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UnknownNCT03437291

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

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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

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":

Conditions

Interventions

TypeNameDescription
PROCEDURECesarean sectionLower 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
DEVICETransabdominal ultrasoundloss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
DEVICETransvaginal ultrasoundloss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass

Timeline

Start date
2016-03-01
Primary completion
2018-02-01
Completion
2018-03-01
First posted
2018-02-19
Last updated
2018-02-19

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03437291. Inclusion in this directory is not an endorsement.