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

The Effects of Unintended Pregnancy on Children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04371900
Acronym
M-CARES-K
Enrollment
4700
Registered
2020-05-01
Start date
2018-08-26
Completion date
2049-12-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

contraception, financial access to reproductive health care, unintended pregnancy

Brief 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.

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.

Interventions

BEHAVIORALMother 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.

BEHAVIORALMother 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.

Sponsors

University of Michigan
Lead SponsorOTHER
Planned Parenthood Federation of America
CollaboratorOTHER
National Opinion Research Center
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of siblings born after study enrollment (1 year)Up to 1 year post enrollmentNumber 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)Up to 3 year post enrollmentNumber 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)Up to 5 year post enrollmentNumber 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)Up to 1 year post enrollmentPercentile on state standardized achievement test (range: 1-100)
Standardized achievement test score (3 year)Up to 3 year post enrollmentPercentile on state standardized achievement test (range: 1-100)
Standardized achievement test score (5 year)Up to 5 year post enrollmentPercentile on state standardized achievement test (range: 1-100)

Countries

United States

Contacts

CONTACTVanessa Lang, PhD
m-carestudy@umich.edu1-844-864-8258

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026