Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage.

BACKGROUND: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle. METHODS: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle. RESULTS: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28). CONCLUSIONS: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery. (Funded by the Bill and Melinda Gates Foundation; E-MOTIVE ClinicalTrials.gov number, NCT04341662.).

Predictors, prevalence and outcome of hypertensive disorders in pregnancy in Nigerian tertiary health facilities.

OBJECTIVE: Determine prevalence, risk factors and outcomes of hypertensive disorders in pregnancy (HDP). DESIGN: Cross-sectional analysis of data captured in the Maternal and Perinatal Database for Quality, Equity and Dignity (MPD-4-QED) between September 2019 and August 2020. SETTING: Fifty-four referral level facilities in Nigeria. POPULATION: Women whose pregnancy ended (irrespective of the location or duration of pregnancy) or who were admitted within 42 days of delivery. METHODS: Descriptive statistics and multilevel mixed-effects logistic regression models. MAIN OUTCOME MEASURES: Prevalence of HDP, sociodemographic and clinical factors associated with HDP and perinatal outcomes. RESULTS: Among the 71 758 women 6.4% had HDP and gestational hypertension accounted for 49.8%. Preeclampsia and eclampsia were observed in 9.5% and 7.0% of all pregnancies, respectively. The predictors of HDP were age over 35 years (OR1.96, 95% CI 1.82-2.12; p < 0.001), lack of formal educational (OR 1.18, 95% CI 1.06-1.32; p = 0.002), primary level of education (OR 1.20, 95% CI 1.03-1.4; p < 0.002), nulliparity (OR 1.21, 95% CI 1.12-1.31; p < 0.001), grand-multiparity (OR 1.36, 95%CI 1.21-1.52; p < 0.001), previous caesarean section (OR 1.26, 95%CI 1.15-1.38; p < 0.001) and previous miscarriage (OR 1.22, 95% CI 1.13-1.31; p < 0.001). Overall 3.7% of the patients with HDP died, with eclampsia having the highest case fatality rate of 27.9%. Stillbirth occurred in 11.9% of pregnancies with hypertensive disorders. CONCLUSIONS: Hypertensive disorders in pregnancy are not uncommon in Nigeria. They are associated with adverse outcomes with over one-quarter of women with eclampsia dying. The main predictors include older age, poor education, extremes of parity and previous CS or miscarriage. Maternal and perinatal outcomes are poor with about a quarter developing complications and about 1 in 10 having stillbirths.

Prevalence of and risk factors for iron deficiency among pregnant women with moderate or severe anaemia in Nigeria: a cross-sectional study.

BACKGROUND: Anaemia during pregnancy causes adverse outcomes to the woman and the foetus, including anaemic heart failure, prematurity, and intrauterine growth restriction. Iron deficiency anaemia (IDA) is the leading cause of anaemia and oral iron supplementation during pregnancy is widely recommended. However, little focus is directed to dietary intake. This study estimates the contribution of IDA among pregnant women and examines its risk factors (including dietary) in those with moderate or severe IDA in Lagos and Kano states, Nigeria. METHODS: In this cross-sectional study, 11,582 women were screened for anaemia at 20-32 weeks gestation. The 872 who had moderate or severe anaemia (haemoglobin concentration < 10 g/dL) were included in this study. Iron deficiency was defined as serum ferritin level < 30 ng/mL. We described the sociodemographic and obstetric characteristics of the sample and their self-report of consumption of common food items. We conducted bivariate and multivariable logistic regression analysis to identify risk factors associated with IDA. RESULTS: Iron deficiency was observed among 41% (95%CI: 38 - 45) of women with moderate or severe anaemia and the prevalence increased with gestational age. The odds for IDA reduces from aOR: 0.36 (95%CI: 0.13 - 0.98) among pregnant women who consume green leafy vegetables every 2-3 weeks, to 0.26 (95%CI: 0.09 - 0.73) among daily consumers, compared to those who do not eat it. Daily consumption of edible kaolin clay was associated with increased odds of having IDA compared to non-consumption, aOR 9.13 (95%CI: 3.27 - 25.48). Consumption of soybeans three to four times a week was associated with higher odds of IDA compared to non-consumption, aOR: 1.78 (95%CI: 1.12 - 2.82). CONCLUSION: About 4 in 10 women with moderate or severe anaemia during pregnancy had IDA. Our study provides evidence for the protective effect of green leafy vegetables against IDA while self-reported consumption of edible kaolin clay and soybeans appeared to increase the odds of having IDA during pregnancy. Health education on diet during pregnancy needs to be strengthened since this could potentially increase awareness and change behaviours that could reduce IDA among pregnant women with moderate or severe anaemia in Nigeria and other countries.

Acceptability of IV iron treatment for iron deficiency anaemia in pregnancy in Nigeria: a qualitative study with pregnant women, domestic decision-makers, and health care providers.

BACKGROUND: Anaemia in pregnancy causes a significant burden of maternal morbidity and mortality in sub-Saharan Africa, with prevalence ranging from 25 to 45% in Nigeria. The main treatment, daily oral iron, is associated with suboptimal adherence and effectiveness. Among pregnant women with iron deficiency, which is a leading cause of anaemia (IDA), intravenous (IV) iron is an alternative treatment in moderate or severe cases. This qualitative study explored the acceptability of IV iron in the states of Kano and Lagos in Nigeria. METHODS: We purposively sampled various stakeholders, including pregnant women, domestic decision-makers, and healthcare providers (HCPs) during the pre-intervention phase of a hybrid clinical trial (IVON trial) in 10 healthcare facilities across three levels of the health system. Semi-structured topic guides guided 12 focus group discussions (140 participants) and 29 key informant interviews. We used the theoretical framework of acceptability to conduct qualitative content analysis. RESULTS: We identified three main themes and eight sub-themes that reflected the prospective acceptability of IV iron therapy. Generally, all stakeholders had a positive affective attitude towards IV iron based on its comparative advantages to oral iron. The HCPs noted the effectiveness of IV iron in its ability to evoke an immediate response and capacity to reduce anaemia-related complications. It was perceived as a suitable alternative to blood transfusion for specific individuals based on ethicality. However, to pregnant women and the HCPs, IV iron could present a higher opportunity cost than oral iron for the users and providers as it necessitates additional time to receive and administer it. To all stakeholder groups, leveraging the existing infrastructure to facilitate IV iron treatment will stimulate coherence and self-efficacy while strengthening the existing trust between pregnant women and HCPs can avert misconceptions. Finally, even though high out-of-pocket costs might make IV iron out of reach for poor women, the HCPs felt it can potentially prevent higher treatment fees from complications of IDA. CONCLUSIONS: IV iron has a potential to become the preferred treatment for iron-deficiency anaemia in pregnancy in Nigeria if proven effective. HCP training, optimisation of information and clinical care delivery during antenatal visits, uninterrupted supply of IV iron, and subsidies to offset higher costs need to be considered to improve its acceptability. Trial registration ISRCTN registry ISRCT N6348 4804. Registered on 10 December 2020 Clinicaltrials.gov NCT04976179. Registered on 26 July 2021.

Low blood level in pregnancy is of public health importance and with common occurrence worldwide, but with a higher rate in low resource settings where its burden greatly affects both the mother and her baby. This low blood level is usually caused by poor intake of an iron-rich diet. It could lead to fatigue, decreased work capacity, and dizziness if not detected. Without treatment, this condition could affect the baby, possibly leading to its sudden demise in the womb, immediately after birth, or even the woman's death.The use of oral iron has been the primary treatment; however, it is associated with significant side effects, which have led to poor compliance. Fortunately, an alternative therapy in the form of a drip has been shown to overcome these challenges. However, it is not routinely used in countries like Nigeria. Moreover, being effective is different from being utilised. Therefore, this study was conducted to understand the factors that will make this treatment widely accepted.We interviewed pregnant women, family support and health care providers in 10 health facilities in Lagos and Kano States, Nigeria. Our findings revealed good attitudes to iron drip. However, its inclusion into routine antenatal health talk, training of health care providers, availability of space, drugs and health workers who will provide this care, and ensuring this drug is of low cost are some of the efforts needed for this treatment to be accepted.

Outcome of interventions to improve the quality of intrapartum care in Nigeria's referral hospitals: a quasi-experimental research design.

BACKGROUND: Evidence indicates that Nigeria's high maternal mortality rate is attributable primarily to events that occur during the intrapartum period. This study determines the effectiveness of multifaceted interventions in improving the quality of intrapartum care in Nigeria's referral hospitals. METHODS: Data collected through an exit interview with 752 women who received intrapartum care in intervention and control hospitals were analyzed. The interventions were designed to improve the quality indicators in the WHO recommendations for positive childbirth and assessed using 12 quality indicators. Univariate, bivariate, Poisson, and logistic regression analyses were used to compare twelve quality indicators at intervention and control hospitals. RESULTS: The interventions showed a 6% increase in composite score of quality of care indicators at intervention compared with control hospitals. Five signal functions of intrapartum care assessed were significantly (< 0.001) better at intervention hospitals. Quality scores for segments of intervention periods compared to baseline were higher at intervention than in control hospitals. CONCLUSIONS: We conclude that multiple interventions that address various components of the quality of intrapartum care in Nigeria's referral hospitals have demonstrated effectiveness. The interventions improved five of ten quality indicators. We believe that this approach to developing interventions based on formative research is important, but a process of integrating the implementation activities with the normal maternal health delivery processes in the hospitals will enhance the effectiveness of this approach. TRIAL REGISTRATION: The study was registered at the Nigeria Clinical Trials Registry. Trial Registration Number NCTR No: 91,540,209 (14/04/2016) http://www.nctr.nhrec.net/ and retrospectively with the ISRCTN. Trial Registration Number 64 ISRCTN17985403 (14/08/2020) https://doi.org/10.1186/ISRCTN17985403 .

HIV self-testing and repeat testing in pregnancy and postpartum in Northern Nigeria.

OBJECTIVE: Incident HIV infections in pregnant and breastfeeding mothers pose significant challenges to prevention of mother-to-child HIV transmission efforts in sub-Saharan Africa. We identified the predictors of willingness to self-test for HIV when retesting in pregnancy and postpartum among antenatal clients in a tertiary hospital in Northern Nigeria. METHODS: Structured and validated questionnaires were administered to a cross section of antenatal attendees (n = 370) in March 2021. Willingness to self-test and adjusted odds ratios of potential predictors were generated from logistic regression models. RESULTS: Of the 317 respondents who agreed to repeat HIV test during pregnancy, 29.3% (n = 93) were willing to self-test. Similarly, of those (n = 350) willing to retest after delivery, 27.4% (n = 96) were willing to self-test. Willingness to self-test during pregnancy was higher among respondents who were multiparous (2-4 births) (adjusted odds ratio, aOR = 2.40, 95% confidence interval CI, 1.14-6.43), employed (aOR = 1.49, 95% CI, 1.13-4.53) and those with at least secondary education (aOR = 2.96, 95% CI, 1.43-11.47). In contrast, willingness to self-test was lower among those who were unaware of the husband's HIV status (aOR = 0.05, 95% CI, 0.02-0.13). Willingness to self-test after delivery was higher among respondents who were married (aOR = 15.41, 95% CI, 3.04-78.2), multiparous (aOR = 2.01, 95% CI, 1.27-5.63), employed (aOR = 1.59, 95% CI, 1.08-2.35) and had at least to secondary education (aOR = 6.12, 95% CI, 1.36-27.47). In contrast, willingness to self-test postpartum was lower among those who booked late (≥29 weeks) (aOR = 0.11, 95% CI, 0.022-0.52), those who were unaware of the risk of HIV transmission during breastfeeding (aOR = 0.29, 95% CI, 0.12-0.68) and participants who were unaware of the husband's HIV status (aOR = 0.076, 95% CI, 0.03-0.19). CONCLUSION: Willingness to self-test for HIV in pregnancy and postpartum was low in this population and was influenced by risk perception, socio-demographic and obstetric attributes. Communication interventions and training of potential mentor mothers among early adopters could improve self-testing in this group and similar settings.

Diabetes mellitus, maternal adiposity, and insulin-dependent gestational diabetes are associated with COVID-19 in pregnancy: the INTERCOVID study.

BACKGROUND: Among nonpregnant individuals, diabetes mellitus and high body mass index increase the risk of COVID-19 and its severity. OBJECTIVE: This study aimed to determine whether diabetes mellitus and high body mass index are risk factors for COVID-19 in pregnancy and whether gestational diabetes mellitus is associated with COVID-19 diagnosis. STUDY DESIGN: INTERCOVID was a multinational study conducted between March 2020 and February 2021 in 43 institutions from 18 countries, enrolling 2184 pregnant women aged ≥18 years; a total of 2071 women were included in the analyses. For each woman diagnosed with COVID-19, 2 nondiagnosed women delivering or initiating antenatal care at the same institution were also enrolled. The main exposures were preexisting diabetes mellitus, high body mass index (overweight or obesity was defined as a body mass index ≥25 kg/m2), and gestational diabetes mellitus in pregnancy. The main outcome was a confirmed diagnosis of COVID-19 based on a real-time polymerase chain reaction test, antigen test, antibody test, radiological pulmonary findings, or ≥2 predefined COVID-19 symptoms at any time during pregnancy or delivery. Relationships of exposures and COVID-19 diagnosis were assessed using generalized linear models with a Poisson distribution and log link function, with robust standard errors to account for model misspecification. Furthermore, we conducted sensitivity analyses: (1) restricted to those with a real-time polymerase chain reaction test or an antigen test in the last week of pregnancy, (2) restricted to those with a real-time polymerase chain reaction test or an antigen test during the entire pregnancy, (3) generating values for missing data using multiple imputation, and (4) analyses controlling for month of enrollment. In addition, among women who were diagnosed with COVID-19, we examined whether having gestational diabetes mellitus, diabetes mellitus, or high body mass index increased the risk of having symptomatic vs asymptomatic COVID-19. RESULTS: COVID-19 was associated with preexisting diabetes mellitus (risk ratio, 1.94; 95% confidence interval, 1.55-2.42), overweight or obesity (risk ratio, 1.20; 95% confidence interval, 1.06-1.37), and gestational diabetes mellitus (risk ratio, 1.21; 95% confidence interval, 0.99-1.46). The gestational diabetes mellitus association was specifically among women requiring insulin, whether they were of normal weight (risk ratio, 1.79; 95% confidence interval, 1.06-3.01) or overweight or obese (risk ratio, 1.77; 95% confidence interval, 1.28-2.45). A somewhat stronger association with COVID-19 diagnosis was observed among women with preexisting diabetes mellitus, whether they were of normal weight (risk ratio, 1.93; 95% confidence interval, 1.18-3.17) or overweight or obese (risk ratio, 2.32; 95% confidence interval, 1.82-2.97). When the sample was restricted to those with a real-time polymerase chain reaction test or an antigen test in the week before delivery or during the entire pregnancy, including missing variables using imputation or controlling for month of enrollment, the observed associations were comparable. CONCLUSION: Diabetes mellitus and overweight or obesity were risk factors for COVID-19 diagnosis in pregnancy, and insulin-dependent gestational diabetes mellitus was associated with the disease. Therefore, it is essential that women with these comorbidities are vaccinated.

Correlates of human papillomavirus vaccine knowledge and acceptability among medical and allied health students in Northern Nigeria.

Prior to its planned introduction, we investigated predictors of baseline knowledge and acceptability of HPV vaccination among medical and allied health care students in Kano, northern Nigeria. A total of 410 medical, dental and allied health students completed structured validated questionnaires. Knowledge scores and acceptability of HPV vaccine were determined and adjusted odds ratios (AOR) for predictors of HPV knowledge and acceptability were derived from multivariate logistic regression models. Overall, 3.7% (n = 15), 30.7% (n = 126) and 65.6% (n = 269) of respondents had good, moderate, and poor knowledge of HPV, respectively. The majority 334 (81.5%) were willing to accept the HPV vaccine, but only 18 (4.4%) had received at least one dose of the vaccine. Knowledge of HPV was better among females, younger (<20 years) medical students, students at higher levels of study, sexually experienced students, and condom users. HPV vaccine acceptance was higher among female students in the faculty of allied health with a family history of cervical cancer and good or moderate knowledge of HPV. In conclusion, most students were willing to receive HPV vaccination, despite their sub-optimal level of knowledge and low vaccine uptake. We recommend piloting the HPV vaccine in health colleges and recruiting early adopters as peer educators and advocates.IMPACT STATEMENTWhat is already known on this subject? Human Papilloma Virus (HPV) vaccine has been introduced in over 80 countries in the past decade, but evidence suggests low awareness of HPV infection and the vaccine, especially in developing countries. Nigeria proposes to introduce the HPV vaccine as part of the routine immunisation program in early 2021.What do the results of this study add? The majority of medical and allied health students in Kano, Nigeria, were willing to receive HPV vaccination, despite their sub-optimal level of knowledge and low vaccine uptake. Vaccine acceptance was predicted by the respondent's sex, course of study, family history of cervical cancer and knowledge of HPV.What are the implications of these findings for clinical practice and/or further research? The findings could inform program implementation and evaluation as HPV vaccine uptake is scaled up across Africa.

The effect of COVID-19 on maternal newborn and child health (MNCH) services in Bangladesh, Nigeria and South Africa: call for a contextualised pandemic response in LMICs.

Global response to COVID-19 pandemic has inadvertently undermined the achievement of existing public health priorities and laregely overlooked local context. Recent evidence suggests that this will cause additional maternal and childhood mortality and morbidity especially in low- and middle-income countries (LMICs). Here we have explored the contextual factors influencing maternal, neonatal and children health (MNCH) care in Bangladesh, Nigeria and South Africa amidst the pandemic. Our findings suggest that between March and May 2020, there was a reduction in utilisation of basic essential MNCH services such as antenatal care, family planning and immunization due to: a) the implementation of lockdown which triggered fear of contracting the COVID-19 and deterred people from accessing basic MNCH care, and b) a shift of focus towards pandemic, causing the detriment to other health services, and c) resource constraints. Taken together these issues have resulted in compromised provision of basic general healthcare. Given the likelihood of recurrent waves of the pandemic globally, COVID-19 mitigation plans therefore should be integrated with standard care provision to enhance system resilience to cope with all health needs. This commentary suggests a four-point contextualised mitigation plan to safeguard MNCH care during the pandemic using the observed countries as exemplars for LMIC health system adaptations to maintain the trajectory of progress regarding sustainable development goals (SDGs).

Acceptability of mentor mother peer support for women living with HIV in North-Central Nigeria: a qualitative study.

BACKGROUND: Mentor mothers provide psychosocial and other support to pregnant and post-partum women living with HIV (WLHIV), which has been shown to enhance maternal-infant outcomes in the prevention of mother-to-child transmission of HIV (PMTCT). Our objective was to assess the acceptability of mentor mothers as a PMTCT intervention, and to explore opinions on mentor mother program composition and delivery among stakeholders in North-Central Nigeria. METHODS: We conducted nine focus group discussions and 31 in-depth interviews with 118 participants, including WLHIV, pregnant women, male partners, health workers, traditional birth attendants, community leaders, PMTCT program implementers, and policymakers. Participants were purposively recruited from health facilities and surrounding communities in the Federal Capital Territory and Nasarawa State. Transcripts were manually analysed using a Grounded Theory approach, where theory was derived from the data collected. RESULTS: Most participants were female (n = 78, 67%), and married (n = 110, 94%). All participant groups found  mentor mothers acceptable as women providing care to pregnant and postpartum women, and as WLHIV supporting other WLHIV. Mentor mothers were uniquely relatable as role models for WLHIV because they were women, living with HIV, and had achieved an HIV-negative status for their HIV-exposed infants. Mentor mothers were recognized as playing major roles in maternal health education, HIV treatment initiation, adherence, and retention, HIV prevention for male partners and infants, and couple HIV disclosure. Most WLHIV preferred to receive mentor mothers' services at health facilities rather than at home, due to concerns about HIV-related stigma and discrimination through association with mentor mothers. Key mentor mother needs were identified as training, remuneration, and validation as lay health workers. CONCLUSIONS: Mentor mothers are an acceptable PMTCT intervention among stakeholders in North-Central Nigeria. However, stigma and discrimination for both mentor mothers and their clients remain a critical challenge, and mentor mother needs such as training, pay, and a sustainably supported niche in health systems require focused attention. TRIAL REGISTRATION: Clinicaltrials.gov registration number ( NCT01936753 ), registered on September 3, 2013 (retrospectively registered).

Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation.

INTRODUCTION: The World Health Organization's (WHO) Labour Care Guide (LCG) is a "next-generation" partograph based on WHO's latest intrapartum care recommendations. It aims to optimize clinical care provided to women and their experience of care. We evaluated the LCG's usability, feasibility, and acceptability among maternity care practitioners in clinical settings. METHODS: Mixed-methods evaluation with doctors, midwives, and nurses in 12 health facilities across Argentina, India, Kenya, Malawi, Nigeria, and Tanzania. Purposively sampled and trained practitioners applied the LCG in low-risk women during labor and rated experiences, satisfaction, and usability. Practitioners were invited to focus group discussions (FGDs) to share experiences and perceptions of the LCG, which were subjected to framework analysis. RESULTS: One hundred and thirty-six practitioners applied the LCG in managing labor and birth of 1,226 low-risk women. The majority of women had a spontaneous vaginal birth (91.6%); two cases of intrapartum stillbirths (1.63 per 1000 births) occurred. Practitioner satisfaction with the LCG was high, and median usability score was 67.5%. Practitioners described the LCG as supporting precise and meticulous monitoring during labor, encouraging critical thinking in labor management, and improving the provision of woman-centered care. CONCLUSIONS: The LCG is feasible and acceptable to use across different clinical settings and can promote woman-centered care, though some design improvements would benefit usability. Implementing the LCG needs to be accompanied by training and supportive supervision, and strategies to promote an enabling environment (including updated policies on supportive care interventions, and ensuring essential equipment is available).

Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. When PPH occurs, early identification of bleeding and prompt management using evidence-based guidelines, can avert most PPH-related severe morbidities and deaths. However, adherence to the World Health Organization recommended practices remains a critical challenge. A potential solution to inefficient and inconsistent implementation of evidence-based practices is the application of a 'clinical care bundle' for PPH management. A clinical care bundle is a set of discrete, evidence-based interventions, administered concurrently, or in rapid succession, to every eligible person, along with teamwork, communication, and cooperation. Once triggered, all bundle components must be delivered. The E-MOTIVE project aims to improve the detection and first response management of PPH through the implementation of the "E-MOTIVE" bundle, which consists of (1) Early PPH detection using a calibrated drape, (2) uterine Massage, (3) Oxytocic drugs, (4) Tranexamic acid, (5) Intra Venous fluids, and (6) genital tract Examination and escalation when necessary. The objective of this paper is to describe the protocol for the formative phase of the E-MOTIVE project, which aims to design an implementation strategy to support the uptake of this bundle into practice. METHODS: We will use behavior change and implementation science frameworks [e.g. capability, opportunity, motivation and behavior (COM-B) and theoretical domains framework (TDF)] to guide data collection and analysis, in Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania. There are four methodological components: qualitative interviews; surveys; systematic reviews; and design workshops. We will triangulate findings across data sources, participant groups, and countries to explore factors influencing current PPH detection and management, and potentially influencing E-MOTIVE bundle implementation. We will use these findings to develop potential strategies to improve implementation, which will be discussed and agreed with key stakeholders from each country in intervention design workshops. DISCUSSION: This formative protocol outlines our strategy for the systematic development of the E-MOTIVE implementation strategy. This focus on implementation considers what it would take to support roll-out and implementation of the E-MOTIVE bundle. Our approach therefore aims to maximize internal validity in the trial alongside future scalability, and implementation of the E-MOTIVE bundle in routine practice, if proven to be effective. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04341662.

Excessive bleeding after birth is the leading cause of maternal death globally. The World Health Organization (WHO) has recommended several treatment options for bleeding after birth. However, these treatments are not used regularly, or consistently for all women. A key underlying issue is that it is challenging for health workers to identify when women are bleeding too much, because measuring the amount of blood loss is difficult.Maternal health experts have proposed a new clinical 'care bundle' for caring for women with excessive bleeding after birth. A care bundle is a way to group together multiple treatments (e.g. 3­5 treatments). These treatments are then given to the woman at the same time, or one after another in quick succession, and supported by strategies to improve teamwork, communication, and cooperation.This is a research protocol for the preliminary phase of our study ("E-MOTIVE"), which means that it is a description of what we plan to do and how we plan to do it. The aim of our study is to develop a strategy for how we will test whether the E-MOTIVE bundle works through collaborative activities with midwives and doctors in five countries (Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania) to develop a strategy for how we will test whether the E-MOTIVE bundle works. We plan to do this by conducting interviews and surveys with midwives and doctors, and reviewing other research conducted on PPH to understand what works in different settings. We will discuss our research findings in a workshop, with midwives and doctors in the study countries to co-create a strategy that will work for them, based on their needs and preferences.

A sexual and reproductive empowerment framework to explore volitional sex in sub-Saharan Africa.

Volitional sex is central to the sexual health and well-being of women and girls globally. To date, few studies have examined women's empowerment and its application to sexual health outcomes, including volitional sex. The aim of this study was to explore the relevance of a sexual and reproductive empowerment framework to volitional sex across four geographically and culturally diverse contexts in sub-Saharan Africa. Qualitative data were collected between July and August 2017 in four sites: Ethiopia, Nigeria (Anambra and Kano states) and Uganda. A total of 352 women aged 15-49 and 88 men aged 18 and older were interviewed through 120 in-depth interviews and 38 focus group discussions (n = 440 total participants). Results describe the substantial barriers restraining women's sexual choices, particularly norms that stigmatise women's requests for sex, even within marriage. Results further highlight women's internal sexual motivations, particularly related to the enjoyment of sex and the role of sex in strengthening partner relationships. Future empowerment research and measurement should focus not only on sexual constraints, but also integrate internal motivations, in order to fully understand the factors that shape women's sexual health outcomes.

Covert use of contraception in three sub-Saharan African countries: a qualitative exploration of motivations and challenges.

BACKGROUND: The balance between increasing men's participation in family planning and rights-based initiatives favoring women's empowerment is highlighted with the issue of covert use of contraception. While covert use has been documented in low- and middle-income countries as a way for women to obtain contraception in light of partner opposition, little is known about women's decision-making processes, actions, and potential consequences of discreet contraceptive use. We aimed to understand women's choices to use contraception covertly and the challenges they faced in concealing their use across three sub-Saharan African countries. METHODS: Women aged 15-49 and their male partners were purposively sampled from urban and rural sites in Ethiopia, Northern and Southern Nigeria, and Uganda for 120 in-depth interviews and 38 focus group discussions. Semi-structured interviews explored women's and girls' empowerment surrounding sex, childbearing, and contraception. Interviews were conducted in local languages, audio-recorded, and transcribed verbatim into English. Inductive thematic analysis was used to analyze data; covert use codes were reviewed and matrices were created based on themes and sub-themes. RESULTS: Findings comprised three thematic areas: the practice of covert contraceptive use and reasons for using covertly; challenges for women who use contraception covertly; and consequences of disclosure or being discovered. While some women initiated using contraception covertly due to tensions within relationships or to keep peace within the home due to known partner opposition, others did not consider family planning to be a male responsibility. Though covert use was commonly discussed, it was also socially sanctioned, and portrayed as an act of female disobedience that questioned the social order of patriarchy. Further challenges of using covertly included lack of financial and social support, and suspicions surrounding delayed fertility and contraceptive-related side effects. Repercussions comprised increased suspicion, threats, or violence, though some women reported improved couple communication with disclosure. CONCLUSIONS: Results indicate that while covert use of contraception is common, continued covert use is challenging, especially when side effects manifest. Covert use may further suggest women taking independent action, symbolizing some level of empowerment. Results underscore the importance of disentangling unique reasons for covert use and the severity of repercussions of disclosure.

Outcome of multifaceted interventions for improving the quality of antenatal care in Nigerian referral hospitals.

BACKGROUND: The study was designed as quasi-experimental research to investigate the effectiveness of multifaceted interventions for improving the quality of antenatal care in referral hospitals in Nigeria. Two referral hospitals (the Central Hospital in Benin City, South-South Nigeria, and the General Hospital in Minna) served as intervention sites, while two hospitals in comparable locations, (the Central Hospital Warri and the Suleja Hospital Abuja) were the control hospitals. METHODS: Intervention activities consisted of the introduction of a strategic plan with the shared vision of reducing maternal mortality by 50% in 1 year in the hospitals; staff training and re-training; the establishment of an automated appointment system; composite health education involving couples and providers; advocacy with policymakers; and the implementation of maternal death reviews and surveillance. These activities were implemented in the intervention hospitals over 21 months (October 2017 to June 2019). Exit interviews of pregnant women at intervention and control sites by trained interviewers were used to assess the quality of antenatal care after their visit, A total of 777 women were interviewed (427 in the intervention sites and 350 in the control sites). Data were analyzed with univariate and multivariate Poisson and logistic regression to determine the extent to which health providers in the clinics completed the 18 signal functions identified in the WHO assessment tool. RESULTS: The regression analyses showed the interventions were effective in improving six quality indicators (QIs) for counseling and information sharing. The difference between intervention and control sites on these QIs was significant at < 0.05. On the contrary, the interventions were less effective for maternal and fetal measurements; and disease testing and management QIs. CONCLUSION: The positive effects of the interventions are likely due to the effectiveness of the training and health education components. The lack of intervention impact observed for maternal and fetal measurements may be due to the high workload of care staff and inadequate clinic supplies, which we did not address. We conclude that interventions that address the quality of antenatal care in low-resource settings should focus on improving all elements of care, including adequate staffing and mobilization of material resources. TRIAL REGISTRATION: This study was registered in the ISRCTN on August 14th, 2020. TRIAL REGISTRATION NUMBER: SRCTN17985403 . Retrospective registration. The reason for the retrospective registration is the current non-recognition of the Nigeria Clinical Trials Registry (NCTR); which is currently not an ICMJE or WHO ICTRP approved registry. (This study was registered in the Nigeria Clinical Trials Registry on April 14th, 2016. Trial Registration Number NCTR No: 91540209 ).

Fertility desire concordance and contraceptive use among couples living with HIV in northern Nigeria.

OBJECTIVES: We aimed to determine the concordance between own and perceived partner fertility intentions and identify predictors of contraceptive use among couples receiving antiretroviral therapy in Kano, Nigeria. METHODS: A structured, validated questionnaire was used to interview 399 married men and women receiving antiretroviral therapy. Adjusted odds ratios for predictors of contraceptive use were derived from multivariate logistic regression models. RESULTS: Most couples (68.9%) had concordant fertility intentions. Only 10.0% of couples had discordant fertility intentions. Among 232 couples (58.1%) at least one partner used contraception. Male condoms were used by 45.9% of couples (n = 183). Female methods were used by 175 couples (43.9%). Contraceptive use was significantly higher in participants who were older (≥30 years), better educated (secondary or post-secondary), had a higher monthly income (NGN ≥30,000), longer marriage duration (≥5 years), at least one living child, >1 year of antiretroviral treatment, and who were living with a serodiscordant partner and in circumstances where the decision on contraception was made by the female partner or jointly by both partners (all p < 0.05). Contraceptive use was significantly lower in participants who had not been sexually active in the last 6 months, where both partners wanted more children, and in situations lacking spousal communication about family planning (all p < 0.05). CONCLUSION: One in 10 couples had discordant fertility intentions. Contraceptive use was suboptimal and was predicted by age, education, income, length of marriage, number of children, duration of antiretroviral therapy, partner's serostatus, sexual activity, fertility intention, spousal communication and the contraceptive decision-maker. Our findings highlight the need for spousal communication, joint contraceptive decision making and the integration of reproductive health services with antiretroviral therapy services.

Prevalence and determinants of stillbirth in Nigerian referral hospitals: a multicentre study.

BACKGROUND: In 2015, Nigeria's estimated 317,700 stillbirths accounted for 12.2% of the 2.6 million estimated global stillbirths. This suggests that Nigeria still makes substantial contribution to the global burden of stillbirths. This study was conducted to determine the prevalence and identify the causes and factors associated with stillbirth in eight referral hospitals in Nigeria. METHODS: This was a cross-sectional study of all deliveries over a period of 6 months in six general hospitals (4 in the south and 2 in the north), and two teaching hospitals (both in the north) in Nigeria. The study population was women delivering in the hospitals during the study period. A pre-tested study protocol was used to obtain clinical data on pregnancies, live births and stillbirths in the hospitals over a 6 months period. Data were analyzed centrally using univariate, bivariate and multivariate logistic regression analyses. The main outcome measure was stillbirth rate in the hospitals (individually and overall). RESULTS: There were 4416 single births and 175 stillbirths, and a mean stillbirth rate of 39.6 per 1000 births (range: 12.7 to 67.3/1000 births) in the hospitals. Antepartum (macerated) constituted 22.3% of the stillbirths; 47.4% were intrapartum (fresh stillbirths); while 30.3% was unclassified. Acute hypoxia accounted for 32.6% of the stillbirths. Other causes were maternal hypertensive disease (6.9%), and intrapartum unexplained (5.7%) among others. After adjusting for confounding variables, significant predictors of stillbirth were referral status, parity, past experience of stillbirth, birth weight, gestational age at delivery and mode of delivery. CONCLUSION: We conclude that the rate of stillbirth is high in Nigeria's referral hospitals largely because of patients' related factors and the high rates of pregnancy complications. Efforts to address these factors through improved patients' education and emergency obstetric care would reduce the rate of stillbirth in the country. TRIAL REGISTRATION: Trial Registration Number NCTR91540209. Nigeria Clinical Trials Registry. http://www.nctr.nhrec.net/ Registered April 14th 2016.

Association of the client-provider ratio with the risk of maternal mortality in referral hospitals: a multi-site study in Nigeria.

BACKGROUND: The paucity of human resources for health buoyed by excessive workloads has been identified as being responsible for poor quality obstetric care, which leads to high maternal mortality in Nigeria. While there is anecdotal and qualitative research to support this observation, limited quantitative studies have been conducted to test the association between the number and density of human resources and risk of maternal mortality. This study aims to investigate the association between client-provider ratios for antenatal and delivery care and the risk of maternal mortality in 8 referral hospitals in Nigeria. METHODS: Client-provider ratios were calculated for antenatal and delivery care attendees during a 3-year period (2011-2013). The maternal mortality ratio (MMR) was calculated per 100,000 live births for the hospitals, while unadjusted Poisson regression analysis was used to examine the association between the number of maternal deaths and density of healthcare providers. RESULTS: A total of 334,425 antenatal care attendees and 26,479 births were recorded during this period. The client-provider ratio in the maternity department for antenatal care attendees was 1343:1 for doctors and 222:1 for midwives. The ratio of births to one doctor in the maternity department was 106:1 and 18:1 for midwives. On average, there were 441 births per specialist obstetrician. The results of the regression analysis showed a significant negative association between the number of maternal deaths and client-provider ratios in all categories. CONCLUSION: We conclude that the maternal mortality ratios in Nigeria's referral hospitals are worsened by high client-provider ratios, with few providers attending a large number of pregnant women. Efforts to improve the density and quality of maternal healthcare providers, especially at the first referral level, would be a critical intervention for reducing the currently high rate of maternal mortality in Nigeria. TRIAL REGISTRATION: Trial Registration Number: NCTR91540209 . Nigeria Clinical Trials Registry. Registered 14 April 2016.

Correlates of Postpartum Sexual Activity and Contraceptive Use in Kano, Northern Nigeria.

Practices related to resumption of coitus after childbirth remains poorly documented in Nigeria. This study examined factors associated with sexual intercourse, delivery-coitus interval, and contraceptive use among postpartum women attending a tertiary centre in Kano, northern Nigeria. A cross section of 317 women attending immunization, postnatal and family planning clinics within 12 months of childbirth was interviewed using a structured questionnaire. Vaginal intercourse was resumed by most women (n=212; 66.9%, 95% Confidence Interval (CI) = 61.8%, 72.2%) with delivery-coitus resumption interval (mean ï½± SD) of 9.6ï½±5.2 weeks postpartum. The majority (67.9%) resumed sexual activity within 8 weeks of delivery. Nearly two-thirds 65.6% (n=139/212) of the sexually active women reported current use of contraceptives. Onset of postpartum sexual activity was independently associated with mode of delivery adjusted odds ratio (AOR) (95%CI)= 1.10 (1.03,1.78), baby's age AOR (95%CI) =2.10 (1.27, 8.70), number of living children AOR (95%CI)=1.21 (1.07,1.79), onset of menstruation AOR (95%CI)=0.34 (0.17,0.69) and co-habitation AOR (95%CI)=0.47 (0.016, 0.14). Contraceptive use was predicted by educational status, sexual activity, baby's age and menstruation. Most women attending maternal and child health clinics resumed sexual intercourse within 2 months of delivery, but only two-thirds used modern contraceptive methods. Contraceptive counseling should commence early, preferably during pregnancy.