PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health

NCT ID: NCT05358483

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-07

Study Completion Date

2046-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility, Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Emily Jungheim

Chief of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Jungheim, MD, MCSI

Role: PRINCIPAL_INVESTIGATOR

Division Chief of Reproductive Endocrinology and Infertility

Locations

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Northwestern Medicine Fertility and Reproductive Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Jungheim, MD, MSCI

Role: CONTACT

312-926-6643

Brianna Borger, BS

Role: CONTACT

312-503-8208

Facility Contacts

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Emily Jungheim, MD, MSCI

Role: primary

Brianna Borger, BS

Role: backup

312-503-8208

Other Identifiers

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STU00215252

Identifier Type: -

Identifier Source: org_study_id

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