Placenta AccretaNCT05979181
Peripartum Cesarean Hysterectomy for Placenta Percreta
An observational study of Placenta Accreta, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to address the possible preoperative determinants of extrauterine diseases in cases of placenta previa percreta and to compare the operative and postoperative characteristics of cases with and without extrauterine disease. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Cesarean hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2018to 17 Feb 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3) diagnosed by color flow Doppler, and confirmed intraoperatively
Who may be able to join
- Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3).
Who cannot join
- Medical conditions complicating pregnancy.
- Blood diseases or bleeding tendencies
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: Peripartum Cesarean Hysterectomy for Placenta Percreta: a Retrospective Analysis of Cases With and Without Extrauterine Disease
The aim of this study is to address the possible preoperative determinants of extrauterine diseases in cases of placenta previa percreta and to compare the operative and postoperative characteristics of cases with and without extrauterine disease.
Read the detailed description
This will be a retrospective study of the data of women who underwent cesarean hysterectomy on placenta previa percreta who were classified as Federation of Gynecology and Obstetrics (FIGO) grade 3. Women without extrauterine disease (FIGO grade 3a) will be compared to women with extrauterine disease (FIGO grades 3b and 3c)
- Conditions
- Placenta Accreta
- Being tested
- Cesarean hysterectomy
- Keywords
- PAS, Placenta previa, Placenta accreta, Cesarean hysterectomy
- Medical subject headings
- Placenta Accreta, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean hysterectomyProcedure or surgery
Cesarean hysterectomy due to placenta previa percreta with no extrauterine disease (FIGO grade 3a) or with extrauterine disease (FIGO grades 3b and 3c)
| Study group | Role | What they receive |
|---|---|---|
| No extrauterine disease group | Women having placenta previa percreta with no extrauterine disease (FIGO grade 3a) Receives: Procedure: Cesarean hysterectomy | |
| Extrauterine disease group | Women having placenta previa percreta with extrauterine disease (FIGO grades 3b and 3c) Receives: Procedure: Cesarean hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated amount of intraoperative blood loss
Calculated amount of blood loss during the operation
Measured: From start to end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start20 Oct 2018
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
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.
- More trials run by Mansoura 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled S Ismail, MD, Principal investigator, Mansoura UniversityMahmoud M Awad, MD, Study director, Mansoura UniversityAlhussein A Mohamed, MD, Study director, Mansoura UniversityMohamed S Abdelhafez, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979181
- Sponsor's protocol ID
- R.23.06.2211
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripartum Cesarean Hysterectomy for Placenta Percreta: a Retrospective Analysis of Cases With and Without Extrauterine Disease
- ClinicalTrials.gov ID
- NCT05979181
- Acronym / sponsor ID
- R.23.06.2211
- Conditions
- Placenta Accreta
- Keywords
- PAS, Placenta previa, Placenta accreta, Cesarean hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 7 Aug 2023 (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.
The aim of this study is to address the possible preoperative determinants of extrauterine diseases in cases of placenta previa percreta and to compare the operative and postoperative characteristics of cases with and without extrauterine disease.
Detailed description
This will be a retrospective study of the data of women who underwent cesarean hysterectomy on placenta previa percreta who were classified as Federation of Gynecology and Obstetrics (FIGO) grade 3. Women without extrauterine disease (FIGO grade 3a) will be compared to women with extrauterine disease (FIGO grades 3b and 3c)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No extrauterine disease group | – | Procedure: Cesarean hysterectomyWomen having placenta previa percreta with no extrauterine disease (FIGO grade 3a) |
| Extrauterine disease group | – | Procedure: Cesarean hysterectomyWomen having placenta previa percreta with extrauterine disease (FIGO grades 3b and 3c) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3) diagnosed by color flow Doppler, and confirmed intraoperatively
Key inclusion criteria (1 listed)
- Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3).
Key exclusion criteria (2 listed)
- Medical conditions complicating pregnancy.
- Blood diseases or bleeding tendencies
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 hysterectomyCesarean hysterectomy due to placenta previa percreta with no extrauterine disease (FIGO grade 3a) or with extrauterine disease (FIGO grades 3b and 3c) | Procedure or surgery | Extrauterine disease group, No extrauterine disease group |
Primary outcome
Estimated amount of intraoperative blood loss
Time frame: From start to end of operation
Calculated amount of blood loss during the operation
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 7 Aug 2023.
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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.
Khaled S Ismail, MD principal investigator
Mansoura University
Mahmoud M Awad, MD study director
Mansoura University
Alhussein A Mohamed, MD study director
Mansoura University
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 Mansoura 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: finished, as of the sponsor's last update on 7 Aug 2023. 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?
Estimated amount of intraoperative blood loss (time frame: From start to end of operation). 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 7 Aug 2023.