Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Davis, Columbia University
ClinicalTrials.gov Identifier:
NCT00737178
First received: August 14, 2008
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Contraception
Device: CuT380A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Immediate Versus Delayed Insertion of the Copper T380A Following Medication Abortion

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Use of the IUD for Contraception at Six Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Insertion Rates [ Time Frame: By six months after medication abortion ] [ Designated as safety issue: No ]
    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.

  • Expulsion and Removal Rates [ Time Frame: Within six months of medication abortion ] [ Designated as safety issue: No ]

    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.



Enrollment: 156
Study Start Date: July 2008
Study Completion Date: August 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: IUD, Copper T

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737178

Locations
United States, New York
Special Gynecology Services
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Anne Davis, MD MPH Columbia University
  More Information

Publications:
Responsible Party: Anne Davis, Associate Professor of OBGYN, Family Planning, Columbia University
ClinicalTrials.gov Identifier: NCT00737178     History of Changes
Other Study ID Numbers: AAAD0438
Study First Received: August 14, 2008
Results First Received: December 31, 2012
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
IUD
Intrauterine device
Intrauterine contraception
Medication abortion
Medical abortion

Additional relevant MeSH terms:
Copper
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 25, 2014