Prevalence, perinatal outcomes and factors associated with neonatal sepsis in Nigeria.

OBJECTIVE: To examine the prevalence, perinatal outcomes and factors associated with neonatal sepsis in referral-level facilities across Nigeria. DESIGN: Secondary analysis of data from the Maternal and Perinatal Database for Quality, Equity and Dignity Programme in 54 referral-level hospitals across Nigeria. SETTING: Records covering the period from 1 September 2019 to 31 August 2020. POPULATION: Mothers admitted for birth during the study period, and their live newborns. METHODS: Analysis of prevalence and sociodemographic and clinical factors associated with neonatal sepsis and perinatal outcomes. Multilevel logistic regression modelling identified factors associated with neonatal sepsis. MAIN OUTCOME MEASURES: Neonatal sepsis and perinatal outcomes. RESULTS: The prevalence of neonatal sepsis was 16.3 (95% CI 15.3-17.2) per 1000 live births (1113/68 459) with a 10.3% (115/1113) case fatality rate. Limited education, unemployment or employment in sales/trading/manual jobs, nulliparity/grand multiparity, chronic medical disorder, lack of antenatal care (ANC) or ANC outside the birthing hospital and referral for birth increased the odds of neonatal sepsis. Birthweight of <2500 g, non-spontaneous vaginal birth, preterm birth, prolonged rupture of membranes, APGAR score of <7 at 5 min, birth asphyxia, birth trauma or jaundice were associated with neonatal sepsis. Neonates with sepsis were more frequently admitted to a neonatal intensive care unit (1037/1110, 93.4% vs 8237/67 346, 12.2%) and experienced a higher rate of death (115/1113, 10.3% vs 933/67 343, 1.4%). CONCLUSIONS: Neonatal sepsis remains a critical challenge in neonatal care, underscored by its high prevalence and mortality rate. The identification of maternal and neonatal risk factors underscores the importance of improved access to education and employment for women and targeted interventions in antenatal and intrapartum care.

Incidence, predictors and immediate neonatal outcomes of birth asphyxia in Nigeria.

OBJECTIVE: To determine the incidence and sociodemographic and clinical risk factors associated with birth asphyxia and the immediate neonatal outcomes of birth asphyxia in Nigeria. DESIGN: Secondary analysis of data from the Maternal and Perinatal Database for Quality, Equity and Dignity Programme. SETTING: Fifty-four consenting referral-level hospitals (48 public and six private) across the six geopolitical zones of Nigeria. POPULATION: Women (and their babies) who were admitted for delivery in the facilities between 1 September 2019 and 31 August 2020. METHODS: Data were extracted and analysed on prevalence and sociodemographic and clinical factors associated with birth asphyxia and the immediate perinatal outcomes. Multilevel logistic regression modelling was used to ascertain the factors associated with birth asphyxia. MAIN OUTCOME MEASURES: Incidence, case fatality rate and factors associated with birth asphyxia. RESULTS: Of the available data, 65 383 (91.1%) women and 67 602 (90.9%) babies had complete data and were included in the analysis. The incidence of birth asphyxia was 3.0% (2027/67 602) and the case fatality rate was 16.8% (339/2022). The risk factors for birth asphyxia were uterine rupture, pre-eclampsia/eclampsia, abruptio placentae/placenta praevia, birth trauma, fetal distress and congenital anomaly. The following factors were independently associated with a risk of birth asphyxia: maternal age, woman's education level, husband's occupation, parity, antenatal care, referral status, cadre of health professional present at the birth, sex of the newborn, birthweight and mode of birth. Common adverse neonatal outcomes included: admission to a special care baby unit (SCBU), 88.4%; early neonatal death, 14.2%; neonatal sepsis, 4.5%; and respiratory distress, 4.4%. CONCLUSIONS: The incidence of reported birth asphyxia in the participating facilities was low, with around one in six or seven babies with birth asphyxia dying. Factors associated with birth asphyxia included sociodemographic and clinical considerations, underscoring a need for a comprehensive approach focused on the empowerment of women and ensuring access to quality antenatal, intrapartum and postnatal care.

Neutrophil Elastase as a Predictor of Delivery in Pregnant Women with Preterm Labour.

Background and objectives: No previous study has been conducted in Nigeria on the role of neutrophil elastase in predicting preterm birth. The present study aimed to determine the role of the neutrophil elastase test in predicting birth in women with preterm labor. Methods: The present prospective cohort study recruited 83 pregnant women with preterm labor between 28 and 36+6 weeks of gestation, and followed up these subjects for 14 days. The controls comprised 85 pregnant women without preterm labor. The cervicovaginal fluid was collected and tested using the neutrophil elastase test. Then, the sensitivity, specificity, and positive and negative predictive parameters were determined. Afterward, the data were scrutinized using the SPSS arithmetic software (Sort23). Results: Among the 168 pregnant women analyzed in the present study, 83 pregnant women were assigned to the preterm labor group, and 85 pregnant women were assigned to the control group. Furthermore, among the 83 pregnant women in the preterm labor group, 11 women had spontaneous preterm delivery, leading to a spontaneous preterm birth proportion of 13.3%. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the neutrophil elastase test within 14 days post-enrollment were 93.8%, 61.2%, 36.6%, 97.6%, and 67.5%, respectively, for the general population, and 87.5%, 66.7%, 35.0%, 96.3%, and 70.2%, respectively, for subjects at <35 weeks of gestation. The positive and negative likelihood ratios for preterm birth prediction were 2.62 and 0.19, respectively. Conclusion: The neutrophil elastase test exhibited high predictive accuracy in pregnant women with preterm labor, when compared to the controls, based on the sensitivity and negative predictive value, but this had poor positive predictive values. The neutrophil elastase test may be used as a screening test, but not as a potential predictive test, in the routine clinical setting.

Trends and Outcomes of Twin Births in Southwest Nigeria: A 14-Year Retrospective Cohort Study.

Background and objectives: The study aimed to analyze the prevalence, trends, and outcomes of twin pregnancies in Ile-Ife, Nigeria, over two distinct periods. Materials and methods: This research, based on a 14-year retrospective cohort study, scrutinized twin births occurring in two-time frames: recent years (2012-2018; Period II) and the recent past (2005-2011; Period I) at a University Teaching Hospital in Ile-Ife, Nigeria. The inclusion criteria were limited to twin births, excluding singleton and higher-order gestations. Outcomes were evaluated based on several parameters, including mode of delivery, birth weights, fetal gender combinations, APGAR scores, perinatal mortality, and maternal complications. Data analysis was conducted using the 26th version of Statistical Package for the Social Science, with a significance threshold of p < 0.05. Results: The study documented a stable prevalence of twin gestations, registering at 20.7 per 1,000 births without a significant discrepancy between the two time periods (21.7‰ versus 19.7‰; p = 0.699). Individuals from the Yoruba tribe predominantly featured in both cohorts, showing no considerable variation between the two time periods [83 (95.4) vs. 120 (99.2); p-value = 0.116]). The data exhibited recurrent instances of caesarean delivery (65.6% vs. 50.2%, p = 0.119), vertex-vertex presentation (38.0% vs. 44.7%, p = 0.352), and differing sex combinations (33.3% vs. 38.0%, p = 0.722) across both time frames. Twin II neonates born through Caesarean section were more frequently admitted to neonatal intensive care units than Twin I (5.1% versus 4.6%; p = 0.001). The recent years witnessed a surge in preterm labor complications, notably higher than the earlier period (17.1% versus 7.8%; p = 0.008). Conclusion: The prevalence of twin births in Ile-Ife, Nigeria, demonstrates a fluctuating decline. To comprehensively understand the dynamics of twin births in the region, there is a pressing need for expansive, community-centric research in southwest Nigeria.

Intravenous versus intramuscular oxytocin injection for preventing uterine atonic primary postpartum haemorrhage in third stage of labour: A double-blind randomised controlled trial.

Objectives: To compare the efficacy and safety of intravenous and intramuscular oxytocin in preventing atonic primary postpartum haemorrhage in the third stage of labour. Methods: A double-blind randomised clinical study on consenting women without risk factors for primary postpartum haemorrhage in labour at term. Two hundred and thirty-two women were randomly allotted into intravenous (n = 115) and intramuscular (n = 117) oxytocin groups in the active management of the third stage of labour. All participants received 10 IU of oxytocin, either IV or IM, and 1 ml of water for injection as a placebo via a route alternate to that of administration of oxytocin within 1 min of the baby's delivery. The primary outcome measures were mean postpartum blood loss and haematocrit change. Trial Registration No.: PACTR201902721929705. Results: The baseline socio-demographic and clinical characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups with regards to the mean postpartum blood loss (254.17 ± 34.85 ml versus 249.4 ± 39.88 ml; p = 0.210), haematocrit change (2.4 (0.8%) versus 2.1 (0.6%); p = 0.412) or adverse effects (p > 0.05). However, the use of additional uterotonics was significantly higher in the intravenous group (25 (21.73%) versus 17 (14.53%); p = 0.032). Conclusion: Although oxytocin in both study groups showed similar efficacy in terms of preventing atonic primary postpartum haemorrhage, participants who received intravenous oxytocin were more likely to require additional uterotonics to reduce their likelihood of having an atonic primary postpartum haemorrhage. However, both routes have similar side effect profiles.

Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial.

BACKGROUND: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN: The study is a double-blind randomized controlled trial. METHODS: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.

Association between serum vitamin D status and uterine leiomyomas: a case-control study.

OBJECTIVE: Uterine leiomyoma is a common gynecological condition that negatively affects women's quality of life. Vitamin D plays an important role in tumor development and progression. However, clinical studies comparing serum vitamin D levels between women with and without uterine leiomyomas are limited and inconclusive. This study aimed to compare serum vitamin D levels in women with and without uterine leiomyomas. METHODS: This hospital-based case-control study included 150 women who visited a gynecological clinic. The cases included 75 women with uterine leiomyoma, whereas the controls included 75 age-and parity-matched participants without uterine leiomyoma. Serum vitamin D levels were measured in each participant and volumes of the uterine leiomyomas were determined using the water displacement method following myomectomy. The statistical significance was inferred at P<0.05. RESULTS: The mean serum vitamin D level was 15.26±4.96 ng/mL and 22.45±6.93 ng/mL for the case and control groups, respectively. The difference was statistically significant (t-value -7.302 and P<0.001). Within the fibroid group, nine (12.0%), 49 (65.33%), and 17 (22.67%) participants had vitamin D deficiency, insufficiency, and sufficiency, respectively; and in the control group, two (2.67%), 24 (45.33%), and 39 (52.0%) participants had vitamin D deficiency, insufficiency, and sufficiency, respectively. There was significant negative correlation between the fibroid volume and the serum vitamin D level (r=-0.591, P<0.001). CONCLUSION: Women with uterine leiomyoma had lower vitamin D levels than women in the control group. Lower vitamin D levels were associated with larger fibroid masses. Therefore, vitamin D supplementation may reduce fibroid growth and development.

Maternal and umbilical cord blood levels of leptin in pre-eclamptic and healthy pregnant women: A comparative cross-sectional study.

BACKGROUND: Pre-eclampsia is a multi-systemic disease with its attendant increased maternal and perinatal morbidities and mortality. It has been hypothesized that leptin contributes immensely to the natural history of pre-eclampsia. However, there is considerable disagreement in the reports of existing research work on the link between fetomaternal serum leptin levels and pre-eclampsia. OBJECTIVE: To determine and compare the maternal and umbilical cord sera levels of leptin in women with pre-eclampsia and healthy pregnant women. STUDY DESIGN: This is an analytical cross-sectional study. METHODS: The study involved consenting 120 pregnant participants (60 on each arm). Pregnant women diagnosed with pre-eclampsia constituted the investigation group, while the controls were normotensive pregnant women. They were matched for maternal age and body mass index. Venous blood specimens were obtained from the participants for assessment of the serum leptin concentration while umbilical cord blood samples were obtained following delivery of the neonate in advance of the removal of the placenta. The collected blood samples were analysed for the levels of leptin in a blinded pattern. The primary outcome measures were maternal serum leptin levels and umbilical cord serum leptin levels. RESULTS: Mean maternal serum leptin concentration in the pre-eclampsia group was significantly higher than that in the control group (24.88 ± 3.92 vs. 15.03 ± 2.98ng/mL, p < 0.001). Similarly, maternal serum leptin concentration was significantly higher in participants with severe pre-eclampsia compared with those with mild pre-eclampsia (25.91 ± 3.5 vs. 22.83 ± 4.02ng/mL, p = 0.003). However, the mean umbilical cord serum leptin level in the pre-eclampsia group was significantly lower than in the control group (6.43 ± 2.08 vs. 7.27 ± 2.24; p = 0.034). There was a weak positive correlation between maternal serum leptin level and neonatal umbilical serum leptin level in the pre-eclamptic group (r = 0.21, p = 0.04). CONCLUSION: Maternal serum leptin concentration is significantly increased in women with pre-eclampsia, compared with their normotensive counterparts. This increase becomes even more pronounced as the severity of the disease progresses. Maternal serum leptin assessment has the potential to become a veritable tool in the diagnosis and monitoring of pregnancies complicated by pre-eclampsia.

The impact of COVID-19 on the birth rate in Nigeria: a report from population-based registries.

Background and objectives: Coronavirus disease 2019 (COVID-19) is a pandemic that has become a major source of morbidity and mortality worldwide, affecting the physical and mental health of individuals influencing reproduction. Despite the threat, it poses to maternal health in sub-Saharan Africa and Nigeria, there is little or no data on the impact it has on fertility, conception, gestation and birth. To compare the birth rate between pre-COVID and COVID times using selected months of the year. Materials and methods: This was a secondary analysis of cross-sectional analytical study data from the birth registries of three tertiary hospitals, comparing two years [2019 (Pre-COVID)] versus [2020 (COVID era)] using three months of the year (October to December). The data relied upon was obtained from birth registries in three busy maternity clinics all within tertiary hospitals in South-East Nigeria and we aimed at discussing the potential impacts of COVID-19 on fertility in Nigeria. The secondary outcome measures were; mode of delivery, booking status of the participants, maternal age and occupation. Results: There was a significant decrease in tertiary-hospital based birth rate by 92 births (P = 0.0009; 95% CI: -16.0519 to -4.1481) among mothers in all the three hospitals in 2020 during the COVID period (post lockdown months) of October to December. There was a significant difference in the mode of delivery for mothers (P = 0.0096) with a 95% confidence interval of 1.0664 to 1.5916, as more gave birth through vaginal delivery during the 2020 COVID-19 period than pre-COVID-19. Conclusion: Tertiary-hospital based birth rates were reduced during the pandemic. Our multi-centre study extrapolated on possible factors that may have played a role in this decline in their birth rate, which includes but is not limited to; decreased access to hospital care due to the total lockdowns/curfews and worsening inflation and economic recession in the country.

Depression, anxiety, and stress and adverse pregnancy outcomes in pregnant women with history of recurrent pregnancy loss in Nigeria.

OBJECTIVE: The primary purpose of this study was to examine whether pregnant women with a history of recurrent pregnancy loss (RPL) are more likely to experience moderate-to-severe depression, anxiety, or stress symptoms than pregnant women without a history of RPL. The secondary purpose was to determine whether women with prior RPL experienced more unfavorable pregnancy outcomes if they had depression, anxiety, or stress. METHODS: A prospective case-control study was conducted that included 47 pregnant women with a history of RPL and 94 pregnant women without prior RPL. Participants 20 weeks of gestation or earlier were included. Both groups completed the Depression, Anxiety, and Stress Scale (DASS-21), and were followed up until delivery to determine the pregnancy outcomes. Multivariate logistic regression was used to compare adverse pregnancy outcomes. RESULT: Among the 47 women with prior RPL, 10 had primary RPL (two or more miscarriages without a successful pregnancy) and 37 secondary RPL (two or more miscarriages with a history of successful pregnancy). RPL was significantly associated with moderate-to-severe levels of depression (P < .001), anxiety (P < .001), and stress (P < .001). Among the RPL group, high stress level was significantly associated with repeat miscarriage (adjusted odds ratio (AOR) = 5.28, 95%CI = 1.25-100.0, P = .03) and preterm labor (AOR = 6.07, 95%CI = 1.61-100.0, P = .04). Depression and anxiety were not associated with adverse pregnancy outcomes. CONCLUSION: Pregnant women with a history of RPL had considerably higher rates of moderate-to-severe depression, anxiety, and stress. Repeat miscarriage and preterm labor were considerably higher among pregnant women with RPL who were experiencing high stress levels at baseline.

Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virus.

