NCT00737178

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

August 14, 2008

Results QC Date

December 31, 2012

Last Update Submit

September 18, 2014

Conditions

Contraception

Keywords

IUDIntrauterine deviceIntrauterine contraceptionMedication abortionMedical abortion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Insertion Rates

    By six months after medication abortion

  • Expulsion and Removal Rates

    Within six months of medication abortion

Study Arms (2)

Immediate IUD insertion

ACTIVE COMPARATOR

Insertion of CuT380A at the routine medication abortion follow-up visit one week after initiation of a medication abortion

Device: CuT380A

Delayed IUD insertion

ACTIVE COMPARATOR

Insertion of CuT380A four to six weeks after initiation of a medication abortion

Device: CuT380A

Interventions

CuT380ADEVICE

Comparison of different timing of IUD insertion

Also known as: IUD, Copper T
Delayed IUD insertionImmediate IUD insertion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing medication abortion
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Gynecology Services

New York, New York, 10032, United States

Location

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

    PMID: 21860292RESULT

  • 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.

    PMID: 24560483RESULT

MeSH Terms

Interventions

Intrauterine Devices

Intervention Hierarchy (Ancestors)

Contraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Results Point of Contact

Title
Anne Davis, MD
Organization
Columbia University
ard4@columbia.edu
2123054951

Study Officials

  • Anne Davis, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of OBGYN, Family Planning

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 18, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2009

Study Completion

August 1, 2011

Last Updated

September 19, 2014

Results First Posted

September 19, 2014

Record last verified: 2014-09

Locations

US(1)