Sanyu Africa Research Institute

BabySaver and NeoBeat devices have the potential to enable bedside neonatal resuscitation, with an intact cord in the presence of the mother. We assessed the feasibility and acceptability of using them together for neonatal resuscitation in a low-resource setting. This was a mixed methods study conducted over a period of 11 months at Mbale Hospital in Uganda. We enrolled 150 mother-infant dyads into a pre-post study. During the pre-implementation phase, neonatal resuscitation was conducted based on the existing standard of care whilst in the post-implementation phase we evaluated the BabySaver and NeoBeat. Our primary outcome was the proportion of babies resuscitated at the bedside with an intact cord. Using in-depth interviews and an inductive thematic analysis approach, we also explored experiences of health workers and mothers with use of the BabySaver and NeoBeat. Bedside resuscitation increased significantly in the post-implementation period (9.3% versus 45.3%, p < 0.001 while early cord clamping decreased (26.7% versus 12.0%, p = 0.042). The median time to successful resuscitation was shorter post-implementation (5 versus 8 minutes, p < 0.001). Infants in the post-implementation phase had higher axillary temperatures at birth and at 0-, 10-, 20-, and 30-minutes post-resuscitation. Neonatal morbidity was lower: APGAR score <7 at 5 minutes (aPR: 0.36; 95%CI: 0.26-0.50), transfer to postnatal ward with mother (aPR: 9.27; 95%CI: 2.23-38.48), transfer to neonatal unit (aPR: 0.66; 95%CI: 0.56-0.78). Health workers found the devices easy to use, and bedside resuscitation reassured mothers, fostering trust and satisfaction. Barriers included misconceptions about delayed cord clamping, hypothermia concerns, cross-infection risks, and difficult use in theatre. The BabySaver and NeoBeat improved bedside neonatal resuscitation and reduced morbidity. Bedside resuscitation was also acceptable to the health workers and mothers. Scaling up should address misconceptions about delayed cord clamping and optimize usability in theatre settings where many asphyxiated infants are delivered.

BackgroundIn high resource settings, lactate and pH levels measured from fetal scalp and umbilical cord blood are widely used as predictors of perinatal mortality. However, the same is not true in low resource settings, where much of perinatal mortality occurs. The scalability of this practice has been hindered by difficulty in collecting fetal scalp and umbilical blood sample. Little is known about the use of alternatives such as maternal blood, which is easier and safer to obtain. Therefore, we aimed to compare maternal and umbilical cord blood lactate levels for predicting perinatal deaths.MethodsThis was secondary analysis of data from a randomized controlled trial assessing the effect of sodium bicarbonate on maternal and perinatal outcomes among women with obstructed labour at Mbale regional referral hospital in Eastern Uganda. Lactate concentration in maternal capillary, myometrial, umbilical venous and arterial blood was measured at the bedside using a lactate Pro 2 device (Akray, Japan Shiga) upon diagnosis of obstructed labour. We constructed Receiver Operating Characteristic curves to compare the predictive ability of maternal and umbilical cord lactate and the optimal cutoffs calculated basing on the maximal Youden and Liu indices.ResultsPerinatal mortality risk was: 102.2 deaths per 1,000 live births: 95% CI (78.1–130.6). The areas under the ROC curves were 0.86 for umbilical arterial lactate, 0.71 for umbilical venous lactate, and 0.65 for myometrial lactate, 0.59 for maternal lactate baseline, and 0.65 at1hr after administration of bicarbonate. The optimal cutoffs for predicting perinatal death were 15 0.85 mmol/L for umbilical arterial lactate, 10.15mmol/L for umbilical venous lactate, 8.75mmol/L for myometrial lactate, and 3.95mmol/L for maternal lactate at recruitment and 7.35mmol/L after 1 h.ConclusionMaternal lactate was a poor predictor of perinatal death, but umbilical artery lactate has a high predictive value. There is need for future studies on the utility of amniotic fluid in predicting intrapartum perinatal deaths.

