Placenta Accreta, Third TrimesterNCT05513092
Placenta Accreta Index Score in Placenta Accreta Spectrum
An observational study of Placenta Accreta, Third Trimester, run by Ain Shams University at 1 site in Egypt.
Trial summary
role of placenta accreta index score in prediction of conservative surgery for placenta placenta accreta spectrum Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta, Third Trimester
- What is being tested?
- placenta accreta index score
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2022to Jul 2024
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: • Pregnant women above 28 weeks gestation by 1st trimesteric U/S,2nd trimesteric U/S or sure reliable dates; diagnosed as placenta previa by 2D ultrasound, Doppler on placental bed. Patients who have done one or more cesarean sections
Who may be able to join
- • Pregnant women above 28 weeks gestation by 1st trimesteric U/S,2nd trimesteric U/S or sure reliable dates; diagnosed as placenta previa by 2D ultrasound, Doppler on placental bed.
- Patients who have done one or more cesarean sections
Who cannot join
- Patients who refuse to participate in our study.
Trial locations and contacts
1 site in 1 country.
Amr S mahmoud contact
Egypt1 site
Ainshams university
Cairo
sahar M Abdelmaksoud, masters, 01110065637, saharabdelmaksoud@yahoo.com
About this study
Official title: Role of Placenta Accreta Index in Predicting Conservative Surgery for Placenta Accreta Spectrum
role of placenta accreta index score in prediction of conservative surgery for placenta placenta accreta spectrum
Read the detailed description
in this study ,we will recruit 60 cases diagnosed placenta previa accreta by 2D ultrasound and Doppler then patients will have 3D Doppler to calculate placenta accreta index score according to agarawl et al criteria , patients will have cs accroding to our hospital protocol "Al demerdash maternity hospital ,Ainshams university" .Intraoperative findings will be noticed ,postoperative histopathological examination may br needed in cases of cs hystrectomy ,placenta accreta index score will be compared to intra and postoperative findings , patients will be followed up for two weeks after delivery for any postoperative complication
- Conditions
- Placenta Accreta, Third Trimester
- Being tested
- placenta accreta index score
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placenta accreta index scoreDiagnostic test
role of placenta accreta index score in prediction of conservative surgery for placenta placenta accreta spectrum
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of PAS index score in prediction of conservative surgery
Measured: 2022 to 2024
Secondary outcomes (1)
Intraoperative blood loss
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta, Third TrimesterStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Mamdouh, Study director, Ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513092
- Sponsor's protocol ID
- 10544
- Status last verified
- Aug 2022
- First submitted
- 21 Aug 2022
- Last updated
- 24 Aug 2022
- 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 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Placenta Accreta Index in Predicting Conservative Surgery for Placenta Accreta Spectrum
- ClinicalTrials.gov ID
- NCT05513092
- Acronym / sponsor ID
- 10544
- Conditions
- Placenta Accreta, Third Trimester
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 24 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.
role of placenta accreta index score in prediction of conservative surgery for placenta placenta accreta spectrum
Detailed description
in this study ,we will recruit 60 cases diagnosed placenta previa accreta by 2D ultrasound and Doppler then patients will have 3D Doppler to calculate placenta accreta index score according to agarawl et al criteria , patients will have cs accroding to our hospital protocol "Al demerdash maternity hospital ,Ainshams university" .Intraoperative findings will be noticed ,postoperative histopathological examination may br needed in cases of cs hystrectomy ,placenta accreta index score will be compared to intra and postoperative findings , patients will be followed up for two weeks after delivery for any postoperative complication
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- • Pregnant women above 28 weeks gestation by 1st trimesteric U/S,2nd trimesteric U/S or sure reliable dates; diagnosed as placenta previa by 2D ultrasound, Doppler on placental bed. Patients who have done one or more cesarean sections
Key inclusion criteria (2 listed)
- • Pregnant women above 28 weeks gestation by 1st trimesteric U/S,2nd trimesteric U/S or sure reliable dates; diagnosed as placenta previa by 2D ultrasound, Doppler on placental bed.
Key exclusion criteria (1 listed)
- Patients who refuse to participate in our study.
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 |
|---|---|---|
| placenta accreta index scorerole of placenta accreta index score in prediction of conservative surgery for placenta placenta accreta spectrum | Diagnostic test | – |
Primary outcome
Accuracy of PAS index score in prediction of conservative surgery
Time frame: 2022 to 2024
1 secondary outcome
Intraoperative blood loss
Time frame: at delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
Amr S mahmoud contact
Ahmed M Mamdouh study director
Ainshams 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, Third Trimester, run by Ain Shams 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 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 24 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 sahar M abdelmaksoud, masters (01110065637, saharabdelmaksoud@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of PAS index score in prediction of conservative surgery (time frame: 2022 to 2024). 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 24 Aug 2022.