Insertion of an Intrauterine Device (IUD) After Medical Abortion

Study Overview
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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).

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.

Official Title
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Insertion of an IUD After Medical Abortion

Conditions
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Intrauterine Device Expulsion, Medical Abortion, Induced Abortion

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


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observation- All subjects<br>Women choosing intra-uterine contraception after medical abortion. | Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]<br>* 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.<br>* Other names: IUD insertion icludes the insertion of either the Copper T-380A or Levonorgestrel (intrauterine system) IUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Women Continuing IUD Use at 3 Months |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine Device, Induced Abortion, Medical Abortion