This trial is active, not recruiting.

Condition contraception
Treatment cut380a
Phase phase 4
Sponsor Columbia University
Collaborator Anonymous
Start date July 2008
End date October 2009
Trial size 156 participants
Trial identifier NCT00737178, AAAD0438


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
cut380a IUD, Copper T
Comparison of different timing of IUD insertion
(Active Comparator)
IUD insertion four to six weeks after initiation of a medication abortion
cut380a IUD, Copper T
Comparison of different timing of IUD insertion

Primary Outcomes

IUD prevalence
time frame: Six months after medication abortion

Secondary Outcomes

Insertion rates
time frame: By six months after medication abortion
Continuation rates
time frame: Three and six months after medication abortion
Expulsion and removal rates
time frame: Within six months of medication abortion
Bleeding and cramping
time frame: Four weeks starting with medication abortion
Physician ease of insertion
time frame: At IUD insertion
Insertion pain measured on VAS scale
time frame: At IUD insertion
Contraceptive prevalence
time frame: Six months after medication abortion

Eligibility Criteria

Female participants at least 18 years old.

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 - HGSIL on most recent pap - IUD insertion contraindicated by the World Health Organization's Medical Eligibility Criteria for Contraceptive Use (category 3 or 4)

Additional Information

Official title A Randomized Trial of Immediate Versus Delayed Insertion of the CuT380A Following Medication Abortion
Principal investigator Anne Davis, MD MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Columbia University.