Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
More than 345,000 women in the United States have sterilization procedures each year to prevent pregnancy permanently. With the Essure procedure, a doctor places metal coils in each fallopian tube. The coils cause scars that block the tubes. Patients can be awake during the Essure procedure. They often return to work the next day.
However, patients must use birth control for at least three months after the Essure procedure. After three months, they must also go back to the doctor for testing to make sure the procedure worked. If they don’t go back for testing, they won’t know if the procedure didn’t work and they may get pregnant. In addition, some women have long-term pain and problems with their periods after this procedure.
Another option is called tubal ligation, when doctors cut or block a woman’s fallopian tubes. Some women have pain and problems with their periods after the procedure.
Intrauterine devices, or IUDs, prevent pregnancy like Essure and tubal ligation, but IUDs are not a permanent method. IUDs be removed if a woman chooses.
In this study, the research team is comparing Essure, tubal ligation, and IUDs to see how well each one prevents pregnancy. The team is also looking at how often women who choose each method have pain or other problems.
Who can this research help?
Women who are interested in preventing pregnancy permanently or over the long term, and their clinicians, can use this research when looking at birth control options.
What is the research team doing?
The research team is reviewing medical records for at least 100,000 women in California with Medicaid who had sterilization procedures or IUDs to prevent pregnancy. The team is comparing how well Essure, tubal ligation, and IUDs work over one to five years. The team wants to know
- How many women got pregnant after the procedure
- How many procedures each woman needed to prevent pregnancy
- What problems women had after the procedure, such as long-term pain, problems with periods, depression, or allergic or autoimmune reactions
- In addition, the team is looking at whether certain groups of women, such as women with diabetes, are more likely to have problems after a procedure
- Women who had Essure, tubal ligation, or IUDs are working with the research team to plan and carry out the study
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Observational: cohort study (retrospective) |
| Population | Women ages 18–50 without cancer who have had a hysteroscopic or laparoscopic sterilization procedure or IUD placement |
| Interventions/ Comparators |
|
| Outcomes |
Primary: pregnancy after sterilization or IUD placement Secondary: blocked fallopian tubes on post-procedure hysterosalpingogram test; reoperation to achieve sterilization or reinsertion to achieve IUD placement; need for subsequent surgery to remove foreign body, fallopian tube(s) (salpingectomy), or uterus (hysterectomy); number of participants with new onset chronic pain; number of participants with new onset depression; sociodemographic and pre-procedure clinical variables |
 |
5-year follow-up for primary outcome |
Project Details