UnknownPhase 3

Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion

Sweden720 participantsStarted 2019-01-16

Plain-language summary

PICO: Population: Women with unwanted pregnancy having a medical abortion and fulfilling inclusion and without exclusion criteria and opting for IUC as post abortion contraception. The medical abortion will be carried out according to the Swedish national evidence based guidelines. Intervention: Randomized to insertion of IUC within 48 hours after medical abortion. Control: Randomized to insertion of IUC at the time of a follow-up visit scheduled 2 to 4 weeks after the abortion according to routine care. Objectives: Evaluation of use of IUC, feasibility, safety, compliance, and acceptability of immediate insertion of IUC 0 to 48 hours after medical abortion compared with delayed IUC insertion at 2 to 4 weeks post abortion. The primary outcome measure will be the use of IUC at 6 months in both groups evaluated by telephone calls/emails follow up. Time plan: Planning: -March 2018 Study start: May 2018 End of recruitment: April 2020 Last patient Last visit April 2021 Analysis: 2021 Report of primary outcome and Safety: 2021

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: * 18 years and older, * eligible for medical abortion, * opting for post abortion IUC, * able and willing to comply with planned follow up. Exclusion Criteria: * Contraindication for medical abortion or * Contraindication for IUC (contraindications may be present for LNG-IUSs but the woman may still choose a Cu-IUD and thereby enter the study), * inability to give informed consent. * Septic abortion * Known hypersensiblity/allergy to levonorgestrel or any of the substances added to the LNG-IUS * Known abnormal uterine cavity * Chorioamnionitis * Abortion associated bleeding \> 1000ml * Uterine atony postabortion * Placental retention * Therapeutic antibiotic treatment during abortion, (antibiotics used only as prophylaxis is accepted) * History of breast cancer * If any of the following conditions are present an individual evaluation and decision must be done before inclusion: pelvic or genital infection, cervicitis, immunocompromised women, untreated cervical dysplasia, neoplasia in cervix or uterus, acute liver disease or hepatic neoplasia, migraine or other very severe headache, icterus, high uncontrolled blood pressure, serious arterial disease i.e. stroke or myocardial infarction, acute venous thrombosis

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

use of intrauterine contraception at 6 months post abortion

Timeframe: 6 months post abortion

Trial details

NCT IDNCT03603145

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Helena Kopp Kallner, MD, PhD

+46704402070 helena.kopp-kallner@ki.se

View on ClinicalTrials.gov More Contraceptive Usage trials