondents, age, marital status and level of education were associated with knowledge and attitudes towards sexual violence. CONCLUSIONS: Our study showed that these rural communities have poor knowledge on sexual violence and have accepting attitudes towards sexual violence. Increasing age and higher education were associated with better knowledge and less accepting attitudes towards sexual violence. The findings have potentially important implications for interventions aimed at preventing violence. The results highlight the challenges associated with changing attitudes towards sexual violence, particularly as the highest levels of support for such violence were found among women.