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.

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.

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.

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.

Haematological and fibrinolytic status of Nigerian women with post-partum haemorrhage.

BACKGROUND: Early treatment with tranexamic acid reduces deaths due to bleeding after post-partum haemorrhage. We report the prevalence of haematological, coagulation and fibrinolytic abnormalities in Nigerian women with postpartum haemorrhage. METHODS: We performed a secondary analysis of the WOMAN trial to assess laboratory data and rotational thromboelastometry (ROTEM) parameters in 167 women with postpartum haemorrhage treated at University College Hospital, Ibadan, Nigeria. We defined hyper-fibrinolysis as EXTEM maximum lysis (ML) > 15% on ROTEM. We defined coagulopathy as EXTEM clot amplitude at 5 min (A5) < 40 mm or prothrombin ratio > 1.5. RESULTS: Among the study cohort, 53 (40%) women had severe anaemia (haemoglobin< 70 g/L) and 17 (13%) women had severe thrombocytopenia (platelet count < 50 × 109/L). Thirty-five women (23%) had ROTEM evidence of hyper-fibrinolysis. Based on prothrombin ratio criteria, 16 (12%) had coagulopathy. Based on EXTEM A5 criteria, 49 (34%) had coagulopathy. CONCLUSION: Our findings suggest that, based on a convenience sample of women from a large teaching hospital in Nigeria, hyper-fibrinolysis may commonly occur in postpartum haemorrhage. Further mechanistic studies are needed to examine hyper-fibrinolysis associated with postpartum haemorrhage. Findings from such studies may optimize treatment approaches for postpartum haemorrhage. TRIAL REGISTRATION: The Woman trial was registered: NCT00872469; ISRCTN76912190 (Registration date: 22/03/2012).

Screening for bacterial vaginosis before intrauterine device insertion at a family planning clinic in south-west Nigeria.

AIM: This study determined the prevalence of bacterial vaginosis (BV) among clients before insertion of intrauterine device (IUD) and compared the incidence of complications between participants who were positive and negative for BV. PATIENTS AND METHODS: This was an observational cohort study that was performed between May 2014 and September 2014. A total of 360 women were recruited and followed up for 1 month. High vaginal swabs were obtained from each participant pre-insertion of the IUD and 1 month post-insertion. BV was diagnosed using Nugent's scoring. Data were collected, collated and analysed using frequency distributions and Chi-square test as appropriate. The level of statistical significance was P< 0.05. RESULTS: The prevalence of BV was 33.3%. The complication rate was 23.9% in which 30.5% complication rate was seen among participants positive for BV and 22.5% among participants negative for BV (P = 0.192). This was done with respect to four primary clinical outcomes. The incidence of BV one month after IUD insertion was 11.5%. CONCLUSION: The prevalence of BV was within the range reported in other populations. The complication rate appeared high; however, the differences in proportion between women positive and negative for BV were not statistically significant.

In-vitro fertilization, gamete donation and surrogacy: perceptions of women attending an infertility clinic in Ibadan, Nigeria.

Infertility affects 20% of couples in Nigeria. Assisted reproductive techniques (ART) offered in Nigeria include in-vitro fertilization (IVF), gamete donation and surrogacy. This cross-sectional questionnaire study aimed at assessing the acceptability of ART to women seeking infertility treatment at the University College Hospital, Ibadan, Nigeria. Of the 307 respondents, 58.3% were aware of IVF and 59.3% would accept it as treatment; 35.2% would accept donor eggs and 24.7% would accept donor sperms-a smaller proportion anticipated acceptability by their husbands. Thirty five percent were aware of surrogacy, 37.8% would accept it as treatment; most preferring a stranger as a surrogate. Most felt surrogates should not be paid. Acceptance of ART was associated with older age, longer duration of infertility, previous failed treatment and women without other children. As chances of successful pregnancy are improved in younger individuals, counselling towards overcome barriers to accepting gamete donation and surrogacy should be instituted early.

The knowledge base and acceptability of prenatal diagnosis by pregnant women in Ibadan.

This cross-sectional study evaluated knowledge and acceptability of prenatal diagnosis among 500 pregnant women at the University College Hospital, Ibadan. Most participants were aged 25-34 years, self-employed, Muslim, monogamy, secondary school leavers, on income of < naira10,000.00 (US$ 67.00)/month. Attitudinal mean score was dependent on age (p = 0.006), educational attainment (p = 0.001), marital status (p = 0.025) and religion (p = 0.012). Knowledge mean score was influenced by marital status (p = 0.028). Overall, acceptance of prenatal diagnosis was high. There was a direct correlation between acceptance and educational attainment: 41.5%, 31.50%, 19%, 19% of women who agreed to have prenatal diagnosis had tertiary, secondary school, primary school and no formal education respectively. Determinants of acceptability were age, educational attainment, marital status and religion. Being married significantly affected knowledge scores, while tertiary education, being divorced, unskilled and self-employed positively influenced attitude towards prenatal diagnosis.

