CClinicalTrials.gg
Status unknownNCT03286998Updated Dec 17, 2020

Ultrasound in Prediction of Operative Findings in Cesarean Section Among Placenta Accreta Cases

An observational study in Placenta Accreta and Placenta Previa, sponsored by Cairo University. Status unknown at 2 sites in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of having placenta previa or low lying placenta by grey scale ultrasound. Placenta will be reexamined by grey scale ultrasound \& color Doppler. Sonographic parameters evaluated will include placental location, loss of retro-placental clear zone, irregularity and thickness of the uterine-placental interface, the smallest myometrial thickness in sagittal and transverse planes, presence of lacunar spaces and bridging vessels \& the presence of abnormal vasculature. The sonographic findings will be compared with intraoperative ones. Hysterectomy specimen (if any was done) will be evaluated histo-pathologically to assess the degree of placental invasion \& to confirm the accreta status. The aim of the study is to determine the efficacy of ultrasound in predicting operative findings and associated co-morbidties among cases of placenta accreta.

Read the detailed description

60 pregnant women with singleton living healthy fetus diagnosed as having placenta previa by grey scale ultrasound and candidate for repeated elective cesarean section (CS) or elective cesarean hysterectomy (if the diagnosis of placenta accreta is confirmed) will be included in the study. Inclusion criteria include: maternal age between 20 \& 40 years old, gestational age more than 28 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan), one or more cesarean section scar \& the presence of placenta previa with high possibility of being placenta accreta when scanned by grey scale ultrasound. Women who had chronic or pregnancy induced diseases or any emergency or unplanned CS will be excluded. Informed consents will be obtained from all patients after explanation of the aim of the study \& the potential risks. For all patients, full history will be taken followed by complete physical examination \& routine obstetric ultrasound (to confirm the presence of placenta previa i.e. placental tissue covers the internal cervical os or within 2 cm from it). For all Participants, the placentae will be reexamined in systematic manner by gray-scale \& color Doppler ultrasound via transabdominal and/or transvaginal approach using Volusion Pro-V ultrasonography machine (GE Healthcare Austria GmbH, Seoul, Korea). All exams will be done by expert sonographer \& the possibility of concomitant placenta accreta will be checked. The placenta will be scanned with adequate bladder volume to visualize the bladder- uterine serosal interface correctly \& the angle of insonation will kept as low as possible. The presence of one or more of the following features in grey scale ultrasound will be indicative of placenta accreta (presence of abnormal placental lacunae / complete loss of retroplacental sonolucent zone / myometrial thinning / disruption of the uterine serosa-bladder interface / presence of mass invading the urinary bladder). Similarly, placenta accreta will be diagnosed by the presence of at least one of the following features in color Doppler scan: diffuse or focal lacunar flow - sonolucent vascular lakes - hypervascularity of the utero-vesical interface with bridging vessels connecting the placenta to the bladder). The sonographic provisional diagnosis (i.e placenta previa, focal accreta, accreta , increta or percreta) with the concomitant invasion of adjacent structures (e.g., the urinary bladder) will be documented. For all participants, termination of pregnancy will be by elective CS or elective cesarean hysterectomy. Furthermore, operative findings as regard the placenta and the invasion of adjacent structures will be documented. All operative procedures will be done by senior staff obstetrician with special interest in placenta accreta. For hysterectomy specimens, histopathological examination will be done to assess the degree of myometrial invasion \& to confirm the diagnosis of placenta accreta. Maternal morbidities (i.e. massive bleeding with the need of blood transfusion, pelvic organ injury or ICU admission) or mortalities will be documented. Neonatal morbidities (i.e. prematurity or NICU admission) or mortalities will be documented. The ultrasonographic findings will be compared to operative details and histopathological reports. The aim of the study is to evaluate the efficacy of ultrasound in predicting operative findings and associated co-morbidities among cases of placenta accreta.

02

Conditions studied

  • Placenta Accreta
  • Placenta Previa

Keywords

  • placenta previa
  • color doppler
  • placenta accreta
  • ultrasonography
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of having placenta previa or low lying placenta by grey scale ultrasound.

Inclusion criteria

  • Maternal age between 20 \& 40 years old
  • Singleton living healthy fetus.
  • Having placenta previa by grey scale ultrasound with high possibility of being placenta accreta when scanned by grey scale ultrasound
  • Gestational age more than 28 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).
  • One or more cesarean section scar

Exclusion criteria

Exclusion Criteria:

  • Women who had chronic or pregnancy induced diseases
  • Emergency or unplanned CS will be performed.
04

Study design

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

Groups and cohorts

  • placenta previa

    pregnant women with singleton living healthy fetus diagnosed as having placenta previa by grey scale ultrasound (placental tissue covers the internal cervical os or within 2 cm from it)

05

What researchers measure

Primary outcomes

  1. the accuracy of ultrasound in predicting operative finding in cases of placenta accreta

    compare ultrasound report findings with the operative details report in hospital records

    Time frame: during cesarean section or elective cesarean hysterectomy

06

Study locations

1 of 2 sites recruiting
  • Kasr Elainy Hospital (Cairo University)
    Cairo, 115431, Egypt
    Not yet recruiting
  • Faculty of medicine- Cairo university
    Cairo, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT03286998
Lead sponsor
Cairo University
Responsible party
Moutaz Sherbini (assistant professor of obstetrics and gynecology, Cairo University) — Principal investigator
First posted
Sep 19, 2017
Start date
Dec 20, 2017
Primary completion
Jan 2021 (estimated)
Completion
Feb 2021 (estimated)
Last update
Dec 17, 2020

Study contacts

Moutaz Elsherbini, M.D.
Contact
mizosherbini@yahoo.com
(+2)01001588300
Marwa Eid, M.D
Contact
marwaeid2014@gmail.com
(+2)01001225079
Moutaz Elsherbini, M.D
principal investigator · Assistant professor of obstetrics and gynecology - Cairo university

Oversight

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

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This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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