Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Pregnancy

Treatments: Drug: Copper T380 IUD; Drug: levonorgestrel

Study type: Interventional

Funder types: Other

Identifiers

NCT00669396

IUDvsPlanBforEC

23111

Details and patient eligibility

About

The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.

Full description

This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.

Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Enrollment: 57 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone.
• Patients selecting the IUD need to identify themselves as desiring long-term contraception.

Exclusion criteria

• Current pregnancy,
• Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days,
• Current behavior suggesting a high risk for pelvic inflammatory disease
• Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy to levonorgestrel (for patients selecting Plan B)
• Intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus that distort the uterine cavity,
• Mucopurulent cervicitis,
• A previously placed IUD that has not been removed
• Genital bleeding of unknown etiology
• Ovarian, cervical or endometrial cancer,
• Small uterine cavity

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

1

Experimental group

Description:

IUD

Treatment:

Drug: Copper T380 IUD

2

Active Comparator group

Description:

Oral levonorgestrel

Treatment:

Drug: levonorgestrel