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

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

Incidence, Bacterial Profile and Predictors of Surgical Site Infection After Cesarean Section in Ethiopia, A Prospective Cohort Study.

Background: Surgical site infections (SSI) after cesarean section are common in Ethiopia and result in maternal morbidity, mortality, hospitalization, and medical costs. This study aimed to determine the incidence, bacterial profile, and associated factors of surgical site infection after cesarean section (CS) in public and private referral hospitals. Methods: A prospective observational cohort study was conducted on 741 pregnant women who underwent CS from July to September 2022. Women who had CS were followed up for at least 30 days. Infected wound specimens from those who had SSIs were collected and bacteriologically analyzed. The data were analyzed with SPSS version 25. The logistic regression model assessed the relationship between the independent variable and the outcome with 95% confidence interval. Results: The incidence of post-cesarean surgical site infection was 11.6% (95% Cl: 9.4, 13.6). Staphylococcus aureus was the most common bacteria in CS wounds 10 (21.2%). Two to three antenatal care visits (ANC) (AOR: 3.11, 95% CI: 1.69, 5.75), delayed antenatal booking (AOR: 6.99, 95% CI: 2.09, 23.32), membrane rupture (AOR: 2.10, 95% CI: 1.04, 4.24), multiple vaginal examinations (AOR = 4.21, 95% CI: 1.35, 6.92) and public hospitals (AOR: 11.1, 95% CI: 1.48, 45, 14) were associated with increased risk of SSI after CS, in contrary shorter hospital stays (AOR = 0.37, 95% CI: 0.15, 0.91) and transversal incisions (AOR = 0.38, 95% CI: 0.15, 0.91) were associated with lower risk SSI after CS. Conclusion: The incidence of SSI after CS was high. Delayed antenatal booking, two to three antenatal visits, multiple vaginal exams, membrane rupture, vertical incision, longer postoperative hospital stays, and procedures in public hospitals were associated with increased risk of SSI after CS. Therefore, intervention programs should focus on post-discharge surveillance and identification of risk to reduce and prevent SSI after CS rate.

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

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

Tranexamic acid for the prevention of postpartum bleeding: Protocol for a systematic review and individual patient data meta-analysis.

BACKGROUND: Tranexamic acid (TXA) reduces the risk of death and is recommended as a treatment for women with severe postpartum bleeding. There is hope that giving TXA shortly before or immediately after birth could prevent postpartum bleeding. Extending the use of TXA to prevent harmful postpartum bleeding could improve outcomes for millions of women; however we must carefully consider the balance of benefits and potential harms. This article describes the protocol for a systematic review and individual patient data (IPD) meta-analysis to assess the effectiveness and safety of TXA for preventing postpartum bleeding in all women giving birth, and to explore how the effects vary by underlying risk and other patient characteristics.   Methods: We will search for prospectively registered, randomised controlled trials involving 500 patients or more assessing the effects of TXA in women giving birth. Two authors will extract data and assess risk of bias. IPD data will be sought from eligible trials. Primary outcomes will be life-threatening bleeding and thromboembolic events. We will use a one-stage model to analyse the data. Subgroup analyses will be conducted to explore whether the effectiveness and safety of TXA varies by underlying risk, type birth, maternal haemoglobin (Hb), and timing of TXA. This protocol is registered on PROSPERO (CRD42022345775).  Conclusions: This systematic review and IPD meta-analysis will address important clinical questions about the effectiveness and safety of the use of TXA for the prevention of postpartum bleeding that cannot be answered reliably using aggregate data and will inform the decision of who to treat.   PROSPERO registration: CRD42022345775  Keywords   Anti-fibrinolytics; Tranexamic acid; childbirth; postpartum haemorrhage; meta-analysis.

Reasons and prevention strategies of unintended pregnancy in Addis Ababa, Ethiopia: a phenomenological qualitative study.

OBJECTIVES: To explore the reasons for unintended pregnancy and effective prevention measures from the perspectives of women and healthcare providers in Addis Ababa, Ethiopia. DESIGN: Phenomenological qualitative study. SETTING AND PARTICIPANTS: This study was conducted at three public health facilities found in Addis Ababa, Ethiopia. Women with unintended pregnancies and healthcare providers currently working in maternal health services were purposively recruited for in-depth interviews. Twenty in-depth interviews were conducted until data saturation was achieved. Data were analysed using thematic analysis. RESULTS: Seven themes emerged from the transcribed interview data. These include: Personal characteristics (negligence; lower pregnancy expectation), family influence (fear of family), sociocultural and economic influence (stigma and discrimination), healthcare provider influence (disrespectful and abusive approach; disregard for women's contraceptive choice), preconception thoughts and behaviours (unprotected early sexual practice; myths and misunderstanding), lack of access to quality family planning services (lack of trained contraceptive counsellor, inappropriate contraceptive use), and preventive strategies for unintended pregnancy (comprehensive sexual education; sexual and reproductive health and rights service integration) CONCLUSIONS: This study identified multilevel reasons for unintended pregnancy from the perspective of the participants. Participants shared their views on preventive measures for unintended pregnancy, including comprehensive sexual education, service integration and male-inclusive contraceptive counselling. This study highlights the need to improve sexual and reproductive health services by shedding light on the viewpoints and experiences of women and healthcare providers.

Association between unintended pregnancy and maternal antenatal care services use in Ethiopia: analysis of Ethiopian demographic and health survey 2016.

Introduction: Unintended pregnancy disproportionately affects women in low and middle-income countries including Ethiopia. Previous studies identified the magnitude and negative health outcomes of unintended pregnancy. However, studies that examined the relationship between antenatal care (ANC) utilization and unintended pregnancy are scarce. Objective: This study aimed to examine the relationship between unintended pregnancy and ANC utilization in Ethiopia. Methods: This is a cross-sectional study conducted using the fourth and most recent Ethiopian Demographic Health Survey (EDHS) data. The study comprised a weighted sample of 7,271 women with last alive birth and responded to questions on unintended pregnancy and ANC use. The association between unintended pregnancy and ANC uptake was determined using multilevel logistic regression models adjusted for possible confounders. Finally p < 5% was considered significant. Results: Unintended pregnancy accounted for nearly a quarter of all pregnancies (26.5%). After adjusting for confounders, a 33% (AOR: 0.67; 95% CI, 0.57-0.79) lower odds of at least one ANC uptake and a 17% (AOR: 0.83; 95% CI, 0.70-0.99) lower odds of early ANC booking were found among women who had unintended pregnancy compared to women with intended pregnancy. However, this study founds no association (AOR: 0.88; 95% CI, 0.74, 1.04) between unintended pregnancy and four or more ANC visits. Conclusion: Our study found that having unintended pregnancy was associated with a 17 and 33% reduction in early initiation and use of ANC services, respectively. Policies and programs designed to intervene against barriers to early initiation and use of ANC should consider unintended pregnancy.

Trend and associated factors of cesarean section rate in Ethiopia: Evidence from 2000-2019 Ethiopia demographic and health survey data.

BACKGROUND: The world health organization considers cesarean section (CS) prevalence of less than 5% suggests an unmet need. On the other hand, a prevalence of more than 15% may pose to risk to mother and child, however, access to CS in a resource-limited country like Ethiopia was much lower than the aforementioned level, Therefore, this was the first study to determine the trend of CS, and factors that influence it. METHODS: This was done based on the five Ethiopia Demographic and Health Surveys. Trend analysis was done separately for rural and urban. The significance of the trend was assessed using the Extended Mantel-Haenszel chi-square test. The factors on CS delivery were identified based on DHS 2016 data. A multi-level logistic regression analysis technique was used to identify the factors associated with cesarean section delivery. The analysis was adjusted for the different individual- and community-level factors affecting cesarean section delivery. Data analysis was conducted using STATA 14.1 software. RESULT: The rate of cesarean section increased from 5.1% in 1995 to 16% in 2019 in an urban area and 0.001 in 1995 to 3% in a rural area, the overall increment of CS rate was 0.7% in 1995 to 2019 at 6%. The odds of cesarean section were higher among 25-34 years (AOR = 2.79; 95% CI: 1.92, 4.07) and 34-49 years (AOR = 5.23;95% CI: 2.85,9.59), among those educated at primary school level (AOR = 1.94; 95% CI: 1.23,3.11), secondary education (AOR = 2.01; 95% CI: 1.17, 3.56) and higher education (AOR = 4.12; 95% CI: 2.33-7.29)with multiple pregnancies (AOR = 11.12; 95% CI: 5.37, 23.), with obesity (AOR = 1.73; 95% CI: 1.22, 2.45), living in an urban area (AOR = 2.28; /95% CI: 1.35-3.88), and increased with the number of ANC visit of 1-3 and 4th(AOR = 2.26; 95% CI: 1.12, 4.58), (AOR = 3.34; 95% CI: 1.12, 4.58), respectively. The odds of cesarean section are lower among parity of 2-4 children (AOR = 0.54; 95% CI: 0 .37, 0.80) and greater than four birth order (AOR = 0.42;95% CI: 0.21,0.84). CONCLUSION: In Ethiopia, the CS rate is below the WHO recommended level in both urban and rural areas, thus, intervention efforts need to be prioritized for women living in a rural area, empowering women's education, encouraging co-services such as ANC usage could all help to address the current problem.

Utilizing first void urine for high-risk HPV testing for cervical cancer screening in HIV-positive women in Katete, Zambia.

BACKGROUND: The World Health Organization targets to screen 70% of women worldwide twice for cervical cancer by the year 2030, first by age of 35, and again by the age of 45. However, with the current low screening coverage in many developing countries, this may not be achieved because the invasive sampling method is unacceptable to some. In Zambia, for instance, despite the availability of free cervical cancer screening through the establishment of the Cervical Cancer Prevention Programme, some women are still reluctant to go for screening. First void urine sampling is non-invasive and thus has the potential to increase screening coverage. We aimed to determine the performance of first void urine for high-risk human papillomavirus DNA detection, the prevalence of high-risk HPV, and the acceptability of first void urine sampling. MATERIALS AND METHOD: A comparative cross-sectional study was conducted among 100 HIV- infected women at St Francis' Hospital in Zambia, attending the routine HIV/AIDS services and cervical cancer screening. 17 mL of first void urine sample collected by each participant was immediately mixed with 3 mL of 0.5 M EDTA preservative solution before cervical sample collection by the clinician. For testing, 2 mL of first void urine and 1 mL of the cervical sample were tested using the GeneXpert platform. An interview-based questionnaire was used to gather data on the acceptability of first void urine sampling. Data was analyzed using Stata version 17. RESULTS: The mean age of the participants was 42.58 years (95% CI 40.98-44.19; SD 8.01). High-risk HPV prevalence was 34% (95% CI 24%-43.9%) in both cervical and first void urine samples. Sensitivity and specificity were 84.8% (95% CI 68.1%-94.9%) and 92.3% (83%-97.5%), respectively. There was 89.80% agreement between the samples (κ = 0.77; 95% CI 0.64-0.91). First void urine sampling was highly accepted. CONCLUSION: High-risk HPV DNA can be detected in first void urine samples using the GeneXpert, with a substantial agreement with cervical samples. An affordable preservative such as Ethylenediamine tetraacetic acid can prevent DNA degradation. With optimization, first void urine sampling has the potential to increase screening coverage.

Sexual and reproductive health knowledge of secondary school adolescents in Fako, Cameroon.

Introduction: the correct sexual and reproductive health knowledge of adolescents remains important to empower them for healthy decision-making. The study aimed to assess the sexual and reproductive health knowledge of secondary school adolescents in Fako, Cameroon. Methods: a cross-sectional survey of 1180 adolescents from nine schools in Fako, was conducted using a structured interviewer - guided questionnaire. Data were analysed using SPSS version 26. Descriptive statistics and logistic regression analysis were used to outline knowledge and to identify predictors of knowledge respectively. Statistical significance was set at p<0.05. Results: more than half (54.0%) of the participants had overall good sexual and reproductive health knowledge. However, 63.1% and 55.3% of the participants had poor knowledge on reproductive system functions and sexually transmissible infections respectively. In addition, 56.0% had overall good contraceptive knowledge, with 51.6% having poor knowledge on condom. Being male (AOR=0.43, 95% CI=0.20, 0.92) and using the internet to search for sexuality related information (AOR=0.46, 95% CI= 0.22, 0.94) were associated with good knowledge. Being in lower secondary school was an independent predictor of poor knowledge (AOR= 3.83, 95% CI= 1.67, 8.81). Conclusion: although slightly above half of adolescent secondary school students had good sexual and reproductive health knowledge, there existed several gaps in such knowledge. Policymakers especially in the education sector need to evaluate the current state of school-based sexual and reproductive health education in Cameroon, in order to design comprehensive curricula, that will begin from lower secondary school. Internet-based comprehensive sexuality education is also needed.

Postpartum haemorrhage in anaemic women: assessing outcome measures for clinical trials.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of maternal mortality worldwide. Maternal anaemia greatly increases the risk of PPH, and over a third of all pregnant women are anaemic. Because anaemia reduces the oxygen-carrying capacity of the blood, anaemic women cannot tolerate the same volume of blood loss as healthy women. Yet the same blood loss threshold is used to define PPH in all women. The lack of an established PPH definition in anaemic women means the most appropriate outcome measures for use in clinical trials are open to question. We used data from the WOMAN-2 trial to examine different definitions of PPH in anaemic women and consider their appropriateness as clinical trial outcome measures. MAIN BODY: The WOMAN-2 trial is assessing tranexamic acid (TXA) for PPH prevention in women with moderate or severe anaemia at baseline. To obtain an accurate, precise estimate of the treatment effect, outcome measures should be highly specific and reasonably sensitive. Some outcome misclassification is inevitable. Low sensitivity reduces precision, but low specificity biases the effect estimate towards the null. Outcomes should also be related to how patients feel, function, or survive. The primary outcome in the WOMAN-2 trial, a 'clinical diagnosis of PPH', is defined as estimated blood loss > 500 ml or any blood loss within 24 h sufficient to compromise haemodynamic stability. To explore the utility of several PPH outcome measures, we analysed blinded data from 4521 participants. For each outcome, we assessed its: (1) frequency, (2) specificity for significant bleeding defined as shock index ≥1.0 and (3) association with fatigue (modified fatigue symptom inventory [MFSI]), physical endurance (six-minute walk test) and breathlessness. A clinical diagnosis of PPH was sufficiently frequent (7%), highly specific for clinical signs of early shock (95% specificity for shock index ≥1) and associated with worse maternal functioning after childbirth. CONCLUSION: Outcome measures in clinical trials of interventions for PPH prevention should facilitate valid and precise estimation of the treatment effect and be important to women. A clinical diagnosis of PPH appears to meet these criteria, making it an appropriate primary outcome for the WOMAN-2 trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT03475342, registered on 23 March 2018; ISRCTN62396133, registered on 7 December 2017; Pan African Clinical Trial Registry PACTR201909735842379, registered on 18 September 2019.

Characterization of primary female infertility in a Nigerian tertiary hospital: A case-control study.

Primary female infertility is a serious reproductive health concern amongst many women in Nigeria with associated psychosocial impact. There is a need for early prediction of this disorder for increased chances of fertility in Nigerian women. This study reported the anthropometric, sociodemographic, and clinical baseline characteristics of primary infertility females and studied their viability as predictors of primary infertility. This is a case-control study of primarily infertile (54) and fertile (50) Nigerian females aged 20-44 years recruited by random selection of patients who visited University College Hospital between August and November 2020. A clinical proforma was utilized to assess sociodemographic data, fertility history and clinical diagnosis of study participants. The body mass index (BMI) of both fertile and infertile females was in the overweight category (27.98±0.87 and 28.18±0.59, respectively). Both fertile and primary infertile females present a normal menarcheal age (13.68±0.27 and 13.91 ± 0.32 years, respectively), and there was no significant difference between the menarcheal age (p = 0.411) in both study groups. Ovarian disorder was the most contributing clinical diagnosis (67%) of primary infertility. There is a significant strong association between menarcheal age, ovarian factor infertility (χ2 = 13.839, φc = 0.458, p = 0.008) and tubal factor infertility (χ2 = 11.111; φc = 0.527, p=0.025). Females with primary infertility may present with overweight in no significantly different way than fertile females and BMI may not be useful in predicting primary infertility. However, menarcheal age may be a valuable tool to predict the ovarian and tubal factors in primary infertility.

Lactobacillus crispatus thrives in pregnancy hormonal milieu in a Nigerian patient cohort.

Steroid hormones are one of the presumed modulators of Lactobacillus abundance in the vaginal epithelium. We set out to characterize the vaginal microbiome (VMB) and also provide an in-depth understanding of the relative contribution of estradiol (E2) and progesterone (P1) in shaping the vaginal microbiome of Nigerian women (n = 38) who experienced both uncomplicated term delivery and preterm delivery using samples longitudinally collected during pregnancy (17-21, 27-31, 36-41 weeks gestation) and 6 weeks postpartum. Vaginal swabs and blood samples were aseptically collected. Vaginal swabs were used for microbiome assessment using 16S ribosomal RNA (rRNA) gene sequencing. Blood samples were used for hormonal measurement using a competitive-based enzyme-linked immunosorbent assay (ELISA). Across several maternal covariates, maternal age, pregnancy status and delivery mode were not significantly associated with the vaginal microbiota whereas maternal E2 level (pE2 = 0.006, Omnibus), and P1 level (pP1 = 0.001, Omnibus) were significantly associated with the vaginal microbiome. E2 and P1 concentrations increased throughout pregnancy commensurately with increasing proportions of L. crispatus (pE2 = 0.036, pP1 = 0.034, Linear Mixed Model). An increasing trend of α-diversity was also observed as pregnancy progressed (pobserved ASV = 0.006, LMM). A compositional microbiome shift from Lactobacillus profile to non-Lactobacillus profile was observed in most postnatal women (pCST IV < 0.001, LMM). Analysis of our data shows a species-specific link between pregnancy steroid hormone concentration and L. crispatus abundance.

Predominance of Atopobium vaginae at Midtrimester: a Potential Indicator of Preterm Birth Risk in a Nigerian Cohort.

Preterm birth (PTB) is the largest contributor to infant death in sub-Saharan Africa and globally. With a global estimate of 773,600, Nigeria has the third highest rate of PTB worldwide. There have been a number of microbiome profiling studies to identify vaginal microbiomes suggestive of preterm and healthy birth outcome. However, studies on the pregnancy vaginal microbiome in Africa are sparse with none performed in Nigeria. Moreover, few studies have considered the concurrent impact of steroid hormones and the vaginal microbiome on pregnancy outcome. We assessed two key determinants of pregnancy progression to gain a deeper understanding of the interactions between vaginal microbiome composition, steroid hormone concentrations, and pregnancy outcome. Vaginal swabs and blood samples were prospectively collected from healthy midtrimester pregnant women. Vaginal microbiome compositions were assessed by analysis of the V3-V5 region of 16S rRNA genes, and potential functional metabolic traits of identified vaginal microbiomes were imputed by PICRUSt (phylogenetic investigation of communities by reconstruction of unobserved states) analysis, while plasma estradiol (E2) and progesterone (P1) levels were quantified by the competitive enzyme-linked immunosorbent assay (ELISA). PTB vaginal samples were characterized by increased microbial richness, high diversity, and depletion of lactobacilli compared to term delivery samples. Women who delivered preterm were characterized by an Atopobium vaginae-dominated vagitype. High relative abundance of Atopobium vaginae at the midtrimester was highly predictive of PTB (area under the receiving operator characteristics [AUROC] of 0.983). There was a marked overlap in the range of plasma E2 and P1 values between term and PTB groups.IMPORTANCE Giving birth too soon accounts for half of all newborn deaths worldwide. Clinical symptoms alone are not sufficient to identify women at risk of giving birth too early, as such a pragmatic approach to reducing the incidence of preterm birth entails developing early strategies for intervention before it materializes. In view of the role played by the vaginal microbiome and maternal steroid hormones in determining obstetric outcome, we assessed the vaginal microbiome composition and steroid hormone during pregnancy and examined their relationship in predicting preterm birth risk in Nigerian women. This study highlights a potential early-driver microbial marker for prediction of preterm birth risk and supports the notion that vaginal microbiome composition varies across populations. A knowledge of relevant preterm birth microbial markers specific to populations would enhance the development of personalized therapeutic interventions toward restoring a microbiome that optimizes reproductive health fitness, therefore reducing the incidence of preterm birth.

A clinical audit of the patterns of presentations and complications of abdominal myomectomy at the University College Hospital, Ibadan, Nigeria.

Abdominal myomectomy is a common modality of treatment for large and symptomatic uterine fibroids in women who wish to retain their fertility. Black women have higher rates and larger sizes of uterine fibroids. We aimed to determine the presentation patterns, peri-operative complications, and determinants of complications in patients who underwent abdominal myomectomy. This was a retrospective review of women who had abdominal myomectomy between July 2016 and June 2019. There were intra-operative complications and post-operative complications in 25% and 29.3% of patients respectively. There were higher odds for developing intra-operative complications among those who had general anaesthesia [OR = 3.514, 95%CI (1.951-6.331)], more than 10 fibroid nodules enucleated [OR = 4.917, 95%CI (2.600-9.298)], pre-operative Packed cell volume (PCV) < 30% [OR = 4.831, 95%CI (2.370-9.880)], presence of adhesions [OR = 2.680, 95%CI (1.510-4.730)], fibroids larger than 10 centimetres [OR = 1.98, 95%CI (1.13-3.49)], previous pelvic surgery [OR = 2.68, 95%CI (1.52-4.63)]. Post-operative complications were higher in those who had general anaesthesia or pre-existing medical conditions.IMPACT STATEMENTWhat is already known on this subject? Abdominal myomectomy is a major surgical procedure globally with a significant morbidity rate. Sufficient evidence relating to the determinants of peri-operative complications are lacking.What do the results of this study add? Our results highlight the factors associated with increased odds of developing complications following abdominal myomectomy.What are the implications of these findings for clinical practice and/or further research? Our study complements existing data on the peri-operative complications following abdominal myomectomy. It also reflects the possibility of mortality albeit a rarerity. A retrospective multivariate analysis like this, while classifying morbidities into intra-operative and post-operative complications, is required to start an audit cycle. Knowing these determinants will help improve patient optimisation for surgery, identify high risk women and enhance more directed counselling. The results from this pilot study will also be used to design a prospective study to be undertaken by the authors.

The vaginal microbiome of sub-Saharan African women: revealing important gaps in the era of next-generation sequencing.

Accurate characterization of the vaginal microbiome remains a fundamental goal of the Human Microbiome project (HMP). For over a decade, this goal has been made possible deploying high-throughput next generation sequencing technologies (NGS), which indeed has revolutionized medical research and enabled large-scale genomic studies. The 16S rRNA marker-gene survey is the most commonly explored approach for vaginal microbial community studies. With this approach, prior studies have elucidated substantial variations in the vaginal microbiome of women from different ethnicities. This review provides a comprehensive account of studies that have deployed this approach to describe the vaginal microbiota of African women in health and disease. On the basis of published data, the few studies reported from the African population are mainly in non-pregnant post pubertal women and calls for more detailed studies in pregnant and postnatal cohorts. We provide insight on the use of more sophisticated cutting-edge technologies in characterizing the vaginal microbiome. These technologies offer high-resolution detection of vaginal microbiome variations and community functional capabilities, which can shed light into several discrepancies observed in the vaginal microbiota of African women in an African population versus women of African descent in the diaspora.

Predictors of postpartum glucose intolerance in women with gestational diabetes mellitus: a prospective cohort study in Ethiopia based on the updated diagnostic criteria.

OBJECTIVES: To identify the incidence of postpartum glucose intolerance and develop a prediction model based on antenatal characteristics to predict postpartum glucose intolerance. DESIGN: Prospective cohort study. SETTING: Gondar town public health facilities in Northwest Ethiopia. PARTICIPANTS: Women who had gestational diabetes mellitus were advised to undergo postpartum oral glucose tolerance test at 6-12 weeks of delivery. MAIN OUTCOME: Postpartum glucose intolerance. DATA ANALYSIS: Predictors of postpartum glucose intolerance were identified using multivariable logistic regression analysis. The discriminative power of the predictor variables for postpartum glucose intolerance and the model accuracy were computed by area under the receiver operating characteristic curve and estimated by area under the curve (AUC) with 95% CI. RESULTS: A total of 112 (85.5%) women with gestational diabetes mellitus returned and completed the postpartum oral glucose tolerance test. The incidence of postpartum glucose intolerance was 21.4% (95% CI14.3 to 28.4), inclusive of 18.7% pre-diabetes and 2.7% diabetes. Multivariable logistic regression analysis revealed that advanced maternal age, high fasting plasma glucose level at diagnosis, overweight and/or obesity, and antenatal depression were predictors of postpartum glucose intolerance. The AUC of the final reduced model to predict postpartum glucose intolerance was 0.884 (95% CI 0.822 to 0.937). Fasting plasma glucose at diagnosis of gestational diabetes mellitus (AUC=0.736, 95% CI0.616 to 0.845) and overweight and/or obesity (AUC=0.718, 95% CI 0.614 to 0.814) were better predictors of postpartum glucose intolerance. Moreover, the AUC for the combined predictors of fasting plasma glucose at diagnosis and mid-upper arm circumference was 0.822 (95% CI 0.722 to 0.907), which was the best predictor. CONCLUSIONS: The incidence of postpartum glucose intolerance was high among women with gestational diabetes mellitus. Antenatal predictors modestly predicted postpartum glucose intolerance. The findings suggest ongoing glucose screening is indicated for all women with gestational diabetes mellitus.

Gestational diabetes mellitus increased the risk of adverse neonatal outcomes: A prospective cohort study in Northwest Ethiopia.

BACKGROUND: Gestational diabetes mellitus is a rising global public health problem that can have short- and long-term sequelae for both mother and offspring. However, there are limited evidences on the effect of gestational diabetes mellitus on adverse neonatal outcomes using the updated international diagnostic criteria on adverse effects on neonatal outcomes. Therefore, this study was aimed to examine the effects of gestational diabetes mellitus on the risk of adverse neonatal outcomes in Ethiopia. METHODS: A prospective cohort study was conducted among pregnant women recruited from antenatal clinics and followed through pregnancy to delivery. Gestational diabetes mellitus was diagnosed using a two-hour 75g oral glucose tolerance test strategy with recent criteria. Multivariable log-binomial model was used to identify the effects of gestational diabetes mellitus on the risk of adverse neonatal outcomes which includes macrosomia, low birth weight, large for gestational age, small for gestational age, preterm birth, low Apgar score at the first minute, low Apgar score at fifth minute, and composite adverse neonatal outcome. RESULTS: Among pregnant women (n=1027) included in the follow up data on neonatal outcomes were available for 684 (118 newborns of mothers with gestational diabetes mellitus and 566 newborns of women without gestational diabetes mellitus). There was a statistical baseline difference between the two groups by maternal age, dietary diversity status, level of physical activity, and antenatal depression. The incidence of composite adverse neonatal outcome was significantly higher (P<0.001) among newborns from mothers with gestational diabetes mellitus (51.7%) than among newborns from mothers without gestational diabetes mellitus (25.8%). Significantly higher risk of developing adverse neonatal outcomes among newborns from gestational diabetes mellitus mothers was observed for composite adverse neonatal outcome (Adjust Relative Risk (ARR)=1.72; 95% CI: 1.35, 2.19), macrosomia (ARR= 3.81; 95% CI: 1.95, 7.45), large for gestational age (ARR= 2.38; 95% CI: 1.41, 4.03), preterm birth (ARR= 2.03; 95% CI: 1.17, 3.53), low Apgar score at the first minute (ARR= 1.71; 95% CI: 1.02, 2.86), and fifth minute (ARR= 2.14; 95% CI: 1.05, 4.36). However, no significant differences in the risk of low birth weight and small for gestational age by gestational diabetes mellitus status. CONCLUSIONS: Gestational diabetes mellitus increases the risk of adverse neonatal outcomes particularly macrosomia, large for gestational age, preterm birth, and poor Apgar score. Hence, the role of preventing gestational diabetes mellitus is quite crucial to improve neonatal outcomes.

Protocol for a Longitudinal Analysis of the Vaginal Microbiome from a Pregnant Cohort of African Women in Nigeria.

BACKGROUND: The vaginal microbiota is an important component of the reproductive health of women as it offers protection against urogenital infection. African women are reported to have a vaginal microbiota colonized with high proportions of strict anaerobes rather than lactobacillus- dominated microbes. These strict anaerobes have been associated with pre-term birth and neonatal disease. The prevalence of pre-term birth (PTB) in Africa poses a major challenge to reproductive healthcare, hence the clinical and scientific attention focused on understanding the causative mechanisms of PTB. A pragmatic approach to curbing PTB requires the identification of the vaginal microbiome during various stages of a healthy pregnancy (the 'normal'). This information will provide baseline data for future investigations of vaginal microbiome that may cause PTB (the 'abnormal'). We present a protocol for the longitudinal analysis of vaginal microbiome in a cohort of pregnant women in Southwest Nigeria. METHODS: We propose to recruit 51 pregnant Nigerian women, enrolling them into the study at 17-21 gestational weeks. Two vaginal swab samples and three milliliters of blood would be collected at enrollment. Sample collection will be repeated at 27-31 weeks' gestation, ≥36 weeks' gestation, 24-48 hours after birth and 6 weeks post-partum. DNA will be extracted from the vaginal samples and 16S rRNA sequencing would be performed. Blood samples collected would be assayed by ELISA technique for placental steroid hormones. Data will be statistically analyzed and considered in the light of vaginal microbial diversity, clinical, nutrition and other health data. CONCLUSION AND GLOBAL HEALTH IMPLICATION: Our data set will bring new insights into the vaginal microbiome of apparently healthy African women in pregnancy and postpartum, which should serve as a baseline for the investigation of vaginal microbes that may provide useful information for the prediction and management of preterm birth. It is anticipated that these data will facilitate future personalized therapeutic management and consequently improve the reproductive health fitness of women in Africa.

Effects of gestational diabetes mellitus on risk of adverse maternal outcomes: a prospective cohort study in Northwest Ethiopia.

BACKGROUND: Gestational diabetes mellitus is a leading medical condition woman encounter during pregnancy with serious short- and long-term consequences for maternal morbidity. However, limited evidence was available on potential impacts of gestational diabetes mellitus using updated international diagnostic criteria on adverse maternal outcomes. Therefore, this study aimed to assess the effects of gestational diabetes mellitus on the risk of adverse maternal outcomes in Northwest Ethiopia. METHODS: A prospective cohort study was conducted among pregnant women followed from pregnancy to delivery. Gestational diabetes mellitus status was determined by using a two-hour 75 g oral glucose tolerance test and based on updated international diagnostic criteria. Multivariable log-binomial model was used to examine the effects of gestational diabetes mellitus on the risk of adverse maternal outcomes. RESULTS: A total of 694 women completed the follow-up and included in the analysis. Women with gestational diabetes mellitus had a higher risk of composite adverse maternal outcome (ARR=1.58, 95% CI: 1.22, 2.04), caesarean delivery (ARR=1.67; 95%: 1.15, 2.44), pregnancy induced hypertension (ARR= 3.32; 95%: 1.55, 7.11), premature rupture of membranes (ARR= 1.83; 95%: 1.02, 3.27), antepartum hemorrhage (ARR= 2.10; 95%: 1.11, 3.98) and postpartum hemorrhage (ARR= 4.85; 95%:2.28, 10.30) compared to women without gestational diabetes mellitus. CONCLUSIONS: Gestational diabetes mellitus increased the risk of adverse maternal outcomes. This implies that maternal care and intervention strategies relating to women with gestational diabetes mellitus should be strengthened.

Prevalence of gestational diabetes mellitus and associated factors among women attending antenatal care at Gondar town public health facilities, Northwest Ethiopia.

BACKGROUND: Globally, Gestational Diabetes Mellitus (GDM) is rising, but it is a neglected health threat to mothers and their children in low resource countries. Although, GDM is known in Ethiopia, information regarding it remains scarce by recent diagnostic criteria. Therefore, this study aimed to determine the prevalence of GDM and associated factors among women attending antenatal care at Gondar town public health facilities, Northwest Ethiopia. METHODS: A cross-sectional study was conducted among 1027 pregnant women selected by the systematic random sampling technique. The universal one-step screening and diagnostic strategy was done using a two-hour 75 g oral glucose tolerance test. GDM was diagnosed using updated diagnostic criteria (2017 American Diabetes Association (ADA) or 2013 World Health Organization (WHO) or modified International Association of the Diabetes and Pregnancy Study Groups diagnostic criteria (IADPSG)). Binary logistic regression model was used to identify factors associated with GDM. RESULTS: Of the total 1027 pregnant women, 12.8% (95% CI: 10.8-14.8) were diagnosed with GDM. Overweight and/or obesity (MUAC ≥28 cm) (AOR = 2.25, 95% CI: 1.18-4.26), previous history of GDM (AOR = 5.82, 95% CI: 2.57-13.18), family history of diabetes (AOR = 4.03, 95% CI: 1.57-10.35), low physical activity (AOR = 3.36, 95% CI: 1.60-7.04), inadequate dietary diversity (AOR = 1.9, 95% CI: 1.02-3.53), and antenatal depression (AOR = 4.12, 95% CI: 1.85-9.20) were significantly associated with GDM. CONCLUSIONS: The prevalence of GDM among women attending antenatal care at Gondar town public health facilities was high. Previous history of GDM, antenatal depression, family history of diabetes, low physical activity, overweight and/or obesity and inadequate dietary diversity were significantly associated with GDM. Routine screening of pregnant women and healthy lifestyle are strongly recommended.