Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion (NCT03505047) | Clinical Trial Compass
CompletedNot Applicable
Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion
South Africa110 participantsStarted 2018-05-10
Plain-language summary
The main objective of the study is to compare use, in a randomised controlled trial, of the the copper IUD if inserted immediately after completion of a second trimester medical abortion, to standard care with insertion 3-4 or more weeks after abortion at community health centres.
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:
* Able to speak English, Afrikaans or Xhosa;
* Requesting and eligible for abortion according to standard practice at the hospital;
* Gestational age 13-20 weeks verified by ultrasound;
* Interested and eligible for the copper IUD as a post-abortion contraceptive method;
* Willingness to participate in the trial including follow-up;
* Able to provide a working phone \& telephone number to allow for contact;
* Willing and able to provide informed consent
* Staying within one hour travel time of GSH
Exclusion Criteria:
* Active pelvic inflammatory disease, pelvic tuberculosis; severe thrombocytopenia;
* Positive N. Gonorrhea or C. Trachomatis that has not been adequately treated
* Copper allergy
* Hb \<10g/dL
* Uterine anomaly preventing placement of the IUD; cervical cancer or carcinoma in-situ, untreated high grade squamous intraepithelial lesions
* Hemorrhage; or ruptured uterus
* History of ectopic pregnancy
* Wilsons' disease
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.
What they're measuring
1
Use of the copper IUD
Timeframe: 6 weeks after second trimester abortion
2
Insertion of the IUD
Timeframe: 6 weeks after second trimester abortion