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

April 28, 2019 updated by: Li Lin, Peking University First Hospital

Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aspirin
Low dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night.
Drug: Aspirin
Low dose aspirin（100mg）per day starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy,taking at night.
Other Names:
  • ASA
  • acetyl salicylic acid
Other: blank
Routine examination during pregnancy.
Other: Blank
Routine examination during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of preeclampsia
Time Frame: 6 months
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of preeclampsia at term
Time Frame: 6 months
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
6 months
Abruptio placenta
Time Frame: 6 months
The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.
6 months
Fetal Growth Restriction
Time Frame: 6 months
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.
6 months
Preterm birth
Time Frame: 6 months
6 months
Maternal hemorrhage and neonatal intracranial hemorrhage
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Study Chair: Huixia Yang, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2016

Primary Completion (Actual)

January 19, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 28, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPEC-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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