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).

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.

Prevalence and determinants of self-reported anxiety and stress among women with abortion-related complications admitted to health facilities in Eastern and Southern Africa: A cross-sectional survey.

OBJECTIVE: To estimate the prevalence of women who were admitted to health facilities with abortion-related complications who reported feeling anxious/stressed during their stay, and to identify sociodemographic, facility, and abortion-related characteristics associated with self-reported experience of anxiety/stress. METHODS: We used data from four countries in Eastern and Southern Africa (Kenya, Malawi, Mozambique, and Uganda) collected from 2017-2018 as part of the World Health Organization (WHO) Multi-Country Survey on Abortion-related morbidity (MCS-A). Information was extracted from women's medical records and their participation in audio computer-assisted self-interviews (ACASI). Based on a question in the ACASI, "Did you encounter any anxiety or stress during your hospital stay?", the percentage of women who self-reported feeling anxious/stressed during their facility stay was calculated. Generalized estimating equations were used to identify the determinants of anxiety/stress following a hierarchical approach whereby potential determinants were grouped from most distal to most proximal and analyzed accordingly. RESULTS: There were 1254 women with abortion-related complications included in the analysis, of which 56.5% self-reported that they felt anxious/stressed during their facility stay. We found evidence that lower socioeconomic status, lower levels of education, no previous childbirth, no previous abortion, higher gestational age at abortion, and use of unsafe methods of abortion were independent determinants of self-reporting anxiety/stress. CONCLUSIONS: Action should be taken to reduce experience of anxiety/stress among women attending facilities for postabortion complications, including reducing the number of women experiencing abortion-related complications by improving access to safe abortion. This issue warrants further study using more comprehensive and validated tools to understand the levels and drivers of anxiety/stress self-reported by women attending facilities with abortion-related complications.

Abortion-related infections across 11 countries in Sub-Saharan Africa: Prevalence, severity, and management.

OBJECTIVE: To estimate the prevalence of infection among abortion-related complications in health facilities, describe their management, and identify sociodemographic and clinical factors associated with abortion-related infections. METHODS: A secondary analysis of the WHO Multi-Country Survey on Abortion-related morbidity (MCS-A) conducted in 210 health facilities of 11 Sub-Saharan African countries between 2017 and 2018. The outcome variable was abortion-related infections, categorized into three mutually exclusive groups of abortion-related complications: infections only, infection with other complications, and other complications without infection. We described the sociodemographic and clinical characteristics and the management of abortion-related infection and identified the factors associated with abortion-related infections using a multinomial logistic model. RESULTS: A total of 9232 women with abortion-related complications were included, with infection occurring among 10.6% of women (n = 974). Infection was involved in 47.4% (n = 153) of severe maternal outcomes with a case fatality rate of 27.4% (n = 42). The most common management approach was antibiotics, uterine evacuation, and uterotonics combined: 43.2% (n = 384) in the group of women with infection only and 48.6% (n = 4235) among those with infection and other complications. In addition, 85.9% (n = 7095) of women without infection also received therapeutic antibiotics. Factors associated with an increased odds of infection only compared with complication without infection were age younger than 20 years compared with those aged over 30 (aOR 1.84; 95% CI,1.24-2.74), not living in a couple (aOR 2.05, 95% CI,1.52-2.76), and gestational age of 13 weeks or more (aOR 1.70, 95% CI,1.27-2.26). The same factors were associated with infection and other complications. CONCLUSION: Infection is frequent among severe abortion-related complications, and its case fatality rate is high. Further research to assess the relationship between abortion-related infections and outcomes is needed. There is also a need to question the quality of postabortion care and improve adequate use of antibiotics.

Health facilities' capability to provide comprehensive postabortion care in Sub-Saharan Africa: Evidence from a cross-sectional survey across 210 high-volume facilities.

