Insertion of an Intrauterine Device (IUD) After Medical Abortion
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Observation- All subjects Women choosing intra-uterine contraception after medical abortion. |
Device: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. [Three months]
Secondary Outcome Measures
- Percentage of Women Continuing IUD Use at 3 Months [3 months]
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 2 | University of Utah | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- Boston University
- University of Utah
Investigators
- Principal Investigator: Sarah J Betstadt, MD, Boston University
- Study Director: Lynn Borgatta, MD, MPH, Boston University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of pregnancy. N Engl J Med. 2000 Mar 30;342(13):946-56. Review.
- 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.
- Henshaw SK, Kost K. Abortion patients in 1994-1995: characteristics and contraceptive use. Fam Plann Perspect. 1996 Jul-Aug;28(4):140-7, 158.
- Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. Review.
- Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzmán-Rodríguez 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.
- Kaunitz AM. Beyond the pill: new data and options in hormonal and intrauterine contraception. Am J Obstet Gynecol. 2005 Apr;192(4):998-1004. Review.
- 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. Erratum in: J Fam Plann Reprod Health Care. 2004 Apr;30(2):134.
- 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. Review.
- H-24902
- H-24902
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Observation- All Subjects |
|---|---|
| Arm/Group Description | Women choosing intra-uterine contraception after medical abortion. |
| Period Title: Overall Study | |
| STARTED | 120 |
| COMPLETED | 97 |
| NOT COMPLETED | 23 |
Baseline Characteristics
| Arm/Group Title | Observation- All Subjects |
|---|---|
| Arm/Group Description | Women choosing intra-uterine contraception after medical abortion. |
| Overall Participants | 120 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
120
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
28
(4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
120
100%
|
| Male |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
120
100%
|
Outcome Measures
| Title | Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. |
|---|---|
| Description | |
| Time Frame | Three months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | |
| Measure Participants | 97 |
| Mean (95% Confidence Interval) [percentage of participants] |
4
3.3%
|
| Title | Percentage of Women Continuing IUD Use at 3 Months |
|---|---|
| Description | |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | |
| Measure Participants | 97 |
| Mean (95% Confidence Interval) [percentage of participants] |
80.
66.7%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Observation- All Subjects | |
| Arm/Group Description | Women choosing intra-uterine contraception after medical abortion. | |
All Cause Mortality |
||
| Observation- All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Observation- All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/118 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Observation- All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/118 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sarah Betstadt, MD, MPH |
|---|---|
| Organization | University of Rochester |
| Phone | 585-276-5368 |
| sarah_betstadt@urmc.rochester.edu |
- H-24902
- H-24902