Placental Vasculature for Prediction of Recurrent Fetal Growth Restriction
3DPD of the Placenta in Fetal Growth Restriction
1 other identifier
observational
200
0 countries
N/A
Brief Summary
: In this Prospective longitudinal observational study, two hundred pregnant women with singleton pregnancy from 11 up to 13 weeks with history of intrauterine growth restriction in a previous pregnancy underwent ultrasound assessment of gestational age , ultrasound assessment of uterine artery pulsatility index, placental volume by 3D ultrasound and placental vascularization by 3D power Doppler (3DPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedMay 22, 2020
May 1, 2020
2.4 years
May 13, 2020
May 21, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
placental volume
Assessment of placental volume.
11-13 week
vascularization index (VI)
expressed as percentage, measures the number of colour voxels in the studied volume, representing the blood vessels within the tissue
11-13 week
uterine doppler
uterine artery pulsatility index
11-13 week
flow index (FI)
the average colour value of all colour voxels, representing average colour intensity.
11-13 week
vascularization flow index (VFI)
the average colour value of all grey and colour voxels, which represents both blood flow and vascularization
11-13 week
Interventions
Eligibility Criteria
Two hundred pregnant women with history of IUGR in previous pregnancy were recruited for the study after full explanation of the method, aim of work and obtaining consent.
You may qualify if:
- singleton pregnancy from 11 up to 13 weeks.
- History of intrauterine growth restriction in previous pregnancy
You may not qualify if:
- Smoking women, and
- pre-existing medical disorders which may affect fetal growth e.g. hypertension, diabetes mellitus, thyroid dysfunction or renal impairment.
- Ultrasound evidence of congenital anomalies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Related Publications (1)
Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.
PMID: 11756390RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
khalid salama
Benha University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 22, 2020
Study Start
December 15, 2016
Primary Completion
May 20, 2019
Study Completion
January 15, 2020
Last Updated
May 22, 2020
Record last verified: 2020-05