Obstetrics & Gynaecology

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Browsing Obstetrics & Gynaecology by Author "Gadama, Luis"

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    Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized,open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial)
    (2021-11-04) Gadama, Luis
    This is a hospital-based, multicenter, two-arm, parallel, open label, active-controlled, randomized, non-inferiority trial. The problem Hypertensive disorders are associated with severe maternal morbidity and hypertensive sequel to mothers and their babies. Pre-eclampsia and eclampsia are the second leading causes of maternal mortality in Malawi and worldwide with excessively larger occurrence in, low- and middle-income countries. Parental Magnesium Sulphate is the anticonvulsant of choice for women with preeclampsia and eclampsia. Due to potential drug toxicities, the treatment is confined to higher levels of care other than Primary level posing a missed opportunity in preventing pre-eclampsia progression to eclampsia. Intramuscular injection with the omission of Intravenous infusion (Iv) remain the dominant route of administration in low and middle countries where resources and skilled staff are limited. Determining alternative methods and regimen to improve treatment coverage among pre and eclamptic women and widening the task sharing base to improving maternal outcomes remain imperative. Objectives The main objectives of the study isare to evaluate superiority level of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IM (Pritchard) magnesium sulfate regimen: Specifically, the study will 1. Evaluate non-inferiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the prevention of maternal eclamptic seizure. 2. Evaluate superiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the proportion of women experiencing adverse events indicative of magnesium toxicity Methods A hospital-based, multicenter, two-arm, parallel, open label, active-controlled, randomized, noninferiority trial conducted at Queen Elizabeth Central Hospital, Zomba Central Hospital, Kamuzu Central Hospital and Bwaila Hospital. The study will start with a pilot study. An interim analysis will be conducted for an independent Data Safety Monitoring Committee (DSMC) and a Trial Steering Committee (TSC) to assess safety, futility, feasibility of recruitment, randomization, adherence to allocated treatment, and retention of trial participants. The study will recruit women admitted with pre-eclampsia during pregnancy, labour or within 24 hours of childbirth, whether with single or multiple tone gestation. Participating women will be randomized to receive the simplified regimen or either the standard IV (Zuspan) or IM (Pritchard) regimen, depending on the standard treatment protocol in the participating hospitals. Dissemination Data and Reports will be shared with the sponsors and the Malawi College of Medicine and Malawi College of Medicine Research Ethics Committee and published in peer reviewed publications
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    Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study: LACTate in mATernal sEpsis
    (Kamuzu University of Health Sciences, 16-03-22) Gadama, Luis
    Type of study This is a prospective, multi-site, phase III test accuracy study. Problem Maternal infections left untreated may lead to sepsis and consequently death. Maternal sepsis can develop in pregnant women and women who have recently experienced pregnancy and is defined as a life-threatening condition with organ dysfunction resulting from infection during pregnancy, childbirth, post-abortion, or the post-partum period”(1) . Multiple studies have tested the accuracy of blood lactate for the early identification of people likely to experience worsening sepsis in high income adult populations. The evidence suggests that lactate levels are informative, and a tiered recommendation was made of different actions based on the lactate measurement. A raised lactate level (>2 mmol/L) can be used as a triage tool to prompt initiation of urgent treatment and the patients can be identified as more severe (lactate level of >4 mmol/L) prompting more intensive treatment and monitoring. The need for high quality evidence of diagnostic accuracy for this test has been highlighted as a research priority. Currently there is no high-quality test accuracy study of lactate testing for maternal sepsis. After multiple systematic reviews we concluded there is no reliable evidence of test accuracy in the pregnant population. There is need to investigate if a lactate measurement has incremental benefit over conventional maternal vital sign assessment in the diagnosis of sepsis and identification of women at risk of severe morbidity or mortality in low resource settings. This study can help determine the diagnostic and prognostic accuracy of venous lactate measurement in the maternity populations, in low resource settings, which is unknown. Broad objective The broad objective of the Lactate test accuracy study is to determine the diagnostic accuracy of maternal venous lactate measurement in addition to maternal vital sign thresholds, in maternal sepsis in low-resource health facility settings in Malawi, Uganda and Pakistan. Specific objectives The specific objectives are to assess the immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard; to assess short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline; to explore if baseline venous lactate, in addition to vital sign measurements, improves prediction of severe morbidity and mortality from infection; to explore if the test accuracy of lactate in addition to maternal vital sign monitoring alone varies by the prespecified subgroups of pregnancy status (pregnant or post-delivery / post miscarriage / postabortion) and recruitment country; to explore and examine the effects of adjusting the threshold values for both vital sign and lactate assessment on the sensitivity and specificity of the index tests; and finally to explore and validate the use of an alternative reference standard in which the SOFA score is modified to use maternity specific ranges for creatinine and platelet concentration Methods The study will be conducted in the maternity wards at Queen Elizabeth Central Hospital in Blantyre, Malawi. Women will be recruited to have an additional blood sample taken at two time points during admission; at day 0 and day one for lactate testing. There will be no additional clinical procedures or interventions conducted with eligible women by members of the study team or by hospital staff for other reasons than those of their usual clinical practice. We will estimate diagnostic accuracy to detect sepsis as defined by comparison with the reference standard diagnosis of sepsis, at baseline and at 24 hours. We will compare (a) baseline index test with baseline reference standard to determine immediate diagnostic value, (b) baseline index test with 24-hour reference standard in those without sepsis at baseline to determine short-term predictive value and (c) baseline index test with occurrence of infection related “severe maternal outcome” (near miss or maternal mortality) prior to hospital discharge to determine predictive value for severe morbidity or mortality Expected findings If lactate testing in this population is found to offer incremental benefit over the standard sepsis triggering approach, and is feasible to implement in an integrated approach, then this has the potential to improve maternal sepsis outcomes. Dissemination The study report will be submitted to College of Medicine Research and Ethics committee (COMREC). Research findings will be disseminated via download on relevant websites and will also be shared with both local (QECH, Blantyre DHO, community gatekeepers and participants) and global stakeholders through research dissemination conferences, peer reviewed publications and via participant and public information groups, national and international forums and conferences and. Data will be retained and be supported to produce additional secondary outputs as appropriate.