A Clinical Study to Assess the Effectiveness of Oral Combination Kit Therapy in Syndromic Management of Abnormal Vaginal Discharge (FEMINE Study) in Kinshasa, Democratic Republic of Congo

Background: Vaginal discharge is one of most common and nagging problems that women face. About 20% - 25% of women who visit gynecology department complain of vaginal discharge and leucorrhoea. An orally administered combination kit, containing 2 g secnidazole, 1 g azithromycin and 150 mg fluconazole (Azimyn FS Kit), has been successfully evaluated in clinical trials and used in several countries for management syndromic vaginal discharge due to infections. Methods: This is a longitudinal study which aimed to verify the clinical efficacy of the combined oral kit containing secnidazole, azithromycin and fluconazole (Azimyn FS Kit®) in the syndromic treatment of abnormal vaginal discharge in patients received in outpatient consultations in Kinshasa/DR Congo from March to September 2023. Results: Majority of patients had whitish vaginal discharge (51.6%) of average abundance (56.2%), accompanied by pruritus in 72.1% of cases, and dyspareunia in 23.5% of cases and hypogastralgia in 40.2% of cases. One week after treatment with the Azimyn FS® combined kit, at the greatest majority of patients (97.3%), abnormal vaginal discharge had decreased by more than 50% (84.1%). Two weeks after treatment with the Azimyn FS® combined kit, almost all patients (97.3%) no longer had abnormal vaginal discharge which had completely disappeared. Conclusion: A single dose of secnidazole, azithromycin and fluconazole in the form of an oral combi-kit (Azimyn FS Kit) has shown excellent therapeutic effectiveness in the syndromic treatment of abnormal vaginal discharge wherein patients were treated without diagnostic confirmation.

Rationale of a Cross-Sectional Descriptive Study on Temporal Evolution of Frequency, Risk Factors and Complications of Preeclampsia in the University Clinics of Kinshasa, DR Congo

Background: Knowledge of temporal evolution of preeclampsia (PE) in its various aspects is essential in strategies to reduce maternal and perinatal morbidity and mortality. Preeclampsia is a public health problem due to maternal mortality associated with it worldwide (5.6%). Improving quality of its management is a major challenge in low-income countries where, despite progress made in this field, PE remains a major factor in maternal morbidity and mortality. Objective: To evaluate temporal evolution of frequency, risk factors and complications of PE at the University clinics of Kinshasa (UCK). Methods: Descriptive and cross-sectional study concerning minimum simple size of 119 pregnant women who consulted for antenatal care at the University clinics of Kinshasa from January 2012 to December 2022. Results will be reported as percentage proportion, mean and standard deviation. Comparison of proportion and means between groups will be made using Student’s t-test and Pearson’s chi-square test, respectively. The test will be statistically significant for a p value ≤ less than 0.05. Data will be collected and analysed anonymously and confidentially. Conclusion: This study will allow us to evaluate the effectiveness of different prevention and treatment modalities used over time in management of preeclampsia in our setting.

Rationale of a Cross Sectional Descriptive Study on Knowledge and Practices of Healthcare Providers on Postpartum Hemorrhage Management in Kinshasa, the Democratic Republic of the Congo

Background: Healthcare Providers’ knowledge and practice of postpartum hemorrhage (PPH) management are essential to reduce maternal morbidity and mortality. PPH is a public health problem due to the high maternal mortality (MM) associated with it worldwide (25%). Improving the quality of PPH management is a major challenge in low-income countries where, despite the progress made in its management, PPH remains a major contributor to maternal morbidity and mortality. Objective: We will evaluate the level of knowledge and practices of providers in the PPH management in Kinshasa in the Democratic Republic of the Congo (DRC). Methods: This study will be descriptive and cross-sectional. The minimum sample size will be 86. Our study population will consist of delivery room care providers. Results will be reported as percentage proportion and mean plus or minus standard deviation. Comparisons of means between groups will be made using Student’s t-test and Pearson’s chi-square test. The test will be statistically significant for a p value 0.05. Data will be collected and processed anonymously and confidentially. Conclusion: Improving quality of care must be a priority in obstetrics. This evaluation requires us to determine the level of knowledge and practices of providers in the PPH management in Kinshasa.

