AbortionNCT02580175
Surgical Evacuation of Abortion Under Ultrasonographic Guide
A study testing Blinded evacuation and Evacuation under ultrasound guidance in people with Abortion, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Abortion
- What is being tested?
- Blinded evacuation and Evacuation under ultrasound guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with non-viable first trimester intrauterine pregnancy
- no contraindication to surgical evacuation under general anesthesia
Who cannot join
- gestational age more than 13 weeks
- hemodynamically unstable
- suspicion of an ectopic pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Abortion
- Being tested
- Blinded evacuation, Evacuation under ultrasound guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded evacuationProcedure or surgery
Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation.
Evacuation under ultrasound guidanceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Blinded evacuation | Active comparator | Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation Receives: Procedure: Blinded evacuation |
| Evacuation under ultrasound guidance | Active comparator | 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. Receives: Procedure: Evacuation under ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of endometrial thickness by ultrasound (mm)
Measured: 1 month
Secondary outcomes (3)
Measurement of blood loss (mL)
Measured: 1 month
measurement of operative time (minutes)
Measured: 1 month
measurement of Hemoglobin level(g/ml)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbortionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580175
- Sponsor's protocol ID
- USEV
- Status last verified
- Jul 2024
- First submitted
- 17 Oct 2015
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Evacuation of First Trimester Missed Miscarriage With or Without Use of Transabdominal Ultrasound
- ClinicalTrials.gov ID
- NCT02580175
- Acronym / sponsor ID
- USEV
- Conditions
- Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded evacuation | Active comparator | Procedure: Blinded evacuationRing evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation |
| Evacuation under ultrasound guidance | Active comparator | Procedure: Evacuation under ultrasound guidanceRing 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women with non-viable first trimester intrauterine pregnancy
- no contraindication to surgical evacuation under general anesthesia
Key exclusion criteria (3 listed)
- gestational age more than 13 weeks
- hemodynamically unstable
- suspicion of an ectopic pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinded evacuationRing evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation. | Procedure or surgery | Blinded evacuation |
| Evacuation under ultrasound guidanceRing 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 or surgery | Evacuation under ultrasound guidance |
Primary outcome
Measurement of endometrial thickness by ultrasound (mm)
Time frame: 1 month
3 secondary outcomes
Measurement of blood loss (mL)
Time frame: 1 month
measurement of operative time (minutes)
Time frame: 1 month
measurement of Hemoglobin level(g/ml)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinded evacuation and Evacuation under ultrasound guidance in people with Abortion, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of endometrial thickness by ultrasound (mm) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.