OBJECTIVE: To evaluate the capability of high-volume comprehensive emergency obstetric care (CEmOC) health facilities on the provision of comprehensive postabortion care (PAC) in Sub-Saharan Africa and to determine the frequency of women with severe abortion-related complications in high capability facilities. METHODS: A cross-sectional analysis conducted across 11 countries in Sub-Saharan Africa, using facility-level information from the World Health Organization (WHO) Multi-Country Survey on Abortion-related morbidity (MCS-A) between 2017 and 2018. PAC signal functions were adapted to assess facilities' capability to deliver comprehensive PAC through infrastructure, standard comprehensive capability, and extended comprehensive capability to provide PAC. The percentage of facilities with each signal function and distribution of facilities by number of signal functions were calculated for the three capability categories. Distribution of severe abortion complications by facility capability score was assessed. RESULTS: Of 210 high-volume CEmOC facilities included, 47.9% (n = 100) had capability to provide all facility infrastructure signal functions, 54.4% (n = 105) for standard comprehensive PAC, reducing to 17.7% (n = 34) for extended comprehensive PAC capability. Overall, there were gaps in extended capabilities including availability of a functioning ICU (available in 37.3% of facilities) and providers 24/7 (65.5% of facilities reported an obstetrician available 24/7 dropping to 41.3% for anesthesiologists). Facilities' PAC capability varied across regions. Overall, 34.6% (n = 614) of women with severe abortion-related complications were treated in facilities with the maximum capability score for extended comprehensive PAC. CONCLUSION: Although high levels of capability to provide abortion-related care for most signal functions were evident, significant gaps that impact on the management of severe abortion-related complications remain, particularly related to extended facility capabilities including specialized human resources and ICU.

Level and determinants of contraceptive uptake among women attending facilities with abortion-related complications in East and Southern Africa.

OBJECTIVE: To investigate the level and determinants of nonreceipt of contraception among women admitted to facilities with abortion-related complications in East and Southern Africa. METHODS: Cross-sectional data from Kenya, Malawi, Mozambique, and Uganda collected as part of the World Health Organization (WHO) Multi-Country Survey on Abortion-related morbidity. Medical record review and the audio computer-assisted self-interviewing system were used to collect information on women's demographic and clinical characteristics and their experience of care. The percentage of women who did not receive a contraceptive was estimated and the methods of choice for different types of contraceptives were identified. Potential determinants of nonreceipt of contraception were grouped into three categories: sociodemographic, clinical, and service-related characteristics. Generalized estimating equations were used to identify the determinants of nonreceipt of a contraceptive following a hierarchical approach. RESULTS: A total of 1190 women with abortion-related complications were included in the analysis, of which 33.9% (n = 403) did not receive a contraceptive. We found evidence that urban location of facility, no previous pregnancy, and not receiving contraceptive counselling were risk factors for nonreceipt of a contraceptive. Women from nonurban areas were less likely not to receive a contraceptive than those in urban areas (AOR 0.52; 95% CI, 0.30-0.91). Compared with women who had a previous pregnancy, women who had no previous pregnancy were 60% more likely to not receive a contraceptive (95% CI, 1.14-2.24). Women who did not receive contraceptive counselling were over four times more likely to not receive a contraceptive (AOR 4.01; 95% CI, 2.88-5.59). CONCLUSION: Many women leave postabortion care having not received contraceptive counselling and without a contraceptive method. There is a clear need to ensure all women receive high-quality contraceptive information and counselling at the facility to increase contraceptive acceptance and informed decision-making.

Adolescents' satisfaction with care for abortion-related complications in 11 Sub-Saharan African countries: A cross-sectional facility-based study.

