Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler

NCT ID: NCT03530475

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2018-08-22

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:

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

Conditions

Placenta Accreta

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

placenta previa

cases diagnosed as placenta previa diagnosed by ultrasound and doppler

Group Type: ACTIVE_COMPARATOR

ultrasound and doppler

Intervention Type: DIAGNOSTIC_TEST

• 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.

placenta accreta

placenta previa diagnosed as placenta accreta by ultrasound and doppler

Group Type: ACTIVE_COMPARATOR

ultrasound and doppler

Intervention Type: DIAGNOSTIC_TEST

• 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

hala nabil

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Nabil, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

Hala Nabil, M.D

Role: CONTACT

fawzy.jana@yahoo.com

02001002412549

Other Identifiers

5000

Identifier Type: -

Identifier Source: org_study_id