Cohort Study on Benefit of Martial Supplementation with EDTA Sodium Iron in Management of Gravidic Anemia at the University Clinics of Kinshasa

Background: Anemia is mainly attributed to nutritional deficiency, especially iron deficiency, which predominates during pregnancy, and is associated with parasitic diseases such as malaria and intestinal parasitosis, acute or chronic diseases such as sickle cell disease, tuberculosis, HIV infection and various micronutrients disorders. It is associated with an increased risk of low birth weight and prematurity and can contribute to impaired cognitive development in early childhood, as well as to maternal mortality. The impact on the fetus is even greater if maternal anemia onset is at an early stage, or prior to pregnancy. Iron salts, such as sulfate or fumarate, are widely used in the treatment of gravidic anemia, but due to various gastrointestinal side effects, many pregnant women are not compliant with treatment. Sodium iron EDTA, on the other hand, is highly absorbable and bioavailable. The latter improves hematological values and appears to be free from the usual iron-related side effects, hence compliance with this supplementation. Objectives: To evaluate the evolution of hemoglobin levels after sodium iron EDTA supplementation at the university Clinics of Kinshasa, to determine the frequency of gravidic anemia, the dose-dependent benefit of sodium iron EDTA supplementation in pregnant women and to identify factors associated with insufficient hemoglobin gain after supplementation. Methods: This longitudinal cohort will take place in the gynecology department of the University Clinics of Kinshasa from September 2022 to August 2023 and will include at least 54 pregnant women with anemia. Conclusion: The study will enable us to better assess the benefits of sodium iron EDTA in improving hematological values, as well as its tolerability in pregnant women suffering from anemia during pregnancy in our environment.

Rationale of Longitudinal Cohort Study on Obstetrical Outcomes of Trichomonas vaginalis Infection in Kinshasa, DR Congo

Background: Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the world, and the occurrence of this infection during pregnancy is responsible for adverse obstetrical outcomes like premature labor, premature rupture of membranes (PROM) and low birth weight (birth weight < 2500 g). The association with a number of factors (maternal age, low level of education, low socio-economic status and multiple sexual partners, etc.) that can be found in our environment suggest its probably high prevalence amongst vaginal infections that are responsible for adverse obstetrical outcomes, but up-to-date estimates are lacking. Objective: To assess the obstetrical risk associated with Trichomonas vaginalis (T. vaginalis) infection in our environment. Methods: We designed a protocol for a prospective cohort study which will take place in four medical facilities in the city of Kinshasa, where all pregnant women with a pregnancy of at least 20 weeks and who will give written consent will be included. Vaginal swab specimens will be collected for T. vaginalis research by direct microscopy wet mount. Follow-up will consist of recording the process of the pregnancy and obstetrical outcomes. Conclusion: Results from this study will allow to enhance management and also bring updated estimates on T. vaginalis prevalence and its obstetrical outcomes for infected pregnant woman in our environment.

Rationale of Cross-Sectional Descriptive Study on Clinical Effectiveness of Oral Combination Therapy Based on Secnidazole, Azithromycin and Fluconazole in Syndromic Treatment of Abnormal Vaginal Discharge in Kinshasa/DR Congo

Background: Vaginal discharge is one of the most common troubles faced by childbearing age women. About 20% - 25% of women who visit service of gynecology complain of vaginal discharge and leucorrhoea. Management of vaginal discharge in low-income countries generally depends on syndromic approach, which limits the understanding of specific responsible agents. Thus targeted management is based on the identification of causal organism and targeting of therapy against it, while syndromic management is based on presence of high risk factors. Thus the oral combination kit (Azimyn FS Kit®) offers convenience of a one-day treatment compared to other multidose treatments, which will also ensure high patient adherence to treatment, thus increasing chances of desired results. Due to its widespread use, it is proposed to evaluate the effectiveness of this oral association kit therapy in management of vaginal discharge in the population of our milieu in the Democratic Republic of Congo (DRC) particularly those received in outpatient consultation in some medical facilities in city of Kinshasa. Expensive laboratory tests and the associated waiting period for result mean that patient remains without treatment while waiting for test results. Therefore, by adopting a syndromic management approach, patient’s eligibility for treatment will be decided based on abnormal vaginal discharge, their characteristics, severity and other presentations symptomatic. This approach will also avoid losing sight of patients during follow-up and will help to reduce financial burden for patients. Objectives: To determine the efficacy and safety of oral combination kit therapy containing secnidazole, azithromycin and fluconazole (Azimyn FS Kit®) in syndromic treatment of abnormal vaginal discharge in patients received in outpatient consultation in some medical facilities in the city of Kinshasa;to measure rate of recurrence of abnormal vaginal discharge in these patients. And to identify the adverse effects observed in these patients who received treatment with the combined oral kit containing secnidazole, azithromycin and fluconazole (Azimyn FS Kit®) in outpatient consultation in some medical facilities in the city of Kinshasa. Methods: It will be a cross-sectional descriptive study. Sample size will be 319 women of childbearing age who consult the gynecology department with complaint of abnormal vaginal discharge and suspicion of vaginal infection, who agree to abstain from sex during treatment and who have given their written consent to use their personal and/or health data in the study. Conclusion: A study on clinical efficacy of oral combination therapy based on secnidazole, azithromycin and fluconazole is beneficial.

