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Completed

NCT Number: NCT00621543

Insertion of an Intrauterine Device (IUD) After Medical Abortion

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).

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Device

When a subject has chosen a method of intra-uterine contraception and has agreed to participate in the study, she will have the intra-uterine device of her choice inserted according to the Food and Druga Administration (FDA) instructions.

Other names: IUD insertion icludes the insertion of either the Copper T-380A or Levonorgestrel (intrauterine system) IUS

Primary outcomes

  1. Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.

    Time frame: Three months

Secondary outcomes

  1. Percentage of Women Continuing IUD Use at 3 Months

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • University of Utah

Registry information

Official study title

Insertion of an IUD After Medical Abortion

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2008
Registry last updated
Jul 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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