Early Prediction of Placenta Accreta by Ultrasound and Color Doppler

Early Prediction of Placenta Accreta by 2 Dimensional Transvaginal Ultrasound and Color Doppler

Placenta accreta is a substantially life threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta previa. in a tertiary south Italian center, The incidence increased from 0.12% during the 1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of placenta accreta was 3.7 per 1000 deliveries.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta
• Intervention / Treatment: Device: two-dimensional ultrasound and color Doppler

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

first trimester pregnancy between 11 weeks and 13 weeks.

Description

Inclusion Criteria:

1. Low implantation of the gestational sac (<4 cm from external os) by transvaginal ultrasound
2. Presence of placental lakes by transvaginal ultrasound
3. Disruption of placental-myometrial interface by transvaginal ultrasound
4. Trophoblast overlapping a uterine scar (Cesarean section, myomectomy) by transvaginal ultrasound
5. Intraplacental dilated vessels by Doppler ultrasound
6. Turbulent blood flows by Doppler ultrasound
7. Greatly increased periplacental vascularity by Doppler ultrasound

Exclusion Criteria:

a) Cases far away from our hospital and expected to be lost to be followed. b) Pregnant women who will refuse to Participate

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
placenta accreta; Having at least one sign suggestive of placenta accreta	Device: two-dimensional ultrasound and color Doppler; the eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (<4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device.
normal placenta; Never having any of the signs suggestive of placenta accreta	Device: two-dimensional ultrasound and color Doppler; the eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (<4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Confirmation of occurrence of placenta accreta during delivery.	duration of pregnancy

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (ESTIMATE): January 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: USPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No