PregnancyM-CARES-KNCT04371900
Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1
A study testing Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023) and Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019) in people with Pregnancy, run by University of Michigan at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023) and Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,700 participants
- Where
- 9 sitesUnited States
- Study dates
- 26 Aug 2018to 31 Dec 2049
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Planned Parenthood - Ann Arbor-West
Ann Arbor, Michigan, 48103
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
- Recruiting
Planned Parenthood - Detroit
Detroit, Michigan, 48201
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
- Recruiting
Planned Parenthood - Ferndale
Ferndale, Michigan, 48220
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
- Recruiting
Planned Parenthood - Grand Rapids
Grand Rapids, Michigan, 49503
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
- Recruiting
Planned Parenthood - Kalamazoo
Kalamazoo, Michigan, 49006
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
- Recruiting
Planned Parenthood - Lansing
Lansing, Michigan, 48912
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
- Recruiting
Planned Parenthood - Livonia
Livonia, Michigan, 48154
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
- Recruiting
Planned Parenthood - Traverse City
Traverse City, Michigan, 49686
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
- Recruiting
Planned Parenthood - Warren
Warren, Michigan, 48093
Suni Jo Roberts, 734.926.4802, SuniJo.Roberts@ppmi.org
About this study
Official title: The Effects of Unintended Pregnancy on Children
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.
Read the detailed description
M-CARES uses a randomized control trial design to assess the effects of providing free contraception to mothers on their children born before the intervention. The population subject to intervention is fecund women age 18-35 years at risk of pregnancy and who are clients at Planned Parenthood clinics of Michigan (PPMI), who meet income eligibility criteria, and who would otherwise pay out-of-pocket for services on the day of recruitment (i.e., lacking insurance coverage for received service). The experimental (treatment) condition is a mother's receipt of a voucher providing access to no-cost contraception (up to the price of a name-brand intrauterine device) for 100 days. The control group of mothers receives no voucher. All enrolled women complete a two-part baseline survey and consent to be re-contacted for two follow-up interviews in outgoing years. They also complete a two-part baseline survey and consent to be re-contacted for two follow up interviews in outgoing years. In addition, mothers consent to linkages to their own and their children's administrative data from records held by state and federal health, education, criminal justice, and tax records. Consent covers children already born to women at the time of intervention and children born after intervention. Survey and administrative data provide outcome measures to assess children's well-being and development up to age 18. The study will compare children of mothers who receive the intervention to those who did not.
- Conditions
- Pregnancy
- Being tested
- Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023), Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)
- Keywords
- contraception, financial access to reproductive health care, unintended pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)Behavioural
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.
Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives Receives: Behavioral: Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023); Behavioral: Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019) |
| Control Group | No intervention | Mothers randomized to NOT receive a voucher. Mothers in this arm receive the Planned Parenthood standard of care priced according to the Planned Parenthood sliding scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of siblings born after study enrollment (1 year)
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Measured: Up to 1 year post enrollment
Number of siblings born after study enrollment (3 year)
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Measured: Up to 3 year post enrollment
Number of siblings born after study enrollment (5 year)
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Measured: Up to 5 year post enrollment
Standardized achievement test score (1 year)
Percentile on state standardized achievement test (range: 1-100)
Measured: Up to 1 year post enrollment
Standardized achievement test score (3 year)
Percentile on state standardized achievement test (range: 1-100)
Measured: Up to 3 year post enrollment
Standardized achievement test score (5 year)
Percentile on state standardized achievement test (range: 1-100)
Measured: Up to 5 year post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start26 Aug 2018
- Primary completion31 Dec 2049 (estimated)
- Study completion31 Dec 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Federation of America, National Opinion Research Center
- Responsible party
- Principal investigator, Martha Bailey, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371900
- Sponsor's protocol ID
- HUM00132909B
- Acronym
- M-CARES-K
- Status last verified
- May 2026
- First submitted
- 29 Apr 2020
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Unintended Pregnancy on Children
- ClinicalTrials.gov ID
- NCT04371900
- Acronym / sponsor ID
- M-CARES-K / HUM00132909B
- Conditions
- Pregnancy
- Keywords
- contraception, financial access to reproductive health care, unintended pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,700 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Planned Parenthood Federation of America, National Opinion Research Center
- Study start
- 26 Aug 2018 (actual)
- Primary completion
- 31 Dec 2049 (estimated)
- Study completion
- 31 Dec 2049 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
M-CARES uses a randomized control trial design to assess the effects of providing free contraception to mothers on their children born before the intervention. The population subject to intervention is fecund women age 18-35 years at risk of pregnancy and who are clients at Planned Parenthood clinics of Michigan (PPMI), who meet income eligibility criteria, and who would otherwise pay out-of-pocket for services on the day of recruitment (i.e., lacking insurance coverage for received service). The experimental (treatment) condition is a mother's receipt of a voucher providing access to no-cost contraception (up to the price of a name-brand intrauterine device) for 100 days. The control group of mothers receives no voucher. All enrolled women complete a two-part baseline survey and consent to be re-contacted for two follow-up interviews in outgoing years. They also complete a two-part baseline survey and consent to be re-contacted for two follow up interviews in outgoing years. In addition, mothers consent to linkages to their own and their children's administrative data from records held by state and federal health, education, criminal justice, and tax records. Consent covers children already born to women at the time of intervention and children born after intervention. Survey and administrative data provide outcome measures to assess children's well-being and development up to age 18. The study will compare children of mothers who receive the intervention to those who did not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023), Behavioral: Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives |
| Control Group | No intervention | –Mothers randomized to NOT receive a voucher. Mothers in this arm receive the Planned Parenthood standard of care priced according to the Planned Parenthood sliding scale. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental Group |
| 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. | Behavioural | Experimental Group |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023) and Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019) in people with Pregnancy, run by University of Michigan at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Lang, PhD (1-844-864-8258, m-carestudy@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of siblings born after study enrollment (1 year) (time frame: Up to 1 year post enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.