Prevalence of antenatal hepatitis B infection in tertiary and non-tertiary health facilities in Ibadan, Nigeria.

BACKGROUND: Hepatitis B infection remains a significant source of morbidity among women and infants at different levels of care particularly in developing countries. AIM: To determine the prevalence of hepatitis B infection among pregnant women in tertiary and non-tertiary health facilities. MATERIALS & METHODS: Women receiving antenatal care in a tertiary centre and 2 non-tertiary centres in Ibadan. Nigeria were consecutively screened for Hepatitis B surface antigen by the ELISA method following written informed consent. The results were entered with socio-demographic and obstetric data into a proforma and significant associations determined by chi-square test and logistic regression (p < 0.05). RESULTS: A total of 658 women were recruited; 389 were from the tertiary hospital while 259 were from nontertiary health facilities. The mean age of the whole population was 30.17 +/- 5.24 years while the median gestational age was 27 weeks. Majority of the participants (64.5%) were between 26 and 35 years. The total prevalence of Hepatitis B infection was 16.3%. Prevalence of hepatitis B infection was 30.9% in the non-tertiary health facilities and 6.4% in the tertiary health facility (p = 0.000).The only significant positive predictor variable for hepatitis B infection was being in a non-tertiary health facility (OR: 0.086 CI: 0.037-0.199, p = 0.004). CONCLUSION: The burden ofAntenatal hepatitis B infection in Ibadan may be significantly greater in nontertiary health facilities. Health policy, particularly in these centres, should be directed towards education, screening and vaccination programmes.

Determinants for male involvement in family planning and contraception in Nakawa Division, Kampala, Uganda; An urban slum qualitative study.

Current evidence shows that male involvement in family planning (FP) is crucial to women's contraceptive use decisions. This study explored the reasons for male involvement in FP and contraception in slum areas in Nakawa Division, Kampala, Uganda. A qualitative study was conducted among sexually active males in a slum area in Nakawa Division, Kampala. A purposive sampling technique was utilised to recruit 40 men for a Focus Group Discussion (FGDs), and 2 key informants (KI) for critical perspective interviews. A semi-structured FGDs and interview guides were used to collect the data. The FGDs were conducted in both English and the local language, Luganda. All interviews were recorded and transcribed verbatim. Transcripts for both FGDs and KI interviews were imported into the NVivo Qualitative Data Analysis Software version 10 application, and thematic data analysis was conducted. The findings show that males' involvement in FP and its decisions were minimal. The findings also show that several factors emerged as contributing to male's participation in FP and utilisation of contraceptives. Inadequate understanding of FP and contraceptives, lack of clarity on males' role in FP, unfriendly healthcare environment and community members' perceptions of male involvement in FP were reported as reasons contributing to male participation in FP and contraction. There is limited involvement of males in FP. There is a need for renewed efforts that will positively alter the factors that impact male involvement favourably. Promotion and education about FP for males will significantly address issues of limited understanding and clarity of males' role in FP services.

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.

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.

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.

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.

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.

Urinary pathogens and drug susceptibility patterns of urinary tract infections among antenatal clinic attendees in Ibadan, Nigeria.

AIM: To determine the bacterial agents involved in urinary tract infections in pregnant women and their antibiotic susceptibility patterns in Ibadan, Nigeria. METHODS: All consenting subjects who attended antenatal clinics of the University College Hospital and Adeoyo Maternity Hospital, Ibadan, Nigeria, from 1 April 2007 and 30 March 2009 were interviewed to obtain demographic and pregnancy health data. Mid-stream urine samples obtained were processed by standard methods. Confirmed bacterial isolates were tested against seven antibiotics using the Kirby-Bauer disc diffusion technique. RESULTS: Of the 473 specimens processed, 136 (28.8%) were positive for microscopy, 118 (25.0%) were culture positive, while 18 (3.8%) were microscopy positive but negative for culture. More than 90% of the bacterial isolates were Gram-negative bacilli, of which approximately 80% were members of the family Enterobacteriaceae. Klebsiella oxytoca accounted for 45 (38.1%) of the causative agents identified, followed by Escherichia coli (31.3%), Pseudomonas aeruginosa (9.3%) and Proteus mirabilis (6.8%). Candida albicans accounted for three (2.6%) of the isolates. Ten isolates (22.2%) of K. oxytoca were resistant to cefuroxime while three (6.7%) were resistant to ofloxacin. The only Gram-positive bacterium isolated, Staphylococcus saprophyticus, accounted for four (4.3%) of all pathogens, of which three (75.0%) were susceptible to nitrofurantoin, ofloxacin, cefuroxime and the amoxicillin-clavulanic acid combination. CONCLUSIONS: In conclusion, the incidence of culture-positive urinary tract infection in pregnancy is common in Ibadan. More studies are needed to evaluate the susceptibility profile of uropathogens to commonly used antibiotics in our environment.