Placenta Accreta SpectrumNCT04314791
Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum
An observational study of Placenta Accreta Spectrum, run by Hatem AbuHashim at 1 site in Egypt.
Trial summary
The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- Ultrasound evaluation, with grayscale and color Doppler imaging
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 31 Dec 2018
- 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
- No healthy volunteers
- Adult
Study population: Pregnant females during the third trimester of pregnancy, with a single fetus in the current pregnancy, a previous delivery by at least 1 cesarean section and having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.
Who may be able to join
- Pregnant women in their third trimester
- with a single fetus in the current pregnancy
- a previous delivery by at least 1 cesarean section
- having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment
Who cannot join
- cases with twin or multiple pregnancies,
- cases with a non-previa placenta or posterior low lying or previa placenta,
- cases without previous deliveries by cesarean section
- cases before the third trimester of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum: A Prospective Study
The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome.
Ultrasound evaluation, with grayscale and color Doppler imaging, is the recommended first-line modality for diagnosing PAS. Grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity, and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color Doppler.
The placenta accreta index (PAI) score (a nine-point score) was proposed in 2015 to predict PAS based on US parameters in a high-risk population by retrospective data analysis. The probability of histological invasion was found to increase with increasing the PAI score. This study aimed to prospectively evaluate the diagnostic performance of the PAI in the prediction of PAS in relation to histopathological findings.
- Conditions
- Placenta Accreta Spectrum
- Being tested
- Ultrasound evaluation, with grayscale and color Doppler imaging
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound evaluation, with grayscale and color Doppler imagingDevice
In pregnant women with previous CS and anterior low-lying or placenta previa, the following three sonographic criteria were assessed: (i) the smallest myometrial thickness in the sagittal plane; (ii) presence of placental lacunae and its grade from 0-3; (iii) bridging vessels using color Doppler. The PAI score (up to 9) was calculated for every patient as described by Rac et al.2015.
| Study group | Role | What they receive |
|---|---|---|
| US scan with calculation of the PAI | Not described Receives: Device: 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.
Diagnostic accuracy of the PAI
The diagnostic accuracy of the PAI in comparison with the histopathological confirmation in hysterectomy specimens.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 Accreta SpectrumStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatem AbuHashim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatem AbuHashim, Mansoura University
- Investigators
- Hatem Abu Hashim, Study chair, Faculty of Medicine, Mansoura UniversityEman Shalaby, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314791
- Sponsor's protocol ID
- MS.17.04.143
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rac MW, Dashe JS, Wells CE, Moschos E, McIntire DD, Twickler DM. Ultrasound predictors of placental invasion: the Placenta Accreta Index. Am J Obstet Gynecol. 2015 Mar;212(3):343.e1-7. doi: 10.1016/j.ajog.2014.10.022. Epub 2014 Oct 18.
PubMed 25446658
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum: A Prospective Study
- ClinicalTrials.gov ID
- NCT04314791
- Acronym / sponsor ID
- MS.17.04.143
- Conditions
- Placenta Accreta Spectrum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hatem AbuHashimUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Mar 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.
The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome.
Ultrasound evaluation, with grayscale and color Doppler imaging, is the recommended first-line modality for diagnosing PAS. Grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity, and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color Doppler.
The placenta accreta index (PAI) score (a nine-point score) was proposed in 2015 to predict PAS based on US parameters in a high-risk population by retrospective data analysis. The probability of histological invasion was found to increase with increasing the PAI score. This study aimed to prospectively evaluate the diagnostic performance of the PAI in the prediction of PAS in relation to histopathological findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US scan with calculation of the PAI | – | Device: Ultrasound evaluation, with grayscale and color Doppler imaging |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant females during the third trimester of pregnancy, with a single fetus in the current pregnancy, a previous delivery by at least 1 cesarean section and having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.
Key inclusion criteria (4 listed)
- Pregnant women in their third trimester
- with a single fetus in the current pregnancy
- a previous delivery by at least 1 cesarean section
- having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment
Key exclusion criteria (4 listed)
- cases with twin or multiple pregnancies,
- cases with a non-previa placenta or posterior low lying or previa placenta,
- cases without previous deliveries by cesarean section
- cases before the third trimester of pregnancy.
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 |
|---|---|---|
| Ultrasound evaluation, with grayscale and color Doppler imagingIn pregnant women with previous CS and anterior low-lying or placenta previa, the following three sonographic criteria were assessed: (i) the smallest myometrial thickness in the sagittal plane; (ii) presence of placental lacunae and its grade from 0-3; (iii) bridging vessels using color Doppler. The PAI score (up to 9) was calculated for every patient as described by Rac et al.2015. | Device | US scan with calculation of the PAI |
Primary outcome
Diagnostic accuracy of the PAI
Time frame: through study completion, an average of 1 year
The diagnostic accuracy of the PAI in comparison with the histopathological confirmation in hysterectomy specimens.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Background: PubMed 25446658Rac MW, Dashe JS, Wells CE, Moschos E, McIntire DD, Twickler DM. Ultrasound predictors of placental invasion: the Placenta Accreta Index. Am J Obstet Gynecol. 2015 Mar;212(3):343.e1-7. doi: 10.1016/j.ajog.2014.10.022. Epub 2014 Oct 18.
Related trials for Placenta Accreta Spectrum
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum
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.
Hatem Abu Hashim study chair
Faculty of Medicine, Mansoura University
Eman Shalaby principal investigator
Mansoura University Hospital
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 Hatem AbuHashim 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 4 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: finished, as of the sponsor's last update on 19 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the PAI (time frame: through study completion, an average of 1 year). 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 NCT04314791, 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 19 Mar 2020.