Missed AbortionNCT01639976
Doppler Flow Measurements in Patients With Misoprostol Treatment for Arrested Pregnancy
An observational study of Missed Abortion, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Testing the whether Doppler studies after cytotec treatment can predict success of treatment. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Missed Abortion
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- 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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with miss abortion who choose treatment with cytotec
Who may be able to join
- Women with miss abortion who choose treatment with cytotec
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera
Alon Shrim, MD, +97246188243, alon.shrim@gmail.com
Alon Shrim, MD
About this study
Official title: Testing the Connection Between the Existence of Endometrial Flows With Doppler Examination if the Treatment Cytotec Success in Women With Miss Abortion
Testing the whether Doppler studies after cytotec treatment can predict success of treatment.
Read the detailed description
All women who are treated with Cytotec for a missed abortion at 1st trimester will have a follow up ultrasound exam.
Doppler measurements will be performed but will be hidden from the clinicians. After the conclusion of treatment, data on Doppler would be vevealed in order to see if positive Doppler after Cytotec is predictive of failure of treatment or the need in several doses of cytotec.
- Conditions
- Missed Abortion
- Keywords
- Missed abortion, early pregnancy loss.
- Medical subject headings
- Abortion, Missed, Abortion, Spontaneous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alon Shrim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639976
- Sponsor's protocol ID
- 0024-12
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Connection Between the Existence of Endometrial Flows With Doppler Examination if the Treatment Cytotec Success in Women With Miss Abortion
- ClinicalTrials.gov ID
- NCT01639976
- Acronym / sponsor ID
- 0024-12
- Conditions
- Missed Abortion
- Keywords
- Missed abortion, early pregnancy loss.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 13 Jul 2012 (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.
Testing the whether Doppler studies after cytotec treatment can predict success of treatment.
Detailed description
All women who are treated with Cytotec for a missed abortion at 1st trimester will have a follow up ultrasound exam.
Doppler measurements will be performed but will be hidden from the clinicians. After the conclusion of treatment, data on Doppler would be vevealed in order to see if positive Doppler after Cytotec is predictive of failure of treatment or the need in several doses of cytotec.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with miss abortion who choose treatment with cytotec
Key inclusion criteria (1 listed)
- Women with miss abortion who choose treatment with cytotec
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
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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.
Alon Shrim, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Missed Abortion, run by Hillel Yaffe Medical Center 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 1 inclusion and 0 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 13 Jul 2012. 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.
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 Alon Shrim, MD (+97246188243, alon.shrim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Jul 2012.