Second Trimester Medical Abortion (NCT04160221) | Clinical Trial Compass
CompletedNot Applicable
Second Trimester Medical Abortion
Israel80 participantsStarted 2019-11-01
Plain-language summary
The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Despite the recommended 24-48 Mifepristone-Misoprostol interval, recent retrospective study of a flexible interval, have revealed shorter total abortion time with shorter intervals. In this study we aim to compare 24 to 12 hours Mifepristone to Misoprostol intervals
Who can participate
Age range18 Years – 43 Years
SexFEMALE
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Inclusion Criteria:
* Women aged 18 years and older about to undergo medical second trimester abortion
* 12+0 to 28+0 weeks of gestation
* Singleton intrauterine pregnancy
* Able to sign informed consent
Exclusion Criteria:
* Inability to give informed consent
* Allergy to any of the drugs used in the study
* Genital bleeding of unknown etiology; cancer of the breast, cervix, uterus, or ovaries; hepatic disease (current or history of)
* Multiple gestation
* Rupture of membranes
* Taken a CYP3A4 inhibitor within 5 elimination half-lives of the drug from the procedure
* Pre-dosing abnormal liver function tests
* Patients at increased risk of hepatitis based on a history of any of the following:
* Any history of underlying liver disorder, including hepatitis
* A family history of hepatitis or currently living with a person 441 who has been given a diagnosis of hepatitis
* A history of or currently working as a sex worker
* A history of or currently using IV drugs
* A self-reported history of alcoholic dependency or abuse
What they're measuring
1
Induction-abortion time
Timeframe: Through completion of abortion, an estimated period of up to 3 days