It is the time to change the paradigms of pregnant and breastfeeding women in clinical research!
作者信息
Sportiello Liberata, Capuano Annalisa
机构信息
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.
Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
出版信息
Front Pharmacol. 2023 Feb 23;14:1113557. doi: 10.3389/fphar.2023.1113557. eCollection 2023.
Abstract
摘要
相似文献
1
It is the time to change the paradigms of pregnant and breastfeeding women in clinical research!
Front Pharmacol. 2023 Feb 23;14:1113557. doi: 10.3389/fphar.2023.1113557. eCollection 2023.
2
Perception and Demands of Pregnant and Breastfeeding Women Regarding Their Role as Participants in Environmental Research Studies.
Int J Environ Res Public Health. 2021 Apr 14;18(8):4149. doi: 10.3390/ijerph18084149.
3
Complementary medicine products information-seeking by pregnant and breastfeeding women in Australia.
Midwifery. 2019 Oct;77:60-70. doi: 10.1016/j.midw.2019.06.011. Epub 2019 Jun 21.
4
Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection - a qualitative study.
BMC Pregnancy Childbirth. 2021 Jan 20;21(1):67. doi: 10.1186/s12884-021-03541-x.
5
Antiretroviral therapy (ART) for treating HIV infection in ART-eligible pregnant women.
Cochrane Database Syst Rev. 2010 Mar 17(3):CD008440. doi: 10.1002/14651858.CD008440.
6
Breastfeeding attitude, health-related quality of life and maternal obesity among multi-ethnic pregnant women: A multi-group structural equation approach.
Int J Nurs Stud. 2017 Feb;67:71-82. doi: 10.1016/j.ijnurstu.2016.12.004. Epub 2016 Dec 16.
7
SafeMotherMedicine: Aiming to Increase Women's Empowerment in Use of Medications During Pregnancy and Breastfeeding.
Matern Child Health J. 2020 May;24(5):531-536. doi: 10.1007/s10995-020-02903-9.
8
Perspectives of Pregnant and Breastfeeding Women on Participating in Longitudinal Mother-Baby Studies Involving Electronic Health Records: Qualitative Study.
JMIR Pediatr Parent. 2021 Mar 5;4(1):e23842. doi: 10.2196/23842.
9
Adherence with prescription drugs in pregnant and breastfeeding women consulting with the Israel Poison Information Center Teratology Service.
Clin Toxicol (Phila). 2021 Jun;59(6):457-463. doi: 10.1080/15563650.2020.1823405. Epub 2020 Oct 23.
10
Mental health status of pregnant and breastfeeding women during the COVID-19 pandemic-A multinational cross-sectional study.
Acta Obstet Gynecol Scand. 2021 Jul;100(7):1219-1229. doi: 10.1111/aogs.14092. Epub 2021 Feb 13.
引用本文的文献
1
Pragmatic and contextualized methods selection for safety assessment of infant systemic exposure through human milk: the Milk4baby decision tree approach - a contribution from the concePTION project.
Front Pharmacol. 2025 Aug 5;16:1602018. doi: 10.3389/fphar.2025.1602018. eCollection 2025.
2
Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach.
Int Breastfeed J. 2025 Jul 4;20(1):53. doi: 10.1186/s13006-025-00743-3.
3
Analysis of 4616 clinical trial initial submissions received by the Medicines and Healthcare products Regulatory Agency between February 2019 and October 2023.
Br J Clin Pharmacol. 2025 Sep;91(9):2524-2533. doi: 10.1002/bcp.70061. Epub 2025 Apr 9.
4
Willingness-to-use and preferences for model-informed antenatal doses: a cross-sectional study among European healthcare practitioners and pregnant women.
Front Pharmacol. 2024 Aug 15;15:1403747. doi: 10.3389/fphar.2024.1403747. eCollection 2024.
5
Medication Use Among Pregnant Women With SARS-CoV-2 Infection and Risk of Hospitalization-A Study in Two Brazilian Hospitals.
J Pregnancy. 2024 Jun 6;2024:8915166. doi: 10.1155/2024/8915166. eCollection 2024.
6
Disease-Modifying Therapies (DMTs) in Pregnant and Lactating Women with Multiple Sclerosis: Analysis of Real-World Data from EudraVigilance Database.
Pharmaceuticals (Basel). 2023 Nov 6;16(11):1566. doi: 10.3390/ph16111566.
本文引用的文献
1
Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.
Front Immunol. 2022 Oct 3;13:965171. doi: 10.3389/fimmu.2022.965171. eCollection 2022.
2
Exclusion of Reproductive-aged Women in COVID-19 Vaccination and Clinical Trials.
Womens Health Issues. 2022 Nov-Dec;32(6):557-563. doi: 10.1016/j.whi.2022.06.004. Epub 2022 Jun 15.
3
Self-Reported Medication Use among Pregnant and Breastfeeding Women during the COVID-19 Pandemic: A Cross-Sectional Study in Five European Countries.
Int J Environ Res Public Health. 2022 Jan 26;19(3):1389. doi: 10.3390/ijerph19031389.
4
Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study.
Int J Environ Res Public Health. 2021 Oct 13;18(20):10717. doi: 10.3390/ijerph182010717.
5
'My primary purpose is to protect the unborn child': Understanding pregnant women's perceptions of maternal vaccination and vaccine trials in Europe.
Vaccine. 2021 Sep 15;39(39):5673-5679. doi: 10.1016/j.vaccine.2021.07.099. Epub 2021 Aug 18.
6
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.
N Engl J Med. 2021 Jun 17;384(24):2273-2282. doi: 10.1056/NEJMoa2104983. Epub 2021 Apr 21.
7
Assuring Access to Safe Medicines in Pregnancy and Breastfeeding.
Clin Pharmacol Ther. 2021 Oct;110(4):941-945. doi: 10.1002/cpt.2212. Epub 2021 May 1.
8
Pregnant women's perceptions of risks and benefits when considering participation in vaccine trials.
Vaccine. 2020 Oct 14;38(44):6922-6929. doi: 10.1016/j.vaccine.2020.08.059. Epub 2020 Sep 4.
9
Change in the Incidence of Stillbirth and Preterm Delivery During the COVID-19 Pandemic.
JAMA. 2020 Jul 10;324(7):705-6. doi: 10.1001/jama.2020.12746.
10
Pregnant Women in Trials of Covid-19: A Critical Time to Consider Ethical Frameworks of Inclusion in Clinical Trials.
Ethics Hum Res. 2020 Jul;42(4):17-23. doi: 10.1002/eahr.500060. Epub 2020 Jun 20.
Zotero 插件