Clinical trial NCT02797249: Low Dose Aspirin in the Prevention of Preeclampsia in China
Official title: Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preeclampsia
Keywords: preeclampsia
low dose aspirin
prevention
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Prevention of preeclampsia
timeFrame: 6 months
Secondary outcomes:
measure: Prevention of preeclampsia at term
timeFrame: 6 months
measure: Fetal Growth Restriction
timeFrame: 6 months
measure: Preterm birth
timeFrame: 6 months
measure: Abruptio placenta
timeFrame: 6 months
measure: Maternal hemorrhage and neonatal intracranial hemorrhage
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Huixia Yang, PhD
role: STUDY_CHAIR
References:
citation: Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
citation: LeFevre ML; U.S. Preventive Services Task Force. Low-dose aspirin use for the prevention of morbidity and mortality from preeclampsia: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Dec 2;161(11):819-26. doi: 10.7326/M14-1884.
citation: WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK140561/
citation: Henderson JT, Whitlock EP, O'Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014 May 20;160(10):695-703. doi: 10.7326/M13-2844.
citation: Duley L, Henderson-Smart DJ, Meher S, King JF. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004659. doi: 10.1002/14651858.CD004659.pub2.
citation: Visintin C, Mugglestone MA, Almerie MQ, Nherera LM, James D, Walkinshaw S; Guideline Development Group. Management of hypertensive disorders during pregnancy: summary of NICE guidance. BMJ. 2010 Aug 25;341:c2207. doi: 10.1136/bmj.c2207. No abstract available.
citation: Lin L, Huai J, Li B, Zhu Y, Juan J, Zhang M, Cui S, Zhao X, Ma Y, Zhao Y, Mi Y, Ding H, Chen D, Zhang W, Qi H, Li X, Li G, Chen J, Zhang H, Yu M, Sun X, Yang H. A randomized controlled trial of low-dose aspirin for the prevention of preeclampsia in women at high risk in China. Am J Obstet Gynecol. 2022 Feb;226(2):251.e1-251.e12. doi: 10.1016/j.ajog.2021.08.004. Epub 2021 Aug 10.
citation: Lin L, Zhu Y, Li B, Yang H; APPEC Study Group. Low-dose aspirin in the prevention of pre-eclampsia in China (APPEC study): protocol for a multicentre randomized controlled trial. Trials. 2018 Nov 6;19(1):608. doi: 10.1186/s13063-018-2970-3.