It is suggested that the higher incidence and greater severity of ischemic mitral regurgitation in patients with inferior compared with anterior myocardial infarction can be related to more severe geometric changes in the mitral valve apparatus with greater displacement of posterior papillary muscle caused by localized inferior basal left ventricular remodeling, which results in therapeutic implications for potential benefit of procedures, such as infarct plication and leaflet or chordal elongation, to reduce leaflet tethering.
Background: South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging from 4.5-9.1% per year. Unfortunately none of the interventions tested had any impact on reducing the risk of HIV acquisition; however, extremely valuable experience was gained, lessons learned and capacity built, while the communities gained associated benefits.Experience: Our experience in conducting these trials ranged from setting up community partnerships to developing clinical research sites and dissemination of trial results. Community engagement included setting up communitybased research sites with approval from both political and traditional leaders, and developing community advisory groups to assist with the research process. Community-wide education on HIV/sexually transmitted infection prevention, treatment and care was provided to over 90 000 individuals. Myths and misconceptions were addressed through methods such as anonymous suggestion boxes in clinic waiting areas and intensive education and counselling. Attempts were made to involve male partners to foster support and facilitate recruitment of women. Peer educator programmes were initiated to provide ongoing education and also to facilitate recruitment of women to the trials. Recruitment strategies such as door-to-door recruitment and community group meetings were initiated. Over 90% of women enrolled were retained.Community benefits from the trial included education on HIV prevention, treatment and care and provision of ancillary care (such as Pap smears, reproductive health care and referral for chronic illnesses). Social benefits included training of home-based caregivers and sustainable ongoing HIV prevention education through peer educator programmes.Challenges: Several challenges were encountered, including manipulation by participants of their eligibility criteria in order to enroll in the trial. Women attempted to co-enroll in multiple trials to benefit from financial reimbursements and individualised care. The trials became ethically challenging when participants refused to take up referrals for care due to stigma, denial of their HIV status and inadequate health infrastructure. Lack of disclosure of HIV status to partners and family members was particularly challenging. Some of the ethical dilemmas put to the test our responsibility as researchers and our obligation to provide health care to research participants. Conclusion:Conducting these five trials in a period of six years provided us with invaluable insights into trial implementation, community participation, recruitment and retention, provision of care and dissemination of trial results. The...
Gestational trophoblastic disease (GTD) represents a spectrum of histologically distinct entities including molar pregnancy and choriocarcinoma. The incidence of GTD varies in different parts of the world with high incidences in countries like Japan (2 / 1000 pregnancies). With the advent of sensitive assays for detection of serum beta human chorionic gonadotrophin (HCG) and ultrasound, GTD can now be detected earlier in pregnancy. To date no studies have been reported from South Africa regarding the epidemiology, management, and outcome of patients with GTD. This study was a retrospective audit based on 112 patients with GTD treated at King Edward VIII Hospital, Durban, South Africa. Clinical records of patients were reviewed with regards to presentation, investigation, management and outcome. Of 112 patients, there were 78 patients (70%) with hydatidiform mole and 34 patients (30%) with choriocarcinoma. The mean age of patients was 28.5 years (SD 8.1 years). The majority of patients were Black females (94.6%) while 4.4% were Asian and 1% Coloured females. The most common presenting symptom was vaginal bleeding (93.8%). There were 74 patients (66.7%) who had a previous normal term pregnancy and only two patients (1.8%) had previous molar pregnancies. Suction curettage was the main treatment modality for patients with molar pregnancy while choriocarcinoma was treated primarily with chemotherapy. A total of 72 percent of patients with molar pregnancy and 28 percent with choriocarcinoma had complete remission after initial treatment. Twelve patients died during the course of treatment mainly due to late presentation and advanced metastatic disease. Complete cure was achieved in 89% of patients. Age, parity, previous history, initial uterine size, presence of theca-lutein cysts, and initial betaHCG concentration was not found to be prognostic for persistent trophoblastic disease. In the present study, the incidence of molar pregnancy and choriocarcinoma was 1.2 / 1000 and 0.5 / 1000 deliveries, respectively. This is much lower than those quoted from countries such as Japan. However, the incidence quoted from our study may be overestimated as this was a hospital-based study and most of the uncomplicated deliveries occur in referring centers. Only 20% of patients in this study were above the age of 35 years with a mean age of 28.5 years. The majority of patients were of Black African ethnic origin mainly due to the fact that our hospital is a referral center for Black patients. Similar to other studies, the majority of patients with molar pregnancy were treated with suction curettage while the majority of patients with choriocarcinoma were treated with chemotherapy. Overall, spontaneous remission was achieved in 60% of patients with molar pregnancy and an overall complete cure was achieved in 89% of patients.
Background: Monthly use of the dapivirine vaginal ring has been shown to be safe and effective for HIV-1 prevention in nonpregnant reproductive-aged women. The impact of dapivirine on pregnancy outcomes and infant is not known. We compared pregnancy incidence and outcomes by study arm among HIV-1 uninfected women who became pregnant while participating in MTN-020/ASPIRE. Methods: ASPIRE was a randomized, double-blind, placebo controlled phase III safety and effectiveness study of the dapivirine ring for HIV-1 prevention. Sexually active women aged 18–45 from Malawi, South Africa, Uganda, and Zimbabwe were enrolled. Urine pregnancy tests were performed monthly and, if positive, study product was withheld during pregnancy and breastfeeding. Pregnancy-related outcomes included: pregnancy incidence, pregnancy outcomes (live birth, preterm birth, pregnancy loss, congenital anomalies), and infant growth. Results: Of 2,629 women enrolled in ASPIRE, 169 became pregnant during follow-up, resulting in 179 incident pregnancies and 181 pregnancy outcomes. No difference in pregnancy incidence by study arm was observed (hazard ratio=0.93; 95% CI 0.68–1.26). The distribution of pregnancy outcomes was similar by study arm, and no difference was noted in the frequency or pattern of congenital anomalies or infant growth parameters by study arm. Conclusion: Dapivirine use in the periconception period does not appear to be associated with adverse effects on pregnancy or infant outcomes. Our findings provide support for additional safety studies of the dapivirine ring throughout pregnancy.
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