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| ID | Type | Description | Link |
|---|---|---|---|
| H-24902 |
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| Name | Class |
|---|---|
| University of Utah | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation- All subjects | Experimental | Women choosing intra-uterine contraception after medical abortion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Women Continuing IUD Use at 3 Months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah J Betstadt, MD | Boston University | Principal Investigator |
| Lynn Borgatta, MD, MPH | Boston University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| University of Utah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8853278 | Background | Henshaw SK, Kost K. Abortion patients in 1994-1995: characteristics and contraceptive use. Fam Plann Perspect. 1996 Jul-Aug;28(4):140-7, 158. | |
| 15157788 | Background | Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. doi: 10.1016/j.contraception.2004.01.009. |
| Label | URL |
|---|---|
| Intrauterine Devices. The Mayo Clinic | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observation- All Subjects | Women choosing intra-uterine contraception after medical abortion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observation- All Subjects | Women choosing intra-uterine contraception after medical 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. | Posted | Mean | 95% Confidence Interval | percentage of participants | Three months |
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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 | Observation- All Subjects | Women choosing intra-uterine contraception after medical abortion. |
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21 women did not return for the 3 months follow-up. Some of the 21 women were contacted earlier 3 months, and none had had an expulsion. 2 women were ineligible at the first visit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Betstadt, MD, MPH | University of Rochester | 585-276-5368 | sarah_betstadt@urmc.rochester.edu |
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| Salt Lake City |
| Utah |
| 84112 |
| United States |
| 15846172 | Background | Kaunitz AM. Beyond the pill: new data and options in hormonal and intrauterine contraception. Am J Obstet Gynecol. 2005 Apr;192(4):998-1004. doi: 10.1016/j.ajog.2004.12.091. |
| 11529209 | Background | Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzman-Rodriguez R. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001 Aug 23;345(8):561-7. doi: 10.1056/NEJMoa010438. |
| 15006311 | Background | Penney G, Brechin S, de Souza A, Bankowska U, Belfield T, Gormley M, Olliver M, Hampton N, Howlett-Shipley R, Hughes S, Mack N, O'Brien P, Rowlands S, Trewinnard K; Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004 Jan;30(1):29-41; quiz 42. doi: 10.1783/147118904322701956. |
| 12618259 | Background | El-Tagy A, Sakr E, Sokal DC, Issa AH. Safety and acceptability of post-abortal IUD insertion and the importance of counseling. Contraception. 2003 Mar;67(3):229-34. doi: 10.1016/s0010-7824(02)00518-8. |
| 11762657 | Background | Stanwood NL, Grimes DA, Schulz KF. Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence. BJOG. 2001 Nov;108(11):1168-73. doi: 10.1111/j.1471-0528.2003.00264.x. |
| 10738054 | Background | Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of pregnancy. N Engl J Med. 2000 Mar 30;342(13):946-56. doi: 10.1056/NEJM200003303421307. |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percentage of Women Continuing IUD Use at 3 Months | Posted | Mean | 95% Confidence Interval | percentage of participants | 3 months |
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| 0 |
| 118 |
| 0 |
| 118 |
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