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After medication abortion, women may quickly become pregnant again and therefore need an effective birth control method right away. Intrauterine devices (IUDs) are very effective for preventing pregnancy. IUDs are usually placed more than a month after abortion. This study will randomly assign women having a medication abortion to two groups, either having the IUD inserted one week after medication abortion or having the IUD inserted more than four weeks later. Women will be followed for six months to compare how many return for IUD placement in the two groups, how many are using the IUD after six months, experience with pain, bleeding, and cramping, how easy or difficult it is to insert the IUD, how many IUDs are expelled or removed, and how many women are using any birth control six months after the abortion.
Women presenting for medication abortion are highly motivated to initiate contraception and are also at high risk for repeat pregnancy. Intrauterine devices (IUDs) are among the most effective reversible methods. IUD insertion is routinely planned for at least four weeks after medication abortion. This leaves women vulnerable to pregnancy while waiting for IUD placement, and many will not return for this visit. While immediate IUD insertion after surgical abortion is known to be safe and effective, it has not been studied after medication abortion.
This study will recruit women undergoing medication abortion at Special Gynecology Services who desire an IUD for contraception. Women will be randomized to two groups: immediate insertion of the copper IUD at the routine one week follow up visit, or delayed insertion of the copper IUD at least four weeks after the medication abortion.
The primary objective of this study is to compare six month IUD prevalence between the immediate and delayed IUD insertion groups. Secondary outcomes include comparison of IUD insertion rates, continuation rates, expulsion and removal rates, and use of any contraception at six months. Pain experienced during insertion and provider ease of insertion will be recorded. A diary collected for four weeks following medication abortion will reveal the impact of early IUD placement on bleeding and cramping. Lastly, we will correlate endometrial stripe thickness and IUD position to outcomes of interest: continuation, expulsion, and removal rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate IUD insertion | Active Comparator | Insertion of CuT380A at the routine medication abortion follow-up visit one week after initiation of a medication abortion |
|
| Delayed IUD insertion | Active Comparator | Insertion of CuT380A four to six weeks after initiation of a medication abortion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CuT380A | Device | Comparison of different timing of IUD insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of the IUD for Contraception at Six Months | Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion Rates | Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period. | By six months after medication abortion |
| Expulsion and Removal Rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Davis, MD MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Special Gynecology Services | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21860292 | Result | Shimoni N, Davis A, Ramos ME, Rosario L, Westhoff C. Timing of copper intrauterine device insertion after medical abortion: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):623-628. doi: 10.1097/AOG.0b013e31822ade67. | |
| 24560483 | Result | Shimoni N, Davis A, Westhoff C. Can ultrasound predict IUD expulsion after medical abortion? Contraception. 2014 May;89(5):434-9. doi: 10.1016/j.contraception.2014.01.006. Epub 2014 Jan 18. |
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For both groups, the routine 1 week follow-up visit will confirm a successful medication abortion by passage of gestational sac on sonogram. Endometrial stripe thickness will be also be noted. For both groups a transvaginal sonogram will be performed immediately after IUD insertion to confirm IUD position.
Women presenting to Columbia University's Special Gynecology Services for medication abortion will receive comprehensive contraceptive counseling. Those interested in the Intrauterine Device (IUD) for contraception will be offered study participation. Those who accept enrollment in the study and sign consent will be randomized into 1 of 2 groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate IUD Insertion | IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion |
| FG001 | Delayed IUD Insertion | IUD insertion four to six weeks after initiation of a medication abortion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate IUD Insertion | IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion |
| BG001 | Delayed IUD Insertion | IUD insertion four to six weeks after initiation of a medication abortion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Insertion Rates | Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period. | Number | participants | By six months after medication abortion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate IUD Insertion | IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Davis, MD | Columbia University | 2123054951 | ard4@columbia.edu |
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| ID | Term |
|---|---|
| D007434 | Intrauterine Devices |
| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study.
Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study.
| Within six months of medication abortion |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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|
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| Secondary | Expulsion and Removal Rates | Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study. Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study. | Per protocol: insertion and removal rates were calculated only for participants undergoing IUD insertion | Number | participants | Within six months of medication abortion |
|
|
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| Primary | Use of the IUD for Contraception at Six Months | Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed). | Number | participants | 6 months |
|
|
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| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Delayed IUD Insertion | IUD insertion four to six weeks after initiation of a medication abortion | 0 | 85 | 0 | 85 |
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