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As caesarean delivery rates continue to increase globally, so are the number of second-stage caesarean deliveries. Second-stage caesareans may carry additional risk of complications for both the mother and fetus owing to fetal head impaction into the maternal pelvis and manipulations required for delivery. So far, data on this procedure's outcomes from low resource countries are limited. To compare adverse maternal and perinatal outcomes between second-stage and first-stage of labour intrapartum primary caesarean deliveries over 12 months at a tertiary referral obstetric hospital in Kenya. In a hospital-based cohort study, 222 women with singleton, cephalic presenting fetuses at term gestation who had intrapartum primary caesarean delivery during active labour were recruited post-partum. Second-stage caesarean deliveries (73) were compared to 149 first-stage caesarean deliveries. The proportion of caesarean deliveries in the second-stage of labour was estimated and the adverse maternal and perinatal outcomes were compared. The study was conducted from August 2021 to July 2022 at the Moi Teaching and Referral Hospital, Eldoret. The proportion of second-stage caesarean deliveries among intrapartum primary caesarean deliveries was 4.3% [95% CI: 2.9% - 4.7%]. Compared to first-stage caesarean deliveries, second-stage caesarean deliveries had a significantly higher risk of adverse maternal outcomes (RR 3.272, 95% CI 2.28-4.71, P < 0.001), including intraoperative trauma, atony, blood transfusion, and a postoperative hospital stay of more than three days. Additionally, there was a higher risk of adverse perinatal outcomes (RR 2.748, 95% CI 2.45-4.50, P < 0.001), including increased risk of a 5-min APGAR ≤3, admission to NBU, and neonatal death. An increased risk of adverse maternal and perinatal outcomes is associated with primary second-stage caesarean deliveries compared to primary first-stage caesarean deliveries.

Although pain relief is a crucial component of modern obstetric care, it remains a poorly established service in sub-Saharan countries such as Kenya. Maternal health care providers have an extensive role to play in meeting the analgesic needs of women during childbirth. This study sought to examine the practice of labour pain relief among Kenyan maternal health care providers. This was an institution-based, cross-sectional, descriptive survey. The study included midwives, obstetricians, and anaesthesiologists (n = 120) working at the second-largest tertiary facility in Kenya. A structured, self-administered questionnaire was used. The labour pain relief practice, knowledge, attitude, and perceived barriers to labour pain management were described. One hundred and seventeen respondents participated in the study representing a response rate of 97.5%. More than half of maternal health care providers routinely provided the service of labour pain relief (61.5%). Sixty-four (88.9%) respondents reported providing pharmacological and non-pharmacological methods, while 11.1% provided only pharmacological ones. The most common pharmacological method prescribed was non-opioids (12.8%). The most preferred non-pharmacological method of pain management was touch and massage (93.8%). Regional analgesia was provided by 3.4% of the respondents. More than half of the respondents (53%) had poor knowledge of labour pain relief methods. Almost all (94%) of the respondents had a positive attitude towards providing labour pain relief. Non-availability of drugs and equipment (58.1%), lack of clear protocols and guidelines (56.4%), and absence of adequate skilled personnel (55.6%) were reported as the health system factors that hinder the provision of labour analgesia. More than half of maternal health care providers routinely relieve labour pain. Epidural analgesia is still relatively underutilized. There is a need to develop institutional labour pain management protocols to meet the analgesic needs of women during childbirth.

Hormonal contraceptives are used widely but their effects on HIV-1 risk are unclear. We aimed to assess the association between hormonal contraceptive use and risk of HIV-1 acquisition by women and HIV-1 transmission from HIV-1-infected women to their male partners. In this prospective study, we followed up 3790 heterosexual HIV-1-serodiscordant couples participating in two longitudinal studies of HIV-1 incidence in seven African countries. Among injectable and oral hormonal contraceptive users and non-users, we compared rates of HIV-1 acquisition by women and HIV-1 transmission from women to men. The primary outcome measure was HIV-1 seroconversion. We used Cox proportional hazards regression and marginal structural modelling to assess the effect of contraceptive use on HIV-1 risk. Among 1314 couples in which the HIV-1-seronegative partner was female (median follow-up 18·0 [IQR 12·6–24·2] months), rates of HIV-1 acquisition were 6·61 per 100 person-years in women who used hormonal contraception and 3·78 per 100 person-years in those who did not (adjusted hazard ratio 1·98, 95% CI 1·06–3·68, p=0·03). Among 2476 couples in which the HIV-1-seronegative partner was male (median follow-up 18·7 [IQR 12·8–24·2] months), rates of HIV-1 transmission from women to men were 2·61 per 100 person-years in couples in which women used hormonal contraception and 1·51 per 100 person-years in couples in which women did not use hormonal contraception (adjusted hazard ratio 1·97, 95% CI 1·12–3·45, p=0·02). Marginal structural model analyses generated much the same results to the Cox proportional hazards regression. Women should be counselled about potentially increased risk of HIV-1 acquisition and transmission with hormonal contraception, especially injectable methods, and about the importance of dual protection with condoms to decrease HIV-1 risk. Non-hormonal or low-dose hormonal contraceptive methods should be considered for women with or at-risk for HIV-1. US National Institutes of Health and the Bill & Melinda Gates Foundation.

IntroductionAnaemia during pregnancy is a widespread health burden globally, especially in low- and middle-income countries, posing a serious risk to both maternal and neonatal health. The primary challenge is that anaemia is frequently undetected or is detected too late, worsening pregnancy complications. The gold standard for diagnosing anaemia is a clinical laboratory blood haemoglobin (Hgb) or haematocrit (Hct) test involving a venous blood draw. However, this approach presents several challenges in resource-limited settings regarding accessibility and feasibility. Although non-invasive blood Hgb testing technologies are gaining attention, they remain limited in availability, affordability and practicality. This study aims to develop and validate a mobile health (mHealth) machine learning model to reliably predict blood Hgb and Hct levels in Black African pregnant women using smartphone photos of the conjunctiva.Methods and analysisThis is a single-centre, cross-sectional and observational study, leveraging existing antenatal care services for pregnant women aged 15 to 49 years in Kenya. The study involves collecting smartphone photos of the conjunctiva alongside conventional blood Hgb tests. Relevant clinical data related to each participant’s anaemia status will also be collected. The photo acquisition protocol will incorporate diverse scenarios to reflect real-world variability. A clinical training dataset will be used to refine a machine learning model designed to predict blood Hgb and Hct levels from smartphone images of the conjunctiva. Using a separate testing dataset, comprehensive analyses will assess its performance by comparing predicted blood Hgb and Hct levels with clinical laboratory and/or finger-prick readings.Ethics and disseminationThis study is approved by the Moi University Institutional Research and Ethics Committee (Reference: IREC/585/2023 and Approval Number: 004514), Kenya’s National Commission for Science, Technology, and Innovation (NACOSTI Reference: 491921) and Purdue University’s Institutional Review Board (Protocol Number: IRB-2023-1235). Participants will include emancipated or mature minors. In Kenya, pregnant women aged 15 to 18 years are recognised as emancipated or mature minors, allowing them to provide informed consent independently. The study poses minimal risk to participants. Findings and results will be disseminated through submissions to peer-reviewed journals and presentations at the participating institutions, including Moi Teaching and Referral Hospital and Kenya’s Ministry of Health. On completion of data collection and modelling, this study will demonstrate how machine learning-driven mHealth technologies can reduce reliance on clinical laboratories and complex equipment, offering accessible and scalable solutions for resource-limited and at-home settings.

Background Research misconduct i.e. fabrication, falsification, and plagiarism is associated with individual, institutional, national, and global factors. Researchers' perceptions of weak or non-existent institutional guidelines on the prevention and management of research misconduct can encourage these practices. Few countries in Africa have clear guidance on research misconduct. In Kenya, the capacity to prevent or manage research misconduct in academic and research institutions has not been documented. The objective of this study was to explore the perceptions of Kenyan research regulators on the occurrence of and institutional capacity to prevent or manage research misconduct. Methods Interviews with open-ended questions were conducted with 27 research regulators (chairs and secretaries of ethics committees, research directors of academic and research institutions, and national regulatory bodies). Among other questions, participants were asked: (1) How common is research misconduct in your view? (2) Does your institution have the capacity to prevent research misconduct ? (3) Does your institution have the capacity to manage research misconduct ? Their responses were audiotaped, transcribed, and coded using NVivo software. Deductive coding covered predefined themes including perceptions on occurrence, prevention detection, investigation, and management of research misconduct. Results are presented with illustrative quotes. Results Respondents perceived research misconduct to be very common among students developing thesis reports . Their responses suggested there was no dedicated capacity to prevent or manage research misconduct at the institutional and national levels. There were no specific national guidelines on research misconduct. At the institutional level, the only capacity/efforts mentioned were directed at reducing, detecting, and managing student plagiarism. There was no direct mention of the capacity to manage fabrication and falsification or misconduct by faculty researchers. We recommend the development of Kenya code of conduct or research integrity guidelines that would cover misconduct .

Background Reducing maternal morbidity and mortality remains a top global health agenda especially in high HIV/AIDS endemic locations where there is increased likelihood of mother to child transmission (MTCT) of HIV. Social health insurance (SHI) has emerged as a viable option to improve population access to health services, while improving outcomes for disenfranchised populations, particularly HIV+ women. However, the effect of SHI on healthcare access for HIV+ persons in limited resource settings is yet to undergo rigorous empirical evaluation. This study analyzes the effect of health insurance on obstetric healthcare access including institutional delivery and skilled birth attendants for HIV+ pregnant women in Kenya. Methods We analyzed cross-sectional data from HIV+ pregnant women (ages 15–49 years) who had a delivery (full term, preterm, miscarriage) between 2008 and 2013 with their insurance enrollment status available in the electronic medical records database of a HIV healthcare system in Kenya. We estimated linear and logistic regression models and implemented matching and inverse probability weighting (IPW) to improve balance on observable individual characteristics. Additionally, we estimated heterogeneous effects stratified by HIV disease severity (CD4 < 350 as “Severe HIV disease”, and CD4 > 350 otherwise). Findings Health Insurance enrollment is associated with improved obstetric health services utilization among HIV+ pregnant women in Kenya. Specifically, HIV+ pregnant women covered by NHIF have greater access to institutional delivery (12.5-percentage points difference) and skilled birth attendants (19-percentage points difference) compared to uninsured. Notably, the effect of NHIF on obstetric health service use is much greater for those who are sicker (CD4 < 350) – 20 percentage points difference. Conclusion This study confirms conceptual and practical considerations around health insurance and healthcare access for HIV+ persons. Further, it helps to inform relevant policy development for health insurance and HIV financing and delivery in Kenya and in similar countries in sub-Saharan Africa in the universal health coverage (UHC) era.

Background To improve future mobile health (mHealth) interventions in resource-limited settings, knowledge of participants’ adherence to interactive interventions is needed, but previous studies are limited. We aimed to investigate how women in prevention of mother-to-child transmission of HIV (PMTCT) care in Kenya used, adhered to, and evaluated an interactive text-messaging intervention. Methods We conducted a cohort study nested within the WelTel PMTCT trial among 299 pregnant women living with HIV aged ≥ 18 years. They received weekly text messages from their first antenatal care visit until 24 months postpartum asking “How are you?”. They were instructed to text within 48 h stating that they were “okay” or had a “problem”. Healthcare workers phoned non-responders and problem-responders to manage any issue. We used multivariable-adjusted logistic and negative binomial regression to estimate adjusted odds ratios (aORs), rate ratios (aRRs) and 95% confidence intervals (CIs) to assess associations between baseline characteristics and text responses. Perceptions of the intervention were evaluated through interviewer-administered follow-up questionnaires at 24 months postpartum. Results The 299 participants sent 15,183 (48%) okay-responses and 438 (1%) problem-responses. There were 16,017 (51%) instances of non-response. The proportion of non-responses increased with time and exceeded 50% around 14 months from enrolment. Most reported problems were health related (84%). Having secondary education was associated with reporting a problem (aOR:1.88; 95%CI: 1.08–3.27) compared to having primary education or less. Younger age (18–24 years) was associated with responding to < 50% of messages (aOR:2.20; 95%CI: 1.03–4.72), compared to being 35–44 years. Women with higher than secondary education were less likely (aOR:0.28; 95%CI: 0.13–0.64), to respond to < 50% of messages compared to women with primary education or less. Women who had disclosed their HIV status had a lower rate of non-response (aRR:0.77; 95%CI: 0.60–0.97). In interviews with 176 women, 167 (95%) agreed or strongly agreed that the intervention had been helpful, mainly by improving access to and communication with their healthcare providers (43%). Conclusion In this observational study, women of younger age, lower education, and who had not disclosed their HIV status were less likely to adhere to interactive text-messaging. The majority of those still enrolled at the end of the intervention reported that text-messaging had been helpful, mainly by improving access to healthcare providers. Future mHealth interventions aiming to improve PMTCT care need to be targeted to attract the attention of women with lower education and younger age.

PurposePharmacovigilance (PV) systems to assess the safety of antiretroviral treatment used periconception and during pregnancy are lacking in low-resource settings with high HIV burdens, and strategies to guide their implementation are limited. We implemented the Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO) study in Kenya to address these gaps.ParticipantsIn MANGO, we ascertained delivery outcomes for pregnant women living with HIV (WLH) and not living with HIV (WNLH) enrolled in care at Moi Teaching and Referral Hospital (MTRH) through two cohorts: C1, a prospective cohort of 1:1 matched WLH and WNLH attending antenatal clinic; and C2, a cross-sectional cohort of all deliveries, including among those who did not attend antenatal clinic at MTRH.Findings to date24 205 deliveries were recorded from October 2020 to September 2023 (853 in C1 and 23 352 in C2). Median maternal age was 32 years, 4.5% were WLH and 2.6% of deliveries were stillbirths. Among liveborn infants, 17.2% were preterm (<37 weeks), and 15.1% were low birth weight (<2.5 kg). Prevalence of ≥1 major congenital abnormality was 73.9/10 000 births (47.7 in C1 and 76.1 in C2). Assessing implementation barriers/facilitators, lack of national PV policy was a barrier overcome through establishing partnerships with the Kenya Ministry of Health. The facility’s size and complexity were barriers to newborn surface exam coverage overcome through staff training and cocreation of a standardised form for newborn surface exam documentation. High staff turnover was addressed by involving head nurses to champion implementation and incentivising staff participation with medical education credits. Use of audit/feedback cycles and focusing on PV as a way to improve care quality facilitated PV institutionalisation at MTRH.Future plansThe MANGO model is a multifaceted strategy with replicative potential in other settings. Research is needed to understand the model’s opportunities for implementation in other settings.

Background Maternal and neonatal morbidity and mortality remain high in low-income and middle- income countries (LMICs), and staffing schedules may contribute to adverse pregnancy outcomes. Particularly, during the nighttime and on weekends, provider staffing is often limited, which may make it difficult for pregnant persons to receive quality care. We leveraged existing data collected in a pharmacovigilance pregnancy project, named Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO) study, to determine any associations between nighttime/weekend deliveries and adverse (1) maternal, (2) birth, or (3) neonatal outcomes. Methods We conducted a secondary analysis of prospective data from the MANGO study, which documents delivery outcomes for pregnant persons at the Moi Teaching and Referral Hospital in western Kenya, from September 2020-November 2023. We utilized multivariable Poisson regression models, with log link, robust standard errors, and adjusted for several covariates, to assess the association between nighttime/weekend deliveries and adverse composite maternal, birth, or neonatal outcomes. Results A total of 25,911 neonates born to 25,247 pregnant persons were included. More than half of deliveries occurred during nighttime (6pm to 7am)/weekends (62.6%). In multivariate modeling, nighttime/weekend delivery was associated with a reduced risk of adverse composite maternal outcomes (adjusted risk ratio [aRR] 0.92, 95% confidence interval [CI]: 0.88, 0.96) and composite birth outcomes (aRR 0.92, 95% CI: 0.88, 0.96). No association was found between nighttime/weekend delivery and neonatal death. In post-hoc analyses, weekend deliveries were associated with reduced risk of emergency Caesarean deliveries, preterm birth, and low birth weight. Having advanced maternal age, obstetric complications, and transferring to the hospital for delivery were associated with adverse maternal and birth outcomes. Poor APGAR score was strongly associated with neonatal death. Conclusions Nighttime/weekend deliveries were associated with better maternal and birth outcomes, perhaps due to decreased emergency Caesarean deliveries for high-risk pregnancies or other factors. Greater attention to individual-level factors, such as obstetric complications, may be considered to improve outcomes for pregnant persons and their neonates. Future research may focus on under-resourced, non-tertiary hospitals to offer a more generalizable view of this exposure-outcome relationship in LMICs.

Retention in prevention of mother-to-child transmission (PMTCT) care is critical to prevent vertical HIV transmission and reduce morbidity and mortality of mother-infant pairs. We investigated whether weekly, interactive text-messaging improved 18-month postpartum retention in PMTCT care. This randomised, two-armed, parallel trial was conducted at six PMTCT clinics in western Kenya. Pregnant women with HIV at least 18 years of age with access to a mobile phone, able to text-message, or had somebody who could text on their behalf, were eligible. Participants were randomly assigned at a 1:1 ratio in block sizes of four to the intervention or control group. The intervention group received weekly text messages asking “How are you?” (“Mambo?” in Swahili) and were requested to respond within 48 h. Healthcare workers called women who indicated a problem or did not respond. The intervention was administered up to 24 months after delivery. Both groups received standard care. The primary outcome was retention in care at 18 months postpartum (i.e., clinic attendance 16–24 months after delivery based on data from patient files, patient registers and Kenya’s National AIDS and STI Control Programme database), which was analysed by intention-to-treat. Researchers and data collectors were masked to group assignment, while healthcare workers were not. Between June 25th, 2015, and July 5th, 2016, we randomly assigned 299 women to the intervention and 301 to standard care only. Follow-up concluded on July 26th, 2019. The proportion of women retained in PMTCT care at 18 months postpartum was not significantly different between the intervention (n = 210/299) and control groups (n = 207/301) (risk ratio 1.02, 95% confidence interval 0.92–1.14, p = 0.697). No adverse events related to the mobile phone intervention were reported. Weekly, interactive text-messaging was not associated with improved retention in PMTCT care at 18 months postpartum or linkage to care up to 30 months postpartum in this setting. (ISRCTN No. 98818734).