BACKGROUND: Hepatitis B virus (HBV)-human Immunodeficiency virus (HIV) co-infection promotes an aggressive disease course of HBV infection. In the only available non-Cochrane systematic review on antiviral therapy during pregnancy for prevention of mother-to-child transmission of HBV, none of the women studied had HBV-HIV co-infection but were either HBV- or HIV-seropositive. Treatment of HBV alone may develop HIV-strains that are resistant to non-nucleoside reverse transcriptase inhibitors. Accordingly, co-treatment of the HIV infection is recommended. OBJECTIVES: To evaluate the benefits and harms of tenofovir-based antiviral combination regimens versus placebo, tenofovir alone, or non-tenofovir-based antiviral regimen either alone or in combination with HBV for the prevention of mother-to-child transmission of HBV in HIV-positive pregnant women co-infected with HBV. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase Ovid, LILACS (Bireme), Science Citation Index Expanded (Web of Science), and Conference Proceedings Citation Index-Science (Web of Science) on 30 January 2023. We manually searched the reference lists of included trials, searched on-line trial registries, and contacted experts in the field and pharmaceutical companies for any further potential trials. SELECTION CRITERIA: We aimed to include randomised clinical trials comparing tenofovir-based antiviral combination regimens (anti-HIV regimen with lopinavir-ritonavir therapy, or any other antiviral therapy, and two drugs with activity against HBV, specifically, tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), plus lamivudine or emtricitabine) with placebo alone, or tenofovir alone, or non-tenofovir-based antiviral regimen (zidovudine, lamivudine, telbivudine, emtricitabine, entecavir, lopinavir-ritonavir, or any other antiviral therapy) either alone or in combination with at least two other antivirals. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Primary outcomes included all-cause infant mortality, proportion of infants with serious adverse events, proportion of infants with HBV mother-to-child transmission, all-cause maternal mortality, and proportion of mothers with serious adverse events. Secondary outcomes included proportion of infants with adverse events not considered serious, proportion of mothers with detectable HBV DNA (deoxyribonucleic acid) (before delivery), maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion (before delivery) and maternal adverse events not considered serious. We used RevMan Web to carry out analyses and presented results, where feasible, using a random-effects model and risk ratios (RR) with 95% confidence intervals (CIs). We performed sensitivity analysis. We assessed risk of bias using predefined domains, assessed the certainty of the evidence using GRADE, controlled risk of random errors with Trial Sequential Analysis, and presented outcome results in a summary of findings table. MAIN RESULTS: Five completed trials were included, of which four trials contributed data to one or more of the outcomes. They included a total of 533 participants randomised to tenofovir-based antiviral combination regimens (196 participants) versus control (337 participants). The control groups received non-tenofovir-based antiviral regimens either as zidovudine alone (three trials) or as a combination of zidovudine, lamivudine and lopinavir-ritonavir (five trials). None of the trials used placebo or tenofovir alone. All trials were at unclear risk of bias. Four trials used intention-to-treat analyses. In the remaining trial, two participants in the intervention group and two in the control group were lost to follow-up. However, the outcomes of these four participants were not described. Tenofovir-based antiviral combination regimen versus control We are very uncertain about the effect of a tenofovir-based antiviral combination regimen versus control on all-cause infant mortality (RR 2.24, 95% CI 0.72 to 6.96; participants = 132; trials = 1; very low-certainty evidence); proportion of infants with serious adverse events (RR 1.76, 95% CI 1.27 to 2.43; participants = 132; trials = 1; very low-certainty evidence), and proportion of mothers with serious adverse events (RR 0.90, 95% CI 0.62 to 1.32; participants = 262; trials = 2; very low-certainty evidence). No trial reported data on the proportion of infants with HBV mother-to-child transmission and all-cause maternal mortality. We are also very uncertain about the effect of tenofovir-based antiviral combination regimens versus control on the proportion of infants with adverse events not considered serious (RR 0.94, 95% CI 0.06 to 13.68; participants = 31; trials = 1; very low-certainty evidence), and proportion of mothers with detectable HBV DNA (before delivery) (RR 0.66, 95% CI 0.42 to 1.02; participants = 169; trials = 2; very low-certainty evidence). No trial reported data on maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion (before delivery) and maternal adverse events not considered serious. All trials received support from industry. AUTHORS' CONCLUSIONS: We do not know what the effects of tenofovir-based antiviral combination regimens are on all-cause infant mortality, proportion of infants with serious adverse events and proportion of mothers with serious adverse events, proportion of infants with adverse events not considered serious, and proportion of mothers with detectable HBV DNA before delivery because the certainty of evidence was very low. Only one or two trials, with insufficient power, contributed data for analyses. We lack randomised clinical trials at low risk of systematic and random errors, and fully reporting all-cause infant mortality, serious adverse events and reporting on clinical and laboratory outcomes, such as infants with HBV mother-to-child transmission, all-cause maternal mortality, maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion before delivery and maternal adverse events not considered serious.

Efficacy and safety of Mojeaga remedy in combination with conventional oral iron therapy for correcting anemia in obstetric population: A phase II randomized pilot clinical trial.

