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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

Tracking Information
First Submitted Date  ICMJE June 7, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE December 7, 2016
Actual Primary Completion Date January 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
Prevention of preeclampsia [ Time Frame: 6 months ]
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02797249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • 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.
  • 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.
  • Preterm birth [ Time Frame: 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.
  • Maternal hemorrhage and neonatal intracranial hemorrhage [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Aspirin in the Prevention of Preeclampsia in China
Official Title  ICMJE Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Preeclampsia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: aspirin
    Low dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night.
    Intervention: Drug: Aspirin
  • blank
    Routine examination during pregnancy.
    Intervention: Other: Blank
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2016)
1000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2019
Actual Primary Completion Date January 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02797249
Other Study ID Numbers  ICMJE APPEC-2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Li Lin, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Huixia Yang, PhD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP