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

Peking University

Status and phase: Completed; Phase 3

Conditions: Preeclampsia

Treatments: Drug: Aspirin; Other: Blank

Study type: Interventional

Funder types: Other

Identifiers

NCT02797249

APPEC-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

aspirin

Experimental group

Description:

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

Treatment:

Drug: Aspirin

blank

Other group

Description:

Routine examination during pregnancy.

Treatment:

Other: Blank