BACKGROUND: To our knowledge, there is no prior randomized trial on the efficacy of Mojeaga remedy (a special blend of Alchornea cordifolia, Pennisetum glaucum and Sorghum bicolor extracts) when co-administered with standard-of-care for correction of anemia in obstetrics practice. This study determined the efficacy, safety and tolerability of Mojeaga as adjunct to conventional oral iron therapy for correction of anemia in obstetric population. METHODS: A pilot open-label randomized clinical trial. Participants with confirmed diagnosis of anemia in three tertiary hospitals in Nigeria were studied. Eligible participants were randomized 1:1 to either Mojeaga syrups 50 mls (200mg/50mls) administered three times daily in conjunction with conventional iron therapy (Mojeaga group) for 2 weeks or conventional iron therapy alone without Mojeaga (standard-of-care group) for 2 weeks. Repeat hematocrit level were done 2 weeks post-initial therapy. Primary outcome measures were changes in hematocrit level and median hematocrit level at two weeks post therapy. Maternal adverse events and neonatal outcomes (birth anomalies, low birthweight, preterm rupture of membranes and preterm labor) were considered the safety outcome measures. Analysis was by intention-to-treat. RESULTS: Ninety five participants were enrolled and randomly assigned to the Mojeaga group (n = 48) or standard-of-care group (n = 47). The baseline socio-demographic and clinical characteristics of the study participants were similar. At two weeks follow-up the median rise in hematocrit values from baseline (10.00±7.00% vs 6.00±4.00%;p<0.001) and median hematocrit values (31.00±2.00% vs 27.00±3.00%;p<0.001) were significantly higher in the Mojeaga group. There were no treatment-related serious adverse events, congenital anomalies or deaths in the Mojeaga group and incidence of other neonatal outcomes were similar (p>0.05). CONCLUSION: Mojeaga represents a new adjuvants for standard-of-care option for patients with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, or adverse neonatal outcomes. CLINICAL TRIAL REGISTRATION: www.pactr.samrc.ac.za: PACTR201901852059636 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822).

Efficacy of zinc supplementation for the treatment of dysmenorrhoea: a double-blind randomised controlled trial.

OBJECTIVES: To determine the efficacy of zinc sulfate supplementation in managing dysmenorrhoea. METHODS: In total, 103 high school students were randomised into an experimental arm (52 students) and a control arm (51 students) and received 40-mg zinc sulfate or placebo, respectively, over three cycles. Primary outcome measures were the mean Visual Analogue Scale score, which measured pain over three cycles, and the frequency of nausea and vomiting. Secondary outcomes were the use of additional analgesics and the frequency of allergic reactions. RESULTS: Fifty participants were analysed in each group. Mean pain scores were not significantly different between the groups before administering zinc sulfate therapy. Following the intervention, the mean pain scores for the treatment (2.80 ± 2.28) and placebo (3.48 ± 2.85) groups were not significantly different in the first cycle; however, scores in the treatment group were significantly better in the second (2.56 ± 1.97 vs 3.80 ± 2.77) and third (1.95 ± 1.72 vs 3.95 ± 2.82) cycles. No significant differences were observed between the groups in the nausea and vomiting incidence and the requirement for additional analgesics. CONCLUSIONS: Zinc sulfate reduces dysmenorrhoea severity with minimal or no adverse effects, especially with more than one cycle of usage.Trial Registration Number: PACTR202105843292338. The trial is publicly available and was registered at www.pactr.org on 25 May 2021.

Gynaecology, general surgery and urology residents' perspective and exposure to endoscopy training and practice: a cross-sectional study of resident doctors in four residency training centres in Abuja, Nigeria from June to August, 2020.

