Immediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication Abortion (NCT00737178) | Clinical Trial Compass
CompletedPhase 4
Immediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication Abortion
United States156 participantsStarted 2008-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.