OBJECTIVE: To assess satisfaction with care for abortion-related complications experienced among adolescents compared to older women. METHODS: A secondary analysis of the WHO Multi-Country Survey on Abortion-related Morbidity and Mortality-a cross-sectional study conducted in health facilities in 11 Sub-Saharan African countries. Women with abortion-related complications who participated in an audio computer-assisted self-interview were included. Two composite measures of overall satisfaction were created based on five questions: (1) study participants who were either satisfied or very satisfied across all five questions; and (2) study participants who reported being very satisfied only across all five questions. Multivariable general estimating equation analyses were conducted to assess whether there was any evidence that age (adolescents 12-19 years and older women 20+) was associated with each composite measure of satisfaction, controlling for key confounders. RESULTS: The study sample consisted of 2817 women (15% adolescents). Over 75% of participants reported being satisfied or very satisfied for four out of five questions. Overall, 52.9% of study participants reported being satisfied/very satisfied across all five questions and 22.4% reported being consistently very satisfied. Multivariable analyses showed no evidence of an association between age group and being either satisfied or very satisfied (OR 1.07; 95% CI, 0.82-1.41, P = 0.60), but showed strong evidence that adolescents were 50% more likely to be consistently very satisfied with their overall care than older women (OR 1.49; 95% CI, 1.13-1.96, P = 0.005). CONCLUSION: Both adolescents and older women reported high levels of satisfaction with care when looking at different components of care individually, but the results of the composite measure for satisfaction showed that many study participants reported being less than satisfied with at least one element of their care. Further studies to explore the expectations, needs, and values of women's satisfaction with care for abortion-related complications are needed.

Reducing anxiety and depression in infertility among Nigerian women: an exploratory psycho-educational intervention trial (RADIANT) study protocol.

RATIONALE: high premium is placed on infertility in Nigerian culture. Data is limited on its association with emotional problems in Nigeria. AIMS: to develop content for a culturally relevant and cost-effective psychoeducational intervention package and to evaluate its effectiveness for reducing symptoms of anxiety and depression. Sample size estimate: Methods and design: a multi-method study design including development and validation (which includes focus group discussions) of an audio-visual tool which will serve as the intervention in a randomized controlled trial. Data will be analyzed with interim and survival analyses. POPULATION STUDIED: one hundred and 138 (68 per group) infertile women attending infertility clinic in Ibadan. STUDY OUTCOMES: anxiety and depressions scores assessed with the hospital depression and anxiety scale (HADS) at 0, 3 and 6 weeks. DISCUSSION: it is hoped that the use of the audio-visual tool will improve participants depression and anxiety scores and that the tool will be used for education in routine clinic use and community awareness on psychosocial effects of infertility.

Understanding abortion-related complications in health facilities: results from WHO multicountry survey on abortion (MCS-A) across 11 sub-Saharan African countries.

INTRODUCTION: Complications due to unsafe abortions are an important cause of morbidity and mortality in many sub-Saharan African countries. We aimed to characterise abortion-related complication severity, describe their management, and to report women's experience of abortion care in Africa. METHODS: A cross-sectional study was implemented in 210 health facilities across 11 sub-Saharan African countries. Data were collected on women's characteristics, clinical information and women's experience of abortion care (using the audio computer-assisted self-interviewing (ACASI) system). Severity of abortion complications were organised in five hierarchical mutually exclusive categories based on indicators present at assessment. Descriptive bivariate analysis was performed for women's characteristics, management of complications and reported experiences of abortion care by severity. Generalised linear estimation models were used to assess the association between women's characteristics and severity of complications. RESULTS: There were 13 657 women who had an abortion-related complication: 323 (2.4%) women were classified with severe maternal outcomes, 957 (7.0%) had potentially life-threatening complications, 7953 (58.2%) had moderate complications and 4424 (32.4%) women had mild complications. Women who were single, multiparous, presenting ≥13 weeks of gestational age and where expulsion of products of conception occurred prior to arrival to facility were more likely to experience severe complications. For management, the commonly used mechanical methods of uterine evacuation were manual vacuum aspiration (76.9%), followed by dilation and curettage (D&C) (20.1%). Most frequently used uterotonics were oxytocin (50∙9%) and misoprostol (22.7%). Via ACASI, 602 (19.5%) women reported having an induced abortion. Of those, misoprostol was the most commonly reported method (54.3%). CONCLUSION: There is a critical need to increase access to and quality of evidence-based safe abortion, postabortion care and to improve understanding around women's experiences of abortion care.

