TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques

NCT02712099 | Completed Results DMC

• 1 other identifier: TUI 3D
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative findings.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (2)

• Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography

  2D grayscale ultrasonography criteria of placenta accreta by Loss of the retro placental sonolucent zone in placenta previa with its lower edge covering the scar of previous cesarean section

  28 -36 weeks of gestation

• Abnormal Placental Lacunae by 2D Grayscale Ultrasonography

  2D grayscale ultrasonography criteria of placenta accreta by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section

  28 -36 weeks of gestation

Secondary Outcomes (4)

• Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography

  28 -36 weeks of gestation

• Abnormal Placental Lacunae by Power Doppler Ultrasonography

  28 -36 weeks of gestation

• Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)

  28 -36 weeks of gestation

• Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)

  28 -36 weeks of gestation

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital. * All patients will undergo the following : 1. History taking 2. Clinical examination. 3. For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.

You may qualify if:

• History of previous cesarean section or hysterotomy.
• Placenta previa with its lower edge covering the scar of previous cesarean section
• From 28 wks to Full term.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr.Rehab Mohamed Abdelrahman
• Organization: Ain Shams University

rehababdulrahman.rm@gmail.com

+201004992772

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 18, 2016
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 15, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share