MiscarriageNCT02419300
Could Colour Dopper Improve the Diagnosis of Retained Placental Fragments After Second Trimester Miscarriage ?
An observational study of Miscarriage, run by Ain Shams University at 1 site in Egypt.
Trial summary
Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Miscarriage
- What is being tested?
- ultrasoungraphy
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Apr 2016
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients visiting The Obstetrics department in Ain Shams University Hospital complaining of early second trimesteric abortion
Who may be able to join
- Pregnancy duration: early mid-trimester from 14 to 20 weeks
- Endometrial mass upon ultrasound examination after second trimesteric miscarriage
Who cannot join
- Uterine congenital anomaly
- Patients with signs of sepsis.
- Negative scan after second trimesteric miscarriage
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate
ahmed kotb, MD, 2001008681999, ahmedmkotp@hotmail.com
ahmed kotb, ahmedmkotp@hotmail.com
About this study
Official title: Value of Pelvic Ultrasonography and Colour Doppler in Diagnosing Retained Placental Fragments After Mid Trimester Miscarriage
Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.
Read the detailed description
This is a study for diagnostic accuracy test where all patients will undergo US and Doppler examination after second trimester miscarriage. Then all patients with endometrial mass on US will undergo colour Doppler then surgical evacuation and results of histopathology will be recorded.
Now, pathological examination of suction evacuation products is considered the gold standard so sensitivity, specificity, PPV and NPV of US and Doppler are the primary outcome
- Conditions
- Miscarriage
- Being tested
- ultrasoungraphy
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoungraphyDevice
pelvic ultrasonography and Doppler
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, PPV and NPV of Doppler in diagnosis of retained placental fragments after second trimester miscarriage
All patients with endometrial mass after spontineous or medical miscarriage will undergo colour Doppler examination within 1 hour of miscarriage
Measured: 60 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (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.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419300
- Sponsor's protocol ID
- USDIA
- Status last verified
- Feb 2016
- First submitted
- 10 Apr 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Pelvic Ultrasonography and Colour Doppler in Diagnosing Retained Placental Fragments After Mid Trimester Miscarriage
- ClinicalTrials.gov ID
- NCT02419300
- Acronym / sponsor ID
- USDIA
- Conditions
- Miscarriage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 17 Apr 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.
Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.
Detailed description
This is a study for diagnostic accuracy test where all patients will undergo US and Doppler examination after second trimester miscarriage. Then all patients with endometrial mass on US will undergo colour Doppler then surgical evacuation and results of histopathology will be recorded.
Now, pathological examination of suction evacuation products is considered the gold standard so sensitivity, specificity, PPV and NPV of US and Doppler are the primary outcome
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients visiting The Obstetrics department in Ain Shams University Hospital complaining of early second trimesteric abortion
Key inclusion criteria (2 listed)
- Pregnancy duration: early mid-trimester from 14 to 20 weeks
- Endometrial mass upon ultrasound examination after second trimesteric miscarriage
Key exclusion criteria (3 listed)
- Uterine congenital anomaly
- Patients with signs of sepsis.
- Negative scan after second trimesteric miscarriage
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 |
|---|---|---|
| ultrasoungraphypelvic ultrasonography and Doppler | Device | – |
Primary outcome
Sensitivity, specificity, PPV and NPV of Doppler in diagnosis of retained placental fragments after second trimester miscarriage
Time frame: 60 minutes after delivery
All patients with endometrial mass after spontineous or medical miscarriage will undergo colour Doppler examination within 1 hour of miscarriage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Individual participant dataSharing planned: Yes
Related trials for Miscarriage
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The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
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Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
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Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
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 Ain Shams 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: status not confirmed, as of the sponsor's last update on 17 Feb 2016. 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 Ahmed dr Mohamed, M.D (201008681999, ahmedmkotp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, PPV and NPV of Doppler in diagnosis of retained placental fragments after second trimester miscarriage (time frame: 60 minutes after delivery). 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 17 Feb 2016.