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

NCT ID: NCT00737178

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-08-31

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.

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate IUD insertion

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

Group Type: ACTIVE_COMPARATOR

CuT380A

Intervention Type: DEVICE

Comparison of different timing of IUD insertion

Delayed IUD insertion

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

Group Type: ACTIVE_COMPARATOR

CuT380A

Intervention Type: DEVICE

Comparison of different timing of IUD insertion

Interventions

CuT380A

Comparison of different timing of IUD insertion

Intervention Type: DEVICE

Other Intervention Names

IUD, Copper T

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Anne Davis

Associate Professor of OBGYN, Family Planning

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Davis, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Special Gynecology Services

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21860292 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24560483 (View on PubMed)

Other Identifiers

AAAD0438

Identifier Type: -

Identifier Source: org_study_id