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Insertion of an Intrauterine Device (IUD) After Medical Abortion

Primary Purpose

Intrauterine Device Expulsion, Medical Abortion, Induced Abortion

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]

About this trial

This is an interventional treatment trial for Intrauterine Device Expulsion focused on measuring Intrauterine Device, Induced Abortion, Medical Abortion

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Boston Medical Center
University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Observation- All subjects

Arm Description

Women choosing intra-uterine contraception after medical abortion.

Outcomes

Primary Outcome Measures

Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.

Secondary Outcome Measures

Percentage of Women Continuing IUD Use at 3 Months

Full Information

NCT ID

NCT00621543

First Posted

January 28, 2008

Last Updated

July 12, 2011

Sponsor

Boston University

Collaborators

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT00621543

Brief Title

Insertion of an Intrauterine Device (IUD) After Medical Abortion

Official Title

Insertion of an IUD After Medical Abortion

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Boston University

Collaborators

University of Utah

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intrauterine Device Expulsion, Medical Abortion, Induced Abortion

Keywords

Intrauterine Device, Induced Abortion, Medical Abortion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Observation- All subjects

Arm Type

Experimental

Arm Description

Women choosing intra-uterine contraception after medical abortion.

Intervention Type

Device

Intervention Name(s)

IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]

Other Intervention Name(s)

IUD insertion icludes the insertion of either the Copper T-380A or Levonorgestrel (intrauterine system) IUS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.

Time Frame

Three months

Secondary Outcome Measure Information:

Title

Percentage of Women Continuing IUD Use at 3 Months

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah J Betstadt, MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lynn Borgatta, MD, MPH

Organizational Affiliation

Boston University

Official's Role

Study Director

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8853278

Citation

Henshaw SK, Kost K. Abortion patients in 1994-1995: characteristics and contraceptive use. Fam Plann Perspect. 1996 Jul-Aug;28(4):140-7, 158.

Results Reference

background

PubMed Identifier

15157788

Citation

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.

Results Reference

background

PubMed Identifier

15846172

Citation

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.

Results Reference

background

PubMed Identifier

11529209

Citation

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.

Results Reference

background

PubMed Identifier

15006311

Citation

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. Erratum In: J Fam Plann Reprod Health Care. 2004 Apr;30(2):134.

Results Reference

background

PubMed Identifier

12618259

Citation

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.

Results Reference

background

PubMed Identifier

11762657

Citation

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.

Results Reference

background

PubMed Identifier

10738054

Citation

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.

Results Reference

background

Links:

URL

http://www.bcbsri.com

Description

Intrauterine Devices. The Mayo Clinic

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Insertion of an Intrauterine Device (IUD) After Medical Abortion

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