Surgical Evacuation of Abortion Under Ultrasonographic Guide

Surgical Evacuation of First Trimester Missed Miscarriage With or Without Use of Transabdominal Ultrasound

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.

Study Overview

• Status: Completed
• Conditions: Abortion
• Intervention / Treatment: Procedure: Blinded evacuation; Procedure: Evacuation under ultrasound guidance

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Blinded evacuation; Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation	Procedure: Blinded evacuation; Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of endometrial thickness by ultrasound (mm)	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of blood loss (mL)	1 month
measurement of operative time (minutes)	1 month
measurement of Hemoglobin level(g/ml)	1 month

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: October 17, 2015
• First Submitted That Met QC Criteria: October 17, 2015
• First Posted (Estimated): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: USEV