(B-266) Landscape and Study Design Characteristics of Prospective Observational Cohort Studies on Pregnant Women in China

Background: Prospective observational cohort studies on pregnant women in China have evolved significantly in recent years, reflecting a growing recognition of the importance of maternal and child health. However, these studies are not frequently funded by industry. The evaluation of drug and medicinal products in pregnant women lacks guidelines from the Center of Drug Evaluation of the NMPA, contrasting with the pregnancy registry study guidelines/requirements established by the FDA and EMA for post-approval safety assessments.

Objectives: To describe the landscape and key study design characteristics of prospective, observational, pregnancy cohort studies in China.

Methods: We conducted a targeted search for prospective observational cohort studies of pregnant women in China in clinicaltrials.gov and in the Chinese Clinical Trial Registry (ChiCTR, www.chictr.org.cn) as of 22 Jan 2025. Key study design characteristics were extracted through a manual review.

Results: Of the 150 studies identified, there were 51 (34.0%) disease-specific, 32 (21.3%) biomarker studies, 26 (17.3%) general pregnant women cohorts, 23 (15.3%) drug-specific, and 18 other types, including diagnostic, genetics, vaccine, and device-specific studies. The number of studies has increased since 2012, with 59.3% initiating between 2019-2024. The indications vary across the 51 disease-specific studies.
More than half (16/23, 69.6%) of the 23 drug-specific studies were comparative. Thirteen (13/23, 56.5%) studies evaluated safety and effectiveness of antiviral treatments to prevent Hepatitis B virus transmissions.
The sample size varied across all types of studies with a median (Q1, Q3) of 900 (200, 3766), whereas the median size of general pregnant women cohorts was higher, at 2900 (1620, 19000).
The most common primary outcomes were maternal, fetal, and infant outcomes, including abortion, stillbirth, live birth, preterm birth, low birth weight, and birth defects.
Almost all the studies were sponsored by government funding or self-funded by the affiliation of the principal investigator. Only 6 (4.0%) studies were funded by industry, including two disease cohorts (Fabry disease and Gaucher disease), two biomarker cohorts to predict pre-eclampsia and preterm birth, one HBV treatment cohort, and one non-invasive device cohort for uterine fibroid treatment.

Conclusions: The landscape of prospective observational pregnancy cohort studies in China has expanded significantly recently. However, industry involvement remains minimal, highlighting a need for clearer regulatory guidelines and increased industry engagement to enhance maternal and child health research specifically on medicinal products.