NCT04371900 · University of Michigan
Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1
(M-CARES-K)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)
M-CARES randomized vouchers for contraception valued up to 100% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred from March 4, 2019, forward.
BEHAVIORAL
Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)
M-CARES randomized vouchers for contraception valued up to 50% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred after November 4, 2019.
Primary outcome measures
Number of siblings born after study enrollment (1 year)
Time frame: Up to 1 year post enrollment
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Number of siblings born after study enrollment (3 year)
Time frame: Up to 3 year post enrollment
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Number of siblings born after study enrollment (5 year)
Time frame: Up to 5 year post enrollment
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Standardized achievement test score (1 year)
Time frame: Up to 1 year post enrollment
Percentile on state standardized achievement test (range: 1-100)
Standardized achievement test score (3 year)
Time frame: Up to 3 year post enrollment
Percentile on state standardized achievement test (range: 1-100)
Standardized achievement test score (5 year)
Time frame: Up to 5 year post enrollment
Percentile on state standardized achievement test (range: 1-100)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Ann Arbor, Michigan
- Detroit, Michigan
- Ferndale, Michigan
- Grand Rapids, Michigan
- Kalamazoo, Michigan
- Lansing, Michigan
- Livonia, Michigan
- Traverse City, Michigan
- Warren, Michigan
Collaborators
Planned Parenthood Federation of America, National Opinion Research Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations