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NCT Number: NCT04371900

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

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.

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Key information

Conditions

Pregnancy

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood - Ann Arbor-West, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)

Behavioral

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)

Behavioral

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 outcomes

  1. 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....)

  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....)

  3. 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....)

  4. Standardized achievement test score (1 year)

    Time frame: Up to 1 year post enrollment

    Percentile on state standardized achievement test (range: 1-100)

  5. Standardized achievement test score (3 year)

    Time frame: Up to 3 year post enrollment

    Percentile on state standardized achievement test (range: 1-100)

  6. Standardized achievement test score (5 year)

    Time frame: Up to 5 year post enrollment

    Percentile on state standardized achievement test (range: 1-100)

Study contacts

Contact information is provided by the study sponsor or research team.

Vanessa Lang, PhD

CONTACT

[email protected]

1-844-864-8258

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Opinion Research Center
  • Planned Parenthood Federation of America

Registry information

Official study title

The Effects of Unintended Pregnancy on Children

Acronym: M-CARES-K

Important dates

Study start
2018
Primary completion
2049
Study completion
2049
First posted
May 1, 2020
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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