Abortion, MissedPhase 4NCT05124314
Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss
A Phase 4 study testing Mifepristone, Oral, 200 Mg and Misoprostol Pill in people with Abortion, Missed, run by Clinical Hospital Merkur at 1 site in Croatia.
Trial summary
The purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Missed
- What is being tested?
- Mifepristone, Oral, 200 Mg and Misoprostol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCroatia
- Study dates
- 27 Oct 2021to Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with missed miscarriage in the first 13+6 weeks of pregnancy opting for medical management
- Age 18 years and older
- Intra-uterine pregnancy
- Hemodynamically stable patient
- No signs of infection
- No signs of incomplete miscarriage
- Willing and able to give informed consent
Who cannot join
- Women opting for alternative methods of miscarriage management (expectant or surgical)
- Diagnosis of incomplete miscarriage
- Life threatening bleeding
- Hemodynamically unstable patient
- Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria
- Previous participation in this trial
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Merkur
Zagreb, City of Zagreb, 10000
Mate Milas, MD, +385992060290, milas.mate@gmail.com
Mate Milas, MD
About this study
Official title: Comparison of Efficacy and Safety of Sequential Use of Mifepristone and Misoprostol vs Misoprostol Alone in Women With Early Pregnancy Loss: Randomized Controlled Trial
The purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss).
The investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.
Read the detailed description
Aim: To investigate the safety and efficacy of combination of mifepristone and misoprostol versus misoprostol alone in medical management of early pregnancy loss.
Primary objective: To test the hypothesis that the sequential combination of mifepristone and misoprostol is superior to misoprostol alone for the complete evacuation of uterus in patients diagnosed with early pregnancy loss.
Secondary objectives: To test the hypothesis that the addition of mifepristone reduces the need for further doses of misoprostol, duration of bleeding, complication rate and side effect frequency. The investigators will also evaluate if the addition of mifepristone improves patient satisfaction and quality of life.
Women with a diagnosis of early pregnancy loss that opt for medical treatment and sign an informed consent will be included. The participants will be randomized to two groups. First group will receive oral mifepristone (600 mg) and the second group will not. The remaining course of treatment will be the same for both groups including giving misoprostol (800 mcg vaginally) 48 hours after receiving mifepristone for the first group or immediately for the second group. 24 hours after receiving first dose of misoprostol, one more dose of misoprostol (also 800 mcg vaginally) will be given if no pregnancy tissue is lost.
Three weeks after medical treatment, primary and secondary outcomes will be assessed. In case of unsuccessful treatment (incomplete evacuation of uterus), surgical evacuation will be performed.
220 women will be randomized in a 1:1 ratio.
- Conditions
- Abortion, Missed
- Being tested
- Mifepristone, Oral, 200 Mg, Misoprostol Pill
- Keywords
- Missed miscarriage, Mifepristone, Misoprostol, Medical management
- Medical subject headings
- Abortion, Missed, Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone, Oral, 200 MgDrug
Also called Mifegyne
Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg
Misoprostol PillDrug
Also called Mispregnol
Regular treatment with vaginal Misoprostol 800 mcg
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone and Misoprostol | Experimental | Patients receive oral mifepristone (600 mg) 48 hours before medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost). Receives: Drug: Mifepristone, Oral, 200 Mg; Drug: Misoprostol Pill |
| Misoprostol | Active comparator | Medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost). Receives: Drug: Misoprostol Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete evacuation of uterus
Complete evacuation of uterus will be assessed by clinical and ultrasound examination three weeks after treatment. There should be no vaginal bleeding and no suspicion of retained products of conception on ultrasound scan (endometrial thickness <= 15 mm) to declare the treatment successful.
Measured: Three weeks after randomization
Secondary outcomes (8)
Total misoprostol dose used
Total dose of misoprostol used during treatment
Measured: Up to three weeks after randomization
Complications
Frequency of complications (by type)
Measured: Up to three weeks after randomization
Side effects
Type and degree of side effects experienced as reported in the patient's diary
Measured: Up to three weeks after randomization
Duration of vaginal bleeding
Duration of vaginal bleeding as reported in the patient's diary
Measured: Up to three weeks after randomization
Hemoglobin change
Hemoglobin change from randomization until three weeks after treatment
Measured: At randomization and three weeks after randomization
Patient quality of life
Overall health status measured using EuroQol-5 dimensions-5 levels questionnaire's (EQ-5D-5L) VAS (visual analog scale) score ranging from 0 to 100 where 0 represents worst health the participant can imagine and 100 represents the best health the participant can imagine
Measured: At randomization, 24 hours after taking first misoprostol dose and three weeks after randomization
Patient satisfaction
Overall patient satisfaction with the treatment measured using validated paper-based Client Satisfaction Questionnaire (CSQ-8) score ranging from 4 to 32, where higher number represents higher satisfaction
Measured: Three weeks after randomization
Indication for surgical treatment
Type and incidence of indications for surgical evacuation of uterus in case of unsuccessful medical treatment
Measured: Three weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start27 Oct 2021
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, MissedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel group, single center study. Before receiving vaginal misoprostol (800 mcg, repeated after 24 hours if no pregnancy tissue is lost), patients will be randomized to either oral mifepristone (600 mg) or nothing.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Merkur
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb
- Responsible party
- Principal investigator, Mate Milas, Clinical Hospital Merkur
- Investigators
- Mate Milas, MD, Principal investigator, Clinical Hospital Merkur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124314
- Sponsor's protocol ID
- 2021-0001
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Sequential Use of Mifepristone and Misoprostol vs Misoprostol Alone in Women With Early Pregnancy Loss: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05124314
- Acronym / sponsor ID
- 2021-0001
- Conditions
- Abortion, Missed
- Keywords
- Missed miscarriage, Mifepristone, Misoprostol, Medical management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Clinical Hospital MerkurUniversity, hospital or other
- Collaborators
- University of Zagreb
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss).
The investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.
Detailed description
Aim: To investigate the safety and efficacy of combination of mifepristone and misoprostol versus misoprostol alone in medical management of early pregnancy loss.
Primary objective: To test the hypothesis that the sequential combination of mifepristone and misoprostol is superior to misoprostol alone for the complete evacuation of uterus in patients diagnosed with early pregnancy loss.
Secondary objectives: To test the hypothesis that the addition of mifepristone reduces the need for further doses of misoprostol, duration of bleeding, complication rate and side effect frequency. The investigators will also evaluate if the addition of mifepristone improves patient satisfaction and quality of life.
Women with a diagnosis of early pregnancy loss that opt for medical treatment and sign an informed consent will be included. The participants will be randomized to two groups. First group will receive oral mifepristone (600 mg) and the second group will not. The remaining course of treatment will be the same for both groups including giving misoprostol (800 mcg vaginally) 48 hours after receiving mifepristone for the first group or immediately for the second group. 24 hours after receiving first dose of misoprostol, one more dose of misoprostol (also 800 mcg vaginally) will be given if no pregnancy tissue is lost.
Three weeks after medical treatment, primary and secondary outcomes will be assessed. In case of unsuccessful treatment (incomplete evacuation of uterus), surgical evacuation will be performed.
220 women will be randomized in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, parallel group, single center study. Before receiving vaginal misoprostol (800 mcg, repeated after 24 hours if no pregnancy tissue is lost), patients will be randomized to either oral mifepristone (600 mg) or nothing.
| Arm | Type | Receives |
|---|---|---|
| Mifepristone and Misoprostol | Experimental | Drug: Mifepristone, Oral, 200 Mg, Drug: Misoprostol PillPatients receive oral mifepristone (600 mg) 48 hours before medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost). |
| Misoprostol | Active comparator | Drug: Misoprostol PillMedical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women diagnosed with missed miscarriage in the first 13+6 weeks of pregnancy opting for medical management
- Age 18 years and older
- Intra-uterine pregnancy
- Hemodynamically stable patient
- No signs of infection
Key exclusion criteria (7 listed)
- Women opting for alternative methods of miscarriage management (expectant or surgical)
- Diagnosis of incomplete miscarriage
- Life threatening bleeding
- Hemodynamically unstable patient
- Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone, Oral, 200 MgAlso: MifegyneAdding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg | Drug | Mifepristone and Misoprostol |
| Misoprostol PillAlso: MispregnolRegular treatment with vaginal Misoprostol 800 mcg | Drug | Mifepristone and Misoprostol, Misoprostol |
Primary outcome
Number of participants with complete evacuation of uterus
Time frame: Three weeks after randomization
Complete evacuation of uterus will be assessed by clinical and ultrasound examination three weeks after treatment. There should be no vaginal bleeding and no suspicion of retained products of conception on ultrasound scan (endometrial thickness <= 15 mm) to declare the treatment successful.
8 secondary outcomes
Total misoprostol dose used
Time frame: Up to three weeks after randomization
Complications
Time frame: Up to three weeks after randomization
Side effects
Time frame: Up to three weeks after randomization
Duration of vaginal bleeding
Time frame: Up to three weeks after randomization
Hemoglobin change
Time frame: At randomization and three weeks after randomization
Patient quality of life
Time frame: At randomization, 24 hours after taking first misoprostol dose and three weeks after randomization
Patient satisfaction
Time frame: Three weeks after randomization
Indication for surgical treatment
Time frame: Three weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mate Milas, MD principal investigator
Clinical Hospital Merkur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone, Oral, 200 Mg and Misoprostol Pill in people with Abortion, Missed, run by Clinical Hospital Merkur at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mate Milas, MD (+385992060290, milas.mate@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complete evacuation of uterus (time frame: Three weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.