Abortion, MissedPhase 4NCT00410345
Cervical Rippening With Antiprogesterone in Midtrimester Abortions
A Phase 4 study testing Mifepristone in people with Abortion, Missed, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abortion, Missed
- What is being tested?
- Mifepristone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2004to May 2008
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- midtrimester late abortion
- midtrimester induced abortion
Who cannot join
- placenta previa
- infected abortion
- rupture of membranes
- s/p cesarean section *2 or more
Trial locations and contacts
1 site in 1 country.
About this study
Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip.
Read the detailed description
The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects.
- Conditions
- Abortion, Missed
- Being tested
- Mifepristone
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Pitocin | Experimental | Treatment with Pitocin after mifegine Receives: Drug: Mifepristone |
| Cytotec | Active comparator | Treatment with cytotec after mifegine Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of abortion induction
abortion induction duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startAug 2004
- Primary completionMay 2008
- Study completionMay 2008
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.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Assaf Ben-Meir, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410345
- Sponsor's protocol ID
- mifepristoneoxytocin-HMO-CTIL
- Status last verified
- May 2008
- First submitted
- 11 Dec 2006
- Last updated
- 1 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Rippening With Antiprogesterone in Midtrimester Abortions
- ClinicalTrials.gov ID
- NCT00410345
- Acronym / sponsor ID
- mifepristoneoxytocin-HMO-CTIL
- Conditions
- Abortion, Missed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Dec 2006 (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.
Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip.
Detailed description
The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitocin | Experimental | Drug: MifepristoneTreatment with Pitocin after mifegine |
| Cytotec | Active comparator | Drug: MifepristoneTreatment with cytotec after mifegine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- midtrimester late abortion
- midtrimester induced abortion
Key exclusion criteria (4 listed)
- placenta previa
- infected abortion
- rupture of membranes
- s/p cesarean section *2 or more
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 | Drug | Cytotec, Pitocin |
Primary outcome
success of abortion induction
abortion induction duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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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.
Assaf Ben-Meir, MD principal investigator
Hadassah Medical Organization
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 in people with Abortion, Missed, run by Hadassah Medical Organization 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of abortion induction. The study lists 2 primary outcomes in all. 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 1 Mar 2017.