Surgical Evacuation of Abortion Under Ultrasonographic Guide

NCT ID: NCT02580175

Last Updated: 2024-07-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-05-31

Brief Summary

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Abortion is considered the most common cause of fetal demise all over the world. The majority of cases occur in the first trimester. The termination of abortion may be by medical or surgical methods, however; the surgical methods represent the greater part of termination. Therefore, the safety of this procedure is a worldwide public health concern. Many clinical studies have reported the safety of surgical evacuation in the first trimester.

The suction-aspiration or vacuum aspiration is the most common surgical method of induced abortion. This consists of removing the fetus, embryo, placenta, and membranes by suction using a manual syringe or electric pump. However; these techniques always need cervical dilation before aspiration. The menstrual extraction does not require cervical dilation and can be used in very early pregnancy.

Detailed Description

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Conditions

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Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Blinded evacuation

Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation

Group Type ACTIVE_COMPARATOR

Blinded evacuation

Intervention Type PROCEDURE

Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation.

Evacuation under ultrasound guidance

Ring evacuation was performed under ultrasound guidance followed by sharp gentle curettage until complete evacuation. The surgery was considered complete when the endometrial cavity appeared as a regular echogenic line.

Group Type ACTIVE_COMPARATOR

Evacuation under ultrasound guidance

Intervention Type PROCEDURE

Ring evacuation was performed under ultrasound guidance followed by sharp gentle curettage until complete evacuation. The surgery was considered complete when the endometrial cavity appeared as a regular echogenic line.

Interventions

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Blinded evacuation

Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation.

Intervention Type PROCEDURE

Evacuation under ultrasound guidance

Ring evacuation was performed under ultrasound guidance followed by sharp gentle curettage until complete evacuation. The surgery was considered complete when the endometrial cavity appeared as a regular echogenic line.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women with non-viable first trimester intrauterine pregnancy
* no contraindication to surgical evacuation under general anesthesia

Exclusion Criteria

* gestational age more than 13 weeks
* hemodynamically unstable
* suspicion of an ectopic pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women Health Hospital - Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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USEV

Identifier Type: -

Identifier Source: org_study_id

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