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Prediction of Preeclampsia by Comprehensive Markers.

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ClinicalTrials.gov Identifier: NCT03665623
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
Preeclampsia is one of the most serious complications in pregnancy that causes maternal death and preterm delivery, the incidence rate is about 5~10% in Chinese population. Series studies has show that multiple markers in early pregnancy has the potential to predict preeclampsia effectively but has show crowd difference. Since preeclampsia is a placental-derived disease, early prevention with aspirin and other intervention has the potential to "treat" the disease .Preeclampsia prediction will change the way doctors treat the disease and profoundly improve both the outcome of mother and the baby.

Condition or disease
Pre-Eclampsia

Detailed Description:
The prospective multi-center observational study aimed to recruit at least 12,000 pregnant woman during the first trimester conducted among 21 medical centers in China. The medical history of each candidate was recorded , blood pressure was measured , blood sample was taken between 11 gestational weeks and 13+6 gestational weeks, to get the PlGF and PAPPA tested. Routine ultrasound was taken with measurement of the uterine artery pulsatility index. The results of the recruited patients were not released to the patients or the doctor. Pregnancy outcome was recorded as to whether the women develop preeclampsia , the SGA babies, or low birth Apgar score and other preeclampsia related adverse maternal and neonatal outcomes. The basic medical information, the mean artery pressure, the PlGF and PAPPA MOM, the UtA PI were used in combination to do the risk stratification, and to develop prediction model for Chinese people.

Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multi-center Study on the Prediction of Preeclampsia by Comprehensive Markers in Early Pregnancy.
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. preeclampsia , early-onset preeclampsia and late-onset preeclampsia [ Time Frame: July,2018 to July,2019 ]
    Primary outcome was whether women in the study population develop preeclampsia, and whether the preeclampsia was diagnosed before or after 34 weeks of gestation: 1.preeclampsia was defined as denovo hypertension at or after 20 weeks' gestation accompanied by proteinuria or evidence of end‐organ dysfunction.2. early-onset preeclampsia was preeclampsia diagnosed before 34 gestational weeks.


Secondary Outcome Measures :
  1. Gestational age at delivery [ Time Frame: July,2018 to October,2019 ]
    preterm delivery will be defined as gestational age before 37 completed weeks, severe preterm delivery will be defined as gestational age before 32 completed weeks

  2. Fetal preeclampsia-related adverse outcomes [ Time Frame: July,2018 to October,2019 ]
    Fetal preeclampsia-related adverse outcomes are defined as perinatal/fetal death, iatrogenic delivery earlier than 34 weeks, intrauterine growth restriction (IUGR), placental abruption, respiratory distress, necrotizing enterocolitis or intraventricular hemorrhage.

  3. Maternal preeclampsia-related adverse outcomes [ Time Frame: July,2018 to October,2019 ]
    Maternal preeclampsia-related adverse outcomes are defined as maternal death, pulmonary edema, acute renal failure, cerebral hemorrhage, and cerebral thrombosis or disseminated intravascular coagulation.


Biospecimen Retention:   Samples Without DNA
maternal serum samples.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   we recruit pregnant women who visit the hospital before 14 gestational weeks and agreed to participate the study and have a pregnancy outcome.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
we aimed to recruit as many as possible the women without discrimination during the study periods.
Criteria

Inclusion Criteria:

  1. gestational weeks between 11~13+6
  2. agreed to participate the study
  3. the baby dot not have chromosome abnormality and has a recorded pregnancy outcome.

Exclusion Criteria:

  1. first obstetric visit beyond 14 gestational weeks
  2. artificial abortion due to medical reasons or do not have pregnancy outcome.
  3. refused to participate the study.

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): NCT03665623


Contacts
Contact: Jinsong Gao, professor +8618601106857 gaojsong@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 010
Contact: Jing Hu, resident    +8618026941630    oghujing@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03665623     History of Changes
Other Study ID Numbers: preeclampsia prediction study
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking Union Medical College Hospital:
prediction
early pregnancy
preeclampsia
multiple markers

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