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- Djimde, Moussa, et al.
(author)
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Efficacy and safety of pyronaridine-artesunate (PYRAMAX) for the treatment of P. falciparum uncomplicated malaria in African pregnant women (PYRAPREG) : study protocol for a phase 3, non-inferiority, randomised open-label clinical trial
- 2023
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In: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:10
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Journal article (peer-reviewed)abstract
- Introduction Malaria infection during pregnancy increases the risk of low birth weight and infant mortality and should be prevented and treated. Artemisinin-based combination treatments are generally well tolerated, safe and effective; the most used being artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP). Pyronaridine-artesunate (PA) is a new artemisinin-based combination. The main objective of this study is to determine the efficacy and safety of PA versus AL or DP when administered to pregnant women with confirmed Plasmodium falciparum infection in the second or third trimester. The primary hypothesis is the pairwise non-inferiority of PA as compared with either AL or DP.Methods and analysis A phase 3, non-inferiority, randomised, open-label clinical trial to determine the safety and efficacy of AL, DP and PA in pregnant women with malaria in five sub-Saharan, malaria-endemic countries (Burkina Faso, Democratic Republic of the Congo, Mali, Mozambique and the Gambia). A total of 1875 pregnant women will be randomised to one of the treatment arms. Women will be actively monitored until Day 63 post-treatment, at delivery and 4–6 weeks after delivery, and infants’ health will be checked on their first birthday. The primary endpoint is the PCR-adjusted rate of adequate clinical and parasitological response at Day 42 in the per-protocol population.Ethics and dissemination This protocol has been approved by the Ethics Committee for Health Research in Burkina Faso, the National Health Ethics Committee in the Democratic Republic of Congo, the Ethics Committee of the Faculty of Medicine and Odontostomatology/Faculty of Pharmacy in Mali, the Gambia Government/MRCG Joint Ethics Committee and the National Bioethics Committee for Health in Mozambique. Written informed consent will be obtained from each individual prior to her participation in the study. The results will be published in peer-reviewed open access journals and presented at (inter)national conferences and meetings.Trial registration number PACTR202011812241529.
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| 2. |
- Mocumbi, Sibone, et al.
(author)
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Mothers' satisfaction with care during facility-based childbirth : a cross-sectional survey in southern Mozambique
- 2019
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In: BMC Pregnancy and Childbirth. - : BMC. - 1471-2393 .- 1471-2393. ; 19:1
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Journal article (peer-reviewed)abstract
- Background Client satisfaction is an essential component of quality of care. Health system factors, processes of care as well as mothers' characteristics influence the extent to which care meets the expectations of mothers and families. In our study, we specifically aimed to address the mothers' experiences of, and satisfaction with, care during childbirth. Methods A population-based cross-sectional study, using structured interviews with published sequences of questions assessing satisfaction, including 4358 mothers who gave birth during the 12 months before June 2016 to estimate satisfaction with childbirth care. Regression analysis was used to determine the predictors of client satisfaction. Results Most mothers (92.5%) reported being satisfied with care during childbirth and would recommend that a family member to deliver at the same facility. Specifically, 94.7% were satisfied with the cleanliness of the facility, 92.0% reported being satisfied with the interaction with the healthcare providers, but only 49.8% felt satisfied with the assistance to feed their baby. Mothers who had negative experiences during the process of care, such as being abandoned when needing help, disrespect, humiliation, or physical abuse, reported low levels of satisfaction when compared to those who had not had such experiences (68.5% vs 93.5%). Additionally, they reported higher levels of dissatisfaction (20.1% vs 2.1%). Regression analysis revealed that mothers who gave birth in primary level facilities tended to be more satisfied than those who gave birth in hospitals, and having a companion increased, on average, the overall satisfaction score, with 0.06 in type II health centres (CI 0.03-0.10) and with 0.05 in type I health centres (CI - 0.02 - 0.13), compared to - 0.01(CI -0.08 - 0.07) in the hospitals, irrespective of age, education and socio-economic background. Conclusion Childbirth at the primary level facilities contributes to the level of satisfaction. The provision of childbirth care should consider women's preferences and needs, including having a companion of choice. We highlight the challenge in balancing safety of care versus satisfaction with care and in developing policies on the optimum configuration of childbirth care. Interventions to improve the interaction with providers and the provision of respectful care are recommended.
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