Separation Sign: New Ultrasound Sign to Rule Out Placenta Accreta
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2023
CompletedStudy Start
First participant enrolled
July 30, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedAugust 2, 2023
August 1, 2023
3 months
July 25, 2023
August 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
1 month before delivery
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- History of previous cesarean section or hysterotomy.
- Placenta previa or low lying anterior placenta.
- From 28 wks to Full term.
You may not qualify if:
- Multiple pregnancies.
- Medical disorder as diabetes mellitus, hypertension. 3. Obese patients. BMI \> 30 4. Intrauterine growth retardation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 2, 2023
Study Start
July 30, 2023
Primary Completion
October 30, 2023
Study Completion
November 30, 2023
Last Updated
August 2, 2023
Record last verified: 2023-08