Prevalence and determinants of low testosterone levels in men with type 2 diabetes mellitus; a case-control study in a district hospital in Ghana.

Diabetes mellitus, an endocrine disorder, has been implicated in many including hypogonadism in men. Given the fact that diabetes mellitus is becoming a fast-growing epidemic and the morbidity associated with it is more disabling than the disease itself. This study sought to assess the prevalence of low testosterone levels and predictors in type 2 diabetes mellitus patients and non-diabetic men in a district hospital in Ghana. This hospital-based case-control study comprised 150 type 2 diabetics and 150 healthy men. A pre-structured questionnaire and patient case notes were used to document relevant demographic and clinical information. Venous blood sample of about 6 ml was taken to measure FBS, HbA1c, FSH, LH, and testosterone levels. All data were analyzed using STATA version 12 (STATA Corporation, Texas, USA). The overall hypogonadism in the study population was 48% (144/300). The prevalence of hypogonadism in type 2 diabetic subjects was almost three times more than in healthy men (70.7% vs 25.3%). The odds of having hypogonadism was lower in the men with normal weight and overweight with their underweight counterparts (AOR = 0.33, 95% CI; 0.12-0.96, p = 0.042) and (AOR = 0.29, 95% CI; 0.10-0.84, p = 0.023) respectively. Also, the odds of suffering from hypogonadism was lower in non-smokers compared with smokers (AOR: 0.16, 95% CI; 0.05-0.58, p = 0.005). Participants who were engaged in light (AOR: 0.29, 95% CI; 0.14-0.61, p = 0.001), moderate (AOR: 0.26, 95% CI; 0.13-0.54, p<0.001) and heavy (AOR: 0.25, 95% CI; 0.10-0.67, p = 0.006) leisure time activities had lower odds hypogonadal compared to those engaged in sedentary living. Type 2 diabetic men have high incidence of hypogonadism, irrespective of their baseline clinical, lifestyle or demographic characteristics. Smoking and sedentary lifestyle and BMI were associated with hypogonadism in the study population. Routine testosterone assessment and replacement therapy for high risk patients is recommended to prevent the detrimental effect of hypogonadism in diabetic men.

Intravenous magnesium sulfate in the management of severe pre-eclampsia: A randomized study of 12-hour versus 24-hour maintenance dose.

OBJECTIVE: To assess the effectiveness of a 12-hour versus 24-hour intravenous maintenance dose of magnesium sulfate (MgSO4 ) in women with pre-eclampsia, and the maternal and fetal outcomes. METHODS: This was a randomized controlled trial conducted at the labor ward complex of University College Hospital, Ibadan, Nigeria between May and August 2014. Pregnant women with severe pre-eclampsia were randomized to receive a 12-hour versus 24-hour maintenance dose of MgSO4 . Study outcomes were occurrence of seizures, adverse maternal effects, neonatal survival, and admission to the intensive care unit. Data analysis involved descriptive statistics and bivariate analysis using Statistical Package for Social Science (SPSS) version 20. RESULTS: There were 80 patients randomized to the 12-hour (n=40) and 24-hour (n=40) groups. The participants in the two groups had comparable demographic features. There was no significant difference (P>0.999) between the satisfactory maternal outcome following the 12-hour maintenance dose and the standard 24-hour regimen (95.0% vs 97.5%). Similarly, there was no significant difference (P=0.276) in perinatal mortality in the 12-hour versus 24-hour arm (17.5% vs 12.5%, respectively). No case of eclampsia and maternal death was recorded. CONCLUSION: A 12-hour maintenance dose of intravenous MgSO4 in the management of severe pre-eclampsia is effective and safe when compared with the 24-hour maintenance dose.

