Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy

Area of Science:

• Obstetrics and Gynecology
• Clinical Trial Methodology
• Health Services Research

Background:

• Recruitment for clinical trials requires understanding participant demographics.
• Maternal characteristics may influence consent to participate in obstetric research.
• Previous studies have not fully explored factors associated with consent for labor induction trials.

Purpose of the Study:

• To identify maternal characteristics associated with consent to a randomized trial of labor induction.
• To analyze the influence of race, ethnicity, insurance type, and age on trial participation.
• To inform future recruitment strategies for obstetric clinical trials.

Main Methods:

• Secondary analysis of low-risk nulliparous women from a randomized trial of labor induction versus expectant management.
• Data collected on maternal age, race, ethnicity, and insurance type for women approached for consent.
• Analysis of reasons for declining consent, including preference for expectant management and research participation reluctance.

Main Results:

• Consent rates varied significantly by race and ethnicity, with Black women more likely and Asian women less likely to consent compared to White women.
• Women without private insurance were more likely to consent than those with private insurance.
• Younger maternal age was associated with a higher likelihood of consent. Preference for expectant management was the most common reason for declining, particularly among Asian women.

Conclusions:

• Maternal consent for labor induction trials is influenced by race, ethnicity, insurance status, and age.
• Understanding these demographic associations is crucial for designing effective recruitment strategies.
• Efforts to enhance participant diversity in clinical trials should address identified barriers and facilitators to consent.