MiscarriageNCT03813849
Remnants of Conception After Suction Evacuation of Missed Abortion
An observational study of Miscarriage, run by University of Alexandria at 1 site in Egypt.
Trial summary
All women admitted for surgical evacuation of missed abortion after failure of medical treatment from June 2016 underwent transvaginal sonography immediately after completion of the procedure as judged by the operator to ensure absence of remnants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Miscarriage
- What is being tested?
- Sonographic examination of uterus after surgical evacuation
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2016to 30 Mar 2020
- Phase
- Observational
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: multiparous women, aged 18 to 45 years with missed abortion up to 12 weeks gestational age, with normal uterus and without suspicion of sepsis.
Who may be able to join
- multiparous. have missed abortion up to 12 weeks gestational age by dating. failed medical evacuation. consented for the procedure.
Who cannot join
- suspicion of sepsis. Suspected molar pregnancy. previous evacuation trial. abnormal uterus like fibroids.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Shatby maternity university hospital
Alexandria, 03312
Mervat S Omran, M.D, 1005277168, Mervat.Elsedeek@alexmed.edu.eg
About this study
Official title: Sonographic Detection of Remnants After Surgical Evacuation of Missed Abortion
All women admitted for surgical evacuation of missed abortion after failure of medical treatment from June 2016 underwent transvaginal sonography immediately after completion of the procedure as judged by the operator to ensure absence of remnants.
Read the detailed description
Women indicated for surgical evacuation of missed abortion up to 12 weeks were included. Standard surgical evacuation of uterus by suction followed by sharp curettage under general anaesthesia were done for all cases. When the operator judged the procedure as complete, transvaginal sonography was done by dedicated sonographer using portable ultrasound machine in theatre. If remnants were detected the procedure was repeated till the cavity seen empty.
- Conditions
- Miscarriage
- Being tested
- Sonographic examination of uterus after surgical evacuation
- Keywords
- remnants of conception
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic examination of uterus after surgical evacuationDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
presence remnants of conception
transvaginal sonographic detection
Measured: immediately after the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start10 Jun 2016
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervat Sheikhelarab Elsedeek Ibrahim Omran, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813849
- Sponsor's protocol ID
- 0409/016
- Status last verified
- Oct 2019
- First submitted
- 9 Apr 2018
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Detection of Remnants After Surgical Evacuation of Missed Abortion
- ClinicalTrials.gov ID
- NCT03813849
- Acronym / sponsor ID
- 0409/016
- Conditions
- Miscarriage
- Keywords
- remnants of conception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 23 Jan 2019 (actual)
- 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.
All women admitted for surgical evacuation of missed abortion after failure of medical treatment from June 2016 underwent transvaginal sonography immediately after completion of the procedure as judged by the operator to ensure absence of remnants.
Detailed description
Women indicated for surgical evacuation of missed abortion up to 12 weeks were included. Standard surgical evacuation of uterus by suction followed by sharp curettage under general anaesthesia were done for all cases. When the operator judged the procedure as complete, transvaginal sonography was done by dedicated sonographer using portable ultrasound machine in theatre. If remnants were detected the procedure was repeated till the cavity seen empty.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- multiparous women, aged 18 to 45 years with missed abortion up to 12 weeks gestational age, with normal uterus and without suspicion of sepsis.
Key inclusion criteria (1 listed)
- multiparous. have missed abortion up to 12 weeks gestational age by dating. failed medical evacuation. consented for the procedure.
Key exclusion criteria (2 listed)
- suspicion of sepsis. Suspected molar pregnancy. previous evacuation trial. abnormal uterus like fibroids.
- -
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 |
|---|---|---|
| Sonographic examination of uterus after surgical evacuation | Diagnostic test | – |
Primary outcome
presence remnants of conception
Time frame: immediately after the end of the procedure
transvaginal sonographic detection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage, run by University of Alexandria 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mervat S Omran, M.D (+2034226106, Mervat.Elsedeek@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence remnants of conception (time frame: immediately after the end of the procedure). 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 28 Oct 2019.