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Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

Primary Purpose

Preeclampsia

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Aspirin

About this trial

This is an interventional prevention trial for Preeclampsia focused on measuring preeclampsia, aspirin, prediction, intervention, PAPP-A, PIGF, sFlt

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

1)Pregnant women assessed as at high risk of preeclampsia 2) live pregnancy 3) gestational weeks < 16 weeks 4) agree to randomized drug intervention studies 5) follow up regularly and obtain reliable pregnancy outcomes

Exclusion Criteria:

1)with severe fetal or chromosomal abnormalities 2) induced labor or spontaneous abortion due to social factors 3) absolute or relative contraindications to aspirin use (allergy to aspirin or other salicylate, or other ingredients of the drug;Acute gastrointestinal ulcer;Active bleeding;In patients with severe G6PD deficiency, acetylsalicylic acid may induce hemolysis or hemolytic anemia.Aspirin asthma)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

aspirin group

control group

Arm Description

aspirin,tablet,100/150mg per day,(BMI<30 100mg/d，BMI≥30 150mg/d)，from pregnancy weeks<16 to 35 weeks or the day of delivery.

with no intervention

Outcomes

Primary Outcome Measures

the rate of preeclampsia

Hypertensive onset after 20 weeks of gestation is accompanied by proteinuria,or with thrombocytopenia, impaired liver function, renal insufficiency,pulmonary edema,headache without other explanation and so on.

the rate of hypertensive disorder during pregnancy

gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome

the rate of placenta abruption

After 20 weeks of pregnancy, the placenta in its normal position is completely or partially removed from the uterine wall before delivery of the fetus

the rate of fetal growth restriction

The birth weight of the fetus is below two standard deviations of the average weight for the same gestational age or below the 10th percentile of normal weight for the same age

the rate of postpartum hemorrhage

Within 24 hours after the delivery of the fetus, the bleeding volume of vaginal delivery ≥500ml, cesarean delivery ≥1000ml

the time and type of delivery

gestational week, vaginal delivery and cesarean section

Secondary Outcome Measures

birth weight of newborn

macrosomia, normal weight, low birth weight

Apgar score for newborns

≥8；4-7,；≤3

the rate of Neonatal NICU occupancy rate

the day of NICU occupancy

Full Information

NCT ID

NCT04631627

First Posted

November 7, 2020

Last Updated

November 15, 2020

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04631627

Brief Title

Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

Official Title

A Prospective Muti-center Study of Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 16, 2020 (Anticipated)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study intends to adopt the method of multi-center prospective randomized controlled study. The aim of this study is to obtain localized excision values through a preeclampsia screening model established in early pregnancy, and to evaluate the efficacy of low-dose aspirin intervention for preeclampsia prevention in pregnant women at high risk of screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preeclampsia

Keywords

preeclampsia, aspirin, prediction, intervention, PAPP-A, PIGF, sFlt

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aspirin group

Arm Type

Active Comparator

Arm Description

aspirin,tablet,100/150mg per day,(BMI<30 100mg/d，BMI≥30 150mg/d)，from pregnancy weeks<16 to 35 weeks or the day of delivery.

Arm Title

control group

Arm Type

Sham Comparator

Arm Description

with no intervention

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

With the result of risk assessment for high risk and the risk of pregnant women, with each research center stratified random aspirin drug intervention, for each center screening high-risk and accord with the standard drug intervention study phase into eliminate pregnant women by using stochastic indicator 1:1 randomly into low-dose aspirin to prevent group and observation group, for each center in screening for risk and comply with the drug intervention study phase into the exclusion standard 1:1 by random indicator method pregnant women randomly into low-dose aspirin to prevent group and observation group.

