Surgical Evacuation of Abortion Under Ultrasonographic Guide

Study Overview
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Brief Summary
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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.

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

Conditions
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Abortion

Intervention / Treatment
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* Procedure: Blinded evacuation
* Procedure: Evacuation under ultrasound guidance


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blinded evacuation<br>Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation | Procedure: Blinded evacuation<br>* Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation.<br>|
| Active Comparator: Evacuation under ultrasound guidance<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of endometrial thickness by ultrasound (mm) |  | 1 year | 

Secondary Outcome Measures

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