Placenta PreviaPhase 2/3NCT04609527
Management of Placenta Accreta Spectrum
A Phase 2/3 study testing Management of placenta accreta spectrum in people with Placenta Previa and Placenta Accreta, run by Assiut University at 2 sites in Egypt.
Trial summary
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Previa, Placenta Accreta
- What is being tested?
- Management of placenta accreta spectrum
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 16 Oct 2020to 31 Dec 2021
- Phase
- Phase 2/3
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All placenta accreta e high possibility of placenta accrete
- consent
- easy follow up visits
Who cannot join
- bleeding tendency
- associated medical disorder hypertension, diabetes, preeclapsia..
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Osama Abdalmageed
Asyut, Non-US/Non-Canadian, 71111
Osama Abdalmageed, 1007972027, drosamast1981@gmail.com
- Recruiting
Assiut University
Asyut, 71515
Abdalmageed, 1007972027, drosamast@yahoo.com.au
About this study
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.
Read the detailed description
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.
- surgical management of placenta accreta
- short term follow up to the outcomes
- long term follow up
- Conditions
- Placenta Previa, Placenta Accreta
- Being tested
- Management of placenta accreta spectrum
- Keywords
- placenta, accreta, praevia, hyterectomy, PPH
- Medical subject headings
- Placenta Previa, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of placenta accreta spectrumProcedure or surgery
Conservative and radical (hysterectomy) treatment of placenta accreta. Follow up to the patients to detect the impact of treatment imposed A novel technique which early identification and repait of uterine wall defects resulted from invasion of the uterine wall by the placenta.
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of the novel conservative management
Need to do peripartum hysterectomy or patient death
Measured: 3 hours
Estimated amount of blood loss
The estimated amount of blood loss during and after surgery
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start16 Oct 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All women with placenta praevia and previous scar in the uterus. Surgical management and follow up will be defined
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Saber Thabet Abdalmageed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609527
- Sponsor's protocol ID
- Placenta Accreta
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Placenta Accreta Spectrum
- ClinicalTrials.gov ID
- NCT04609527
- Acronym / sponsor ID
- Placenta Accreta
- Conditions
- Placenta Previa, Placenta Accreta
- Keywords
- placenta, accreta, praevia, hyterectomy, PPH
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Oct 2020 (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.
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.
Detailed description
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.
- surgical management of placenta accreta
- short term follow up to the outcomes
- long term follow up
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- All women with placenta praevia and previous scar in the uterus. Surgical management and follow up will be defined
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All placenta accreta e high possibility of placenta accrete
- consent
- easy follow up visits
Key exclusion criteria (2 listed)
- bleeding tendency
- associated medical disorder hypertension, diabetes, preeclapsia..
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 |
|---|---|---|
| Management of placenta accreta spectrumConservative and radical (hysterectomy) treatment of placenta accreta. Follow up to the patients to detect the impact of treatment imposed A novel technique which early identification and repait of uterine wall defects resulted from invasion of the uterine wall by the placenta. | Procedure or surgery | – |
Primary outcome
Failure of the novel conservative management
Time frame: 3 hours
Need to do peripartum hysterectomy or patient death
Estimated amount of blood loss
Time frame: 6 hours
The estimated amount of blood loss during and after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Management of placenta accreta spectrum in people with Placenta Previa and Placenta Accreta, run by Assiut University at 2 sites 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 3 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Osama Abdalmageed (01012234876, drosamast@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of the novel conservative management (time frame: 3 hours). 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 3 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.