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NCT Number: NCT02797249

Low Dose Aspirin in the Prevention of Preeclampsia in China

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age between 12+ and 20 weeks of pregnancy
  • 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）.

  • Signed informed consent.

Exclusion criteria

  • Allergy to aspirin
  • Asthma
  • Peptic ulcers
  • Severe heart, liver, renal disease who can not burden the experiment
  • Rheumatic immune disease
  • Mental disease
  • Alcohol and drug abuse
  • Being in another drug experiment within 3 months
  • Difficult to follow-up

Treatment and study plan

Aspirin

Drug

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

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Other

Routine examination during pregnancy.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.

Acronym: APPEC

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2016
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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