Insertion of an Intrauterine Device (IUD) After Medical Abortion

This study has been completed.

Study NCT00621543 Information provided by Boston University

First Received on January 28, 2008. Last Updated on July 12, 2011 History of Changes

Results First Received: April 4, 2011

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Intrauterine Device Expulsion Medical Abortion Induced Abortion
Intervention:	Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Observation- All Subjects	Women choosing intra-uterine contraception after medical abortion.

Participant Flow: Overall Study

	Observation- All Subjects
STARTED	120
COMPLETED	97
NOT COMPLETED	23
Lost to Follow-up	23

Baseline Characteristics

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Reporting Groups

	Description
Observation- All Subjects	Women choosing intra-uterine contraception after medical abortion.

Baseline Measures

	Observation- All Subjects
Number of Participants [units: participants]	120
Age [units: participants]
<=18 years	0
Between 18 and 65 years	120
>=65 years	0
Age [units: years] Mean ± Standard Deviation	28 ± 4
Gender [units: participants]
Female	120
Male	0
Region of Enrollment [units: participants]
United States	120

Outcome Measures

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1. Primary:

Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. [ Time Frame: Three months ]

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2. Secondary:

Percentage of Women Continuing IUD Use at 3 Months [ Time Frame: 3 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Sarah Betstadt, MD, MPH
Organization: University of Rochester
phone: 585-276-5368
e-mail: sarah_betstadt@urmc.rochester.edu

Publications:

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.

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.

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.

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.

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.

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.

Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of pregnancy. N Engl J Med. 2000 Mar 30;342(13):946-56. Review.

Responsible Party:	Dr. Sarah J. Betstadt, Boston University
ClinicalTrials.gov Identifier:	NCT00621543 History of Changes
Other Study ID Numbers:	H-24902, H-24902
Study First Received:	January 28, 2008
Results First Received:	April 4, 2011
Last Updated:	July 12, 2011
Health Authority:	United States: Institutional Review Board