Rationale of the Cross-Sectional Descriptive Study on Factors Associated with Failure of Vaginal Delivery Trial after Cesarean Section in the University Clinics of Kinshasa, DR Congo

Background: Delivery in a scarred uterus is nowadays a real problem in Obstetrics practice, due to the inflation in the number of caesarean sections and the non-unanimous attitude of Obstetrics’ teams towards uterine scars. The factors associated with failed vaginal birth attempts after caesarean section (VBAC) are crucial information that would contribute effectively to deciding on the most appropriate mode of delivery for the mother and her fetus. Their identification would enable us to detect pregnant women at high risk of failure to attempt vaginal birth after caesarean section, and thus contribute to reducing the complications associated with this failure. Objective: We will study the factors associated with failure to vaginal delivery trial after caesarean section at the University Clinics of Kinshasa (UCK). Methods: This study will be a cross-sectional descriptive study with analytical aims. The minimum sample size will be 239. Our study population will consist of records of pregnant women with unicatricial uterus who underwent attempted vaginal delivery after caesarean section at UCK from January 2014 to June 2023. Results will be reported as percentage proportion and mean plus or minus standard deviation. Comparison of means between groups will be made using Student’s t-test, and of proportions using Pearson’s Chi-square test. Logistic regression will be used to generate Odds Ratios to measure the strength of association between variables. The test will be statistically significant for a p value 0.05. Data will be collected and processed confidentially and anonymously. Conclusion: This study will identify the factors associated with the failure of attempted vaginal delivery after caesarean section in order to contribute to the reduction of complications related to its failure in our setting. .

Benefit of Iron Supplementation with Ferric Sodium EDTA (NaFe ³⁺-EDTA) in the Treatment of Anemia during Pregnancy in Democratic Republic of Congo (FERARI Study)

Background: Oral iron supplements, usually in the form of ferrous salts, are associated with gastric side effects, poor compliance and failure of anemia treatment. To make iron more bioavailable, reduce the gastric side effects and increase the patient compliance, newer iron form, Ferric Sodium EDTA, has become available on the market. Objective: To assess the change in hemoglobin level after iron supplementation with Ferric Sodium EDTA during pregnancy. Materials and Methods: This is a longitudinal study concerning 337 women attending antenatal care in maternity hospitals in the Democratic Republic of Congo from May to December 2020. The study included sociodemographic and anthropometric variables along with type of feed, hemoglobin level at recruitment and after three weeks of taking iron supplement with Ferric Sodium EDTA (Hemoforce Plus Zinc® syrup). For statistical analysis, we used t-test or ANOVA and chi-square test, the significance being stated at p < 0.05. Results: The frequency of pregnancy anemia was 51.4%. The mean hemoglobin value of the overall study group was 8.7 ± 0.5 g/dL. The mean maternal age and weight were 28.9 ± 6.2 years and 65.3 ± 11.7 kg, respectively. Most pregnant women (83.1%) had a diet consisting of food of plant and animal origin in equal proportions. Mean of Body Mass Index (BMI) was 24.6 ± 4.6 Kg/m2 and 44.3% were overweight and obese. The co-morbidities associated were malaria and intestinal parasitosis found in 45% and 5.9% of cases, respectively. After iron treatment with Ferric Sodium EDTA, the average hemoglobin level increased to 11.2 g/dL with mean gain of 2.5 g/dL (p < 0.001). Pregnant women with excess weight (≥90 kg) and malaria as a comorbidity achieved a significantly lower mean hemoglobin gain (p = 0.014 and p = 0.022, respectively). Majority of women (91.2%) had not experienced the metallic taste of the syrup. Conclusion: Ferric Sodium EDTA as a novel iron formulation (Hemoforce Plus Zinc®) has shown a rapid increase in hemoglobin levels in pregnant women suffering from anemia. The speedy rise in hemoglobin is related to the property of Ferric Sodium EDTA to enhance the iron absorption by inhibiting the dietary iron inhibitors. Thus, Ferric Sodium EDTA should be used as an effective and promising iron supplement in pregnant women with iron deficiency anemia.