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Low Dose Aspirin in the Prevention of Preeclampsia in China (APPEC)

Primary Purpose

Preeclampsia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aspirin
Blank
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia focused on measuring preeclampsia, low dose aspirin, prevention

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Gestational age between 12+ and 20 weeks of pregnancy

  2. High risk of preeclampsia, based in clinical risk factors as:

    2.1 if they have one or more of the following risk factors： Preeclampsia in a previous pregnancy ,Diabetes Mellitus(Type 1 or 2),Chronic Hypertension .

    2.2 if they have two or more of the following risk factors: Pre-pregnancy Body Mass Index ≥28kg/m2, Elderly pregnancy(age ≥35 years), Mother or sisters with preeclampsia in a previous pregnancy, Primiparity or Famliy history (Mother or sister that developed preeclampsia in a previous pregnancy）.

  3. Signed informed consent.

Exclusion Criteria:

  1. Allergy to aspirin
  2. Asthma
  3. Peptic ulcers
  4. Severe heart, liver, renal disease who can not burden the experiment
  5. Rheumatic immune disease
  6. Mental disease
  7. Alcohol and drug abuse
  8. Being in another drug experiment within 3 months
  9. Difficult to follow-up

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

aspirin

blank

Arm Description

Low dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night.

Routine examination during pregnancy.

Outcomes

Primary Outcome Measures

Prevention of preeclampsia
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.

Secondary Outcome Measures

Prevention of preeclampsia at term
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
Fetal Growth Restriction
The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.
Preterm birth
Abruptio placenta
The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.
Maternal hemorrhage and neonatal intracranial hemorrhage

Full Information

First Posted
June 7, 2016
Last Updated
April 28, 2019
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02797249
Brief Title
Low Dose Aspirin in the Prevention of Preeclampsia in China
Acronym
APPEC
Official Title
Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2016 (Actual)
Primary Completion Date
January 19, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin in Chinese pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical characteristics aiming to reduce the incidence of preeclampsia.
Detailed Description
Detailed Description: The investigators will conduct a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in Chinese pregnant women who are evaluated with risk factors. The investigators will also obtain biological specimen including maternal blood, cord blood, placenta specimen and etc. for basic science studies. Rationale for Design:There is a lack of evidences or guideline of aspirin using in preventing PE for Chinese women. The investigators will conduct a randomized control trial, which is the 'gold standard' of research design, hoping to answer the question.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
preeclampsia, low dose aspirin, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aspirin
Arm Type
Experimental
Arm Description
Low dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night.
Arm Title
blank
Arm Type
Other
Arm Description
Routine examination during pregnancy.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
ASA, acetyl salicylic acid
Intervention Description
Low dose aspirin（100mg）per day starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy,taking at night.
Intervention Type
Other
Intervention Name(s)
Blank
Intervention Description
Routine examination during pregnancy.
Primary Outcome Measure Information:
Title
Prevention of preeclampsia
Description
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Prevention of preeclampsia at term
Description
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
Time Frame
6 months
Title
Fetal Growth Restriction
Description
The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.
Time Frame
6 months
Title
Preterm birth
Time Frame
6 months
Title
Abruptio placenta
Description
The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.
Time Frame
6 months
Title
Maternal hemorrhage and neonatal intracranial hemorrhage
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age between 12+ and 20 weeks of pregnancy High risk of preeclampsia, based in clinical risk factors as: 2.1 if they have one or more of the following risk factors： Preeclampsia in a previous pregnancy ,Diabetes Mellitus(Type 1 or 2),Chronic Hypertension . 2.2 if they have two or more of the following risk factors: Pre-pregnancy Body Mass Index ≥28kg/m2, Elderly pregnancy(age ≥35 years), Mother or sisters with preeclampsia in a previous pregnancy, Primiparity or Famliy history (Mother or sister that developed preeclampsia in a previous pregnancy）. Signed informed consent. Exclusion Criteria: Allergy to aspirin Asthma Peptic ulcers Severe heart, liver, renal disease who can not burden the experiment Rheumatic immune disease Mental disease Alcohol and drug abuse Being in another drug experiment within 3 months Difficult to follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huixia Yang, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
25200125
Citation
LeFevre ML; U.S. Preventive Services Task Force. Low-dose aspirin use for the prevention of morbidity and mortality from preeclampsia: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Dec 2;161(11):819-26. doi: 10.7326/M14-1884.
Results Reference
background
PubMed Identifier
23741776
Citation
WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK140561/
Results Reference
background
PubMed Identifier
24711050
Citation
Henderson JT, Whitlock EP, O'Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014 May 20;160(10):695-703. doi: 10.7326/M13-2844.
Results Reference
background
PubMed Identifier
17443552
Citation
Duley L, Henderson-Smart DJ, Meher S, King JF. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004659. doi: 10.1002/14651858.CD004659.pub2.
Results Reference
background
PubMed Identifier
20739360
Citation
Visintin C, Mugglestone MA, Almerie MQ, Nherera LM, James D, Walkinshaw S; Guideline Development Group. Management of hypertensive disorders during pregnancy: summary of NICE guidance. BMJ. 2010 Aug 25;341:c2207. doi: 10.1136/bmj.c2207. No abstract available.
Results Reference
background
PubMed Identifier
34389292
Citation
Lin L, Huai J, Li B, Zhu Y, Juan J, Zhang M, Cui S, Zhao X, Ma Y, Zhao Y, Mi Y, Ding H, Chen D, Zhang W, Qi H, Li X, Li G, Chen J, Zhang H, Yu M, Sun X, Yang H. A randomized controlled trial of low-dose aspirin for the prevention of preeclampsia in women at high risk in China. Am J Obstet Gynecol. 2022 Feb;226(2):251.e1-251.e12. doi: 10.1016/j.ajog.2021.08.004. Epub 2021 Aug 10.
Results Reference
derived
PubMed Identifier
30400937
Citation
Lin L, Zhu Y, Li B, Yang H; APPEC Study Group. Low-dose aspirin in the prevention of pre-eclampsia in China (APPEC study): protocol for a multicentre randomized controlled trial. Trials. 2018 Nov 6;19(1):608. doi: 10.1186/s13063-018-2970-3.
Results Reference
derived

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Low Dose Aspirin in the Prevention of Preeclampsia in China

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