News & Research

    Research Institute at Nationwide Children's Hospital, Columbus, Ohio

Safety and effectiveness of hormonal contraception in women with diabetes

General Research Subject: Both Type 1 And Type 2 Diabetes

Focus: Complications\ Macrovascular-Atherosclerotic CVD and Human Diabetes, Epidemiology

Type of Grant: Clinical Science and Epidemiology

Project Start Date: January 1, 2013

Project End Date: December 31, 2014

Research Description

Access to safe and effective contraception is important for women with diabetes because they face increased risks of pregnancy-related complications. However, women with diabetes are less likely than non-diabetic women to receive contraceptive counseling and use contraception, and nearly two-thirds of pregnancies in diabetic women are unplanned. One barrier to contraception use in women with diabetes is that estrogen-containing contraceptives further increase their risk of blood clots, and there is little evidence about the safety of progestin-only contraceptives for women with diabetes.

This application proposes to study 150,000 reproductive-age women with diabetes using a large administrative health plan claims data source. The investigators will compare the safety of contraceptive choices by identifying the risk of blood clots (including heart attacks, strokes, and/or deep vein thrombosis) in women with diabetes prescribed progestin-only, combination (estrogen + progestin), or no hormonal contraception. The study will also compare the effectiveness and duration of use of combination and progestin-only contraception in women with diabetes by comparing rates of pregnancy and rates of discontinuation.

The scientific hypothesis is that the risk of blood clots in women with diabetes using progestin-only contraception is not higher than the risk of blood clots in reproductive-age diabetic women not using contraception. The secondary hypothesis is that progestin-only contraception has a lower risk of blood clots than estrogen-containing contraception. Better understanding of contraception safety is a necessary first step in eliminating existing patient and provider barriers to contraceptive counseling and prescribing for women with diabetes.

Research Profile

What area of diabetes research does your project cover? What role will this particular project play in preventing, treating, and curing diabetes?

Access to safe and effective contraception is imperative for diabetic women of reproductive age. However, there is little to no evidence about the safety of progestin-only contraceptives for diabetic women who face increased risk of blood clots. Using a large dataset of health plan claims from >150,000 reproductive-age women with diabetes, our work will provide valuable information regarding the safety of progestin-only contraceptives in this understudied population.

If a person with diabetes were to ask you how your project will help them in the future, how would you respond?

Our work will provide valuable information regarding the safest and most effective of contraception for women with diabetes.

Why is it important for you, personally, to become involved in diabetes research? What role will this award play in your efforts?

As physicians at tertiary care centers, we care for women with a variety of chronic diseases who have difficulty gaining access to safe and effective contraception. Our motivation to perform this research is our knowledge that the results can directly impact women's health care in diabetes, and directly impact the patients we see in our clinics. We are grateful to the American Diabetes Association for funding our work, and are honored to be ADA grant recipients. The financial support of the ADA will allow us to purchase this large and unique dataset that we otherwise would not have the ability to access and analyze.

In what direction do you see the future of diabetes research going?

The long-term goal is for pregnancy planning that allows all pregnancies in women with diabetes to occur when mom is euglycemic, reducing rates of birth defects to population baseline levels.