NCT03032770

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

January 24, 2017

Last Update Submit

May 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Confirmation of occurrence of placenta accreta during delivery.

    duration of pregnancy

Study Arms (2)

placenta accreta

Having at least one sign suggestive of placenta accreta

Device: two-dimensional ultrasound and color Doppler

normal placenta

Never having any of the signs suggestive of placenta accreta

Device: two-dimensional ultrasound and color Doppler

Interventions

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 placentaplacenta accreta

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

first trimester pregnancy between 11 weeks and 13 weeks.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

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

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 26, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations