Study of the Copper IUD or Oral Levonorgestrel and the Levonorgestrel IUD for Women Seeking Emergency Contraception (COLIEC)
The purpose of this study is to see how often women who come to a family planning clinic for emergency contraception, the morning after pill, are willing to use either the copper IUD or the levonorgestrel IUD. The investigators will also see if pregnancies occur in those choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception|
- Pregnancy rates in first month after IUD insertion [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Participants will have a urine pregnancy test at the clinic. They will also be given a home urine pregnancy test to check if they are not able to return to clinic and will give results by phone or electronic communication.
- 1 Year IUD continuation rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]IUD continuation rates will be compared between those who selected the copper IUD and thos who selected the levonorgestrel IUD
- Willingness to be randomized to either the copper or levonorgestrel IUD for emergency contraception. [ Time Frame: At enrollment ] [ Designated as safety issue: No ]We will query all participants to see if they would be willing to participate in a randomized study where the type of IUD (copper vs. levonorgestrel) was chosen at random.
Biospecimen Retention: Samples Without DNA
Urine to test for progesterone and/or pregnandiol
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Women selecting the copper IUD for emergency contraception and to use for contraception after
Drug: Copper IUD
Other Name: Paragard IUD
Women who select oral levonorgestrel for emergency contraception and begin the levonorgestrel IUD for ongoing contraception at the same time.
Drug: Levonorgestrel IUD
Other Name: Mirena IUD
Widely available oral levonorgestrel (LNG) for emergency contraception (EC) has not reduced unplanned pregnancy rates. However, our study of the copper T380 IUD vs. oral LNG for EC showed lower pregnancy rates 12 months after presenting for EC in the copper IUD group. Because there is a strong preference for the LNG IUD among women offered the IUD, the objective of this research project is to initiate investigation into, and use of the LNG IUD in the setting of EC. Our experienced team of EC researchers proposes the following aims to provide needed information in this understudied area:
Aim 1: To assess uptake of the LNG IUD vs. the copper IUD among women presenting for EC exposed to standardized counseling.
Aim 2: Gather baseline data on one-year continuation and pregnancy rates from women initiating the LNG IUD vs. the copper T380 IUD when presenting for EC.
Aim 3: Assess willingness of women presenting for EC to participate in a future randomized controlled trial comparing the LNG IUD vs. the copper T380 IUD for EC.
The study aims will be accomplished with a prospective observational trial of women who choose either method of EC. The investigative team will recruit 180 women who present for EC at two participating family planning clinics and follow study participants for 12 months. This project will compare continuation and pregnancy rates between LNG and copper IUD users in the year following presentation for EC. This proposal is another aspect in our growing research program offering highly effective contraception at the time of EC presentation. Results of this project will direct future study in this area aimed at reducing population unplanned pregnancy rates among EC users with the potential to inform a future RCT of the LNG vs. copper IUD for EC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01963962
|United States, Utah|
|Planned Parenthood Association of Utah|
|Salt Lake City, Utah, United States, 84102|
|Principal Investigator:||David Turok, MD||University of Utah|