Placenta AccretaNCT03372538
Multidisciplinary Team in Management of Placenta Accreta
An observational study of Placenta Accreta, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
comparative study between the incidence of urological injury in case of placenta accreta in cases where urological surgical staff are participating in the operation from the start and in cases where the operation is carried by the gynecological staff only Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- cesarean section or cesarean hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2017to Mar 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 1000 patients pregnant 38 weeks with placenta accreta
Who may be able to join
- pregnant 38 weeks
- placenta accreta
Who cannot join
- medical disorders complicating pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: is There Any Superior Benefit of Multidisciplinary Team in Management of Placenta Accreta
comparative study between the incidence of urological injury in case of placenta accreta in cases where urological surgical staff are participating in the operation from the start and in cases where the operation is carried by the gynecological staff only
Read the detailed description
cohort of 1000 patients of placenta accreta are followed regarding the incidence of urological injury in the cases with assistance from the urological staff members
- Conditions
- Placenta Accreta
- Being tested
- cesarean section or cesarean hysterectomy
- Keywords
- placenta accreta
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean section or cesarean hysterectomyProcedure or surgery
upper segment cesarean section and or cesarean hysteroctomy
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary team group | 500 patients of placenta accreta managed by obstetricans and urologists Receives: Procedure: cesarean section or cesarean hysterectomy | |
| obstetricians only group | 500 patients of placenta accreta managed by obstetricans only Receives: Procedure: cesarean section or cesarean hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
urological injury
badder or ureteric injury
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372538
- Sponsor's protocol ID
- 494608
- Status last verified
- Dec 2017
- First submitted
- 9 Dec 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- is There Any Superior Benefit of Multidisciplinary Team in Management of Placenta Accreta
- ClinicalTrials.gov ID
- NCT03372538
- Acronym / sponsor ID
- 494608
- Conditions
- Placenta Accreta
- Keywords
- placenta accreta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 13 Dec 2017 (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.
comparative study between the incidence of urological injury in case of placenta accreta in cases where urological surgical staff are participating in the operation from the start and in cases where the operation is carried by the gynecological staff only
Detailed description
cohort of 1000 patients of placenta accreta are followed regarding the incidence of urological injury in the cases with assistance from the urological staff members
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary team group | – | Procedure: cesarean section or cesarean hysterectomy500 patients of placenta accreta managed by obstetricans and urologists |
| obstetricians only group | – | Procedure: cesarean section or cesarean hysterectomy500 patients of placenta accreta managed by obstetricans only |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 1000 patients pregnant 38 weeks with placenta accreta
Key inclusion criteria (2 listed)
- pregnant 38 weeks
- placenta accreta
Key exclusion criteria (1 listed)
- medical disorders complicating 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 |
|---|---|---|
| cesarean section or cesarean hysterectomyupper segment cesarean section and or cesarean hysteroctomy | Procedure or surgery | multidisciplinary team group, obstetricians only group |
Primary outcome
urological injury
Time frame: intraoperative
badder or ureteric injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
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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?
An observational study of Placenta Accreta, run by Kasr El Aini Hospital 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 1 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 13 Dec 2017. 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?
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?
urological injury (time frame: intraoperative). 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 13 Dec 2017.