NCT03437291

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

February 13, 2018

Last Update Submit

February 13, 2018

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

  • abnormal placental invasion

    detection of abnormally invsive placenta at histopathological examination

    At time of cesarean section

Study Arms (2)

Abnormal placental invasion

patients had placenta previa with histopathologically confirmed abnormal invasion with all three grades i.e. accreta, increta and percreta,

Procedure: Cesarean sectionDevice: Transabdominal ultrasoundDevice: Transvaginal ultrasound

Normal placenta

patients had placenta previa with no abnormal invasion

Procedure: Cesarean sectionDevice: Transabdominal ultrasoundDevice: Transvaginal ultrasound

Interventions

Cesarean sectionPROCEDURE

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
Abnormal placental invasionNormal placenta
Transabdominal ultrasoundDEVICE

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
Abnormal placental invasionNormal placenta
Transvaginal ultrasoundDEVICE

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
Abnormal placental invasionNormal placenta

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Placenta previa posterior wall
  • unscarred uterus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Accreta

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed Maged, MD

    professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+2001005227404prof.ahmedmaged@gmail.com

Sherif Dahab, MD

CONTACT

dahoob@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 19, 2018

Study Start

March 1, 2016

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

EG(1)