Early Pregnancy FailureNCT00782860
Early Pregnancy Failure: Factors Affecting Successful Medical Termination Treatment
An observational study of Early Pregnancy Failure, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
The main purpose of our study was to which determine factors, those measured by ultrasound and also demographic and clinical factors (age, number of previous pregnancies, abortions and deliveries) predict outcome of medical treatment for early pregnancy failure. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Early Pregnancy Failure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with missed abortion or anembryonic pregnancy, with existing intrauterine pregnancy sac
Who may be able to join
- Crown rump length (CRL) is appropriate to less than 12 weeks.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of our study was to which determine factors, those measured by ultrasound and also demographic and clinical factors (age, number of previous pregnancies, abortions and deliveries) predict outcome of medical treatment for early pregnancy failure. Our hypothesis was that gestational sac volume predicts outcome of medical treatment for early pregnancy failure.
- Conditions
- Early Pregnancy Failure
- Keywords
- Early pregnancy failure, Misoprostol, Gestational sac volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| unsuccessful termination | unsuccessful termination of early pregnancy failure with Misoprostol | |
| successful termination | successful termination of early pregnancy failure with Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
An empty uterus or an endometrial lining with thickness of less than 30mm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy FailureStudies 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782860
- Sponsor's protocol ID
- 03-08-2008
- Status last verified
- Mar 2009
- First submitted
- 28 Oct 2008
- Last updated
- 31 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pregnancy Failure: Factors Affecting Successful Medical Termination Treatment
- ClinicalTrials.gov ID
- NCT00782860
- Acronym / sponsor ID
- 03-08-2008
- Conditions
- Early Pregnancy Failure
- Keywords
- Early pregnancy failure, Misoprostol, Gestational sac volume
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- First posted
- 31 Oct 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.
The main purpose of our study was to which determine factors, those measured by ultrasound and also demographic and clinical factors (age, number of previous pregnancies, abortions and deliveries) predict outcome of medical treatment for early pregnancy failure. Our hypothesis was that gestational sac volume predicts outcome of medical treatment for early pregnancy failure.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unsuccessful termination | – | –unsuccessful termination of early pregnancy failure with Misoprostol |
| successful termination | – | –successful termination of early pregnancy failure with Misoprostol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with missed abortion or anembryonic pregnancy, with existing intrauterine pregnancy sac
Key inclusion criteria (1 listed)
- Crown rump length (CRL) is appropriate to less than 12 weeks.
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
An empty uterus or an endometrial lining with thickness of less than 30mm.
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 31 Mar 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Early Pregnancy Failure, run by Western Galilee Hospital-Nahariya 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: finished, as of the sponsor's last update on 31 Mar 2009. 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?
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?
An empty uterus or an endometrial lining with thickness of less than 30mm.. 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 31 Mar 2009.