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Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester

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ClinicalTrials.gov Identifier: NCT02990767
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai First Maternity and Infant Hospital

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.

Condition or disease
Pre-Eclampsia

Detailed Description:
Preeclampsia (PE) is still a leading cause of fetal and maternal morbidity and mortality with an incidence of 3-5% worldwide. Despite intensive research efforts the pathogenesis of the disease is still unknown but it is likely to be multifactorial.Clinical risk factors traditionally have been used to identify women at high risk of developing preeclampsia,and biophysical factors that may help predict hypertensive disorders of pregnancy.In addition,changes in the serum concentrations of angiogenic and antiangiogenic factors are implied in the pathogenesis of PE and have possible relevance in the diagnosis of the disease.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort
observational women
collecting maternal factors, biophysical and biochemical markers at 11-13 weeks of gestation.



Primary Outcome Measures :
  1. Early preeclampsia [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Selective intrauterine fetal growth restriction [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • pregnancies with major fetal abnormalities and those ending in termination, miscarriage or fetal death before 24 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990767


Contacts
Contact: Luming Sun, PhD 021-20261151 luming_sun@163.com

Locations
China, Shanghai
Shanghai First Maternity and Infant Hospital Recruiting
Shanghai, Shanghai, China, 200051
Contact: Luming Sun, PhD    021-20261151    luming_sun@163.com   
Sponsors and Collaborators
Shanghai First Maternity and Infant Hospital

Responsible Party: Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT02990767     History of Changes
Other Study ID Numbers: ShanghaiFMIH-FMU3
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications