Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT04371900

Conditions

Pregnancy

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Accepted

Interventions

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)

Study Details

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.

Conditions

Pregnancy

Study ID

NCT04371900

Start date

Aug 26, 2018

Status verified date

May, 2026

Completion date

Dec 31, 2049

Anticipated

Primary completion date

Dec 31, 2049

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Accepted

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

Enrollment

4700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental Group

Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives

no intervention: Control Group

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.

Interventions

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.

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 measure

  • Number of siblings born after study enrollment (1 year) [ Time Frame: Up to 1 year post enrollment ]
  • Number of siblings born after study enrollment (3 year) [ Time Frame: Up to 3 year post enrollment ]
  • Number of siblings born after study enrollment (5 year) [ Time Frame: Up to 5 year post enrollment ]
  • Standardized achievement test score (1 year) [ Time Frame: Up to 1 year post enrollment ]
  • Standardized achievement test score (3 year) [ Time Frame: Up to 3 year post enrollment ]
  • Standardized achievement test score (5 year) [ Time Frame: Up to 5 year post enrollment ]

Central Contacts and Locations

Central contacts

Vanessa Lang, PhD

1-844-864-8258m-carestudy@umich.edu

Locations

Planned Parenthood - Ann Arbor-West

Recruiting

Ann Arbor, Michigan, United States, 48103

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

Planned Parenthood - Detroit

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

Planned Parenthood - Ferndale

Recruiting

Ferndale, Michigan, United States, 48220

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

Planned Parenthood - Grand Rapids

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

Planned Parenthood - Kalamazoo

Recruiting

Kalamazoo, Michigan, United States, 49006

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

Planned Parenthood - Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

Planned Parenthood - Livonia

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

Planned Parenthood - Traverse City

Recruiting

Traverse City, Michigan, United States, 49686

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

Planned Parenthood - Warren

Recruiting

Warren, Michigan, United States, 48093

Contacts

Suni Jo Roberts

734.926.4802SuniJo.Roberts@ppmi.org

More Information

Sponsor

University of Michigan

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • contraception
  • financial access to reproductive health care
  • unintended pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-02.