Surgical Evacuation of Abortion Under Ultrasonographic Guide

Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580175
• Other study ID #: USEV
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2015
• Last updated: October 17, 2015
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abortion

Intervention

Procedure:
• Blinded evacuation
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.

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of endometrial thickness by ultrasound (mm)		1 year	Yes
Secondary	Measurement of blood loss (mL)		1 year	Yes
Secondary	measurement of operative time (minutes)		1 year	Yes
Secondary	measurement of Hemoglobin level(g/ml)		1 year	Yes