Over 250 million infants in low and middle-income countries do not fulfill their neurodevelopment potential. In this study, we assessed the incidence and risk factors for neurodevelopmental delay (NDD) among children born following obstructed labor in Eastern Uganda. Between October 2021 and April 2022, we conducted a cohort study of 155 children (aged 25 to 44 months), born at term and assessed their neurodevelopment using the Malawi Developmental Assessment Tool. We assessed the gross motor, fine motor, language and social domains of neurodevelopment. The incidence of neurodevelopmental delay by 25 to 44 months was 67.7% (105/155) (95% CI: 59.8-75.0). Children belonging to the poorest wealth quintile had 83% higher risk of NDD compared to children belonging to the richest quintile (ARR (Adjusted Risk Ratio): 1.83; 95% CI (Confidence Interval): [1.13, 2.94]). Children fed the recommended meal diversity had 25% lower risk of neurodevelopmental delay compared to children who did not (ARR: 0.75; 95% CI: [0.60, 0.94]). Children who were exclusively breastfed for the first 6 months had 27% lower risk of neurodevelopmental delay compared to children who were not (ARR: 0.73; 95% CI: [0.56, 0.96]). We recommend that infants born following obstructed labor undergo neurodevelopmental delay screening.

BackgroundModern contraceptive use among adolescents is low despite the adverse effects of adolescent pregnancies. Understanding correlates of modern contraceptive use in different settings is key to the design of effective context-specific interventions. We aimed to determine factors associated with modern contraceptives use among adolescents in rural and urban settings of Zambia.MethodsWe analyzed secondary data from 2018 Zambia demographic and health survey (ZDHS) focusing on adolescent girls aged 15–19 years. We used multivariable logistic regression in SPSS version 25 to examine rural-urban variations in factors associated with modern contraceptive utilization.ResultsOverall, 12.0% (360/3000, 95% CI: 10.9–13.2) of adolescents in Zambia were using modern contraceptives. Use of modern contraceptives was higher in rural areas at 13.7% (230/1677, 95% CI: 12.1–15.3) compared to 9.8% (130/1323, 95% CI: 8.3–11.6) in urban areas. In the rural areas, having a child (aOR = 13.99; 95% CI 8.60–22.77), being married (aOR = 2.13; 95% CI 1.42–3.18), being older at 19 years (aOR = 3.90; 95% CI 1.52–10.03), having been visited by a field health worker (aOR = 1.62; 95% CI 1.01–2.64), having been exposed to family planning messages on mass media (aOR = 2.87; 95% CI 1.01–8.18) and belonging to the richest wealth quintile (aOR = 2.27; 95% CI 1.43–3.62) were associated with higher odds of contraceptive utilization. Furthermore, adolescents in the Northern (aOR = 0.29; 95% CI 0.11–0.80) and Luapula (aOR = 0.35; 95% CI 0.15–0.81) provinces were associated with less odds of utilizing contraceptives compared to those in Western province. In the urban areas, older age at 19 years (aOR = 4.80; 95% CI 1.55–14.84) and having a child (aOR = 18.52; 95% CI 9.50–36.14) were the only factors significantly associated with modern contraceptive utilization.ConclusionAge and having a child were associated with modern contraceptive use in both rural and urban areas. In rural areas (province, marital status, being visited by field health workers, family planning messages exposure and wealth index) were the only associated factors. This indicates that interventions aiming to increase contraceptive utilization should be context specific.

