Second Trimester AbortionPhase 4NCT03044093
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion
A Phase 4 study testing Mifepristone and Misoprostol in people with Second Trimester Abortion, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Second Trimester Abortion
- What is being tested?
- Mifepristone and Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Jan 2019
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- no allergy known to these drugs
- second trimester abortion
Who cannot join
- hematology diseases
- clotting factor deficiency
Trial locations and contacts
1 site in 1 country.
MEIR NIZRI, MD contact
About this study
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial
- Conditions
- Second Trimester Abortion
- Being tested
- Mifepristone, Placebo, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
The group that will get in addition to Misoprostol also Mifepristone
PlaceboDrug
The group that will only get Misoprostol
MisoprostolDrug
Both groups will get think drug
| Study group | Role | What they receive |
|---|---|---|
| MISOPROSTOL alone | Active comparator | the common practice currently in our medical center for second trimester medical abortion/ Placebo Receives: Drug: Placebo; Drug: Misoprostol |
| Mifepristone and Misoprostol | Experimental | in addition to the common practice currently in our medical center for second trimester medical abortion we will add Mifepristone before administering Misoprostol.
Mifepristone Receives: Drug: Mifepristone; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Hospital Stay Duration
number of days of hospital stay
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Trimester AbortionStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044093
- Sponsor's protocol ID
- 0299-16-RMB
- Status last verified
- Feb 2017
- First submitted
- 18 Jan 2017
- Last updated
- 6 Feb 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion
- ClinicalTrials.gov ID
- NCT03044093
- Acronym / sponsor ID
- 0299-16-RMB
- Conditions
- Second Trimester Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 6 Feb 2017 (estimated)
- 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.
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MISOPROSTOL alone | Active comparator | Drug: Placebo, Drug: Misoprostolthe common practice currently in our medical center for second trimester medical abortion/ Placebo |
| Mifepristone and Misoprostol | Experimental | Drug: Mifepristone, Drug: Misoprostolin addition to the common practice currently in our medical center for second trimester medical abortion we will add Mifepristone before administering Misoprostol. Mifepristone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- no allergy known to these drugs
- second trimester abortion
Key exclusion criteria (2 listed)
- hematology diseases
- clotting factor deficiency
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 |
|---|---|---|
| MifepristoneThe group that will get in addition to Misoprostol also Mifepristone | Drug | Mifepristone and Misoprostol |
| PlaceboThe group that will only get Misoprostol | Drug | MISOPROSTOL alone |
| MisoprostolBoth groups will get think drug | Drug | MISOPROSTOL alone, Mifepristone and Misoprostol |
Primary outcome
Reduction in Hospital Stay Duration
Time frame: Up to 24 months
number of days of hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- 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.
MEIR NIZRI, MD contact
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 and Misoprostol in people with Second Trimester Abortion, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 2 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 6 Feb 2017. 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 Israel. 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 MEIR NIZRI, MD (972-50-2061521), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Hospital Stay Duration (time frame: Up to 24 months). 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 6 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.