NCT03665623

Brief Summary

Preeclampsia is one of the most serious complications in pregnancy that causes maternal death and preterm delivery. Series studies has show that the competing risk model developed by the Fetal Maternal FouNdation in early pregnancy has the potential to predict preeclampsia effectively but has show crowd difference. We aim to evaluate the performance of various screening model based on FMF model in Chinese population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11,741

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

June 12, 2018

Last Update Submit

November 28, 2020

Conditions

Pre-Eclampsia

Keywords

preeclampsia predictioncompeting risk model11~13+6 gestational weeks

Outcome Measures

Primary Outcomes (1)

  • detection rate of preterm preeclampsia at fixed false positive rate 5%,10%,15%,20%

    PE defined according to the International Society for the Study of Hypertension in Pregnancy and the American College of Obstetricians and Gynecologists.

    at delivery and reviewed 60 days postpartum

Secondary Outcomes (1)

  • detection rate of small for gestational neonates at fixed risk cut of defined in primary outcome

    at delivery

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswe recruit pregnant women who visit the hospital between gestational weeks 11-13+6 days ,have routine visits and planned delivery in registered hospital,singed agreement to participate the study.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

we aimed to recruit as many as possible the women without discrimination during the study periods.

You may qualify if:

  • gestational weeks between 11\~13+6
  • agreed to participate the study
  • live fetus at recruitment.

You may not qualify if:

  • first obstetric visit beyond 14 gestational weeks
  • artificial abortion or spontaneous abortion before 20 weeks or lost to follow-up.
  • refused to participate the study.
  • fetus with major chromosome or structural abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

maternal serum samples.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

September 11, 2018

Study Start

December 1, 2017

Primary Completion

December 30, 2019

Study Completion

August 31, 2020

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations

CN(1)