Clinical trial NCT04801706: Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum
Official title: Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta, Unspecified Trimester
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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

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:

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 .

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Bseline
Secondary outcomes:
measure: Association of each ultrasonographic parameter of placental invasion with maternal and fetal complications
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References: