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

Last updated: May 18, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

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)

Clinical Study ID

NCT04371900
HUM00132909B
  • Ages < 17
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 4700
Treatment Group(s): 2
Primary Treatment: Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)
Phase:
Study Start date:
August 26, 2018
Estimated Completion Date:
December 31, 2049

Study 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.

Connect with a study center

  • Planned Parenthood - Ann Arbor-West

    Ann Arbor, Michigan 48103
    United States

    Active - Recruiting

  • Planned Parenthood - Detroit

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Planned Parenthood - Ferndale

    Ferndale, Michigan 48220
    United States

    Active - Recruiting

  • Planned Parenthood - Grand Rapids

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Planned Parenthood - Kalamazoo

    Kalamazoo, Michigan 49006
    United States

    Active - Recruiting

  • Planned Parenthood - Lansing

    Lansing, Michigan 48912
    United States

    Active - Recruiting

  • Planned Parenthood - Livonia

    Livonia, Michigan 48154
    United States

    Active - Recruiting

  • Planned Parenthood - Traverse City

    Traverse City, Michigan 49686
    United States

    Active - Recruiting

  • Planned Parenthood - Warren

    Warren, Michigan 48093
    United States

    Active - Recruiting

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