ArticlePatient preference and adherence2021
Clinical Drug Trial Participation: Perspectives of Pregnant Women and Their Spouses.
Article in Patient preference and adherence, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.PLoS medicine · 2024Pooled it
- Understanding willingness and barriers to participate in clinical trials during pregnancy and lactation: findings from a US study.BMC pregnancy and childbirth · 2024Article
- Understanding knowledge, perception, and willingness of non-invasive prenatal testing for fetal aneuploidy: a survey among Chinese high-risk pregnant women.Frontiers in medicine · 2023Article
- Registered Clinical Trials Comprising Pregnant Women in China: A Cross-Sectional Study.Frontiers in pharmacology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study aimed at investigating the factors influencing clinical drug trial participation by pregnant women and their spouses.
methodsThis hospital-based cross-sectional study was conducted at Women's Hospital, School of Medicine, Zhejiang University, from July to September 2020. A self-administered questionnaire was distributed to pregnant women and their spouses in the maternity ward. The questionnaire consisted of two sections: The first part was aimed at collecting demographic information data while the second part consisted of 10 open-ended questions regarding clinical drug trial knowledges, financial compensation, risk awareness, psychological impact, and pregnancy outcomes.
resultsA total of 206 questionnaires (115 from pregnant women and 91 from their spouses) were included in the statistical analysis. About 50% of pregnant women and their spouses had heard of clinical trials (50.43% vs 49.45%, p=0.888). Compared to their spouses, the proportion of pregnant women who thought that there is a need for the development of drugs during pregnancy was significantly higher (94.78% vs 16.48%, p=0.008). Moreover, a significant number of full-time employed pregnant women believed that clinical drug trials will increase the possibility of disease cure, relative to part-time/not employed pregnant women (98.21% vs 88.13%, p=0.030). Spouses whose education levels were below high school and those whose education level was high school or above exhibited significant differences regarding whether financial compensation will motivate their participation in clinical trials (77.78% vs 58.90%, p=0.044). Pregnant women and their spouses had no significant differences regarding various aspects: drug treatment during pregnancy, clinical trial drugs should be free, the need to increase the protection of pregnant women in clinical trials.
conclusionDue to fetus-associated concerns, most pregnant women are reluctant to be included in clinical trials. However, pregnant women and their spouses agree that medical treatment should be accessible for illnesses during pregnancy, and clinical drug trials during pregnancy should be performed. The usage of untested or sub-therapeutic drug regimens in clinical practice paradoxically increases the risk for fetuses. When recruiting pregnant volunteers for clinical drug trials, researchers should conduct in-depth consultations and comprehensively inform the pregnant women and their families on the pros and cons of their involvement.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.