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

Not Applicable

Suspended

• Conditions: Placenta; Implantation
• Interventions: Other: ultrasound exam; Procedure: hysteroscopy diagnostic

• Registration Number: NCT04579796
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2020-08-26
• Status Verified: 2020-10
• Primary Completion: 2020-10-01
• Study First Submitted QC: 2020-10-02
• Last Update Submitted: 2020-10-02
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
women with first trimester missed abortion	ultrasound exam	-
women with first trimester missed abortion	hysteroscopy diagnostic	-

Primary Outcome Measures

Name	Time	Method
The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester	up to 12 weeks	Transabdominal ultrasonography detection of gestational sac insertion location will be compared with gestational sac location diagnosed with hysteroscopy.

Trial Locations

Locations (1)

Asaf ha Rofeh, MC; 🇮🇱 Zrifin, Israel