Intra-uterine ResiduaPhase 2NCT01134926
Non Surgical Management for Uterine Residua After Pregnancy Termination, Abortion or Delivery
A Phase 2 study testing misoprostol in people with Intra-uterine Residua, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The aim of the study is to find out whether conservative treatment - expectant management or medical therapy using misoprostol is beneficial in the case of uterine residua, and which treatment is better. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intra-uterine Residua
- What is being tested?
- misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to May 2012
- Phase
- Phase 2
- 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 with sonographic examination reveals suspicion of intra-uterine residua after completion of pregnancy
- intrauterine cavity, including endometrium, will be at least 15mm
Who cannot join
- the need for emergency surgical treatment (curettage)
- fever - at least 38 celsius degree
- women who had medical termination of pregnancy and the examination is after less then 2 weeks since treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Study Comparing Between Expectant Management and Misoprostol Treatment for Intra-uterine Residua After Pregnancy Termination, Abortion or Delivery
The aim of the study is to find out whether conservative treatment - expectant management or medical therapy using misoprostol is beneficial in the case of uterine residua, and which treatment is better.
Read the detailed description
Retained products of conception are estimated to occur after approximately 1-6% of pregnancies, probably more often after termination of early pregnancies then after term pregnancy. Complication are abdominal pain, infection, bleeding and for the long term - intrauterine adhesions.Blood clots in the uterine cavity can cause similar complications. The definitive treatment is curettage or hysteroscopy, both of which are carried out under general anesthesia and require an operating theater. Although expectant management and uterotonic drugs are practically used in such situation, they are not described in the literature.This study compare between the outcome of misoprostol treatment and expectant management in the case of intrauterine residua after completion of pregnancy.
- Conditions
- Intra-uterine Residua
- Being tested
- misoprostol
- Keywords
- Retained products of conception, residua, misoprostol, expectant management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
Also called cytotec
8oo mcg intravaginal, second dose after one day if there is no response
| Study group | Role | What they receive |
|---|---|---|
| intra-uterine residua. expectant management | No intervention | The patients in this arm will not get any treatment and be followed up by US examinations |
| Intra-uterine residua. misoprostol | Experimental | The patients in this arm will be treated with misoprostol at the recruitment day. If there will be sonographic evidence of intra-uterine residua the day after, they'll gat another dose. Receives: Drug: misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
abscence of sonographic finding in the uterine cavity
ofter one week, the patients will undergo an US examination.Failure of management defined as uterine cavity width > 15mm
Measured: one week since recruitment
Secondary outcomes (2)
Complications
During the study,there will be collection of data considering pain, bleeding, infection and surgical evacuation.
Measured: Within one week since recruitment
Woman's satisfaction
At the end of the week, the patient will be asked about her satisfaction with the treatment
Measured: One week since recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: The principal investigator left the organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-uterine ResiduaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yfat kadan, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134926
- Sponsor's protocol ID
- 0014-10-EMC
- Status last verified
- Jun 2015
- First submitted
- 29 May 2010
- Last updated
- 23 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Study Comparing Between Expectant Management and Misoprostol Treatment for Intra-uterine Residua After Pregnancy Termination, Abortion or Delivery
- ClinicalTrials.gov ID
- NCT01134926
- Acronym / sponsor ID
- 0014-10-EMC
- Conditions
- Intra-uterine Residua
- Keywords
- Retained products of conception, residua, misoprostol, expectant management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The principal investigator left the organization
- Enrolment
- 23 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Jun 2010 (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.
The aim of the study is to find out whether conservative treatment - expectant management or medical therapy using misoprostol is beneficial in the case of uterine residua, and which treatment is better.
Detailed description
Retained products of conception are estimated to occur after approximately 1-6% of pregnancies, probably more often after termination of early pregnancies then after term pregnancy. Complication are abdominal pain, infection, bleeding and for the long term - intrauterine adhesions.Blood clots in the uterine cavity can cause similar complications. The definitive treatment is curettage or hysteroscopy, both of which are carried out under general anesthesia and require an operating theater. Although expectant management and uterotonic drugs are practically used in such situation, they are not described in the literature.This study compare between the outcome of misoprostol treatment and expectant management in the case of intrauterine residua after completion of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-uterine residua. expectant management | No intervention | –The patients in this arm will not get any treatment and be followed up by US examinations |
| Intra-uterine residua. misoprostol | Experimental | Drug: misoprostolThe patients in this arm will be treated with misoprostol at the recruitment day. If there will be sonographic evidence of intra-uterine residua the day after, they'll gat another dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women with sonographic examination reveals suspicion of intra-uterine residua after completion of pregnancy
- intrauterine cavity, including endometrium, will be at least 15mm
Key exclusion criteria (3 listed)
- the need for emergency surgical treatment (curettage)
- fever - at least 38 celsius degree
- women who had medical termination of pregnancy and the examination is after less then 2 weeks since treatment
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 |
|---|---|---|
| misoprostolAlso: cytotec8oo mcg intravaginal, second dose after one day if there is no response | Drug | Intra-uterine residua. misoprostol |
Primary outcome
abscence of sonographic finding in the uterine cavity
Time frame: one week since recruitment
ofter one week, the patients will undergo an US examination.Failure of management defined as uterine cavity width > 15mm
2 secondary outcomes
Complications
Time frame: Within one week since recruitment
Woman's satisfaction
Time frame: One week since recruitment
Results and safety
The study was stopped early (reason given: The principal investigator left the organization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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.
yfat kadan, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing misoprostol in people with Intra-uterine Residua, run by HaEmek Medical Center, Israel 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 3 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: stopped early, as of the sponsor's last update on 23 Jun 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The principal investigator left the organization). Results are not available in the source record.
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?
abscence of sonographic finding in the uterine cavity (time frame: one week since recruitment). 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 23 Jun 2015.