An observational study in Accreta, Placenta, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by Beni-Suef University · Observational
To assess the 'separation sign' as a predictor of normal placental separation in a large cohort of women at risk for placenta accrete spectrum and in a high-risk subgroup with placenta previa or anterior low-lying placenta and have history of at least one previous Cesarean delivery.
A prospective Observational Cohort study The study population includes high-risk cohort of women was defined as those who had placenta previa or an anterior low-lying placenta, in addition to at least one previous Cesarean delivery. They will be asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria.
Women will be enrolled in the study after giving written informed consent
The patients will be submitted to:
**Full history taking including: Details of gestational age at the time of scanning, maternal age and risk factors , history of dilatation and curettage, in-vitro fertilization and other previous uterine surgery were assessed.
***Detailed trans-abdominal sonographic examination of the placenta was performed, assessing standard ultrasound markers of PAS. Two experienced sonographic operators performed all examinations using (Toshiba Xario 200) with 3D/4D curved-array trans-abdominal transducer (4-8.5 MHz). All examinations were performed with a full bladder, defined as a volume between 250mL 500mL quantified using the inbuilt ellipsoid volume calculation.
To assess for the separation sign, pressure was applied using an ultrasound probe so that the hypoechoic retroplacental clear zone normally observed between the placenta and myometrium disappeared. The pressure was then rapidly released in order to generate the force required to see movement. On release, in cases with normal placentation, the non-elastic placenta keeps moving away from the probe after the highly elastic myometrium has 'snapped' back into place. This sometimes causes the placenta either to keep moving briefly or even to 'bounce' and leads to the appearance or enhancement of the clear zone. With a negative separation sign, no separate movement of the placenta from the myometrium can be seen. The separation sign was recorded as positive if separation of the myometrium from the placenta was observed in all areas of the placenta. The sign was recorded as negative if the myometrium and placenta moved as one structure and no clear zone could be seen over any part of the placenta after release, even if separation was noted at the margins of the placenta. Classification into positive or negative separation sign was highly stringent and, in case of any doubt, the result was recorded as uncertain. The latter occurred most often when the images obtained were suboptimal, for example, owing to tissue attenuation, high body mass index (BMI) or significant scarring. If women were scanned on multiple occasions, the separation sign result obtained closest to 28 weeks' gestation was used in order to minimize differences in scanning over the course of gestation.
***Based on histopathology results in cases in which hysterectomy was performed. A diagnosis of PAS was excluded if the placenta separated spontaneously at delivery, was delivered by controlled cord traction or was delivered by simple manual removal. Histopathological analysis was carried out by a pathologist with expertise in PAS, with the specific sampling site marked by the surgical team according to intrapartum findings. The pathologists were blinded to the separation sign classification but not to surgical findings.
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 100 is above the median of 87 across 78 observational studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes high-risk cohort of women was defined as those who had placenta previa or an anterior low-lying placenta, in addition to at least one previous Cesarean delivery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
History of previous cesarean section or hysterotomy.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The separation sign was recorded as positive if separation of the myometrium from the placenta was observed in all areas of the placenta. The sign was recorded as negative if the myometrium and placenta moved as one structure and no clear zone could be seen over any part of the placenta after release, even if separation was noted at the margins of the placenta.
separation sign
The separation sign was recorded as positive if separation of the myometrium from the placenta was observed in all areas of the placenta. The sign was recorded as negative if the myometrium and placenta moved as one structure and no clear zone could be seen over any part of the placenta after release, even if separation was noted at the margins of the placenta.
Time frame: 1 month before delivery
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2023; primary completion for Oct 2023, 3 months later.
Of 34 observational studies under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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