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

NCT03286998 | Unknown DMC

• 1 other identifier: 110149
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Placenta Accreta; Placenta Previa

Keywords

placenta previa; color doppler; placenta accreta; ultrasonography

Outcome Measures

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

  during cesarean section or elective cesarean hysterectomy

Study Arms (1)

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)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Kasr Elainy Hospital (Cairo University)

Cairo, 115431, Egypt

NOT YET RECRUITING

Faculty of medicine- Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Accreta; Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Moutaz Elsherbini, M.D

  Assistant professor of obstetrics and gynecology - Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moutaz Elsherbini, M.D.

CONTACT

(+2)01001588300; mizosherbini@yahoo.com

Marwa Eid, M.D

CONTACT

(+2)01001225079; marwaeid2014@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of obstetrics and gynecology

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: December 20, 2017
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

EG (2)