Introduction: the use of endoscopy in the surgical management of a wide range of ailments has revolutionised the practice of surgery. Endoscopy however has been underutilised in developing nations. Optimal training exposure during the residency training program is considered as very crucial to the improvement of endoscopy practice in this region. The objective of this study was to evaluate the perception and endoscopy training exposure of resident doctors in gynaecology, general surgery and urology in four residency training centres in Abuja. Methods: this was an analytical cross-sectional study of endoscopy exposure of gynaecology, general surgery and urology resident doctors in four residency training centres in Abuja from June through August 2020. Using a structured questionnaire, information was obtained on demography, perception of endoscopy, exposure to and expectations for endoscopy training and practice. Data were analysed with SPSS version 25 (IBM Corp., Armonk, NY, USA). Results: a total of 125 questionnaires were distributed with a 92% response rate. The mean age of the respondents was 36.17±4.62 years with a mean duration of training of 53.91±28.02 months. Eighteen (15.8%) were satisfied with endoscopy practice in their centre and only five respondents (4.4%) had attained competence in operative endoscopy. Twelve trainees (10.5%) reported that they had received formal training in endoscopy outside their workplace and 109 (95.6%) desired to have post-fellowship training. Competence was statistically significantly higher among the senior registrars compared to registrars (Fisher 51.81, P=< 0.001). Lack of funding was the most reported limiting factor to endoscopy training (66.7%) while most (85.1%) desired the incorporation of structured endoscopy training into the residency training curriculum. Conclusion: this study showed poor endoscopy training exposure, a high level of dissatisfaction with the state of endoscopy practice and high expectations of the trainees for improved training facilities and human capacity.

A Five-Year Review of Feto-Maternal Outcome of Antepartum Haemorrhage in a Tertiary Center.

Background: Pregnancies complicated with antepartum-haemorrhage is high risk pregnancies associated with adverse maternal, fetal-and-perinatal-outcomes. It contributes significantly to fetal and maternal mortality especially in the developing countries. Proper antenatal care and prompt intervention is necessary to forestall adverse and improve outcome. Objective: To determine the prevalence, sociodemographic characteristics, risk factors, fetomaternal outcome of pregnancies with antepartum haemorrhage. Methods: The case files of the patients were retrieved from the medical records department. The total number of deliveries within the study period was obtained from the labour ward records. The feto-maternal-outcome-measures were; prevalence of caesarean-section, postpartum-haemorrhage, hysterectomy, need for blood-transfusion, maternal-death, prematurity, need for admission in intensive-care-unit and still births. The data was analysed using SPSS version 21. Chi-square was used to test for significance. Results: Within the 5-year period under review, out of a total of 6974 deliveries, 234 had antepartum-haemorrhage (3.4% prevalence rate). Abruptio-placentae was the commonest cause and accounted for 69.5% of the cases (prevalence of 2.1%) while placenta praevia accounted for 28.2% of the cases (prevalence rate of 0.9%). The mean age of the women was 31.8±5.3 years. The mean parity was 3.4±1.7 and majority (63.8%) of the women were unbooked. The commonest identifiable risk factors were multiparity and advanced maternal age. One-hundred-and sixty-six (77.9%) women were delivered through the abdominal route. Postpartum-haemorrhage occurred in 22.1% (47) of the cases while prematurity was the commonest fetal complications. Maternal mortality was 0.47% (1) while still birth was 44.1% (94). Conclusion: There is high prevalence of antepartum-haemorrhage in our environment. Abruptio-placentae was the commonest cause and associated with significant adverse fetomaternal-outcome when compared with placenta-praevia. Thus, good and quality antenatal care as well as high index of suspicion, prompt diagnosis and treatment remain the key to forestall these complications and improve fetomaternal-outcome.

A randomised control trial on oral dydrogesterone versus micronized vaginal progesterone pessary for luteal phase support in in vitro fertilization cycles.

This study aimed to evaluate the pregnancy rates, adverse reactions, and medication costs of two luteal phase support regimens: oral dydrogesterone and micronized vaginal progesterone (MVP) pessary in in vitro fertilization cycles. A randomized open-label trial with participants randomly assigned to either 400 mg MVP twice daily or 10 mg dydrogesterone three times daily. The primary endpoints were pregnancy rates, and the secondary endpoints included tolerance, miscarriage rates, and medication cost. Per-protocol principle analysis was performed. The baseline characteristics of the 162 participants were similar. Dydrogesterone had statistically similar (p>0.05) positive pregnancy test rates fifteen days post embryo transfer (35.8% vs. 32.7%), clinical pregnancy rates at the gestational age of 6 weeks (32.1% vs. 28.8%), ongoing pregnancy rates (26.4% vs. 23.1%) and miscarriage rates at 14 weeks of gestation (9.2% vs. 9.4%) and safety profile to MVP. Dydrogesterone was better tolerated as vaginal itching was significantly more prevalent in the MVP arm (p=0.008). Dydrogesterone is significantly less expensive than MVP pessary. Oral dydrogesterone and MVP pessary had similar pregnancy rates and adverse effects. Dydrogesterone appears more user-friendly and less expensive in cases of luteal-phase support in in vitro fertilization cycles.

