Clinical Trial: Low Dose Aspirin in the Prevention of Preeclampsia in China

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Peking University First Hospital

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Peking University First Hospital

Dates:
Date Received: June 7, 2016
Date Started: November 2016
Date Completion: June 2018
Last Updated: December 6, 2016
Last Verified: December 2016