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

Pregnancy Clinical Trial

— M-CARES-K  

Official title:

The Effects of Unintended Pregnancy on Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04371900
• Other study ID #: HUM00132909B
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2018
• Est. completion date: December 31, 2049

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Vanessa Lang, PhD
• Phone: 1-844-864-8258
• Email: m-carestudy[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4700
• Est. completion date: December 31, 2049
• Est. primary completion date: December 31, 2049
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Planned Parenthood - Ann Arbor-West	Ann Arbor	Michigan
United States	Planned Parenthood - Detroit	Detroit	Michigan
United States	Planned Parenthood - Ferndale	Ferndale	Michigan
United States	Planned Parenthood - Grand Rapids	Grand Rapids	Michigan
United States	Planned Parenthood - Kalamazoo	Kalamazoo	Michigan
United States	Planned Parenthood - Lansing	Lansing	Michigan
United States	Planned Parenthood - Livonia	Livonia	Michigan
United States	Planned Parenthood - Traverse City	Traverse City	Michigan
United States	Planned Parenthood - Warren	Warren	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Opinion Research Center, Planned Parenthood Federation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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....)	Up to 1 year post enrollment
Primary	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....)	Up to 3 year post enrollment
Primary	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....)	Up to 5 year post enrollment
Primary	Standardized achievement test score (1 year)	Percentile on state standardized achievement test (range: 1-100)	Up to 1 year post enrollment
Primary	Standardized achievement test score (3 year)	Percentile on state standardized achievement test (range: 1-100)	Up to 3 year post enrollment
Primary	Standardized achievement test score (5 year)	Percentile on state standardized achievement test (range: 1-100)	Up to 5 year post enrollment