Insertion of an Intrauterine Device (IUD) After Medical Abortion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Intrauterine Device Expulsion Medical Abortion Induced Abortion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Observation- All subjects

Women choosing intra-uterine contraception after medical abortion.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No