Letter to the Editor: COVID-19 vaccine during pregnancy: it is time to have a fair inclusion of pregnant women in clinical trials

Upon completion of this chapter, the reader should be able to describe the appropriate management of antiretrovirals for pregnant women living with HIV. Over time, research has demonstrated that proper prevention strategies and interventions during pregnancy, labor, and delivery can significantly reduce the rate of mother-to-child transmission (MTCT) of HIV. In 1994, a pivotal study in the field of HIV medicine, the Pediatric AIDS Clinical Trials Group 076, demonstrated that the use of zidovudine (ZDV) monotherapy during pregnancy substantially reduced the risk of HIV transmission to infants by 67% (...

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P10 Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-esdppp.49 ◽

2019 ◽

Vol 104 (6) ◽

pp. e21.1-e21

Author(s):

B Aurich ◽

T Martin-Montoya ◽

D Zhang ◽

E Jacqz-Aigrain

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Hiv Infection ◽

Pregnant Women ◽

Health Care Professionals ◽

Full Text ◽

Treatment Options ◽

Safety Data ◽

Chronic Medication ◽

Neonatal Deaths

BackgroundAccording to international guidelines clinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for both the mother and her offspring. Consolidated Standards of Reporting Trials (CONSORT) reporting criteria apply to these trials and should include safety data on the offspring. The safety of maternal treatments is a key issue for health care professionals and parents. Diabetes, human immunodeficiency virus (HIV) infection and hypertension are among the most frequent chronic diseases worldwide in women of child bearing potential. The objective of this systematic review was to analyse offspring data reported in clinical trials conducted in pregnant women receiving chronic drug treatment for one of these conditions.MethodsPubmed and Embase (01/01/1997–31/12/2017) were searched for drug trials in pregnant women with diabetes, HIV infection or hypertension. Titles and abstracts were screened, followed by a full text review of eligible articles. Inclusion criteria were interventional clinical trials in pregnant women treated with chronic medication and full text in English. Trial characteristics, maternal and offspring data were extracted. Data was summarised by disease and study. Twelve key items were considered for the offspring. The protocol was registered on PROSPERO (CRD42017057024).ResultsOverall, 196 articles reporting 132 clinical trials (diabetes n=55; HIV n=59; hypertension n=18) were included. The number of births were frequently not reported (diabetes 40%; HIV 24%; hypertension 56%). Congenital malformations were infrequently reported with sufficient detail (diabetes 27%; HIV 34%; hypertension 6%). Similar observations were made for other key items (e.g. foetal losses, neonatal deaths, birth weight corrected for gestational age).ConclusionsUnderreporting of key data for the offspring was frequent in publications of clinical trials in pregnant women with diabetes, HIV infection or hypertension making the assessment of the benefit-risk ratio of treatment options during pregnancy difficult.Disclosure(s)Nothing to disclose

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Response to the letter to the editor regarding our article: “The immediate effects of pelvic compression belt with a textured sacral pad on the sacroiliac function in pregnant women with lumbopelvic pain: A cross-over study”

Musculoskeletal Science and Practice ◽

10.1016/j.msksp.2020.102247 ◽

2020 ◽

Vol 50 ◽

pp. 102247

Author(s):

Bahareh Delshad ◽

Elaheh Zarean ◽

Gillian Yeowell ◽

Ebrahim Sadeghi-Demneh

Keyword(s):

Pregnant Women ◽

Letter To The Editor

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Maternal and Infant Death and the rVSV-ZEBOV Vaccine Through Three Recent Ebola Virus Epidemics-West Africa, DRC Équateur and DRC Kivu: 4 Years of Excluding Pregnant and Lactating Women and Their Infants from Immunization

Current Tropical Medicine Reports ◽

10.1007/s40475-019-00195-w ◽

2019 ◽

Vol 6 (4) ◽

pp. 213-222 ◽

Cited By ~ 9

Author(s):

David A. Schwartz

Keyword(s):

At Risk ◽

Clinical Trials ◽

West Africa ◽

Pregnant Women ◽

Ebola Virus ◽

Disease Outbreaks ◽

Case Fatality ◽

Viral Disease ◽

Lactating Women ◽

Health Communities

Abstract Purpose of Review Ebola virus infection has one of the highest overall case fatality rates of any viral disease. It has historically had an especially high case mortality rate among pregnant women and infants—greater than 90% for pregnant women in some outbreaks and close to 100 % in fetuses and newborns. The Merck recombinant vaccine against Ebola virus, termed rVSV-ZEBOV, underwent clinical trials during the 2013–2015 West Africa Ebola epidemic where it was found to be 100% efficacious. It was subsequently used during the 2018 DRC Équateur outbreak and in the 2018 DRC Kivu Ebola which is still ongoing, where its efficacy is 97.5 %. Pregnant and lactating women and their infants have previously been excluded from the design, clinical trials, and administration of many vaccines and drugs. This article critically examines the development of the rVSV-ZEBOV vaccine and its accessibility to pregnant and lactating women and infants as a life-saving form of prevention through three recent African Ebola epidemics—West Africa, DRC Équateur, and DRC Kivu. Recent Findings Pregnant and lactating women and their infants were excluded from participation in the clinical trials of rVSV-ZEBOV conducted during the West Africa epidemic. This policy of exclusion was continued with the occurrence of the DRC Équateur outbreak in 2018, in spite of calls from the public health and global maternal health communities to vaccinate this population. Following the onset of the DRC Kivu epidemic, the exclusion persisted. Eventually, the policy was reversed to include vaccination of pregnant and lactating women. However, it was not implemented until June 2019, 10 months after the start of the epidemic, placing hundreds of women and infants at risk for this highly fatal infection. Summary The historical policy of excluding pregnant and lactating women and infants from vaccine design, clinical trials, and implementation places them at risk, especially in situations of infectious disease outbreaks. In the future, all pregnant women, regardless of trimester, breastfeeding mothers, and infants, should have access to the Ebola vaccine.

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