A prospective study of severity of complications associated with use of misoprostol and other abortion methods in South West Nigeria.

OBJECTIVES: To assess the severity of complications following misoprostol used to induce abortion compared with other methods among women admitted for postabortion complications. METHODS: A cross-sectional study of women who presented with complications of induced abortion at nine secondary and tertiary hospitals in South West Nigeria between April 1, 2013 and May 31, 2014. Face-to-face interviews were conducted and information on the current admission was extracted from patient records. Associations between abortion method used and severity of abortion complications were evaluated using χ2 and Fisher exact tests. RESULTS: Of 522 women included in the study, 177 reported an induced abortion: 41 women (23.2%) had used misoprostol at the first attempt to induce abortion, whereas 79 (44.6%) women had undergone surgical abortion. Occurrence of fever (P=0.06), bleeding (P=0.3), and lower abdominal pain (P=0.32) was not significantly different between the misoprostol and surgical abortion/other methods groups. Severe complications were rare with misoprostol, but more common among women in the surgical abortion/other methods group. Maternal mortality occurred only among women in the surgical abortion/other methods group. CONCLUSION: Use of misoprostol for induced abortion was associated with fewer complications and no maternal mortality compared with surgical abortion/other methods.

A randomized controlled trial of azithromycin and sulphadoxine-pyrimethamine as prophylaxis against malaria in pregnancy among human immunodeficiency virus-positive women.

BACKGROUND: Malaria and human immunodeficiency virus (HIV) infections in pregnancy are important and major contributing factors to maternal morbidity and mortality in sub-Saharan Africa. Prevention of malaria in HIV-positive pregnant woman will reduce the burden of malaria-HIV comorbidity. The objective of this study was to compare effects and safety of azithromycin (AZ) with sulphadoxine-pyrimethamine (SP) for intermittent preventive therapy for malaria in HIV-positive pregnant women. METHODS: We performed a randomized, controlled, open-label pregnancy trial of 140 HIV-positive pregnant patients attending antenatal clinics at the University College Hospital and Adeoyo Maternity Teaching Hospital, Ibadan, Nigeria. Participants were enrolled from a gestational age of 16 weeks and randomized to receive AZ or SP. The primary outcome was peripheral parasitaemia at delivery. Secondary outcomes were drug tolerability, foetal outcome and birthweight. The χ2 test (or Fisher's exact test, as appropriate) and Student's t test were used in the per-protocol analysis. The level of statistical significance was p<0.05. RESULTS: A total of 123 participants (87.9%) completed the study: 60 participants received AZ and 63 received SP. The incidence of malaria parasitaemia at delivery in the AZ group was 6 (10.0%), compared with 7 (11.1%) in the SP group (relative risk 0.89 [95% confidence interval 0.28 to 2.82], p=0.84). Placental parasitization was demonstrated in 1 (1.6%) participant in the SP group compared with 3 (5.0%) in the AZ group (p=0.36). CONCLUSIONS: The findings suggest that AZ is comparable to SP in malaria prevention and safety in HIV-positive pregnant women.

Narratives of women presenting with abortion complications in Southwestern Nigeria: A qualitative study.

