Low Dose Aspirin in the Prevention of Preeclampsia in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-07

Study Completion Date

2019-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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aspirin

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

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

blank

Routine examination during pregnancy.

Group Type OTHER

Blank

Intervention Type OTHER

Routine examination during pregnancy.

Interventions

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Aspirin

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

Intervention Type DRUG

Blank

Routine examination during pregnancy.

Intervention Type OTHER

Other Intervention Names

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ASA acetyl salicylic acid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No