Morbidly Adherent PlacentaNCT04938050
Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings
An observational study of Morbidly Adherent Placenta, run by Cairo University at 1 site in Egypt.
Trial summary
This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings. Read more about this study
- Who is it for?
- Ages 28 to 42 years, women only
- Conditions the study is for
- Morbidly Adherent Placenta
- What is being tested?
- Ultrasound
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jun 2021to 28 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 28 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: 21 pregnant females during their late 3rd trimester between (34 0/7: 37 0/7 weeks gestation)
Who may be able to join
- Age group 28:42 years.
- Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).
- With a single living fetus in the current pregnancy.
- A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)
- Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.
Who cannot join
- Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.
- Maternal chronic medical disorders( diabetes mellitus, hypertension)
- Patients presented with severe attack of bleeding.
- Patients presented with rupture of membrane.
- Emergency delivery regardless the cause.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university Kasr Alainy OBGYN hospital
Cairo
Hassan Gaafar, M.D., 01224022330, hassangaafar@kasralainy.edu.eg
About this study
This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.
- Conditions
- Morbidly Adherent Placenta
- Being tested
- Ultrasound
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Ultrasound evaluation, with grayscale and color Doppler imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign)
Measured: June 2021- July 2022
Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse)
Measured: June 2021- July 2022
Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta)
Measured: June 2021- July 2022
Secondary outcomes (1)
1- Correlation between US signs and intraoperative findings including morbidity and mortality
Measured: June 2021- July 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start18 Jun 2021
- Primary completion30 Jan 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidly Adherent PlacentaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Fathy Hafez Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938050
- Sponsor's protocol ID
- 23-2021
- Status last verified
- Dec 2022
- First submitted
- 18 Jun 2021
- Last updated
- 8 Dec 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings
- ClinicalTrials.gov ID
- NCT04938050
- Acronym / sponsor ID
- 23-2021
- Conditions
- Morbidly Adherent Placenta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 24 Jun 2021 (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.
This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 28 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 21 pregnant females during their late 3rd trimester between (34 0/7: 37 0/7 weeks gestation)
Key inclusion criteria (5 listed)
- Age group 28:42 years.
- Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).
- With a single living fetus in the current pregnancy.
- A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)
- Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.
Key exclusion criteria (5 listed)
- Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.
- Maternal chronic medical disorders( diabetes mellitus, hypertension)
- Patients presented with severe attack of bleeding.
- Patients presented with rupture of membrane.
- Emergency delivery regardless the cause.
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 |
|---|---|---|
| UltrasoundUltrasound evaluation, with grayscale and color Doppler imaging. | Diagnostic test | – |
Primary outcome
Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign)
Time frame: June 2021- July 2022
Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse)
Time frame: June 2021- July 2022
Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta)
Time frame: June 2021- July 2022
1 secondary outcome
1- Correlation between US signs and intraoperative findings including morbidity and mortality
Time frame: June 2021- July 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: Undecided
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 Morbidly Adherent Placenta, run by Cairo 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 5 inclusion and 5 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 8 Dec 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign) (time frame: June 2021- July 2022). The study lists 3 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 8 Dec 2022.