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

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ClinicalTrials.gov Identifier: NCT02797249
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Li Lin, 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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Aspirin Other: Blank Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.
Actual Study Start Date : December 7, 2016
Actual Primary Completion Date : January 19, 2019
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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

blank
Routine examination during pregnancy.
Other: Blank
Routine examination during pregnancy.




Primary Outcome Measures :
  1. Prevention of preeclampsia [ Time Frame: 6 months ]
    The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Preterm birth [ Time Frame: 6 months ]
  4. Abruptio placenta [ Time Frame: 6 months ]
    The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.

  5. Maternal hemorrhage and neonatal intracranial hemorrhage [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797249


Locations
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China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Study Chair: Huixia Yang, PhD Peking University First Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Li Lin, PhD, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02797249     History of Changes
Other Study ID Numbers: APPEC-2016
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Li Lin, Peking University First Hospital:
preeclampsia
low dose aspirin
prevention

Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Aspirin
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents