SaferBirths bundle of care protocol: a stepped-wedge cluster implementation project in 30 public health-facilities in five regions, Tanzania.

BACKGROUND: The burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middle-income countries, especially around the time of birth. There are scarce resources and/or support implementation of evidence-based training programs. SaferBirths Bundle of Care is a well-proven package of innovative tools coupled with data-driven on-the-job training aimed at reducing perinatal and maternal deaths. The aim of this project is to determine the effect of scaling up the bundle on improving quality of intrapartum care and perinatal survival. METHODS: The project will follow a stepped-wedge cluster implementation design with well-established infrastructures for data collection, management, and analysis in 30 public health facilities in regions in Tanzania. Healthcare workers from selected health facilities will be trained in basic neonatal resuscitation, essential newborn care and essential maternal care. Foetal heart rate monitors (Moyo), neonatal heart rate monitors (NeoBeat) and skills trainers (NeoNatalie Live) will be introduced in the health facilities to facilitate timely identification of foetal distress during labour and improve neonatal resuscitation, respectively. Heart rate signal-data will be automatically collected by Moyo and NeoBeat, and newborn resuscitation training by NeoNatalie Live. Given an average of 4000 baby-mother pairs per year per health facility giving an estimate of 240,000 baby-mother pairs for a 2-years duration, 25% reduction in perinatal mortality at a two-sided significance level of 5%, intracluster correlation coefficient (ICC) to be 0.0013, the study power stands at 0.99. DISCUSSION: Previous reports from small-scale Safer Births Bundle implementation studies show satisfactory uptake of interventions with significant improvements in quality of care and lives saved. Better equipped and trained birth attendants are more confident and skilled in providing care. Additionally, local data-driven feedback has shown to drive continuous quality of care improvement initiatives, which is essential to increase perinatal and maternal survival. Strengths of this research project include integration of innovative tools with existing national guidelines, local data-driven decision-making and training. Limitations include the stepwise cluster implementation design that may lead to contamination of the intervention, and/or inability to address the shortage of healthcare workers and medical supplies beyond the project scope. TRIAL REGISTRATION: Name of Trial Registry: ISRCTN Registry. TRIAL REGISTRATION NUMBER: ISRCTN30541755 . Date of Registration: 12/10/2020. Type of registration: Prospectively Registered.

Implementation of a novel continuous fetal Doppler (Moyo) improves quality of intrapartum fetal heart rate monitoring in a resource-limited tertiary hospital in Tanzania: An observational study.

BACKGROUND: Intrapartum Fetal Heart Rate (FHR) monitoring is crucial for the early detection of abnormal FHR, facilitating timely obstetric interventions and thus the potential reduction of adverse perinatal outcomes. We explored midwifery practices of intrapartum FHR monitoring pre and post implementation of a novel continuous automatic Doppler device (the Moyo). METHODOLOGY: A pre/post observational study among low-risk pregnancies at a tertiary hospital was conducted from March to December 2016. In the pre-implementation period, intermittent monitoring was conducted with a Pinard stethoscope (March to June 2016, n = 1640 women). In the post-implementation period, Moyo was used for continuous FHR monitoring (July-December 2016, n = 2442 women). The primary outcome was detection of abnormal FHR defined as absent, FHR<120or FHR>160bpm. The secondary outcomes were rates of assessment/documentation of FHR, obstetric time intervals and intrauterine resuscitations. Chi-square test, Fishers exact test, t-test and Mann-Whitney U test were used in bivariate analysis whereas binary and multinomial logistic regression were used for multivariate. RESULTS: Moyo use was associated with greater detection of abnormal FHR (8.0%) compared with Pinard (1.6%) (p<0.001). There were higher rates of non-assessment/documentation of FHR pre- (45.7%) compared to post-implementation (2.2%) (p<0.001). At pre-implementation, 8% of deliveries had FHR documented as often as ≤ 60 minutes, compared to 51% post-implementation (p<0.001). Implementation of continuous FHR monitoring was associated with a shorter time interval from the last FHR assessment to delivery i.e. median (IQR) of 60 (30,100) to 45 (21,85) minutes (p<0.001); and shorter time interval between each FHR assessment i.e. from 150 (86,299) minutes to 60 (41,86) minutes (p<0.001). Caesarean section rates increased from 2.6 to 5.4%, and vacuum deliveries from 2.2 to 5.8% (both p<0.001). Perinatal outcomes i.e. fresh stillbirths and early neonatal deaths were similar between time periods. The study was limited by both lack of randomization and involvement of low-risk pregnant women with fewer adverse perinatal outcomes than would be expected in a high-risk population. CONCLUSION: Implementation of the Moyo device, which continuously measures FHR, was associated with improved quality in FHR monitoring practices and the detection of abnormal FHR. These improvements led to more frequent and timely obstetric responses. Follow-up studies in a high-risk population focused on a more targeted description of the FHR abnormalities and the impact of intrauterine resuscitation is a critical next step in determining the effect on reducing perinatal mortality.

Intrapartum fetal heart rate monitoring using a handheld Doppler versus Pinard stethoscope: a randomized controlled study in Dar es Salaam.

BACKGROUND: Fetal stethoscopes are mainly used for intermittent monitoring of fetal heart rate (FHR) during labor in low-income countries, where perinatal mortality is still high. Handheld Dopplers are rarely available and are dependent on batteries or electricity. The objective was to compare the Pinard stethoscope versus a new wind-up handheld Doppler in the detection of abnormal FHR. MATERIALS AND METHODS: We conducted a randomized controlled study at Muhimbili National Hospital, Tanzania, from April 2013 to September 2015. Women with gestational age ≥37 weeks, cephalic presentation, normal FHR on admission, and cervical dilatation <7 cm were included. Primary outcome was abnormal FHR detection (<120 or >160 beats/min). Secondary endpoints were time to delivery, mode of delivery, and perinatal outcomes. χ2, Fisher's exact test, Mann-Whitney test, and logistic regression were conducted. Unadjusted and adjusted odds ratios were calculated with respective 95% confidence interval. RESULTS: In total, 2,844 eligible women were assigned to FHR monitoring with Pinard (n=1,423) or Doppler (n=1,421). Abnormal FHRs were more often detected in the Doppler (6.0%) versus the Pinard (3.9%) arm (adjusted odds ratio =1.59, 95% confidence interval: 1.13-2.26, p=0.008). Median (interquartile range) time from abnormal FHR detection to delivery was comparable between Doppler and Pinard, ie, 80 (60,161) and 89 (52,165) minutes, respectively, as was the incidence of cesarean delivery (12.0% versus 12.2%). The incidence of adverse perinatal outcomes (fresh stillbirths, 24-hour neonatal admissions, and deaths) was similar overall; however, among newborns with abnormal FHR delivered vaginally, adverse outcomes were less incident in Doppler (7 of 43 births, 16.3%) than in the Pinard arm (10 of 23 births, 43.5%), p=0.021. CONCLUSION: Intermittent FHR monitoring using Doppler was associated with an increased detection of abnormal FHR compared to Pinard in a low-risk population. Time intervals from abnormal FHR detection to delivery were longer than recommended in both arms. Perinatal outcomes were better among vaginally delivered newborns with detected abnormal FHR in the Doppler arm.

Evaluation of the Families Matter! Program in Tanzania: An Intervention to Promote Effective Parent-Child Communication About Sex, Sexuality, and Sexual Risk Reduction.

The Families Matter! Program (FMP) is a curriculum-based intervention designed to give parents and other primary caregivers the knowledge, skills, comfort, and confidence to deliver messages to their 9-12-year-old children about sexuality and practice positive parenting skills. A pre- and post-intervention evaluation study on FMP outcomes was conducted with 658 parent participants and their preadolescent children in two administrative wards in Tanzania in 2014. There was an increase in the proportion of study participants (parent-preadolescent pairs) that had positive attitudes toward sex education. On parent-child communication, the majority of participants (59-87%) reported having had more sexuality discussions. On communication responsiveness about sexual issues, scores improved in the period between surveys, with parents showing more improvements than preadolescents. Our results corroborate evidence from previous FMP evaluations, lending support to the conclusion that FMP is successful in promoting attitude and behavior change among parents and preadolescents in different cultural contexts.