Ectopic PregnancyNCT02963012
The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy
An observational study of Ectopic Pregnancy, run by HaEmek Medical Center, Israel.
Trial summary
A prospective trail. Pregnant women in the first trimester with positive BHCG and no visualization of gestational sac will be recruited. The correlation between endometrial pattern and ectopic pregnancy will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- ultrasound examination
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2019
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with ectopic pregnancy, in the first trimester.
Who may be able to join
- First trimester of pregnancy
- No visualization of gestational sac
Who cannot join
- Hemodynamic instability
About this study
A prospective trail. Pregnant women in the first trimester with positive BHCG and no visualization of gestational sac will be recruited.
The correlation between endometrial pattern and ectopic pregnancy will be assessed.
- Conditions
- Ectopic Pregnancy
- Being tested
- ultrasound examination
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examinationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
the corellation between presence and width of trilaminar endometrium as evaluated by transvaginal ultrasound and the diagnosis of ectopic pregnancy
Measured: first trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Ziv Medical Center
- Responsible party
- Principal investigator, Etty Spiegel, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963012
- Sponsor's protocol ID
- emc 0164-15
- Status last verified
- Nov 2016
- First submitted
- 12 Sep 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT02963012
- Acronym / sponsor ID
- emc 0164-15
- Conditions
- Ectopic Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Ziv Medical Center
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Nov 2016 (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.
A prospective trail. Pregnant women in the first trimester with positive BHCG and no visualization of gestational sac will be recruited.
The correlation between endometrial pattern and ectopic pregnancy will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with ectopic pregnancy, in the first trimester.
Key inclusion criteria (2 listed)
- First trimester of pregnancy
- No visualization of gestational sac
Key exclusion criteria (1 listed)
- Hemodynamic instability
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 |
|---|---|---|
| ultrasound examination | Other | – |
Primary outcome
the corellation between presence and width of trilaminar endometrium as evaluated by transvaginal ultrasound and the diagnosis of ectopic pregnancy
Time frame: first trimester of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Ectopic Pregnancy
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
RecruitingPhase 2
Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS
Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS)
Active, not recruitingPhase 2
Metyrapone for Mild Autonomous Cortisol Secretion (MACS)
Autonomous Cortisol Secretion, Mild Autonomous Cortisol Secretion (MACS)
Active, not recruitingPhase 2/3
Sequential vs. Combined Letrozole and Methotrexate for Tubal Ectopic Pregnancy.
Ectopic Pregnancy
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, run by HaEmek Medical Center, 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 1 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
the corellation between presence and width of trilaminar endometrium as evaluated by transvaginal ultrasound and the diagnosis of ectopic pregnancy (time frame: first trimester of pregnancy). 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 15 Nov 2016.