Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial

González, Raquel; García‐Otero, Laura; Pons‐Duran, Clara; Marbán-Castro, Elena; Goncé, Anna; Llurba, Elisa; Gil, M. M.; Rodríguez-Zambrano, Miguel Ángel; Chen, Haily; Ramírez, Máximo; Bardají, Azucena; Menéndez, Clara

doi:10.1186/s13063-020-04557-y

Cited by 11 publications

(12 citation statements)

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“…The study design was informed by a definition of acceptability referred to as "a multifaceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention" [28]. The study was conducted in Spain, between July and October 2020, within the frame of a clinical trial assessing the efficacy of hydroxychloroquine (HCQ) in preventing SARS-Cov-2 infection and severity of COVID-19 during pregnancy and postpartum [29]. The study was performed at the end of the first COVID-19 pandemic wave and the beginning of the second wave in the country.…”

Section: Study Design and Populationmentioning

confidence: 99%

Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study

Marbán-Castro

Pons‐Duran

García‐Otero

et al. 2021

IJERPH

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Participation of pregnant women in clinical trials entails challenges mainly related to concerns about the risks for fetuses. We undertook a qualitative study from June to October 2020 to assess the acceptability of participating in COVID-19 clinical trials among pregnant women in Spain. Phenomenology and grounded theory were used as methodological approaches. Semi-structured interviews were conducted with 24 pregnant women and six healthcare providers. Women were unsure if pregnancy was a risk factor to acquire the infection or to develop severe disease and expressed the limited information they had received, which led to uncertainties and emotional suffering. They had concerns regarding participation in clinical trials on COVID-19, regardless of the drug under study. Healthcare providers alluded to the importance of involving pregnant women’s relatives at the recruitment visit of the clinical trial. These findings may be useful to facilitate pregnant women’s participation in clinical trials.

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Section: Study Design and Populationmentioning

confidence: 99%

Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study

Marbán-Castro

Pons‐Duran

García‐Otero

et al. 2021

IJERPH

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“…The resistance ranged from low to moderate [ 69 ], thus SP is still used for IPTp and remains efficacious against asymptomatic parasitemia [ 70 , 71 ]. Evaluation of alternative drugs for IPTp like dihydroartemisinin-piperaquine or mefloquine is ongoing, as well as exploration of new strategies such as community-based malaria screening and treatment in pregnancy, alone or in combination with IPTp-SP [ 15 , 72 , 73 ]. Placental malaria prevention could be better achieved by adding the benefit from sleeping under an insecticide-treated bed net starting in the first trimester of pregnancy to that of SP intake [ 69 ].…”

Section: Discussionmentioning

confidence: 99%

Age-modified factors associated with placental malaria in rural Burkina Faso

Bihoun

Zango

Traoré-Coulibaly

et al. 2022

BMC Pregnancy Childbirth

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Background Malaria in pregnancy can result in placental infection with fetal implications. This study aimed at assessing placental malaria (PM) prevalence and its associated factors in a cohort of pregnant women with peripheral malaria and their offspring. Method The data were collected in the framework of a clinical trial on treatments for malaria in pregnant women . Placental malaria (PM) was diagnosed by histopathological detection of parasites and/or malaria pigment on placenta biopsies taken at delivery. Factors associated with PM were assessed using logistic regression. Results Out of 745 biopsies examined, PM was diagnosed in 86.8 % of women. Acute, chronic and past PM were retrieved in 11 (1.5 %), 170 (22.8 %), and 466 (62.6 %) women, respectively. A modifying effect was observed in the association of gravidity or anemia at the study start with pooled PM (presence of parasites and/or malaria pigment). In women under 30, gravidity ≤ 2 was associated with an increased prevalence of pooled PM but in women aged 30 years or more, gravidity was no more associated with pooled PM (OR 6.81, 95 % CI 3.18 – 14.60; and OR 0.52, 95 % CI 0.10 – 2.76, respectively). Anemia was associated with pooled PM in women under 30 (OR 1.96, 95 % CI 1.03 – 3.72) but not in women aged 30 years or more (OR 0.68, 95 % CI 0.31 – 1.49). Similarly, the association of gravidity with past-chronic PM depended also on age. A higher prevalence of active PM was observed in women under 30 presenting with symptomatic malaria (OR 3.79, 95 % CI 1.55 – 9.27), while there was no significant increase in the prevalence of active PM (presence of parasites only) in women with symptomatic malaria when aged 30 years or more (OR 0.42, 95 % CI 0.10 – 1.75). In women with chronic PM, the prevalence of low birth weight or prematurity was the highest (31.2 %) as compared with past PM or no PM. Conclusion Despite the rapid diagnosis and efficacious treatment of peripheral infection, the prevalence of placental malaria remained high in women with P. falciparum peripheral infection in Nanoro, especially in younger women This underlines the importance of preventive measures in this specific group.

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“…For much of the COVID-19 pandemic, pregnant women were excluded from preventive and therapeutic trials 5 although there were some exceptions, such as the UK RECOVERY Trial (https://www.recoverytrial. net/files/recovery-in-pregnant-women-for-hcp-v15-1-2021-12-22.pdf) (https://clinicaltrials.gov/ct2/show/NCT04765384) and others 6 . Consequently, effective treatments such as corticosteroids for severe COVID-19 patients which was implemented into clinical practice in the UK in June 2020, remain less frequently used in pregnant than nonpregnant women 7 .…”

Section: Pregnant Women In Covid-19 Clinical Trialsmentioning

confidence: 99%

Call for a unified approach to Monkeypox infection in pregnancy: Lessons from the COVID-19 pandemic

et al. 2022

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Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial

Cited by 11 publications

References 0 publications

Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study

Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study

Age-modified factors associated with placental malaria in rural Burkina Faso

Call for a unified approach to Monkeypox infection in pregnancy: Lessons from the COVID-19 pandemic

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