BackgroundGlobally, 15 million infants are born preterm each year, and 1 million die due to complications of prematurity. Over 60% of preterm births occur in Sub-Saharan Africa and south Asia. Care at birth for premature infants may be critical for survival and long term outcome. We conducted a prospective audit to assess whether women giving birth preterm could be identified, and to describe cord clamping and neonatal care at hospitals in Africa and south Asia.MethodsThis prospective audit of livebirths was conducted at six hospitals in Uganda, Kenya, India and Pakistan. Births were considered preterm if between 28+ 0 and 33+ 6 weeks gestation and/or the birthweight was 1.00 to 1.99 kg. A pre-specified audit plan was agreed with each hospital. Livebirths before 28 weeks gestation with birthweight less than 1.0 kg were excluded. Data were collected on estimated and actual gestation and birthweight, cord clamping, and neonatal care.ResultsOf 4149 women who gave birth during the audit, data were available for 3687 (90%). As 107 were multiple births, 3781 livebirths were included, of which 257 (7%) were preterm. Antenatal assessment correctly identified 148 infants as ‘preterm’ and 3429 as ‘term’, giving a positive predictive value of 72% and negative predictive value of 97%. For term births, cord clamping was usually later at the two Ugandan hospitals, median time to clamping 50 and 76 s, compared with 23 at Kenyatta (Kenya), 7 at CMC (India) and 12 at FBH/LNH (Pakistan). At the latter two, timing was similar between term and preterm births, and between vaginal and Caesarean births. For all the hospitals, the cord was clamped quickly at Caesarean births, with Mbale (Uganda) having the highest median time to clamping (15 s ‘term’, 19 ‘preterm’). For preterm infants temperature on admission to the neonatal unit was below 35.5 °C for 50%, and 59 (23%) died before hospital discharge.ConclusionsAntenatal identification of preterm birth was good. Timing of cord clamping varied between hospitals, although at each there was no difference between ‘term’ and ‘preterm’ births. For premature infants hypothermia was common, and mortality before hospital discharge was high.

Background Poor participant understanding of research information can be a problem in community interventional studies in rural African women where levels of illiteracy, dependency and compliance are high. We assessed the impact of alternative consent models on participants’ understanding of the clinical trial information and its contribution to the informed consent process in rural Uganda. Methods This was a prospective comparative cohort, nested within a pilot study of community distribution of alcohol-based hand rub to prevent neonatal sepsis (BabyGel). As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information; a ‘slide show’ using illustrated text on a flip chart; and a video showing the patient information sheet (PIS) being read as if by a newsreader in either English or the local language. In addition, all women received a written PIS in their preferred language. Each information method was used for 1 week of recruitment. Two days after recruitment, women’s understanding of the clinical trial was evaluated. Results A total of 30 pregnant women from 13 villages in Mbale participated in this study. Majority 90% (27/30) were assessed for recall of trial information within planned 48 hours. The slide-show was the most popular, with a mean score not less than 4.2 highest [mean (sd) range: 4.8 (0.6) [4–5]] by women who had been recruited using any of the three models. The slide show was preferred by 63% of the women (19/30), compared with 17% (5/30) and 20% (6/30) who preferred the standard and video show message, respectively. Reasons given included the benefits of having pictures to aid understanding, and the logical progression of the information. Conclusion Our results suggest that a slide-show message is an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom had little or no literacy.

