Insertion of an Intrauterine Device (IUD) After Medical Abortion

Boston University

Status: Completed

Conditions: Induced Abortion; Intrauterine Device Expulsion; Medical Abortion

Treatments: Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]

Study type: Interventional

Funder types: Other

Identifiers

NCT00621543

H-24902

Details and patient eligibility

About

The purpose of this study is to determine the expulsion and continuation rate of an intruterine device (IUD) placed immediately after medical abortion.

Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy).

Full description

Women who seek abortion care often desire more effective or longer- lasting contraception. Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the US. We are interested in determining whether placement of an intreatuereine device (IUD) at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as IUDs placed after pregnancy (usually a 4-6 week time period). If this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. FDA labeling does not specify or restrict time of insertion and therefore this study is in compliance with FDA labeling.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who completed a medical abortion in the last 14 days
• At least 18 years old.
• Desiring long-term contraception with an IUD.
• Able and willing to give consent for participation in research.
• Gonorrhea and chlamydia screen negative within 60 days of entry to study.
• Willing to comply with the study requirements.
• Accessible by telephone.

Exclusion criteria

• Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days.
• Allergy to copper, or Wilson's disease (for Paragard; may have Mirena)
• Intracavitary of symptomatic uterine fibroids.
• Ovarian, cervical or endometrial cancer.
• Severe anemia (defined as hgb < 8).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Observation- All subjects

Experimental group

Description:

Women choosing intra-uterine contraception after medical abortion.

Treatment:

Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]