Early Prediction of Placenta Accreta by Ultrasound and Color Doppler

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032770
• Other study ID #: USPA
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Placenta Accreta

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of occurrence of placenta accreta during delivery.		duration of pregnancy