Placenta AccretaNCT06712576
Evaluation of Planned Conservative Surgical Management of Placenta Accreta Spectrum in Women's Health Center, Assiut University Hospital
An observational study of Placenta Accreta, run by Assiut University.
Trial summary
In recent years, with the application of an abdominal artery balloon and the improvement of surgical techniques, efforts are made to preserve the uterus for patients PAS. the aim of the study To evaluate conservative surgical management of placenta accreta spectrum in Assiut University hospital regarding maternal and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placenta Accreta
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with placenta accrete spectrum secondary to previous cesarean section and Gestational age above 28 weeks
Who may be able to join
- Pregnant women with history of previous caesarean section.
- Age above 18 years.
- Gestational age above 28 weeks.
- U/S signs suggestive of placenta previa accreta.
- Confirmed diagnosis of Placenta previa accreta spectrum disorder by 3 D U/S, Doppler or MRI if needed.
Who cannot join
- Gestational age less 28 weeks.
- Age less than 18 years.
- Patients with known bleeding disorders.
- Multiple pregnancy.
- Other pathology (fibroid, ………………..).
- Patients with placental separation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
In recent years, with the application of an abdominal artery balloon and the improvement of surgical techniques, efforts are made to preserve the uterus for patients PAS. the aim of the study To evaluate conservative surgical management of placenta accreta spectrum in Assiut University hospital regarding maternal and fetal outcomes.
Read the detailed description
Placenta accreta spectrum disorder (PAS) is a serious obstetric disorder that is characterized by low lying and deep penetration of the villi which are abnormally attached to the myometrium of the uterus. This obstructs its complete separation during the third stage of labor which induces continued bleeding and have potentially life- threatening for the mother. Most commonly, it is a consequence of a partial or complete absence of the compact and spongy layer known as the decidua basalis, and mis-development of the fibrinoid Nitabuch's layer which lies between the boundary zone of the thick endometrium and the cytotrophoblastic shell in the placenta.
Traditionally, caesarean hysterectomy at the time of delivery has been the preferred management strategy for placenta previa accreta. Not only does this approach preclude future fertility, but it is also a procedure synonymous with significant perioperative risks. For women who wish to conserve their reproductive function, other treatment options have been described.
Different methods have been employed to manage the PA, ranging from uterine conservation, which involves leaving the placenta in situ, to conventional hysterectomy. Classical cesarean sections (C- sections) prevent the excessive bleeding by leaving the adherent placenta in situ and by adopting strategic planning with a comprehensive analysis that aids the reduction in maternal morbidity and mortality rates.
- Conditions
- Placenta Accreta
- Keywords
- planned conservative surgical managemen
- 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 |
|---|---|---|
| patients with placenta accrete spectrum | patients with placenta accrete spectrum secondary to previous cesarean section will be recruited from the outpatient clinic and reception unit, Assiut, Egypt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of blood loss
amount of blood loss during operation according to number of towels and amount of blood in suction pump
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Ahmed Saleh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712576
- Sponsor's protocol ID
- placenta accreta spectrum
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cali G, Forlani F, Giambanco L, Amico ML, Vallone M, Puccio G, Alio L. Prophylactic use of intravascular balloon catheters in women with placenta accreta, increta and percreta. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:36-41. doi: 10.1016/j.ejogrb.2014.05.007. Epub 2014 May 21.
PubMed 24965977
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Planned Conservative Surgical Management of Placenta Accreta Spectrum in Women's Health Center, Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06712576
- Acronym / sponsor ID
- placenta accreta spectrum
- Conditions
- Placenta Accreta
- Keywords
- planned conservative surgical managemen
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 2 Dec 2024 (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.
In recent years, with the application of an abdominal artery balloon and the improvement of surgical techniques, efforts are made to preserve the uterus for patients PAS. the aim of the study To evaluate conservative surgical management of placenta accreta spectrum in Assiut University hospital regarding maternal and fetal outcomes.
Detailed description
Placenta accreta spectrum disorder (PAS) is a serious obstetric disorder that is characterized by low lying and deep penetration of the villi which are abnormally attached to the myometrium of the uterus. This obstructs its complete separation during the third stage of labor which induces continued bleeding and have potentially life- threatening for the mother. Most commonly, it is a consequence of a partial or complete absence of the compact and spongy layer known as the decidua basalis, and mis-development of the fibrinoid Nitabuch's layer which lies between the boundary zone of the thick endometrium and the cytotrophoblastic shell in the placenta.
Traditionally, caesarean hysterectomy at the time of delivery has been the preferred management strategy for placenta previa accreta. Not only does this approach preclude future fertility, but it is also a procedure synonymous with significant perioperative risks. For women who wish to conserve their reproductive function, other treatment options have been described.
Different methods have been employed to manage the PA, ranging from uterine conservation, which involves leaving the placenta in situ, to conventional hysterectomy. Classical cesarean sections (C- sections) prevent the excessive bleeding by leaving the adherent placenta in situ and by adopting strategic planning with a comprehensive analysis that aids the reduction in maternal morbidity and mortality rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with placenta accrete spectrum | – | –patients with placenta accrete spectrum secondary to previous cesarean section will be recruited from the outpatient clinic and reception unit, Assiut, Egypt. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with placenta accrete spectrum secondary to previous cesarean section and Gestational age above 28 weeks
Key inclusion criteria (5 listed)
- Pregnant women with history of previous caesarean section.
- Age above 18 years.
- Gestational age above 28 weeks.
- U/S signs suggestive of placenta previa accreta.
- Confirmed diagnosis of Placenta previa accreta spectrum disorder by 3 D U/S, Doppler or MRI if needed.
Key exclusion criteria (6 listed)
- Gestational age less 28 weeks.
- Age less than 18 years.
- Patients with known bleeding disorders.
- Multiple pregnancy.
- Other pathology (fibroid, ………………..).
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
amount of blood loss
Time frame: baseline
amount of blood loss during operation according to number of towels and amount of blood in suction pump
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Results publication: PubMed 24965977Cali G, Forlani F, Giambanco L, Amico ML, Vallone M, Puccio G, Alio L. Prophylactic use of intravascular balloon catheters in women with placenta accreta, increta and percreta. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:36-41. doi: 10.1016/j.ejogrb.2014.05.007. Epub 2014 May 21.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, run by Assiut University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Gamal Ahmed Saleh, resident doctor (+2 01003787826, Ahmed.16266067@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of blood loss (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06712576, which also lists 1 linked publication.
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 2 Dec 2024.