Placenta Accreta, Unspecified TrimesterNCT04801706
Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum
An observational study of Placenta Accreta, Unspecified Trimester, run by Assiut University.
Trial summary
To evaluate the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta… 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, Unspecified Trimester
- What is being tested?
- Ultrasound
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Aug 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All females in age range between 18 years old and 45 years old who are diagnosed as placenta accreta spectrum disorder in antenatal care at Assiut University, Women Health Hospital at time between May 2021 and May 2023 will be included in the study
Who may be able to join
- All patients diagnosed with placenta previa previa or low lying placenta during pregnancy at any gestational age will be included and followed up until termination of pregnancy. The diagnosis of placenta previa was based on the presence of placental tissue overing the internal cervical os and Low-lying placenta was diagnosed when the placenta was within 2 cm from the internal cervical os but did not cover it
Who cannot join
- Impaired liver or renal functions.
- Coagulation disorders.
- Associated uterine pathology needing hysterectomy.
- Patient's refusal to participate in clinical research.
- Multiple pregnancy
Trial locations and contacts
No sites are listed yet.
Kamal M Zahran, professor contact
About this study
Official title: Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum: A Prospective Cohort Study
To evaluate the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens
Read the detailed description
Evaluation of the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens The following ultrasound items will be examined: number and viability of fetuses, amniotic fluid assessment, fetal biometries, fetal gender if possible, fetal presentation, Estimated fetal weight using Hadlock formula, Umbilical Artery Pulsatility Index (UA PI) measured from an automated/manual trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The UA PI will be recorded from a free-floating section of cord.
Next step the investigators will look for suggestive ultrasound parameters of placenta accreta including:
- Location of placenta: Placenta previa anterior / posterior / totally covering the internal cervical os.
- Lacunae staging according to Finberg and Williams as follows: grade 0, none seen; grade 1, 1-3 present and generally small; grade 2, 4-6 present and tending to be larger and more irregular; grade 3, many throughout the placenta and appearing large and bizarre.
- Loss of the clear zone, defined as loss or irregularity of the hypoechoic plane in the myometrium underneath the placental bed
- Bladder wall interruption, defined as loss or interruption of the bright bladder wall (hyperechoic band or 'line' between the uterine serosa and bladder lumen)
- Uterovescical hypervascularity, defined as a striking amount of color Doppler signal seen between the myometrium and the posterior wall of the bladder, including vessels appearing to extend from the placenta, across the myometrium and beyond the serosa, into the bladder or other organs, often running perpendicular to the myometrium.
- Increased vascularity in the parametrial region, defined as the presence of hypervascularity extending beyond the lateral uterine walls and involving the region of the parametria .
- Conditions
- Placenta Accreta, Unspecified Trimester
- 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
Association of each ultrasonographic parameter with FIGO clinical grading of placenta accreta and with histopathological diagnosis of placenta accreta in hysterectomy specimens
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the association of ultrasonographic parameters with the intraoperative FIGO clinical grading for diagnosis of placenta accreta spectrum disorder and histopathological diagnosis of placenta accreta in hysterectomy specimens
Grade 1 : Complete placental separation at third stage, Grade 2 : removal of placenta required and parts of placenta thought to be abnormally adherent, Grade 3 : Manual removal of placenta required and the whole placental bed thought to be abnormally adherent, Grade 4 : Placental tissue seen to have invaded through the serosa of the uterus but a clear surgical plane can be identified between the bladder and uterus, Grade 5 : Placental tissue seen to have invaded through the serosa of the uterus and a clear surgical plane cannot be identified between the bladder and uterus, Grade 6 : Placental tissue seen to have invaded through the serosa of the uterus and infiltrating the parametrium or any organ other than the urinary bladder
Measured: Bseline
Secondary outcomes (1)
Association of each ultrasonographic parameter of placental invasion with maternal and fetal complications
- Maternal complications both intra and post-operatively including cesarean hysterectomy, ICU admission, bladder injury, bowel injury and death.
- Fetal and neonatal complications including Apgar score less than 7 at 5 min, RDS, NICU, preterm and neonatal death.
- Development of ultrasound scoring system for prediction of placenta accreta.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta, Unspecified TrimesterStudies 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Sayed Reyad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801706
- Sponsor's protocol ID
- Prenatal US and clinical FIGO
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04801706
- Acronym / sponsor ID
- Prenatal US and clinical FIGO
- Conditions
- Placenta Accreta, Unspecified Trimester
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 17 Mar 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.
To evaluate the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens
Detailed description
Evaluation of the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens The following ultrasound items will be examined: number and viability of fetuses, amniotic fluid assessment, fetal biometries, fetal gender if possible, fetal presentation, Estimated fetal weight using Hadlock formula, Umbilical Artery Pulsatility Index (UA PI) measured from an automated/manual trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The UA PI will be recorded from a free-floating section of cord.
Next step the investigators will look for suggestive ultrasound parameters of placenta accreta including:
- Location of placenta: Placenta previa anterior / posterior / totally covering the internal cervical os.
- Lacunae staging according to Finberg and Williams as follows: grade 0, none seen; grade 1, 1-3 present and generally small; grade 2, 4-6 present and tending to be larger and more irregular; grade 3, many throughout the placenta and appearing large and bizarre.
- Loss of the clear zone, defined as loss or irregularity of the hypoechoic plane in the myometrium underneath the placental bed
- Bladder wall interruption, defined as loss or interruption of the bright bladder wall (hyperechoic band or 'line' between the uterine serosa and bladder lumen)
- Uterovescical hypervascularity, defined as a striking amount of color Doppler signal seen between the myometrium and the posterior wall of the bladder, including vessels appearing to extend from the placenta, across the myometrium and beyond the serosa, into the bladder or other organs, often running perpendicular to the myometrium.
- Increased vascularity in the parametrial region, defined as the presence of hypervascularity extending beyond the lateral uterine walls and involving the region of the parametria .
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
- All females in age range between 18 years old and 45 years old who are diagnosed as placenta accreta spectrum disorder in antenatal care at Assiut University, Women Health Hospital at time between May 2021 and May 2023 will be included in the study
Key inclusion criteria (1 listed)
- All patients diagnosed with placenta previa previa or low lying placenta during pregnancy at any gestational age will be included and followed up until termination of pregnancy. The diagnosis of placenta previa was based on the presence of placental tissue overing the internal cervical os and Low-lying placenta was diagnosed when the placenta was within 2 cm from the internal cervical os but did not cover it
Key exclusion criteria (5 listed)
- Impaired liver or renal functions.
- Coagulation disorders.
- Associated uterine pathology needing hysterectomy.
- Patient's refusal to participate in clinical research.
- Multiple 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 |
|---|---|---|
| UltrasoundAssociation of each ultrasonographic parameter with FIGO clinical grading of placenta accreta and with histopathological diagnosis of placenta accreta in hysterectomy specimens | Diagnostic test | – |
Primary outcome
To evaluate the association of ultrasonographic parameters with the intraoperative FIGO clinical grading for diagnosis of placenta accreta spectrum disorder and histopathological diagnosis of placenta accreta in hysterectomy specimens
Time frame: Bseline
Grade 1 : Complete placental separation at third stage, Grade 2 : removal of placenta required and parts of placenta thought to be abnormally adherent, Grade 3 : Manual removal of placenta required and the whole placental bed thought to be abnormally adherent, Grade 4 : Placental tissue seen to have invaded through the serosa of the uterus but a clear surgical plane can be identified between the bladder and uterus, Grade 5 : Placental tissue seen to have invaded through the serosa of the uterus and a clear surgical plane cannot be identified between the bladder and uterus, Grade 6 : Placental tissue seen to have invaded through the serosa of the uterus and infiltrating the parametrium or any organ other than the urinary bladder
1 secondary outcome
Association of each ultrasonographic parameter of placental invasion with maternal and fetal complications
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- 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.
Kamal M Zahran, professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, Unspecified Trimester, 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 1 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 17 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad S Reyad, Resident (0201000089087, ahmadzamora90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the association of ultrasonographic parameters with the intraoperative FIGO clinical grading for diagnosis of placenta accreta spectrum disorder and histopathological diagnosis of placenta accreta in hysterectomy specimens (time frame: Bseline). 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 17 Mar 2021.