Conducting clinical trials with pregnant women presents significant challenges due to extensive omission of these women from research. In the past, concerns about potential harm to fetuses w

provide me full research paper on Regarding: “Inclusion of pregnant woman in clinical trials to discover therapies safe during pregnancy” in English.
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Executive Summary:
The inclusion of pregnant women in clinical trials aims to assess the effectiveness of treatments that enhance maternal health, pregnancy outcomes, and birth outcomes. This involvement is only possible if both parents supply informed consent after being fully informed about the potential impacts on the fetus. The purpose is to hasten the development of treatment recommendations.
Thesis Statement:
Conducting clinical trials with pregnant women presents significant challenges due to extensive omission of these women from research. In the past, concerns about potential harm to fetuses were cited as reasons for excluding pregnant women from clinical trials. However, this risk can be managed and does not always justify barring women who are expecting from research. Further research is needed to better understand and address these challenges. Some areas that could be explored include scenarios where the clinical trial may pose significant risks or uncertainties, whether exposing a pregnant woman and fetus to potential harm is acceptable for the sake of advancing medical knowledge, differences in conducting clinical trials on different biological systems, updates to regulations for improving the quality of clinical trials, and a moral perspective for conducting clinical trials with pregnant women to protect the fetus.
Abstract:
In recent years, there have been many advancements in biomedical research aimed at developing effective medicines that can improve the quality of life for a broader population. The priority in clinical trials is always the safety of human subjects. This is why it is important to include a diverse range of people, including pregnant women and children, in these trials. This allows for the evaluation of different response rates, safety profiles, adverse events, and efficacy. The inclusion of pregnant women is crucial because their biological and physiological response is different from women without a fetus. In the past, some vaccines tested on certain races or sexes have shown efficacy with minimal safety concerns. However, the same vaccine may cause an abortion in a pregnant woman if it poses a risk to the fetus. Hence, it is recommended to include everyone without discrimination because of age, sex, race, or ethnicity.
Key concepts:
Clinical trials involving pregnant women must take place with the informed consent of the participants. Research on this population requires careful consideration, as the well-being of both the mother and the fetus must be considered. Obtaining informed consent from pregnant women who take part in these trials is critical to ensuring that the rights and autonomy of the participants are respected.

Sources:
In a 2013 study, Belhar et al. examined the difficulties in recruiting expectant women for clinical research. issues with women’s health.: An Official Jacobs Institute of Women’s Health Publication released this study. The research’s findings were obtained on February 13, 2022. Enrolling Pregnant Women: Issues in Clinical Research – PMC (nih.gov)
Pediatrics published an essay by H. S. on “therapeutic orphans.” On February 13, 2022, this article was recovered. Therapeutic orphans – PubMed (nih.gov)
The American College of Obstetricians and Gynecologists (ACOG) released a statement about the moral issues surrounding the recruitment of women as research subjects. This message was collected from their website on February 13, 2022. Ethical Considerations for Including Women as Research Participants | ACOG

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