CClinicalTrials.gg
Status unknownNCT03437291Updated Feb 19, 2018

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

An observational study in Placenta Accreta, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 45 Years
Sex
Female
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Study 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

Read the 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":

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Conditions studied

  • Placenta Accreta
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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

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

Exclusion Criteria:

  • Placenta previa posterior wall
  • unscarred uterus
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 · Device: Transabdominal ultrasound · Device: Transvaginal ultrasound

  • Normal placenta

    patients had placenta previa with no abnormal invasion

    Procedure: Cesarean section · Device: Transabdominal ultrasound · Device: Transvaginal ultrasound

Interventions

  • ProcedureCesarean 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

    Also known as: lower segment cesarean section

  • DeviceTransabdominal ultrasound

    loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass

    Also known as: 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducer

  • DeviceTransvaginal ultrasound

    loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass

    Also known as: 2D ultrasound system equipped with a 12 MHz transvaginal transducer

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What researchers measure

Primary outcomes

  1. abnormal placental invasion

    detection of abnormally invsive placenta at histopathological examination

    Time frame: At time of cesarean section

06

Study locations

1 of 1 sites recruiting
  • Kasr Alainy medical school
    Cairo, 12111, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03437291
Lead sponsor
Cairo University
Responsible party
Ahmed Maged (professor, Cairo University) — Principal investigator
First posted
Feb 19, 2018
Start date
Mar 2016
Primary completion
Feb 2018 (estimated)
Completion
Mar 2018 (estimated)
Last update
Feb 19, 2018

Study contacts

Ahmed Maged, MD
Contact
prof.ahmedmaged@gmail.com
+2001005227404
Sherif Dahab, MD
Contact
dahoob@yahoo.com
Ahmed Maged, MD
principal investigator · professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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