Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03530475
Recruitment Status : Unknown
Verified May 2018 by hala nabil, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : May 21, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
hala nabil, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed).

All of those patients are presenting during the period of may 2018 to july 2018 to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.

All of them will be assorted according to certain inclusion and exclusion criterions as follow:


Condition or disease Intervention/treatment Phase
Placenta Accreta Diagnostic Test: ultrasound and doppler Not Applicable

Detailed Description:

This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed).

Those patients are attending to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.

Ultrasound and doppler will be done to all patients to diagnose placenta accreta . The diagnosis will be confirmed by intraoperative assessments and histopathological examination of the uterus after cesarean hysterectomy

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler in Cases of Placenta Accreta
Estimated Study Start Date : May 22, 2018
Estimated Primary Completion Date : August 22, 2018
Estimated Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: placenta previa
cases diagnosed as placenta previa diagnosed by ultrasound and doppler
 Diagnostic Test: ultrasound and doppler

• Ultrasound examination (2D gray scale and color doppler )

1. Confirming the presence of placenta previa 2,To assess the possibility of concomitant placenta accreta (Sonographic findings that have been associated with placenta accreta (1) Loss of normal hypoechoic retroplacental zone (2) Multiple vascular lacunae (irregular vascular spaces) within placenta, (3) Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1 (4) Retroplacental myometrial thickness of 1 mm (5) Bladder wall interruption (6) Presence of placental bulge (7) Utero-vesical hypervascularity (8) presence of lacunae feeder vessels.

3. Assessment of uterine artery Doppler in different cases of placenta previa.

. Documentation of the operative findings during cesarean section and/or cesarean hysterectomy procedures.

Histopathological examination of the hysterectomy specimens to assess the degree of myometrial invasion.
Active Comparator: placenta accreta
placenta previa diagnosed as placenta accreta by ultrasound and doppler
 Diagnostic Test: ultrasound and doppler

• Ultrasound examination (2D gray scale and color doppler )

1. Confirming the presence of placenta previa 2,To assess the possibility of concomitant placenta accreta (Sonographic findings that have been associated with placenta accreta (1) Loss of normal hypoechoic retroplacental zone (2) Multiple vascular lacunae (irregular vascular spaces) within placenta, (3) Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1 (4) Retroplacental myometrial thickness of 1 mm (5) Bladder wall interruption (6) Presence of placental bulge (7) Utero-vesical hypervascularity (8) presence of lacunae feeder vessels.

3. Assessment of uterine artery Doppler in different cases of placenta previa.

. Documentation of the operative findings during cesarean section and/or cesarean hysterectomy procedures.

Histopathological examination of the hysterectomy specimens to assess the degree of myometrial invasion.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. accuracy of ultrasound and doppler in detecting placenta accreta [ Time Frame: 3 moths ]
    accuracy of uterine artery doppler in diagnosing placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy


Secondary Outcome Measures :
  1. accuracy of ultrasound in detecting placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy [ Time Frame: 3 months ]
    1. Loss of normal hypoechoic retroplacental zone
    2. Multiple vascular lacunae (irregular vascular spaces) within placenta
    3. Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1
    4. Retroplacental myometrial thickness of 1 mm
    5. Bladder wall interruption
    6. Presence of placental bulge
    7. Utero-vesical hypervascularity

    3.Intraoperative complications



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Criteria:Inclusion Criteria

  • Gestational age more than 28 weeks
  • Single living fetus.
  • One or more cesarean section or hysterotomy.
  • Placenta previa (all grades) with high possibility of morbidly adherent placenta accreta (all types).

Exclusion Criteria:

  • Maternal chronic medical disorder (diabetes mellitus or hypertension).
  • Pregnancy induced disorders (pre-eclampsia or gestational diabetes).
  • Associated fetal anomalies.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530475


Contacts
Layout table for location contacts
Contact: Hala Nabil, M.D 02001002412549 fawzy.jana@yahoo.com

Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hala Nabil, M.D Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: hala nabil, principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03530475    
Other Study ID Numbers: 5000
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases