Low Dose Aspirin in the Prevention of Preeclampsia in China

Preeclampsia Clinical Trial

— APPEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797249
• Other study ID #: APPEC-2016
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2016
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2019
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 30, 2019
• Est. primary completion date: January 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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:
• Blank
Routine examination during pregnancy.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

American College of Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-31. doi: 10.1097/01.AOG.0000437382.03963.88. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia. Geneva: World Health Organization; 2011. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of preeclampsia	The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.	6 months
Secondary	Prevention of preeclampsia at term	The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.	6 months
Secondary	Fetal Growth Restriction	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.	6 months
Secondary	Preterm birth		6 months
Secondary	Abruptio placenta	The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.	6 months
Secondary	Maternal hemorrhage and neonatal intracranial hemorrhage		6 months