The U.S. has the highest unintended pregnancy rate of any developed country, mostly in teens and women in their early twenties due to ineffective contraceptive use. Once a young woman has given birth, helping her choose an effective method of postpartum contraception is crucial to preventing an unintended pregnancy. The injectable depomedroxyprogesterone acetate (DMPA) is a highly effective method of contraception, with better compliance and lower pregnancy rates than oral contraceptives. It is commonly recommended to young women for postpartum contraception. However, up to 50% of women stop using it in the first year due to the side effects of irregular bleeding and perceived weight gain. Clinicians also have concerns that DMPA may worsen depression and inhibit maximum bone density in young women. The levonorgestrel intrauterine device (LNG-IUD) is a very effective, well-tolerated contraceptive. It has not been traditionally considered in this population due to a false perception that IUDs lead to a long-term increased risk of pelvic inflammatory disease (PID). Modern evidence counters these fears, suggesting that LNG-IUD may actually decrease the risk of PID. Its performance as a postpartum contraceptive for young women merits evaluation.
We aim to perform a pilot randomized trial of 30 women aged 14 to 25 years comparing postpartum DMPA and LNG-IUD with regard to method continuation and side effects. We also aim to assess the recruitment of postpartum young women for randomization between DMPA and LNG-IUD, measuring the number needed to screen to enroll and randomize one subject. We will recruit subjects during the third trimester of prenatal care and will follow them for one year postpartum for the outcomes of method continuation, unintended pregnancy rate, menstrual complaints, patient satisfaction, complications and side effects. The best postpartum method of contraception is one that works well and that women continue to use. The LNG-IUD is highly effective and has high patient satisfaction and continuation rates in older women. Whether younger women find it satisfactory for postpartum contraception and continue to use it is unknown. If this pilot is successful, we plan to perform a larger trial powered to detect a difference in continuation rates between DMPA and LNG-IUD. Such a study could provide evidence for the safe and effective use of LNG-IUD in young postpartum women, leading to fewer unintended pregnancies. ? ?

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Research Grants (R03)
Project #
1R03HD047238-01
Application #
6807537
Study Section
Pediatrics Subcommittee (CHHD)
Program Officer
Kaufman, Steven
Project Start
2004-09-01
Project End
2006-08-31
Budget Start
2004-09-01
Budget End
2005-08-31
Support Year
1
Fiscal Year
2004
Total Cost
$78,000
Indirect Cost
Name
University of Rochester
Department
Obstetrics & Gynecology
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627