Adherent PlacentaNCT02736058
Surgical Classification of Abnormal Placentation
A study testing Trans- abdominal sonography, Trans-vaginal sonography and post-operative pathological specimen examination in people with Adherent Placenta, run by Cairo University at 1 site in Egypt.
Trial summary
Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adherent Placenta
- What is being tested?
- Trans- abdominal sonography, Trans-vaginal sonography and post-operative pathological specimen examination
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Dec 2016
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- abnormal placental site (placenta previa)
Who cannot join
- refusal to participate in the study
- cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr el aini hospital
Cairo, Cairo Governorate, 12211
Ahmed M Hussein, MD, 01223515652 ext. 002, ahmed_mhussein@live.com
About this study
Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.
- Conditions
- Adherent Placenta
- Being tested
- Trans- abdominal sonography, Trans-vaginal sonography, post-operative pathological specimen examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans- abdominal sonographyDevice
Trans-vaginal sonographyDevice
post-operative pathological specimen examinationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | the included pregnant females will undergo trans-abdominal sonography as well as trans-vaginal sonography , to diagnose the abnormal placentation and the results will be compared to the intra- operative as well as the pathological examination of the specimen. Receives: Device: Trans- abdominal sonography; Device: Trans-vaginal sonography; Procedure: post-operative pathological specimen examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherent PlacentaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Hussein, Cairo University
- Investigators
- Ahmed M Hussein, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736058
- Sponsor's protocol ID
- PP2202016
- Status last verified
- May 2016
- First submitted
- 22 Feb 2016
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Classification of Abnormal Placentation
- ClinicalTrials.gov ID
- NCT02736058
- Acronym / sponsor ID
- PP2202016
- Conditions
- Adherent Placenta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Apr 2016 (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.
Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: Trans- abdominal sonography, Device: Trans-vaginal sonography, Procedure: post-operative pathological specimen examinationthe included pregnant females will undergo trans-abdominal sonography as well as trans-vaginal sonography , to diagnose the abnormal placentation and the results will be compared to the intra- operative as well as the pathological examination of the specimen. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- abnormal placental site (placenta previa)
Key exclusion criteria (2 listed)
- refusal to participate in the study
- cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)
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 |
|---|---|---|
| Trans- abdominal sonography | Device | Participants |
| Trans-vaginal sonography | Device | Participants |
| post-operative pathological specimen examination | Procedure or surgery | Participants |
Primary outcome
intraoperative blood loss
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Individual participant dataSharing planned: Undecided
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.
Ahmed M Hussein, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans- abdominal sonography, Trans-vaginal sonography and post-operative pathological specimen examination in people with Adherent Placenta, run by Cairo 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 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 1 Jun 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 M Hussein, MD (01223515652 ext. 002, ahmed_mhussein@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative blood loss (time frame: 24 hours). 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 1 Jun 2016.