Placenta; ImplantationNCT04579796
The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester.
A study testing ultrasound exam and hysteroscopy diagnostic in people with Placenta; Implantation, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The investigators speculate that ultrasound examination in the first trimester can accurately detect placental location. By performing both transabdominal ultrasound and later hysteroscopy on women with a first trimester missed abortions and comparing the ultrasound findings to those of the hysteroscopy the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta; Implantation
- What is being tested?
- ultrasound exam and hysteroscopy diagnostic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2019to 30 Dec 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women .
- Clinical diagnosis of first trimester spontaneous abortion.
Who cannot join
- viable pregnancy
- women below 18 years
- women with chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester When Compared to Hysteroscopy in Early Abortions
The investigators speculate that ultrasound examination in the first trimester can accurately detect placental location. By performing both transabdominal ultrasound and later hysteroscopy on women with a first trimester missed abortions and comparing the ultrasound findings to those of the hysteroscopy the investigators will evaluate the performance of the ultrasound in detecting the placenta location.
Read the detailed description
All women with a first trimester missed abortion who will sign an informed consent form will undergo an ultrasound examination. During the examination, the operator will assess the location of the placenta/sac insertion. After the performance of the ultrasound, the women will undergo hysteroscopy with a different operator who will be blinded to the results of the previous exam result. During the hysteroscopy the second operator will assess again the location of the sac insertion .The investigatorswill then compare the results of the two tests using the histeroscopy as the gold standard and evaluate the performance of abdominal ultrasound exam in the evaluation of placenta/ sac inserion.
- Conditions
- Placenta; Implantation
- Being tested
- ultrasound exam, hysteroscopy diagnostic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examOther
An abdominal ultrasound exam to assess the placenta implantation site.
hysteroscopy diagnosticProcedure or surgery
Diagnostic hysteroscopy to asses the placenta implantation site.
| Study group | Role | What they receive |
|---|---|---|
| women with first trimester missed abortion | Experimental | Not described Receives: Other: ultrasound exam; Procedure: hysteroscopy diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester
Transabdominal ultrasonography detection of gestational sac insertion location will be compared with gestational sac location diagnosed with hysteroscopy.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Feb 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta; ImplantationStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579796
- Sponsor's protocol ID
- # 0178-19
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester When Compared to Hysteroscopy in Early Abortions
- ClinicalTrials.gov ID
- NCT04579796
- Acronym / sponsor ID
- # 0178-19
- Conditions
- Placenta; Implantation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: lack of funding
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 8 Oct 2020 (actual)
- 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 investigators speculate that ultrasound examination in the first trimester can accurately detect placental location. By performing both transabdominal ultrasound and later hysteroscopy on women with a first trimester missed abortions and comparing the ultrasound findings to those of the hysteroscopy the investigators will evaluate the performance of the ultrasound in detecting the placenta location.
Detailed description
All women with a first trimester missed abortion who will sign an informed consent form will undergo an ultrasound examination. During the examination, the operator will assess the location of the placenta/sac insertion. After the performance of the ultrasound, the women will undergo hysteroscopy with a different operator who will be blinded to the results of the previous exam result. During the hysteroscopy the second operator will assess again the location of the sac insertion .The investigatorswill then compare the results of the two tests using the histeroscopy as the gold standard and evaluate the performance of abdominal ultrasound exam in the evaluation of placenta/ sac inserion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with first trimester missed abortion | Experimental | Other: ultrasound exam, Procedure: hysteroscopy diagnostic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy women .
- Clinical diagnosis of first trimester spontaneous abortion.
Key exclusion criteria (3 listed)
- viable pregnancy
- women below 18 years
- women with chronic disease
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 examAn abdominal ultrasound exam to assess the placenta implantation site. | Other | women with first trimester missed abortion |
| hysteroscopy diagnosticDiagnostic hysteroscopy to asses the placenta implantation site. | Procedure or surgery | women with first trimester missed abortion |
Primary outcome
The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester
Time frame: up to 12 weeks
Transabdominal ultrasonography detection of gestational sac insertion location will be compared with gestational sac location diagnosed with hysteroscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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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?
A study testing ultrasound exam and hysteroscopy diagnostic in people with Placenta; Implantation, run by Assaf-Harofeh 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 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: paused, as of the sponsor's last update on 8 Oct 2020. 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?
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 accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester (time frame: up to 12 weeks). 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 8 Oct 2020.