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Comparison Between the Role of Transabdominal Ultrasound Versus Transvaginal Ultrasound in Evaluation of Placental Invasion in Cases of Placenta Previa Anterior Wall With Previous Uterine Scar

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ClinicalTrials.gov Identifier: NCT03437291
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:

Objective:

To compare between the role of Transabdominal ultrasound versus Transvaginal ultrasound in evaluation of placental invasion in cases of placenta previa anterior wall with previous uterine scar applying the unified ultrasonographic descriptors suggested by the European working group on abnormally invasive placenta "EW-AIP' Also to evaluate the sensitivity and specificity of each criterion by comparing them with the final outcome of pregnancy Fifty pregnant women with persistent placenta previa (after 28 weeks' gestation) were prospectively enrolled into this study. Both transabdominal and transvaginal ultrasound were performed by two different operators who were blinded to the results of each other.

the placenta was studied as regarding the exact loacalization and the unified descriptors were applied and evaluated by TAS and TVS.

The ultrasound findings were analyzed with reference to the final diagnosis made during Cesarean delivery and histopathological examination


Condition or disease Intervention/treatment
Placenta Accreta Procedure: Cesarean section Device: Transabdominal ultrasound Device: Transvaginal ultrasound

Detailed Description:

Definitive diagnosis of Abnormally Invasive Placenta was made at delivery when the myometrium was seen to be invaded by the placenta, and the pathological examination of the removed uterus showed the villi attached to the myometrium without intervening decidua (accreta), invading into the myometrium (increta) or reaching the serosa (percreta).

-Complete imaging using all diagnostic techniques (gray-scale, color Doppler) by both transabdominal and transvaginal by two expert operators, then an offline analysis of the acquired images & volumes was done Ultrasound examination was performed using a 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducer and a 12 MHz transvaginal transducer The transvaginal ultrasound was performed by a highly experienced operator whereas the transabdominal ultrasound was performed by a less experienced one and both were blinded from the results of each other Placenta was examined while the bladder was partially full about 300 ml for adequate visualization and precise localization

The Examined placenta is considered to be suspicious of abnormal invasion in case of having one or more of the unified descriptors described by the European working Group on Abnormally Invasive Placenta "EW-AIP":


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between the Role of Transabdominal Ultrasound Versus Transvaginal Ultrasound in Evaluation of Placental Invasion in Cases of Placenta Previa Anterior Wall With Previous Uterine Scar
Actual Study Start Date : March 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars Ultrasound

Group/Cohort Intervention/treatment
Abnormal placental invasion
patients had placenta previa with histopathologically confirmed abnormal invasion with all three grades i.e. accreta, increta and percreta,
Procedure: Cesarean section
Lower segment CS with evaluation of Placental site, spontaneous separation, placental invasion into the bladder and other surrounding organs, Uterotonic administration, Bladder , ureteric or bowel injury, blood loss and blood transfusion
Other Name: lower segment cesarean section

Device: Transabdominal ultrasound
loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
Other Name: 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducer

Device: Transvaginal ultrasound
loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
Other Name: 2D ultrasound system equipped with a 12 MHz transvaginal transducer

Normal placenta
patients had placenta previa with no abnormal invasion
Procedure: Cesarean section
Lower segment CS with evaluation of Placental site, spontaneous separation, placental invasion into the bladder and other surrounding organs, Uterotonic administration, Bladder , ureteric or bowel injury, blood loss and blood transfusion
Other Name: lower segment cesarean section

Device: Transabdominal ultrasound
loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
Other Name: 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducer

Device: Transvaginal ultrasound
loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
Other Name: 2D ultrasound system equipped with a 12 MHz transvaginal transducer




Primary Outcome Measures :
  1. abnormal placental invasion [ Time Frame: At time of cesarean section ]
    detection of abnormally invsive placenta at histopathological examination



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women in the reproductive age group (18 - 45) diagnosed persistent placenta previa anterior wall after 28 weeks of gestation , with history of previous Caesarian Section and/or any other type of uterine surgeries
Criteria

Inclusion Criteria:

  • Pregnant women in the reproductive age group (18 - 45) diagnosed persistent placenta previa anterior wall after 28 weeks of gestation , with history of previous Caesarian Section and/or any other type of uterine surgeries

Exclusion Criteria:

  • Placenta previa posterior wall
  • unscarred uterus

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): NCT03437291


Contacts
Contact: Ahmed Maged, MD +2001005227404 prof.ahmedmaged@gmail.com
Contact: Sherif Dahab, MD dahoob@yahoo.com

Locations
Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12111
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Ahmed Maged, MD professor

Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03437291     History of Changes
Other Study ID Numbers: 27
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Placenta Previa
Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases