PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health (PROMISE)

Northwestern University

Status: Enrolling

Conditions: Infertility, Female

Study type: Observational

Funder types: Other

Identifiers

NCT05358483

STU00215252

Details and patient eligibility

About

The goal of the PROMISE study is to determine how pre-conception lifestyle factors (e.g., sleep, nutrition, physical activity) affect short- and long-term reproductive outcomes.

Full description

The overall goal of the PROMISE study is to identify strategies to improve health outcomes for women and their children. The proposed study is important and novel as it aims to capture women before they are pregnant. Current research on maternal and child health often focuses on women who are already pregnant. This time period is likely too late to make a meaningful clinical impact on long term maternal and child health outcomes influenced by social and epidemiologic determinants of health as important epigenetic changes are or have already taken place. Examples of tools that will be used to capture social and epidemiologic data include validated surveys for nutrition, physical activity, sleep, and stress. The importance of these tools is that many of the data points captured are modifiable, and therefore if associations are noted between these data points and health outcomes, actionable interventions may be developed and implemented for women who are preconceptional.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women ages 18-44 seeking pregnancy at Northwestern Fertility and Reproductive Medicine (FRM) who agree to

  1. Be followed for a period for up to 25 years
  2. Share information regarding their child's health

• No prior IVF cycles

Exclusion criteria

• Women using donor oocytes or gestational carriers
• Inability or unwillingness to provide informed consent for any aspects of the study