Clinical trial NCT01963962: Study of the Copper IUD or Oral Levonorgestrel and the Levonorgestrel IUD for Women Seeking Emergency Contraception
Official title: A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Contraception
Keywords: Emergency contraception
Levonorgestrel IUD
Copper IUD
Oral Levonorgestrel
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting for emergency contraception to family planning clinics in Salt Lake City, UT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:1. Between 18-35 years old

2. In need of EC (had unprotected intercourse within 120 hours - 5 days)

3. Desire to prevent pregnancy for 1 year

4. Fluent in English and/or Spanish

5. Have a regular menstrual cycle (24-35 days)

6. Know their last menstrual period (+/-3 days)

7. Be willing to comply with the study requirements

8. Participants current preferred phone number must be functioning at the time of study entry and will be tested prior to enrollment

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Exclusion Criteria:

* 1. Current pregnancy

  2. Breastfeeding

  3. Intrauterine infection within the past 3 months

  4. Sterilization

  5. Already have an IUD or contraceptive implant (Implanon) in place

  6. Vaginal bleeding of unknown etiology

  7. Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry)

  8. Allergy to LNG (for LNG IUD patients)

  9. Allergy to copper or Wilson's disease (for Copper IUD patients)

  10. Known abnormalities of the uterus that distort the uterine cavity

Primary outcomes:
measure: Pregnancy rates in first month after IUD insertion
timeFrame: 4 weeks
Secondary outcomes:
measure: 1 Year IUD continuation rates
timeFrame: 1 year
Other outcomes:
measure: Willingness to be randomized to either the copper or levonorgestrel IUD for emergency contraception.
timeFrame: At enrollment
Locations:
city: Salt Lake City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: David Turok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boraas CM, Sanders JN, Schwarz EB, Thompson I, Turok DK. Risk of Pregnancy With Levonorgestrel-Releasing Intrauterine System Placement 6-14 Days After Unprotected Sexual Intercourse. Obstet Gynecol. 2021 Apr 1;137(4):623-625. doi: 10.1097/AOG.0000000000004118.
citation: Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016 Jun;93(6):526-32. doi: 10.1016/j.contraception.2016.01.009. Epub 2016 Mar 2.