Improved pregnant women's understanding of research information by an enhanced informed consent form: a randomised controlled study nested in neonatal research.

Objective: This study aimed to test the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in neonatal research requiring maternal consent.

Design: A single-centre open-label randomised controlled study.

Setting: Antenatal care clinics at Phramongkutklao Hospital, Thailand.