Abortion, MissedPhase 4NCT00784797
Misopristol Versus Pitocin for Second Trimester Abortion
A Phase 4 study testing mifepristone and misopristol and mifepristone and oxytocin in people with Abortion, Missed, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Abortion, Missed
- What is being tested?
- mifepristone and misopristol and mifepristone and oxytocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jun 2012
- 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 50 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
Official title: Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion
Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. The investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects.
Working hypothesis and aims: To compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.
- Conditions
- Abortion, Missed
- Being tested
- mifepristone and misopristol, mifepristone and oxytocin
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristone and misopristolDrug
200 mg mifepristone and after 48 hours vaginal misopristol 800 mgr followed by oral misopristol 400 mgr every 3 hours for maxamum 5 doses
mifepristone and oxytocinDrug
200 mg mifepristone followed 48 hours with high dose oxytocin drip (9 unit per hour)
| Study group | Role | What they receive |
|---|---|---|
| pitocin | Active comparator | high dose pitocin drip 48 hours after mifepristone preparation. Receives: Drug: mifepristone and oxytocin |
| misopristol | Active comparator | vaginal and oral misopristol 48 hours after mifepristone preparation. Receives: Drug: mifepristone and misopristol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of abortion
Measured: 24 hours
Interval to abortion
Measured: 24 hours
Secondary outcomes (1)
Side effects
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assaf Ben Meir, Hadassah Medical Organization
- Investigators
- Assaf Ben-Meir, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784797
- Sponsor's protocol ID
- PitocinPGMyf-HMO-CTIL
- Status last verified
- Nov 2013
- First submitted
- 2 Nov 2008
- Last updated
- 21 Nov 2013
- Results posted
- No
Publications
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PubMed 34061352Freeman MD, Porat N, Rojansky N, Elami-Suzin M, Winograd O, Ben-Meir A. Physical symptoms and emotional responses among women undergoing induced abortion protocols during the second trimester. Int J Gynaecol Obstet. 2016 Nov;135(2):154-157. doi: 10.1016/j.ijgo.2016.05.008. Epub 2016 Aug 15.
PubMed 27539053Elami-Suzin M, Freeman MD, Porat N, Rojansky N, Laufer N, Ben-Meir A. Mifepristone followed by misoprostol or oxytocin for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):815-820. doi: 10.1097/AOG.0b013e3182a2dcb7.
PubMed 24084539
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion
- ClinicalTrials.gov ID
- NCT00784797
- Acronym / sponsor ID
- PitocinPGMyf-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
- Jan 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Nov 2008 (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.
Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. The investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects.
Working hypothesis and aims: To compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pitocin | Active comparator | Drug: mifepristone and oxytocinhigh dose pitocin drip 48 hours after mifepristone preparation. |
| misopristol | Active comparator | Drug: mifepristone and misopristolvaginal and oral misopristol 48 hours after mifepristone preparation. |
Who may qualify
- Ages
- 18 to 50 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 and misopristol200 mg mifepristone and after 48 hours vaginal misopristol 800 mgr followed by oral misopristol 400 mgr every 3 hours for maxamum 5 doses | Drug | misopristol |
| mifepristone and oxytocin200 mg mifepristone followed 48 hours with high dose oxytocin drip (9 unit per hour) | Drug | pitocin |
Primary outcome
Success rate of abortion
Time frame: 24 hours
Interval to abortion
Time frame: 24 hours
1 secondary outcome
Side effects
Time frame: 24 hours
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 21 Nov 2013.
- Derived from this study: PubMed 34061352Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
- Derived from this study: PubMed 27539053Freeman MD, Porat N, Rojansky N, Elami-Suzin M, Winograd O, Ben-Meir A. Physical symptoms and emotional responses among women undergoing induced abortion protocols during the second trimester. Int J Gynaecol Obstet. 2016 Nov;135(2):154-157. doi: 10.1016/j.ijgo.2016.05.008. Epub 2016 Aug 15.
- Derived from this study: PubMed 24084539Elami-Suzin M, Freeman MD, Porat N, Rojansky N, Laufer N, Ben-Meir A. Mifepristone followed by misoprostol or oxytocin for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):815-820. doi: 10.1097/AOG.0b013e3182a2dcb7.
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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 and misopristol and mifepristone and oxytocin 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 21 Nov 2013. 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 rate of abortion (time frame: 24 hours). 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?
On the ClinicalTrials.gov record for NCT00784797, which also lists 3 linked publications.
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 21 Nov 2013; AzTrials last refreshed its copy on 30 Oct 2026.