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PreeclampsiaPhase 3APPECNCT02797249

Low Dose Aspirin in the Prevention of Preeclampsia in China

A Phase 3 study testing Aspirin and Blank in people with Preeclampsia, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Preeclampsia
What is being tested?
Aspirin and Blank
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteChina
Study dates
7 Dec 2016to 30 Mar 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Allergy to aspirin
  • Asthma
  • Peptic ulcers
  • Severe heart, liver, renal disease who can not burden the experiment
  • Rheumatic immune disease
  • Mental disease
Show all 9Show fewer
  • Alcohol and drug abuse
  • Being in another drug experiment within 3 months
  • Difficult to follow-up

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Preeclampsia
Being tested
Aspirin, Blank
Keywords
preeclampsia, low dose aspirin, prevention
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Also called ASA, acetyl salicylic acid

    Low dose aspirin（100mg）per day starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy,taking at night.

  • BlankOther

    Routine examination during pregnancy.

Study groups in NCT02797249
Study groupRoleWhat they receive
aspirinExperimentalLow dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night.
Receives: Drug: Aspirin
blankOtherRoutine examination during pregnancy.
Receives: Other: Blank

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevention of preeclampsia

    The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.

    Measured: 6 months

Secondary outcomes (5)

  1. Prevention of preeclampsia at term

    The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. Preterm birth

    Measured: 6 months

  4. Abruptio placenta

    The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.

    Measured: 6 months

  5. Maternal hemorrhage and neonatal intracranial hemorrhage

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2016 (estimated)
  2. Study start7 Dec 2016
  3. Primary completion19 Jan 2019
  4. Study completion30 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02797249
Sponsor's protocol ID
APPEC-2016
Acronym
APPEC
Status last verified
Apr 2019
First submitted
7 Jun 2016
Last updated
1 May 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 24150027

  • 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.

    PubMed 25200125

  • 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/

    PubMed 23741776

  • 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.

    PubMed 24711050

  • 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.

    PubMed 17443552

  • 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.

    PubMed 20739360

  • 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.

    PubMed 34389292

  • 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.

    PubMed 30400937

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aspirin and Blank in people with Preeclampsia, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevention of preeclampsia (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02797249, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.

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