BackgroundAlcohol-based hand rub (ABHR) is widely used in both health and social facilities to prevent infection, but it is not known whether supplying it for regular perinatal use can prevent newborn sepsis in African rural homes. Our study piloted a cluster randomised trial of providing ABHR to postpartum mothers to prevent neonatal infection-related morbidity in the communities.MethodsWe conducted a pilot parallel cluster randomised controlled trial across ten villages (clusters) in rural Eastern Uganda. Pregnant women of over 34 weeks’ gestation were recruited over a period of 3 months. Both clusters received the standard of care of antenatal health education, Maama Kit, and clinic appointments. In addition, women in the intervention villages received ABHR, instructions on ABHR use, a poster on the ‘three moments of hand hygiene’, and training. We followed up each mother-baby pair for 3 months after birth and measured rates of consent, recruitment, and follow-up (our target rate was more than 80%). Other measures included ABHR use (the acceptable use was more than four times a day) and its mode of distribution (village health workers (VHWs) or pharmacy), acceptability of study protocol and electronic data capture, and the use of WHO Integrated Management of Childhood Illness (IMCI) tool to screen for newborn infection.ResultsWe selected 36% (10/28) of villages for randomisation to either intervention or control. Over 12 weeks, 176 pregnant women were screened and 58.5% (103/176) were eligible. All, 100% (103/103), eligible women gave consent and were enrolled into the trial (55 intervention and 48 control). After birth, 94.5% (52/55) of mothers in the intervention and 100% (48/48) of mothers in the control villages were followed up within 72 h. Most, 90.9% (50/55), of the mothers in the intervention villages (96.2% of live births) and 95.8% (46/48) of mothers in the control villages (95.9% of live births) were followed up at 3 months. In intervention villages, the average hand rub use was 6.6 times per day. VHWs accounted for all ABHR stock, compared to the pharmacy that could not account for 5 l of ABHR. The screening tool was positive for infection among a third of babies, i.e. 29.2% (14/48) in the intervention villages versus 31.4% (16/51) in the control villages.VHWs completed the first four questions of IMCI screening tool with ease and accuracy. There were no adverse reactions with the ABHR.ConclusionIt is feasible to conduct a cluster-randomised controlled trial (cRCT) of the provision of ABHR to postpartum mothers to prevent neonatal infection-related morbidity in the community in resource-poor settings. Our results indicate that home recruitment promotes excellent follow-up and retention of participants in community trials. The intervention was safe. This pilot study informed the substantial changes necessary in the larger cRCT, including a change in the primary outcome to a composite outcome considering multiple methods of infection detection. A large BabyGel cluster randomised controlled trial is now required.Trial registrationISRCTN67852437, registered March 02, 2015Trial fundingMedical Research Council/WellcomeTrust/DfID (Global Health Trials Scheme)

BackgroundNeonatal sepsis causes 0.5 million deaths annually, mostly in low resource settings. Babies born in African rural homes without running water or toilet facilities are especially vulnerable. Alcohol-based hand rub (ABHR) may be used by mothers and carers as an alternative to hand washing with soap to prevent neonatal infection. However, no definite study has established the preferred formulation of hand rub for the mothers. This study aimed to assess the effects of addition of bitterants and perfume towards the acceptability of the alcohol-based hand rubs by the mothers in their homes after childbirth.MethodsThis was a 3-way blinded cross-over study design. Mothers with children aged ≤3 months were recruited from immunisation clinics at 3 local health facilities in rural eastern Uganda and received 3-different ABHR formulations (in the order plain, bitterant and perfumed) packed in 100 ml bottles. Each ABHR was used for 5 consecutive days followed by a 2-day ‘washout’ period (evaluation period). Overall satisfaction with each hand rub was evaluated at the end of each week using a 7-point Likert scale.ResultsA total of 43 women were recruited, whose ages ranged from 16 to 45 years (mean 26.2 years old). None of the participants normally used a hand protective lotion/cream. The three formulations were used for a mean of 5 (range 3–7) days. A significantly greater volume of the “bitterant” and “perfumed” formulations (mean 91 and 83 ml respectively) were used in comparison to the “plain” formulation (mean 64 ml). Overall satisfaction was high with all the hand rubs, but the perfumed formulation had a significantly higher overall satisfaction score [mean 6.7, range 4–7] compared with the plain [6.4, 3–7] and bitterant [6.2, 2–7] formulations.ConclusionsAll the 3 ABHR formulations were well accepted with little to choose between them. The ABHR with added perfume scored highest on overall satisfaction and was used significantly more often than plain ABHR. ABHR with bitterant additive did, however, score highly and may be a preferable choice to those with concern over alcohol misuse.Trial registrationISRCTN67852437, prospectively registered on 18/03/2018

Patients’ roles and rights in research are vital.1 In Africa, the challenges are greater than in other parts of the world owing to the large educational and societal gap between researchers and patients. Researchers may study matters affecting patients categorised as “illiterate” or “literate but not emancipated” and whose life experience is atypical. This can lead to well meaning but …