RESUMO
Nigeria has the highest reported incidence of peripartum cardiomyopathy worldwide. This open-label, pragmatic clinical trial randomized pregnant and postpartum women to usual care or artificial intelligence (AI)-guided screening to assess its impact on the diagnosis left ventricular systolic dysfunction (LVSD) in the perinatal period. The study intervention included digital stethoscope recordings with point of-care AI predictions and a 12-lead electrocardiogram with asynchronous AI predictions for LVSD. The primary end point was identification of LVSD during the study period. In the intervention arm, the primary end point was defined as the number of identified participants with LVSD as determined by a positive AI screen, confirmed by echocardiography. In the control arm, this was the number of participants with clinical recognition and documentation of LVSD on echocardiography in keeping with current standard of care. Participants in the intervention arm had a confirmatory echocardiogram at baseline for AI model validation. A total of 1,232 (616 in each arm) participants were randomized and 1,195 participants (587 intervention arm and 608 control arm) completed the baseline visit at 6 hospitals in Nigeria between August 2022 and September 2023 with follow-up through May 2024. Using the AI-enabled digital stethoscope, the primary study end point was met with detection of 24 out of 587 (4.1%) versus 12 out of 608 (2.0%) patients with LVSD (intervention versus control odds ratio 2.12, 95% CI 1.05-4.27; P = 0.032). With the 12-lead AI-electrocardiogram model, the primary end point was detected in 20 out of 587 (3.4%) versus 12 out of 608 (2.0%) patients (odds ratio 1.75, 95% CI 0.85-3.62; P = 0.125). A similar direction of effect was observed in prespecified subgroup analysis. There were no serious adverse events related to study participation. In pregnant and postpartum women, AI-guided screening using a digital stethoscope improved the diagnosis of pregnancy-related cardiomyopathy. ClinicalTrials.gov registration: NCT05438576.
RESUMO
OBJECTIVES: This study aimed to compare the efficacy of oral misoprostol with manual vacuum aspiration (MVA) in first trimester incomplete abortions. METHODS: This randomised controlled trial study was conducted at the University of Ilorin Teaching Hospital, Ilorin, Nigeria between April 2014 and November 2015. Pregnant women who presented with clinical features of incomplete abortion at a gestational age of 13 weeks or less were included. Patients who had profuse vaginal bleeding, an intrauterine device in situ, signs of pelvic infections or who were younger than 18 years old and had no accompanying adults to give informed consent were excluded. A total of 200 participants were randomly and equally allocated to either the MVA or misoprostol treatment group. The treatment group were given 600 µg of misoprostol orally. The primary outcome measure was complete uterine evacuation, while secondary outcome measures included the need for additional surgical evacuation for failed treatment, adverse effects/complications, acceptability of and satisfaction with the treatment. RESULTS: Both misoprostol and MVA had high complete evacuation rates, yet MVA was significantly higher (99% versus 83%, relative risk [RR]: 0.84, confidence interval [CI]: 0.766-0.918; P <0.001). Significantly more women in the misoprostol group required additional MVA for failed treatment than in the MVA treatment group (17% versus 1%, RR: 16.67, CI: 2.260-12.279; P <0.001). No significant difference was found between the misoprostol and MVA treatment groups in terms of satisfaction (92.7% versus 89.8%, RR: 1.04, CI: 0.946-1.127; P = 0.473). CONCLUSION: Treatments with misoprostol and MVA had high complete uterine evacuation rates, as well as high rates of acceptability and satisfaction. However, MVA had a significantly higher complete evacuation rate than misoprostol.