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

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: CuT380A

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Special Gynecology Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate IUD insertion; Insertion of CuT380A at the routine medication abortion follow-up visit one week after initiation of a medication abortion	Device: CuT380A; Comparison of different timing of IUD insertion; Other Names: IUD, Copper T
Active Comparator: Delayed IUD insertion; Insertion of CuT380A four to six weeks after initiation of a medication abortion	Device: CuT380A; Comparison of different timing of IUD insertion; Other Names: IUD, Copper T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Anne Davis, MD MPH, Columbia University

Publications and helpful links

General Publications

• 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):623-628. doi: 10.1097/AOG.0b013e31822ade67.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 14, 2008
• First Submitted That Met QC Criteria: August 15, 2008
• First Posted (Estimate): August 18, 2008

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Medical abortion; Intrauterine device; IUD; Intrauterine contraception; Medication abortion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper
• Other Study ID Numbers: AAAD0438