Surgical Evacuation of Abortion Under Ultrasonographic Guide

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

The abortion considers 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 represents the greater part of termination. Therefore, the safety of this procedure is a worldwide public health concern . Many clinical studies have been reported the safety of surgical evacuation in the first trimester.

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

The surgical evacuation is generally considered safe, however; short-term complications are reported due to need of dilatation of the cervix and incomplete evacuation because the surgeon is the only one who can decide the end of the operation depending on his subjective sense.

However; with continuous ultrasound guidance, the process could be almost complete because the ultrasound can accurately identify the direction and size of the uterus, position of the gestational sac, observe the insertion of surgical instruments and the advancement of the operation especially when the configuration of the uterus is distorted.

At present; ultrasonography is not considered to be an essential pre-requisite for abortion in all cases so our study aims to detect if complete evacuation can be achieved by ultrasonographic assistance or not. We also tried in this study to compare the operative time, amount of blood loss and the occurrence of accidental uterine perforation during the procedure with and without use of ultrasound.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

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
• Genders Eligible for Study: Female

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 year

Secondary Outcome Measures

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

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 (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 17, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: USEV