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Accreta, PlacentaNCT05972915

Separation Sign: New Ultrasound Sign to Rule Out Placenta Accreta

An observational study of Accreta, Placenta, run by Beni-Suef University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Accreta, Placenta
What is being tested?
Separation sign
How many people
100 participants
Where
1 siteEgypt
Study dates
30 Jul 2023to 30 Nov 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 20 to 40 years
  • Women only
  • Adult

Study population: 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.

Who may be able to join

  • History of previous cesarean section or hysterotomy.
  • Placenta previa or low lying anterior placenta.
  • From 28 wks to Full term.

Who cannot join

  • Multiple pregnancies.
  • Medical disorder as diabetes mellitus, hypertension. 3. Obese patients. BMI > 30 4. Intrauterine growth retardation.

Trial locations and contacts

1 site in 1 country.

Beni-suef University contact

082 2318605 ext. 02

fom@med.bsu.edu.eg

Egypt1 site
  • Beni-suef university Hospital

    Banī Suwayf, Beni Suweif Governorate, 62521

Other trials in Egypt

About this study

Official title: Separation Sign: New Ultrasound Sign to Rule Out Diagnosis of Placenta Accreta

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.

Read the detailed description

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.

Being tested
Separation sign
Keywords
placenta accreta
Medical subject headings
Placenta Accreta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Separation signDiagnostic test

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month before delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2023
  2. Study start30 Jul 2023 (estimated)
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05972915
Sponsor's protocol ID
Separation sign
Status last verified
Aug 2023
First submitted
25 Jul 2023
Last updated
2 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Accreta, Placenta, run by Beni-Suef University 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 3 inclusion and 2 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 2 Aug 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Beni-suef University (082 2318605 ext. 02, fom@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

separation sign (time frame: 1 month before delivery). 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 2 Aug 2023.

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