Clinical trial • Not applicable • Other
Mifepristone for Early pregnancy loss (miscarriage)
Not applicable trial of Mifepristone for Early pregnancy loss (miscarriage).
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Early pregnancy loss (miscarriage)
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-09-2025
- First CTIS Authorization Date
- 26-11-2025
Trial design
Randomised, open-label, surgical arm: hysteroscopic resection. medical management arm: mifepristone 200 mg (mifegyne) oral and misoprostol 200 µg (cytotec) (products included in the trial documentation/smpcs).-controlled Not applicable trial across 1 site in Belgium.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Surgical arm: Hysteroscopic resection. Medical management arm: Mifepristone 200 mg (Mifegyne) oral and Misoprostol 200 µg (Cytotec) (products included in the trial documentation/SmPCs).
- Target Sample Size
- 152
Eligibility
Recruits 152 No vulnerable populations selected. Participants are adult women (Age ≥18 ≤50) and must provide signed informed consent..
- Pregnancy Exclusion
- Pregnancy of unknown location
- Vulnerable Population
- No vulnerable populations selected. Participants are adult women (Age ≥18 ≤50) and must provide signed informed consent.
Inclusion criteria
- {"criterion_text":"- EPL < 10 weeks of gestation\n- Age ≥18 ≤ 50 years\n- Signed informed consent"}
Exclusion criteria
- {"criterion_text":"- Pregnancy of unknown location\n- Severe bleeding requiring immediate surgical intervention\n- Previous history of uterine surgery without proof of a normal cavity following the procedure\n- Contra-indication to medical treatment including: Women who present with hemorrhage, hemodynamic instability, or signs of infection, Adrenal insufficiency, severe asthma.\n- Women with severe anemia, bleeding disorders, or cardiovascular disease."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Complete trophoblastic tissue expulsion, measured by the presence of a retained product of conception (RPOC) at ultrasound and diagnostic hysteroscopy ~1-2 month following intervention and the need for a secondary hysteroscopic resection","definition_or_measurement_approach":"Measured by the presence of a retained product of conception (RPOC) at ultrasound and diagnostic hysteroscopy approximately 1-2 months following the intervention and the need for a secondary hysteroscopic resection."}
Secondary endpoints
- {"endpoint_text":"- Intra-uterine adhesion rates at diagnostic hysteroscopy 1-2 months following complete evacuation\n- Pregnancy rates in the year following randomization\n- Rate of successful genetic analysis on the product of conception\n- Time needed to conceive\n- Complications occurring until 30 days post treatment\n- Patient well-being and quality of life evaluated by questionnaires 1-month and 3-months after the procedure","definition_or_measurement_approach":"Intra-uterine adhesions: assessed at diagnostic hysteroscopy 1-2 months after complete evacuation; Pregnancy rates: assessed during the year following randomization; Rate of successful genetic analysis: proportion of products of conception with successful genetic analysis; Time to conceive: time from randomization to conception; Complications: monitored up to 30 days post treatment; Patient well-being and QoL: assessed by questionnaires at 1 month and 3 months post-procedure."}
Recruitment
- Planned Sample Size
- 152
- Recruitment Window Months
- 48
- Consent Approach
- Written informed consent required from participants (adult women). Subject information and informed consent forms available in English, Dutch and French (documents L1 and patient-facing annexes provided in EN/NL/FR). No assent procedures (participants are adults).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 152
Belgium
- Earliest CTIS Part Ii Submission Date
- 04-11-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 152
Sites
- Site Name
- UZ Brussel
- Department Name
- Brussels IVF
- Principal Investigator Name
- Michelle Soares
- Principal Investigator Email
- michelle.soares@uzbrussel.be
- Contact Person Name
- Michelle Soares
- Contact Person Email
- michelle.soares@uzbrussel.be
- Number Of Participants
- 152
Sponsor
Primary sponsor
- Full Name
- UZ Brussel
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Mifegyne 200 mg (Mifegyne 200 mg comprimés / tabletten)
- Active Substance
- Mifepristone
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (marketing authorisation present in product record)
- Starting Dose
- 200 mg
- Maximum Dose
- 200 mg
- Investigational Product Name
- Cytotec 200 microgrammes / Cytotec 200 microgram tabletten (Cytotec)
- Active Substance
- Misoprostol
- Modality
- Small molecule
- Routes Of Administration
- VAGINAL USE
- Route
- VAGINAL USE
- Authorisation Status
- Authorised (marketing authorisation present in product record)
- Starting Dose
- 200 µg
- Maximum Dose
- 800 µg
- Combination Treatment
- Yes
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