Unsafe abortion continues to impact negatively on women's health in countries with restrictive abortion laws. It remains one of the leading causes of maternal mortality and morbidity. Paradoxically, modern contraceptive prevalence remains low and the unmet need for contraception continues to mirror unwanted pregnancy rates in many countries within sub-Saharan Africa. This qualitative study assessed women's knowledge; their expectation and experiences of the methods employed for abortion; and their health care-seeking decisions following a complicated abortion. Women who presented with abortion complications were purposively sampled from seven health facilities in south-west Nigeria. In-depth interviews were conducted by social scientists with the aid of a semi-structured interview guide. Coding schemes were developed and content analysis was performed with WEFTQDA software. Thirty-one women were interviewed. Misoprostol was used by 16 women; 15 women used other methods. About one-fifth of respondents were aged ≤ 20 years; almost one-third were students. Common reasons for terminating a pregnancy were: "too young/still in school/training"; "has enough number of children"; "last baby too young" and "still breastfeeding". Women had little knowledge about methods used. Friends, nurses or pharmacists were the commonest sources of information. Awareness about use of misoprostol for abortion among women was high. Women used misoprostol to initiate an abortion and were often disappointed if misoprostol did not complete the abortion process. Given its clandestine manner, women were financially exploited by the abortion providers and only presented to hospitals for post-abortion care as a last resort. Women's narratives of their abortion experience highlight the difficulties and risks women encounter to safeguard and protect their sexual and reproductive health. To reduce unsafe abortion therefore, urgent and synergized efforts are required to promote prompt access to family planning and post-abortion care services.

Comparative study of mefloquine and sulphadoxine-pyrimethamine for malaria prevention among pregnant women with HIV in southwest Nigeria.

OBJECTIVE: To compare the effectiveness of mefloquine and sulphadoxine-pyrimethamine as intermittent preventive therapy for malaria among pregnant women with HIV. METHODS: The present randomized, controlled, prospective, open-label study enrolled women with HIV who had reached at least 16 weeks of pregnancy attending prenatal clinics at secondary and tertiary health facilities in South West Nigeria between January 1 and August 31, 2016. Block randomization was used to assign patients to treatment with mefloquine or sulphadoxine-pyrimethamine for malaria prophylaxis. The primary outcome was malaria parasitemia at delivery. Data were compared with the χ2 and t tests on a per-protocol basis. RESULTS: Of 142 women enrolled and randomized equally to each group, 131 (92.3%) completed the study (64 in the mefloquine group and 67 in the sulphadoxine-pyrimethamine group). Blood-sample malaria parasites were isolated from 6 (9%) and 5 (7%) patients in the mefloquine and sulphadoxine-pyrimethamine groups, respectively, at enrolment, and 6 (9%) and 9 (13%) patients in the mefloquine and sulphadoxine-pyrimethamine groups, respectively, at delivery; the differences between the groups was not significant at enrolment (P=0.693) or delivery (P=0.466). CONCLUSION: Outcomes following prophylactic use of mefloquine for intermittent preventive therapy for malaria among pregnant women with HIV were comparable to sulphadoxine-pyrimethamine treatment; mefloquine is a feasible alternative therapy. ClinicalTrials.gov: NCT02524444.

The spillover effect of midwife attrition from the Nigerian midwives service scheme.

BACKGROUND: The Nigerian Midwives Service Scheme (MSS) increased use of antenatal services at rural public sector clinics. However, it is unclear if women who would not have otherwise sought care, or those who would have sought care in rural private sector clinics caused this change. Additionally, it is also unclear if the reported midwife attrition was associated with a spillover of the scheme's effect on urban areas. We sought to answer these two questions using data from two nationally representative surveys. METHODS: We used an interrupted time series model to assess trends in the use of obstetric (i.e. antenatal and delivery) services among rural and urban respondents in the 2008 and 2013 Nigerian demographic and health surveys. RESULTS: We found that the MSS led to a 5-percentage point increase in the use of antenatal services at rural public sector clinics, corroborating findings from a previous study. This change was driven by women who would not have sought care otherwise. We also found that there was a 4-percentage point increase in the use of delivery services at urban public sector clinics, and a concurrent 4-percentage point decrease in urban home deliveries. These changes are most likely explained by midwives' attrition and exemplify a spillover of the scheme's effect. CONCLUSION: Midwife attrition from the Nigerian MSS was associated with a spillover of the scheme's effect on the use of delivery services, on urban areas.

Trends in misoprostol use and abortion complications: A cross-sectional study from nine referral hospitals in Nigeria.

OBJECTIVE: The study aimed to assess the use of misoprostol and complications associated with abortions in referral hospitals in Nigeria, a country with restrictive abortion laws. METHODS: A cross-sectional study at nine referral hospitals in South-west Nigeria. Nine years' data were retrieved from medical records, including 699 induced abortions. Independent variable was the method of abortion; dependent variables were complications, need for treatment and mortality. Statistical significance was tested with Chi-square, Fishers' exact and chi-square for trend tests (p<0.05). RESULTS: There were 699 induced abortions amongst 2,463 abortions found in records. Nearly 70% were surgical abortions, but misoprostol use significantly increased over the study period in a linear trend (Χ2 trend: 30.96, P <0.001). Patients who used misoprostol were significantly less likely to have infectious morbidity, genital tract injuries or medical complications. There was no difference in incomplete abortion in the groups. Patients were more likely to have in-patient care with surgical abortions (p<0.001), to need prolonged antibiotic regimens (p = 0.003), need further surgeries or additional specialist care (p = 0.009). CONCLUSION: Misoprostol abortion has significantly increased over time, and was associated with less morbidity and need for further treatment, in this study. It appears to be the safer option.

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.

Attitude to the Menopause and Sex amongst Middle-Aged Women in a Family Medicine Clinic in Ibadan, Nigeria.

Background. Menopause is the expected end of reproductive life. Having a positive attitude towards it has been shown to result in a positive experience, while a negative attitude is associated with negative experiences and symptoms. Traditionally, women often abstain from sex after menopause. The study aimed to determine the level of awareness and perceptions about the menopause and sex in perimenopausal women attending a general outpatient clinic. Methods. Women over 40 years were recruited from the Family Medicine Department of University College Hospital, excluding those who were menopausal. Data analyses were done with chi-square test (p < 0.05). Results. Most (302; 86.4%) of the 352 surveyed participants were aware of the menopause. Only 36.1% anticipated associated symptoms. About half (55.7%) were indifferent to menopause onset, while 23% had a positive attitude and 21.4% had a negative attitude, respectively. Younger women were less likely to have a positive attitude to the menopause (p = 0.04). There were negative cultural beliefs towards sex. Sexual activity was low and declined with age (p < 0.001). Many women would like treatment to improve their sexual activity. Conclusion. Most participants had a favourable disposition towards the menopause, though sexual relationships suffer. Counselling and treatment should be offered.

A comparative study of azithromycin and sulphadoxine-pyrimethamine as prophylaxis against malaria in pregnancy.

CONTEXT: The benefit of malaria prophylaxis in pregnancy is threatened by emergence of Plasmodium falciparum resistance to antimalarial agents for chemoprophylaxis and treatment. AIM: This study aimed to compare the effectiveness of azithromycin (AZ) with sulphadoxine-pyrimethamine (SP) for malaria prevention. SETTINGS AND DESIGN: A prospective comparative study of antenatal clinic attendees at the University College Hospital, Ibadan, Nigeria. Participants were randomised to receive SP or AZ. SUBJECTS AND METHODS: The subjects were antenatal attendees and Samples for malaria parasitaemia were collected and repeated at follow-up visits; maternal peripheral blood film, placental and cord blood samples were collected at delivery. STATISTICAL ANALYSIS USED: Chi-square test and t-test in a per-protocol analysis. RESULTS: Of 200 participants (100 in each group), 166 (83.0%) completed the study: 86 (86.0%) of SP and 80 (80.0%) of AZ groups, respectively (P = 0.26). Four (4.7%) participants who had SP compared to five (6.2%) in AZ group developed malaria at mean gestational ages of 30.3 ± 1.56 and 33.0 ± 8.6, respectively (P = 0.56). Positive peripheral, placental and cord blood parasitaemia were found in ≤2% of the participants. Drug tolerability and foetal outcomes were comparable for both groups. CONCLUSION: AZ was comparable to SP for prevention of malaria in pregnancy and may be used in patients who do not tolerate SP.