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

Placenta; Implantation Clinical Trial

Official title:

The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester When Compared to Hysteroscopy in Early Abortions

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04579796
• Other study ID #: # 0178-19
• Status: Suspended
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2020
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 investigators will evaluate the performance of the ultrasound in detecting the placenta location.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 25
• Est. completion date: December 30, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy women .

• Clinical diagnosis of first trimester spontaneous abortion.

Exclusion Criteria:

• viable pregnancy

• women below 18 years

• women with chronic disease

Related Conditions & MeSH terms

• Placenta; Implantation

Intervention

Other:
• ultrasound exam
An abdominal ultrasound exam to assess the placenta implantation site.

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

Locations

Country	Name	City	State
Israel	Asaf ha Rofeh, MC	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 12 weeks