RecruitingNot Applicable

Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1

United States4,700 participantsStarted 2018-08-26

Plain-language summary

This project builds on the Michigan Contraceptive Access Research and Evaluation Study (M-CARES) to evaluate the long-term effects of mothers' access to free contraceptives and reductions in unintended pregnancies on their children's well-being.

Who can participate

Age range

0 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The proposed project will analyze the outcomes of children ages 0 to 17 years old whose mothers enrolled in the Michigan Contraceptive Access, Research and Evaluation Study (M-CARES). M-CARES participation requires that mothers are: * 18-35 years old * physically capable (biologically female and fecund) and at risk of having a pregnancy, * not pregnant at the time of enrollment * not wishing to become pregnant in the 12 months after enrollment, * are seeking care at Planned Parenthood of Michigan, and * face out-of-pocket costs for contraceptives at Planned Parenthood of Michigan.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of siblings born after study enrollment (1 year)

Timeframe: Up to 1 year post enrollment

Number of siblings born after study enrollment (3 year)

Timeframe: Up to 3 year post enrollment

Number of siblings born after study enrollment (5 year)

Timeframe: Up to 5 year post enrollment

Standardized achievement test score (1 year)

Timeframe: Up to 1 year post enrollment

Standardized achievement test score (3 year)

Timeframe: Up to 3 year post enrollment

Standardized achievement test score (5 year)

Timeframe: Up to 5 year post enrollment

Trial details

NCT IDNCT04371900

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2049-12-31

Contact for this trial

Vanessa Lang, PhD

1-844-864-8258 m-carestudy@umich.edu

View on ClinicalTrials.gov More Pregnancy trials

Who can participate

Age range

0 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of siblings born after study enrollment (1 year)

Timeframe: Up to 1 year post enrollment

Number of siblings born after study enrollment (3 year)

Timeframe: Up to 3 year post enrollment

Number of siblings born after study enrollment (5 year)

Timeframe: Up to 5 year post enrollment

Standardized achievement test score (1 year)

Timeframe: Up to 1 year post enrollment

Standardized achievement test score (3 year)

Timeframe: Up to 3 year post enrollment

Standardized achievement test score (5 year)

Timeframe: Up to 5 year post enrollment