Free or Discounted IUD Vouchers to Prevent Unintended Pregnancies

(M-CARES-K Trial)

Recruiting at 8 trial locations

Overseen By Vanessa Lang, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnant, Not seeking contraceptives, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

4700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how providing free or discounted vouchers for IUDs (a type of birth control) affects unintended pregnancies and children's well-being. The research aims to determine if mothers who receive these vouchers experience fewer unintended pregnancies and if this positively impacts their children's lives. Participants are divided into two groups: one receives a voucher for an IUD, and the other receives standard care at Planned Parenthood. This trial suits mothers who have children, seek birth control, and face contraceptive costs at Planned Parenthood in Michigan. As an unphased trial, it offers a unique opportunity to understand the broader impact of accessible birth control on families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these IUDs are safe for use?

A large study of IUDs found that these devices are generally safe and effective for long-term birth control. However, some risks require attention. The risk of a uterine tear increases when the IUD is inserted soon after childbirth. In rare cases, if pregnancy occurs with an IUD in place, serious issues like miscarriage or early delivery can arise. Some brands, such as LILETTA, may cause more bleeding or spotting in the first few months of use. Overall, IUDs are considered a safe and reliable option for preventing pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to make IUDs more accessible and affordable for preventing unintended pregnancies. Unlike current options, which might be limited by cost barriers, this trial offers vouchers that cover either 100% or 50% of the cost of a name-brand IUD. This approach could significantly increase access to effective contraceptive methods, particularly for those who might otherwise struggle to afford them. By potentially reducing financial obstacles, the trial aims to provide more equitable access to reliable birth control, which could lead to a decrease in unintended pregnancies.

What evidence suggests that these IUD vouchers could be effective in preventing unintended pregnancies?

Research has shown that providing free or low-cost IUDs (intrauterine devices) can help prevent unintended pregnancies. In this trial, some participants will receive a voucher covering 100% of the cost of a name-brand IUD, while others will receive a voucher covering 50% of the cost. Studies have found that offering IUDs for free results in fewer abortions and teenage births. Specifically, one study discovered that women who received free birth control experienced fewer unexpected pregnancies. The levonorgestrel IUD, in particular, proves very effective at preventing pregnancies compared to other IUD types. Overall, making IUDs more affordable leads to better birth control outcomes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for mothers aged 18-35 who are not pregnant, do not wish to become pregnant within a year, and are seeking care at Planned Parenthood of Michigan. They must be biologically female, able to have children, and face costs for contraceptives.

Inclusion Criteria

I am a woman aged 18-35, not pregnant, don't plan to be for a year, need contraception, and face costs at Planned Parenthood.

I am a child aged 0-17, and my mother is part of the M-CARES study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers receive a voucher providing access to no-cost contraception for 100 days

14 weeks

Follow-up

Participants are monitored for children's well-being and development through surveys and administrative data

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Mother receives voucher valued at 100% of cost of name-brand IUD
• Mother receives voucher valued at 50% of cost of name-brand IUD

Trial Overview The study provides vouchers covering either 100% (from March 4, 2019) or 50% (until March 3, 2019) of the cost for name-brand IUDs to see how free or reduced-cost birth control affects their children's well-being over time.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 2 Interventions

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

Group II: Control Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Planned Parenthood Federation of America

Collaborator

Trials

17

Recruited

21,600+

National Opinion Research Center

Collaborator

Trials

15

Recruited

251,000+

Published Research Related to This Trial

The levonorgestrel intrauterine system (LNG-IUS), known as Mirena, is an FDA-approved device that effectively prevents unintended pregnancies and treats abnormal uterine bleeding, offering significant benefits for women's health.

Despite its proven efficacy and cost-effectiveness, the LNG-IUS remains underutilized in the United States, highlighting a gap in the adoption of evidence-based practices in women's healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost effectiveness in obstetrics and gynecology: The levonorgestrel intrauterine system. Mattson, L.[2013]

The etonogestrel implant and levonorgestrel IUD resulted in the lowest number of pregnancies and costs over a 3-year period, costing $1.75 million and $2.0 million respectively, compared to $3.4 million for generic oral contraceptives.

Despite higher initial costs, the etonogestrel implant and levonorgestrel IUD proved to be more cost-effective within one year due to lower failure rates and reduced pregnancy-related expenses, making them the least expensive hormonal contraceptives overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budget impact analysis of 8 hormonal contraceptive options. Crespi, S., Kerrigan, M., Sood, V.[2019]

The new, affordable levonorgestrel intrauterine system (LNG IUS) from Medicines360 is expected to have a direct service delivery cost per couple-years of protection that is competitive with other contraceptive methods in Kenya, potentially increasing its uptake.

Key opinion leaders believe that the LNG IUS's non-contraceptive health benefits, such as reduced menstrual bleeding, will attract women, but addressing myths and misconceptions about IUDs and prioritizing demand creation and provider training will be crucial for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding Access to a New, More Affordable Levonorgestrel Intrauterine System in Kenya: Service Delivery Costs Compared With Other Contraceptive Methods and Perspectives of Key Opinion Leaders. Rademacher, KH., Solomon, M., Brett, T., et al.[2018]

Jaydess/Skyla and Kyleena are low-dose levonorgestrel releasing intrauterine systems (LNG-IUS) that differ from Mirena in their pharmacological properties and physical dimensions, but there are currently no clear guidelines on when to use them over Mirena.

The clinical research available on Jaydess/Skyla and Kyleena is limited and primarily sponsored by the manufacturers, leading to inconsistencies in terminology and insufficient information for clinicians to make informed decisions about their use compared to other LNG-IUS options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clarification of the role of the Jaydess(Skyla) LNG- IUS 13.5mg and Kyleena LNG-IUS 19.5mg as intrauterine contraceptive systems. Goldstuck, ND.[2018]

The levonorgestrel intra-uterine system (IUS) is effective not only as a contraceptive but also as a treatment for idiopathic menorrhagia, which is heavy menstrual bleeding without a known cause.

The IUS is particularly beneficial for women who need both contraception and management of heavy menstrual bleeding, highlighting its dual purpose and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levonorgestrel intra-uterine system for menorrhagia. [2019]

Ulipristal acetate is more effective and cost-efficient than levonorgestrel when taken within 24 hours after unprotected intercourse, potentially saving significant costs associated with unintended pregnancies.

Overall, ulipristal acetate is a cost-effective option compared to levonorgestrel within 72 hours, suggesting that providing it free of charge to minors could be beneficial for reducing unintended pregnancy rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cost-Effectiveness of Emergency Hormonal Contraception with Ulipristal Acetate versus Levonorgestrel for Minors in France. Schmid, R.[2023]

The increased use of intrauterine devices (IUDs) in the US has likely contributed to a significant decline in unintended pregnancies, highlighting their effectiveness as a contraceptive method.

All available IUDs, including hormonal and copper options, are shown to be safe and effective, with newer models tested in diverse populations, although larger studies have raised awareness about potential risks, such as perforation, particularly in postpartum and breastfeeding women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in intrauterine device use: focus on the US. Nelson, AL., Massoudi, N.[2023]

The intrauterine device (IUD) is one of the most effective and safe contraceptive methods available, yet its usage in the United States is less than 1% due to historical concerns and misconceptions.

Misunderstandings about the IUD's safety, mechanism of action, and complication rates have led to inadequate training for physicians, limiting its availability to women who could benefit from this highly effective form of birth control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The intrauterine device: still misunderstood after all these years. Cheng, D.[2014]

The levonorgestrel intrauterine system (IUS) known as Kyleena was approved for use in the UK in 2016 and is effective for contraception for up to 5 years, containing 19.5mg of levonorgestrel.

Kyleena is the fourth LNG IUS product licensed in the UK and is reported to have advantages over other similar devices like Mirena and Jaydess, although specific benefits were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kyleena - another levonorgestrel IUS. [2018]

Intrauterine devices (IUDs) are highly effective contraceptives that require only a one-time insertion and can last for 5-10 years, making them a reliable option for preventing unintended pregnancies.

The newer IUDs, such as ParaGard and Mirena, have superior safety profiles compared to older models and demonstrate improved efficacy in preventing both intrauterine and ectopic pregnancies, highlighting their potential as a preferred contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in contraception: IUDs from a managed care perspective. Doyle, J., Stern, L., Hagan, M., et al.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4000282/

Preventing Unintended Pregnancies by Providing No-Cost ... We noted a clinically and statistically significant reduction in abortion rates, repeat abortions, and teenage birth rates. Unintended pregnancies may be ...

2. withpower.com withpower.com/trial/phase-7-2018-3d34b

Free or Discounted IUD Vouchers to Prevent Unintended ... What data supports the effectiveness of this treatment in preventing unintended pregnancies? Research shows that the levonorgestrel intrauterine system (LNG ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6798342/

Association between the use of free-of-charge intrauterine ... Our study adds to growing evidence that when contraceptives are offered for free, women who have recently had an abortion [9–11], as well as ...

4. jogc.com jogc.com/article/S1701-2163(21)00210-3/fulltext

Similar contraceptive outcomes with free and ... We investigated rates of pregnancy, abortion, and alternative contraceptives acquired up to 5 years following placement of free IUD/S at time of therapeutic ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00505-4/fulltext

a meta-analysis of randomized controlled trials Recent RCTs indicated that the LNG (52 mg) IUD was more effective than the Cu (380 mm2 and 220 mm2) IUDs in preventing unintended pregnancies.

6. mirenahcp.com mirenahcp.com/safety

Mirena® IUD Safety Information | Official HCP Site In a large US retrospective, postmarketing safety study of IUDs, the risk of uterine perforation was highest when insertion occurred within ≤6 weeks postpartum ...

7. mirena-us.com mirena-us.com/mirena-side-effects-and-safety

Important Safety Information and Side Effects | Mirena® IUD Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an intrauterine device (IUD).

8. kyleena-us.com kyleena-us.com/safety-and-side-effects

kyleena side effects and safety information Kyleena can cause serious side effects, including: · Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you become pregnant while using ...

9. lilettahcp.com lilettahcp.com/safety

LILETTA® Safety and Side Effects | For Healthcare Providers During the first 3 to 6 months of LILETTA use, the number of bleeding and spotting days may be increased and bleeding patterns may be irregular.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2770406/

Review of the safety, efficacy and patient acceptability ... The levonorgestrel-containing intrauterine system is an extremely effective, reversible and safe form of long-term yet reversible birth control.