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

NCT ID: NCT04579796

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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

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Placenta; Implantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The performer of the hysteroscopy will not be aware of the result of the ultrasound exam

Study Groups

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women with first trimester missed abortion

Group Type EXPERIMENTAL

ultrasound exam

Intervention Type OTHER

An abdominal ultrasound exam to assess the placenta implantation site.

hysteroscopy diagnostic

Intervention Type PROCEDURE

Diagnostic hysteroscopy to asses the placenta implantation site.

Interventions

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ultrasound exam

An abdominal ultrasound exam to assess the placenta implantation site.

Intervention Type OTHER

hysteroscopy diagnostic

Diagnostic hysteroscopy to asses the placenta implantation site.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* viable pregnancy
* women below 18 years
* women with chronic disease
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh MC

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asaf ha Rofeh, MC

Zrifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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# 0178-19

Identifier Type: -

Identifier Source: org_study_id

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