Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester
1 other identifier
observational
1,000
1 country
1
Brief Summary
The aims of this study are to develop algorithms based on a combination of maternal factors, uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
1 active site
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
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedDecember 13, 2016
December 1, 2016
1 year
December 9, 2016
December 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Early preeclampsia
1 year
Secondary Outcomes (1)
Selective intrauterine fetal growth restriction
1 year
Study Arms (1)
observational women
collecting maternal factors, biophysical and biochemical markers at 11-13 weeks of gestation.
Eligibility Criteria
Twin pregnancies were recruited prospectively from women attending their routine first hospital visit in Shanghai First Maternity and Infant Hospital between December 2016 and December 2018.
You may qualify if:
- twins pregnancies delivering a phenotypically normal stillbirth or live birth at or after 24 weeks of gestation.
- twins pregnancies at at 11-14 weeks of gestation
You may not qualify if:
- pregnancies with major fetal abnormalities and those ending in termination, miscarriage or fetal death before 24 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200051, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2016
First Posted
December 13, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2019
Last Updated
December 13, 2016
Record last verified: 2016-12