Recruitment

It is important that all stakeholders, particularly patients, health care providers and ethical review committees, raise public and patient awareness of opportunities to participate in pregnancy-related research. This is critical in those regions where the participation of pregnant and lactating women in clinical studies is stigmatized.

Recruitment of pregnant and lactating women requires a tailored approach that recognizes the emotional, cultural, and practical realities of pregnancy and early motherhood, ensuring that women feel safe and supported to participate in research. Health care providers (including midwives) and patient representatives play an important role in introducing research opportunities. Time and support are essential to build rapport and trust with patients and patients' relatives and secure the willingness of women to participate in trials. Training and professional development are needed to encourage health care providers and allied professionals to engage in, and promote, research that includes pregnant and lactating women.

Several approaches may be taken to minimize the burden on, and disruption to, health services and women as described below.

Study procedures

Ensure efficiency in study processes by removing redundant and unnecessary tests, such as mandatory pregnancy tests in known pregnant individuals.

Ensure flexible scheduling and, where possible, offer remote options, childcare support, or home visits or utilize existing consultation opportunities such as antenatal care contacts to make participation easier for women with limited mobility or support.

Select equitable study locations, including remote and community sites. Use mobile technologies for reminders and ensure good communication to foster inclusivity.

Avoid or, where possible, adjust procedures that are known to pose fetal risk (e.g., X-rays, teratogenic drugs).

Ensure study procedures accommodate pregnancy-specific conditions, symptoms and medical needs (e.g., morning sickness, high-risk pregnancy monitoring).

Reduce or eliminate any financial burdens resulting from participation in the trial (e.g., travel and childcare costs and loss of income).

Ensure approaches are trauma-informed with empathic communication to address the emotional needs of women. Such an approach may help increase the recruitment and participation of women.

 

Study information

Utilize existing resources such as antenatal packs and pregnancy tests as a useful opportunity to share and discuss research information.

Social media platforms such as the National Institute for Health and Care Research (NIHR) “Be Part of Research” platform in the United Kingdom of Great Britain and Northern Ireland help individuals, including pregnant and lactating women, to find and take part in health and care research. Caution should be taken, however, to ensure materials are evidence-based, validated and from reliable sources to counter misinformation that could create fear or confusion.

Community-based organizations provide a valuable resource to build trust and ensure cultural sensitivity. Maintaining collaboration with community organizations throughout the study helps to foster long-term trust and feedback. Engaging women with lived experiences early in the process may lead them to act as advocates to enhance relevance and acceptability.

Ensure accessibility in patient-facing materials by creating materials in multiple languages and formats to meet the needs of diverse populations. Test materials with women from diverse backgrounds to ensure clarity and cultural sensitivity.

Offer regular, respectful, and accessible communication through a variety of platforms (e.g., phone, email, virtual platforms) and modalities (e.g., regular script, braille, closed-captioned, keyboard-only navigation) as preferred by participants and be inclusive of their companion/s, to foster participant understanding.