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The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579796
Recruitment Status : Suspended (lack of funding)
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

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.

Condition or disease Intervention/treatment Phase
Placenta; Implantation Other: ultrasound exam Procedure: hysteroscopy diagnostic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The performer of the hysteroscopy will not be aware of the result of the ultrasound exam
Primary Purpose: Diagnostic
Official Title: The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester When Compared to Hysteroscopy in Early Abortions
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: women with first trimester missed abortion Other: ultrasound exam
An abdominal ultrasound exam to assess the placenta implantation site.

Procedure: hysteroscopy diagnostic
Diagnostic hysteroscopy to asses the placenta implantation site.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women .
  • Clinical diagnosis of first trimester spontaneous abortion.

Exclusion Criteria:

  • viable pregnancy
  • women below 18 years
  • women with chronic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579796


Locations
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Israel
Asaf ha Rofeh, MC
Zrifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
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Responsible Party: Assaf Harofeh MC, Doctor, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT04579796    
Other Study ID Numbers: # 0178-19
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No