Immediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication Abortion

Contraception Clinical Trial

Official title:

A Randomized Trial of Immediate Versus Delayed Insertion of the Copper T380A Following Medication Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737178
• Other study ID #: AAAD0438
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2008
• Last updated: September 18, 2014
• Start date: July 2008
• Est. completion date: August 2011

Study information

• Verified date: September 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing medication abortion

• 18 or older

• Desires IUD as birth control method for a minimum of six months

• Speaks Spanish or English

• Has a working phone number or pager

• Is willing to attend visits and will be in the area for next six months

• Has signed informed consent

Exclusion Criteria:

• Chlamydia, gonorrhea, or pelvic inflammatory disease within the past three months

• Known bleeding diathesis including anti-coagulation

• Uterine abnormality including sub-mucous myomas that significantly distort the uterine cavity

• Current cervical, uterine, or ovarian malignancy

• high-grade squamous intraepithelial lesion on most recent pap

• IUD insertion contraindicated by the World Health Organization's Medical Eligibility Criteria for Contraceptive Use (category 3 or 4)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• CuT380A
Comparison of different timing of IUD insertion

Locations

Country	Name	City	State
United States	Special Gynecology Services	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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):623-8. doi: 10.1097/AOG.0b013e31822ade67. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	6 months	No
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.	By six months after medication abortion	No
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.	Within six months of medication abortion	No