NCT03349671

Brief Summary

The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible. The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was employed whereby fetal biometry and placental location were detected. Later on, Doppler measurements \& 3-dimensional (3D) representation became feasible further revolutionizing this area

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

November 17, 2017

Last Update Submit

June 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of preeclampsia during pregnancy.

    number of women developed preeclampsia

    5 months

Interventions

ultrasoundPROCEDURE

A 3D volume of the uterus will be acquired by transabdominal sonography. The sweep angle was set at 85º and the probe will be kept perpendicular to the placental plate. The placenta will be examined and the size of the volume box will be adapted in such a way that the placenta fitted into it completely. The volume will then stored for later offline analysis.

Eligibility Criteria

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

Women who meet the eligibility criteria of the study will be invited to participate and only those who will give agreement on the informed written consent.

You may qualify if:

  • Pregnant female.
  • Pregnant ± 22 to 26 weeks gestation
  • Singleton pregnancy.
  • Consenting to participate

You may not qualify if:

  • Intrauterine fetal death
  • Diagnosed to have Any congenital anomalies
  • Symmetrical IUGR
  • Established fetal compromise that necessitates delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Ahmed Abbas, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations