Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum

Placenta Accreta, Unspecified Trimester Clinical Trial

Official title:

Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum: A Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04801706
• Other study ID #: Prenatal US and clinical FIGO
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: August 2023

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: Ahmad S Reyad, Resident
• Phone: 0201000089087
• Email: ahmadzamora90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 in hysterectomy specimens

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:

1. Location of placenta: Placenta previa anterior / posterior / totally covering the internal cervical os.

2. 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.

3. Loss of the clear zone, defined as loss or irregularity of the hypoechoic plane in the myometrium underneath the placental bed

4. Bladder wall interruption, defined as loss or interruption of the bright bladder wall (hyperechoic band or 'line' between the uterine serosa and bladder lumen)

5. 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.

6. 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: August 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Impaired liver or renal functions.

• Coagulation disorders.

• Associated uterine pathology needing hysterectomy.

• Patient's refusal to participate in clinical research.

• Multiple pregnancy

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta, Unspecified Trimester

Intervention

Diagnostic Test:
• Ultrasound
Association of each ultrasonographic parameter with FIGO clinical grading of placenta accreta and with histopathological diagnosis of placenta accreta in hysterectomy specimens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bseline
Secondary	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.	Baseline

External Links

•   Influence of prenatal diagnosis of abnormally invasive placenta on maternal outcome: systematic review and meta-analysis
•   Prenatal ultrasound staging system for placenta accreta spectrum disorders