Diagnostic Accuracy of Placental Thickness in Lower Uterine Segment Measured By Ultrasound in Prediction of Placenta Accreta Spectrum in Patients With Placenta Previa. A Diagnostic Test Accuracy Study

NCT05500404 | Completed DMC

• 1 other identifier: 5
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Current prenatal diagnosis of placenta accrete spectrum disorders relies on subjective individual interpretations of visual sonographic findings on grayscale and color Doppler imaging. When blinded to clinical data, there is significant interobserver variability in the diagnosis of invasive placentation. This study will evaluate placental thickness among pregnant women with placenta previa and determine if increased placenta thickness correlates with the risk for placenta accreta spectrum (PAS) disorders.

Conditions

Placenta Accreta Spectrum

Outcome Measures

Primary Outcomes (1)

• Placental thickness threshold

  Threshold of placental thickness which can be used as cutoff level with appropriate sensitivity and specificity so it can be used as a screening test for such morbid condition.

  after 26 weeks of pregnancy

Interventions

Ultrasound measurment of placental thickness DIAGNOSTIC_TEST

The maximum placental thickness in the lower uterine segment will obtained using trans-abdominal ultrasound scan. For the image to be deemed suitable, a midline sagittal section of the lower uterine segment (with the implanted placenta) and the cervical canal, with the intervening urinary bladder will be required (Bhide et al., 2019). The measurement will be performed by a researcher who will be blinded to the final diagnosis.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with placenta Previa attending outpatient obstetric clinic at Ain Shams University Maternity Hospital

You may qualify if:

• Pregnant women with ultrasound diagnosis of placenta previa or low lying placenta
• Gestational age above 26 weeks
• singleton pregnancy
• fetal life positive
• Past history of cesarean section regardless of the number

You may not qualify if:

• Hemodynamically unstable women.
• Patients with pregestational or gestational DM.
• Multiple gestation.
• Medical disorders which can lead to uteroplacental insufficiency (preeclampsia - SLE - antiphospholipid antibody syndrome).
• Any condition which can lead to enlarged placenta such as fetal hydrops

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

AinShams university maternity hospital

Cairo, Egypt

Location

Related Publications (7)

• Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.

  PMID: 29669225 BACKGROUND

• Li Y, Choi HH, Goldstein R, Poder L, Jha P. Placental thickness correlates with placenta accreta spectrum (PAS) disorder in women with placenta previa. Abdom Radiol (NY). 2021 Jun;46(6):2722-2728. doi: 10.1007/s00261-020-02894-9. Epub 2021 Jan 2.

  PMID: 33388802 BACKGROUND

• Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.

  PMID: 28599899 BACKGROUND

• Morgan EA, Sidebottom A, Vacquier M, Wunderlich W, Loichinger M. The effect of placental location in cases of placenta accreta spectrum. Am J Obstet Gynecol. 2019 Oct;221(4):357.e1-357.e5. doi: 10.1016/j.ajog.2019.07.028. Epub 2019 Jul 22.

  PMID: 31344349 BACKGROUND

• Bhide A, Laoreti A, Kaelin Agten A, Papageorghiou A, Khalil A, Uprichard J, Thilaganathan B, Chandraharan E. Lower uterine segment placental thickness in women with abnormally invasive placenta. Acta Obstet Gynecol Scand. 2019 Jan;98(1):95-100. doi: 10.1111/aogs.13422. Epub 2018 Aug 2.

  PMID: 29978457 BACKGROUND

• Petpichetchian C, Pranpanus S, Suntharasaj T, Kor-Anantakul O, Hanprasertpong T. Comparison of transabdominal and transvaginal sonography in the diagnosis of placenta previa. J Clin Ultrasound. 2018 Jul;46(6):386-390. doi: 10.1002/jcu.22600. Epub 2018 Apr 25.

  PMID: 29693718 BACKGROUND

• Elmaraghy AM, Taha Fayed S, Abd ElHamid Ali M, Ali Hassanien M, Mohamed Mamdouh A. Diagnostic Accuracy of Placental Thickness in Lower Uterine Segment Measured by Ultrasound in Prediction of Placenta Accreta Spectrum in Patients with Placenta Previa. A Diagnostic Test Accuracy Study. Int J Womens Health. 2023 Feb 16;15:311-320. doi: 10.2147/IJWH.S399520. eCollection 2023.

  PMID: 36814526 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cases with morbidly adherent placenta who will undergo cesarean hysterectomy will have thier uteri sent for histopathologic examination

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Ahmed M Mamdouh, MD

  Ainshams university maternity hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: December 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)