Placenta Accreta SpectrumNCT05510076
Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital
An observational study of Placenta Accreta Spectrum, run by Sohag University at 1 site in Egypt.
Trial summary
The objective of this study is to evaluate different intra-operative procedures to control bleeding in cases of PAS disorders aiming to determine the best procedure regarding maternal morbidity and mortality post-operatively, and to evaluate the long-term effects of conservative management of PAS disorders. Read more about this study
- Who is it for?
- Ages Up to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta Spectrum
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 30 Jun 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 Up to 51 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: community sample, any suspected case of PAS disorders.
Who may be able to join
- Women with at least one previous caesarean section and suspected PAS disorders by imaging studies
Who cannot join
- Patients with intraoperative spontaneous placental separation.
- Patients with a preoperative diagnosis of placenta percreta who chose to have an elective hysterectomy.
- Any other associated uterine pathology requiring hysterectomy.
- Coagulation disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
AbdAllah Refaat, +201141519467, abdallah.refaat@med.sohag.edu.eg
About this study
The objective of this study is to evaluate different intra-operative procedures to control bleeding in cases of PAS disorders aiming to determine the best procedure regarding maternal morbidity and mortality post-operatively, and to evaluate the long-term effects of conservative management of PAS disorders.
Read the detailed description
The term "placenta accreta spectrum" (PAS), formerly known as "morbidly adherent placenta" or "abnormally invasive placenta," refers to the aberrant trophoblast invasion of all or a portion of the placenta into the myometrium of the uterus. according to the depth of the villous invasion into the myometrium, the spectrum is assorted into three groups: placenta accreta (villi attach to the myometrium without invading it), placenta increta (villi infiltrate the myometrium), and placenta percreta (villi pierce through the uterine serosa and may infiltrate the surrounding tissues). The optimal strategy for managing PAS disorders remains debatable. Conservative management of PAS disorders includes all techniques aimed at preserving the uterus. Because intraoperative bleeding from PAS disorders is frequently massive and dramatic, causing severe maternal morbidity and mortality, it is essential to have a well-planned, effective, and rapid approach to this surgical challenge.
- Conditions
- Placenta Accreta Spectrum
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | in which full-thickness vertical compression suture combined with inflated intrauterine balloon are used to control bleeding | |
| Group B | in this group, a resective-reconstructive technique is used, which involves resecting the invasive accreta area followed by immediate uterine reconstruction and bladder reinforcement | |
| Group C | In this group, bilateral uterine artery ligations combined with cervical tamponade which is performed by elevating the cervix into the uterine cavity with Allis forceps, then suturing the anterior and/ or posterior cervical lip(s) into the anterior and/ or posterior uterine segment(s) depending on the site of bleeding with two or three simple interrupted stitches, with the patency of the cervical canal confirmed, followed by closure of the uterine incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful intervention procedure
Preservation of the uterus
Measured: 1 day
maternal mortality and morbidity
ICU admission, need of re-exploration, drop of hemoglobin and hematocrit values, massive blood transfusion, bladder and/ or ureteric injury, coagulopathy, infection and hospital re-admission within 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Aug 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Ahmed Refaat, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510076
- Sponsor's protocol ID
- Soh-Med-22-08-03
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 22 Aug 2022
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05510076
- Acronym / sponsor ID
- Soh-Med-22-08-03
- Conditions
- Placenta Accreta Spectrum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Aug 2022 (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 objective of this study is to evaluate different intra-operative procedures to control bleeding in cases of PAS disorders aiming to determine the best procedure regarding maternal morbidity and mortality post-operatively, and to evaluate the long-term effects of conservative management of PAS disorders.
Detailed description
The term "placenta accreta spectrum" (PAS), formerly known as "morbidly adherent placenta" or "abnormally invasive placenta," refers to the aberrant trophoblast invasion of all or a portion of the placenta into the myometrium of the uterus. according to the depth of the villous invasion into the myometrium, the spectrum is assorted into three groups: placenta accreta (villi attach to the myometrium without invading it), placenta increta (villi infiltrate the myometrium), and placenta percreta (villi pierce through the uterine serosa and may infiltrate the surrounding tissues). The optimal strategy for managing PAS disorders remains debatable. Conservative management of PAS disorders includes all techniques aimed at preserving the uterus. Because intraoperative bleeding from PAS disorders is frequently massive and dramatic, causing severe maternal morbidity and mortality, it is essential to have a well-planned, effective, and rapid approach to this surgical challenge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –in which full-thickness vertical compression suture combined with inflated intrauterine balloon are used to control bleeding |
| Group B | – | –in this group, a resective-reconstructive technique is used, which involves resecting the invasive accreta area followed by immediate uterine reconstruction and bladder reinforcement |
| Group C | – | –In this group, bilateral uterine artery ligations combined with cervical tamponade which is performed by elevating the cervix into the uterine cavity with Allis forceps, then suturing the anterior and/ or posterior cervical lip(s) into the anterior and/ or posterior uterine segment(s) depending on the site of bleeding with two or three simple interrupted stitches, with the patency of the cervical canal confirmed, followed by closure of the uterine incision |
Who may qualify
- Ages
- Up to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- community sample, any suspected case of PAS disorders.
Key inclusion criteria (1 listed)
- Women with at least one previous caesarean section and suspected PAS disorders by imaging studies
Key exclusion criteria (4 listed)
- Patients with intraoperative spontaneous placental separation.
- Patients with a preoperative diagnosis of placenta percreta who chose to have an elective hysterectomy.
- Any other associated uterine pathology requiring hysterectomy.
- Coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
successful intervention procedure
Time frame: 1 day
Preservation of the uterus
maternal mortality and morbidity
Time frame: 6 weeks
ICU admission, need of re-exploration, drop of hemoglobin and hematocrit values, massive blood transfusion, bladder and/ or ureteric injury, coagulopathy, infection and hospital re-admission within 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- 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 Placenta Accreta Spectrum, run by Sohag 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 4 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 22 Aug 2022. 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 AbdAllah Refaat (+201141519467, abdallah.refaat@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful intervention procedure (time frame: 1 day). The study lists 2 primary outcomes in all. 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 22 Aug 2022.