Surgical Evacuation of Abortion Under Ultrasonographic Guide
Surgical Evacuation of First Trimester Missed Miscarriage With or Without Use of Transabdominal Ultrasound
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 17, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedJuly 31, 2024
July 1, 2024
11 months
October 17, 2015
July 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of endometrial thickness by ultrasound (mm)
1 month
Secondary Outcomes (3)
Measurement of blood loss (mL)
1 month
measurement of operative time (minutes)
1 month
measurement of Hemoglobin level(g/ml)
1 month
Study Arms (2)
Blinded evacuation
ACTIVE COMPARATORRing evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation
Evacuation under ultrasound guidance
ACTIVE COMPARATORRing 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
Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation.
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.
Eligibility Criteria
You may qualify if:
- women with non-viable first trimester intrauterine pregnancy
- no contraindication to surgical evacuation under general anesthesia
You may not qualify if:
- gestational age more than 13 weeks
- hemodynamically unstable
- suspicion of an ectopic pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women Health Hospital - Assiut university
Asyut, 71111, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 17, 2015
First Posted
October 20, 2015
Study Start
May 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
July 31, 2024
Record last verified: 2024-07