ClinicalTrials.Gov: Pitfalls for pregnant women looking to enroll in studies

• Published in: Contemporary clinical trials communications Vol. 26; p. 100890
• Main Authors: Franceschini, Robert, Wicks, Sarah L.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01-04-2022; Elsevier
• Subjects: Clinical trials registries; ClinicalTrials.gov; HIV research; Pregnant women; ClinicalTrials.gov; HIV research; Clinical trials registries; Pregnant women
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2022.100890

The common exclusion of pregnant women from clinical HIV research warrants inquiry into those few studies that do include pregnant women. This commentary highlights some of the pitfalls of the ClinicalTrials.gov platform for its intended users--study participants, particularly pregnant women--and investigators looking to use its data for study. Some of the pitfalls include missing information; lack of historical reporting enforcement; difficulty searching for studies focused on pregnant women versus the fetus; inability to consistently find studies targeted at specific stages of pregnancy; and lack of information relating to whether a study intervention is investigational or previously approved by the FDA.
•Missing information prevents ClinicalTrials.gov from being a reliable source of information.•Pregnant women may have difficulty determining ClinicalTrials.gov if studies are meant to benefit the woman or the fetus.•Inconsistent use of descriptors regarding pregnancy makes it challenging for pregnant women to ClinicalTrials.gov identify studies.•Lack of information ClinicalTrials.gov makes it hard to determine whether interventional products have been approved for use.