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Ultrasound Staging in the Placenta Accreta

Primary Purpose

Obstetric Labor Complications, Staging of Placental Invasion

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Ultrasound

About this trial

This is an interventional diagnostic trial for Obstetric Labor Complications

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Prior lower segment cesarean section
Low lying anterior placenta
Singleton pregnancy

Exclusion Criteria:

Medical disorders
vasa previa

Sites / Locations

Beni-Suef University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Morbidly adherent placenta

Arm Description

This arm was given stage according to ultrasound features.

Outcomes

Primary Outcome Measures

Confirmation of the stage of myometrial placental invasion

By ultrasound, placental invasion in myometrium was given a stage

Secondary Outcome Measures

Blood loss

Documentation of complications intraoperative

Full Information

NCT ID

NCT04253197

First Posted

January 30, 2020

Last Updated

January 31, 2020

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT04253197

Brief Title

Ultrasound Staging in the Placenta Accreta

Official Title

Efficacy of Ultrasound Staging System in Prediction of Morbidly Adherent Placenta

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

March 14, 2017 (Actual)

Primary Completion Date

July 20, 2019 (Actual)

Study Completion Date

December 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.

Detailed Description

Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta accreta, increta, and percreta, which are associated with significant maternal and fetal morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta include the loss of myometrial interface or retroplacental clear space, reduced myometrial thickness and the presence of intraplacental lacunae. Using a staging system by antenatal ultrasound can predict placental invasion antenatally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstetric Labor Complications, Staging of Placental Invasion

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pregnant women in 3rd trimester

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Morbidly adherent placenta

Arm Type

Other

Arm Description

This arm was given stage according to ultrasound features.

Intervention Type

Device

Intervention Name(s)

Ultrasound

Intervention Description

Pregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted.

Primary Outcome Measure Information:

Title

Confirmation of the stage of myometrial placental invasion

Description

By ultrasound, placental invasion in myometrium was given a stage

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Blood loss

Description

Documentation of complications intraoperative

Time Frame

1 hour

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prior lower segment cesarean section Low lying anterior placenta Singleton pregnancy Exclusion Criteria: Medical disorders vasa previa

Facility Information:

Facility Name

Beni-Suef University

City

Cairo

ZIP/Postal Code

11211

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21806571

Citation

Albayrak M, Ozdemir I, Koc O, Demiraran Y. Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):377-80. doi: 10.1111/j.1479-828X.2011.01309.x. Epub 2011 Apr 18.

Results Reference

background

Citation

American institute of ultrasound in medicine 2015.

Results Reference

background

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Ultrasound Staging in the Placenta Accreta

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