CompletedPhase 4

Medical Termination of II Trimester Pregnancy

Sweden457 participantsStarted 2018-12-10

Plain-language summary

The objective of this study is to compare two groups of women requiring termination of pregnancy from the gestational age of 85 days. All women will receive Mifepristone during their first visit to the out-patient ward. One group of women will receive Misoprostol to administer the first dose (vaginally) at home and 2 hours later they will be admitted to the in-patient ward. They will be informed to present earlier if they start bleeding or experience pain corresponding to more than normal menstrual cramping. The other group will receive the first dose of Misoprostol (vaginally) when admitted in the in-patient ward (usually in the morning) according to current practice.

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: * Women aged \>/= 18 years requesting a termination of pregnancy, for social, medical or foetal indications * gestational age 85 - 153 days (with ultrasonography), * willing and able to understand and participate after the study has been explained, with good understanding of Swedish or English language, * general good health, * single intra-uterine pregnancy, Exclusion Criteria: * do not wish to participate or unable to communicate in Swedish or English. * non-viable pregnancy (confirmed by ultrasonography). * a history or evidence of disorders that represent a contraindication to the use of Mifepristone or Misoprostol (adrenal pathology, steroid dependent cancer, porphyria, known allergy to the medication). * any pre-existing health conditions for whom the execution of a medical abortion as judged by the investigator could compromise their condition (Examples of health conditions of concern are: severe anaemia, severe asthma, haemorrhagic disorders, treatment with anticoagulants or corticoids, severe cardiac disease or hypertension, severe liver disease, severe kidney disease or severe psychiatric disorders). * Fetal malformation that may impact time-to-expulsion (such as hydrocephalus, hydrops/edema) or a duplex pregnancy.

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

Number of women treated as day care patients

Timeframe: 9 hours from admission to the out patient clinic

Trial details

NCT IDNCT03600857

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Unwanted Pregnancy trials