NCT07755709

Brief Summary

Primary Objective: To determine the optimal cutoff values of the ultrasound score for different PAS subtypes (no PAS, placenta accreta, placenta increta, and placenta percreta). To evaluate the diagnostic accuracy of the novel Ultrasound Scoring System in predicting the severity of Placenta Accreta Spectrum (PAS) (placenta accreta, increta, and percreta). Secondary Objective:

  • To correlate the novel ultrasound score with intraoperative findings (considered the gold standard) during cesarean delivery, including the degree of placental invasion and the need for surgical interventions (hysterectomy, bladder repair).
  • To assess the relationship between the novel ultrasound score and postoperative complications, such as:
  • Requirement for hysterectomy
  • Bladder or bowel injury
  • Blood transfusion requirement
  • ICU admission rates
  • To explore the potential for integrating the Ultrasound Scoring System with other clinical indicators (e.g., patient age, parity, and history of cesarean sections) to enhance the predictive accuracy for PAS.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Study Progress3%
Aug 2026Jun 2027

First Submitted

Initial submission to the registry

August 4, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

placenta accreta

Outcome Measures

Primary Outcomes (1)

  • degree of placental invasion and inability to conserve the uterus

    Need for Hysterectomy: Determined by the degree of placental invasion and inability to conserve the uterus \&Histopathogy confirmation. Bladder Injury: Recorded if any injury occurs during the procedure. Blood Transfusion Requirement: Amount of blood transfused intraoperatively. ICU Admission: Postoperative ICU admission requirement due to hemorrhage or other complications.

    1 week

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women aged 18 to 45 years. * Gestational age ≥28 weeks at the time of enrollment. * Diagnosed Placenta Previa with a history of: * One or more previous cesarean sections * Uterine scarring due to previous surgery as (myomectomy, D\&C, Metroplasty).
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women aged 18 to 45 years. Gestational age ≥28 weeks at the time of enrollment. Diagnosed Placenta Previa with a history of: One or more previous cesarean sections Uterine scarring due to previous surgery as (myomectomy, D\&C, Metroplasty).

You may qualify if:

  • Pregnant women aged 18 to 45 years.
  • Gestational age ≥28 weeks at the time of enrollment.
  • Diagnosed Placenta Previa with a history of:
  • One or more previous cesarean sections
  • Uterine scarring due to previous surgery as (myomectomy, D\&C, Metroplasty).
  • Singleton pregnancy.

You may not qualify if:

  • Women with multiple pregnancies (twins, triplets, etc.).
  • Pregnancies complicated by acute medical conditions (e.g., heart failure, uncontrolled diabetes).
  • Prior history of Blood diseases. (other than those related to pregnancy).
  • Women who refuse to participate or withdraw consent during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Ahmed Adel Khalifa, resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmed Adel Khalifa Mansour

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 10, 2026

Study Start

August 4, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08