The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester When Compared to Hysteroscopy in Early Abortions
Overview
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester
Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
The performer of the hysteroscopy will not be aware of the result of the ultrasound exam
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy women .
- •Clinical diagnosis of first trimester spontaneous abortion.
Exclusion Criteria
- •viable pregnancy
- •women below 18 years
- •women with chronic disease
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Assaf Harofeh MC
Doctor
Assaf-Harofeh Medical Center