Primary Outcome Measure Information:

Title

the rate of preeclampsia

Description

Time Frame

through study completion, an average of 1 year

Title

the rate of hypertensive disorder during pregnancy

Description

gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome

Time Frame

through study completion, an average of 1 year

Title

the rate of placenta abruption

Description

After 20 weeks of pregnancy, the placenta in its normal position is completely or partially removed from the uterine wall before delivery of the fetus

Time Frame

through study completion, an average of 1 year

Title

the rate of fetal growth restriction

Description

The birth weight of the fetus is below two standard deviations of the average weight for the same gestational age or below the 10th percentile of normal weight for the same age

Time Frame

through study completion, an average of 1 year

Title

the rate of postpartum hemorrhage

Description

Within 24 hours after the delivery of the fetus, the bleeding volume of vaginal delivery ≥500ml, cesarean delivery ≥1000ml

Time Frame

within 24 hours after the delivery

Title

the time and type of delivery

Description

gestational week, vaginal delivery and cesarean section

Time Frame

within 24 hours after the delivery

Secondary Outcome Measure Information:

Title

birth weight of newborn

Description

macrosomia, normal weight, low birth weight

Time Frame

delivery time

Title

Apgar score for newborns

Description

≥8；4-7,；≤3

Time Frame

delivery time

Title

the rate of Neonatal NICU occupancy rate

Description

the day of NICU occupancy

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

gestational women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1)Pregnant women assessed as at high risk of preeclampsia 2) live pregnancy 3) gestational weeks < 16 weeks 4) agree to randomized drug intervention studies 5) follow up regularly and obtain reliable pregnancy outcomes Exclusion Criteria: 1)with severe fetal or chromosomal abnormalities 2) induced labor or spontaneous abortion due to social factors 3) absolute or relative contraindications to aspirin use (allergy to aspirin or other salicylate, or other ingredients of the drug;Acute gastrointestinal ulcer;Active bleeding;In patients with severe G6PD deficiency, acetylsalicylic acid may induce hemolysis or hemolytic anemia.Aspirin asthma)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jinsong Gao, PhD

Phone

18601106857

Ext

69155810

gaojsong@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The aim of this study was to obtain localized excision values through a preeclampsia screening model established in early pregnancy, and to evaluate the efficacy of low-dose aspirin intervention for preeclampsia prevention in pregnant women at high risk of screening.

IPD Sharing Time Frame

31 June, 2022

Citations:

PubMed Identifier

19464502

Citation

Duley L. The global impact of pre-eclampsia and eclampsia. Semin Perinatol. 2009 Jun;33(3):130-7. doi: 10.1053/j.semperi.2009.02.010.

Results Reference

background

PubMed Identifier

25103301

Citation

Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

Results Reference

background

PubMed Identifier

24150027

Citation

Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

Results Reference

background

PubMed Identifier

22906914

Citation

Akolekar R, Syngelaki A, Poon L, Wright D, Nicolaides KH. Competing risks model in early screening for preeclampsia by biophysical and biochemical markers. Fetal Diagn Ther. 2013;33(1):8-15. doi: 10.1159/000341264. Epub 2012 Aug 16. Erratum In: Fetal Diagn Ther. 2013;34(1):43.

Results Reference

background

PubMed Identifier

25678383

Citation

Park F, Russo K, Williams P, Pelosi M, Puddephatt R, Walter M, Leung C, Saaid R, Rawashdeh H, Ogle R, Hyett J. Prediction and prevention of early-onset pre-eclampsia: impact of aspirin after first-trimester screening. Ultrasound Obstet Gynecol. 2015 Oct;46(4):419-23. doi: 10.1002/uog.14819. Epub 2015 Aug 31.

Results Reference

background

PubMed Identifier

29239588

Citation

Sentilhes L, Azria E, Schmitz T. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Dec 14;377(24):2399-400. doi: 10.1056/NEJMc1713798. No abstract available.

Results Reference

background

PubMed Identifier

30710362

Citation

FIGO Working Group on Good Clinical Practice in Maternal-Fetal Medicine. Good clinical practice advice: First trimester screening and prevention of pre-eclampsia in singleton pregnancy. Int J Gynaecol Obstet. 2019 Mar;144(3):325-329. doi: 10.1002/ijgo.12741. No abstract available.

Results Reference

background

PubMed Identifier

30797761

Citation

Wright D, Nicolaides KH. Aspirin delays the development of preeclampsia. Am J Obstet Gynecol. 2019 Jun;220(6):580.e1-580.e6. doi: 10.1016/j.ajog.2019.02.034. Epub 2019 Feb 21.

Results Reference

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Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

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