Prevalence and associated factors of recurrent pregnancy loss in Nigeria according to different national and international criteria (ASRM/ESHRE vs. WHO/RCOG).

Background: In low-and middle-income countries, no conclusive research explains the prevalence and associated factors of women with a history of recurrent pregnancy loss (RPL). Some authorities have recommended further scientific research on the effect of various definitions of RPL. Objective: To assess prevalence and associated factors of RPL among pregnant women in Nigeria according to different national and international criteria: the American Society for Reproductive Medicine/ European Society for Human Reproduction and Embryology (ASRM/ESHRE; two losses) and the World Health Organization/ Royal College of Obstetricians and Gynecologists (WHO/RCOG; three consecutive losses) criteria. Methods: This is a cross-sectional analytical study wherein, pregnant women with prior RPL were investigated. The outcome measures were prevalence and risk factors. The associations between independent variables and outcome variable were explored using bivariate and multivariable logistic regression models. The results of these analyses were reported as adjusted odds ratios (AORs) with 95% confidence intervals (95%CI). Factors associated with RPL were identified using multivariate regression models. Result: Of the 378 pregnant women interviewed, the overall prevalence of RPL in this study was found to be 15.34% (95% confidence interval = 11.65%-19.84%). The prevalence of RPL was 15.34% (58/378; 95%CI = 11.65%-19.84%) and 5.29% (20/378; 95%CI = 3.23%-8.17) according to the ASRM and the WHO criterion respectively. Regardless of diagnostic criteria, unexplained (AOR = 23.04; 95%CI: 11.46-36.32), endocrine disturbances (AOR = 9.76; 95%CI: 1.61-63.19), uterine abnormalities (AOR = 13.57; 95%CI: 3.54-50.60), and antiphospholipid syndrome (AOR = 24.59; 95%CI: 8.45-71.04) were positively and independently associated with RPL. No significant risk factors were seen when the ASRM/ ESHRE criterion vs. WHO/RCOG criterion were compared. Advanced maternal age was significantly higher in secondary than in primary type of RPL. Conclusion: The prevalence of RPL was 15.34% and 5.29% according to ASRM/ESHRE and WHO/RCOG criterion respectively, with secondary type predominating. No significant differences with regard to risk factors were seen according to diagnostic criteria studied, though advanced maternal age was significantly higher in secondary RPL. Further research is needed to confirm our findings and to better characterize the magnitude of differences.

A randomized clinical trial of Premaquick biomarkers versus transvaginal cervical length for pre-induction cervical assessment at term among pregnant women.

Objectives: To compare Premaquick biomarkers (combined insulin-like growth-factor binding protein 1 and interleukin-6) and cervical length measurement via transvaginal ultrasound for pre-induction cervical evaluation at term among pregnant women. Methods: A randomized clinical trial of consenting pregnant women at the Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria. The women were randomized equally into Premaquick group (n = 36) and transvaginal ultrasound group (n = 36). The cervix was adjudged 'ripe' if the Premaquick test was positive or if the trans-vaginal measured cervical length was less than 28 mm. The primary outcome measures were the proportions of women who needed prostaglandin analogue for cervical ripening and the proportion that achieved vaginal delivery after induction of labour. The trial was registered in Pan African clinical trial registry (PACTR) registry with approval number PACTR202001579275333. Results: The baseline characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups in terms of proportion of women that required prostaglandins for pre-induction cervical ripening (41.7 versus 47.2%, p = 0.427), vaginal delivery (77.8 versus 80.6%, p = 0.783), mean induction to delivery interval (22.9 ± 2.81 h versus 24.04 ± 3.20 h, p = 0.211), caesarean delivery (22.2 versus 19.4%, p = 0.783), proportion of neonate with birth asphyxia (8.30 versus 8.30%, p = 1.00) and proportion of neonate admitted into special care baby unit (16.7 versus 13.9%, p = 0.872). Subgroup analysis of participants with 'ripe' cervix at initial pre-induction assessment showed that the mean induction to active phase of labour interval and mean induction to delivery interval were significantly shorter in Premaquick than transvaginal ultrasound group. Conclusion: Pre-induction cervical assessment at term with either Premaquick biomarkers or transvaginal ultrasound for cervical length is effective, objective and safe with similar and comparable outcome. However, when compared with women with positive transvaginal ultrasound at initial assessment, women with positive Premaquick test at initial assessment showed a significantly shorter duration of onset of active phase of labour and delivery of baby following induction of labour.