Low Dose Aspirin in the Prevention of Preeclampsia in China

Phase 3

Completed

• Conditions: Preeclampsia
• Interventions: Other: Blank; Drug: Aspirin

• Registration Number: NCT02797249
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Study Start: 2016-12-07
• Primary Completion: 2019-01-19
• Study Completion: 2019-03-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-28
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
blank	Blank	Routine examination during pregnancy.
aspirin	Aspirin	Low dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night.

Primary Outcome Measures

Name	Time	Method
Prevention of preeclampsia	6 months	The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China