PreeclampsiaNCT05580523
Aspirin Versus Metformin in Pregnancies at High Risk of Preterm Preeclampsia: a 3-arm Randomized Controlled Trial
A study testing 75 mg acetylsalicylic acid, 1.5g Metformin and 150 mg acetylsalicylic acid in people with Preeclampsia, run by Chinese University of Hong Kong at 6 sites in China.
Trial summary
This is a prospective, multicenter, randomized controlled, double-blind trial of three treatment arms: (1) aspirin 75 mg/day vs. (2) aspirin 150 mg/day vs. (3) aspirin 75 mg/day with metformin 1.5 g/day from the first trimester to compare the incidence of preterm preeclampsia with delivery at <37 week's gestation… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- 75 mg acetylsalicylic acid, 1.5g Metformin and 150 mg acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 6 sitesChina
- Study dates
- 3 Jul 2023to 30 Nov 2025
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancies
- Live fetus at 11-13 weeks' gestation
- High-risk for preterm preeclampsia at 11-13 weeks by the algorithm combining maternal characteristics, medical and obstetric history, MAP and serum PlGF
- Informed and written consent
Who cannot join
- Age <18 years old
- Multiple pregnancies
- Treatment with low-dose aspirin and metformin at the time of screening
- Pregnancies complicated by major fetal abnormality identified during the first trimester
- Women with learning difficulties, or serious mental illness
- Bleeding disorders such as Von Willebrand's disease
Show all 14Show fewer
- Active peptic ulceration or gastrointestinal bleeding
- Hypersensitivity to aspirin, metformin hydrochloride and other biguanides
- Treatment with long term nonsteroidal anti-inflammatory medication
- Hyperemesis gravidarum
- Renal, liver or heart failure
- A serious medical condition
- Concurrent participation in another drug trial or at any time within the previous 28 days
- Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 5 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Xueyin Wang, PhD, +86-1083573227, xueyin0925@163.com
Yuchun Zhu, MD, +86-13911102732, zhu_yuchun@163.com
- Recruiting
West China Second University Hospital, Sichuan University
Chengdu, Sichuan
Yanping Zhang, MD, 18280173971, 1187256353@qq.com
Rong Zhou, MD, 18180609085, zhourong_hx@scu.edu.cn
- Withdrawn
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong
- Not yet recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Zhihua Li, MD, 18998321631, zhihuali2004@163.com
Dunjin Chen, MD, 18928916722, gzdrchen@gzhmc.edu.cn
- Recruiting
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality
Weirong Gu, MD,PhD, +86-13501674753, guweirong1237@fckyy.org.cn
Qiongjie Zhou, MD,PhD, +86-13671558865, zhouqiongjie1732@fckyy.org.cn
- Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality
Hao Ying, MD, +86 13371985049, stephenying_2011@163.com
Xiang Jiang, MD, +86 18502129988, jiangxiang79@163.com
About this study
This is a prospective, multicenter, randomized controlled, double-blind trial of three treatment arms: (1) aspirin 75 mg/day vs. (2) aspirin 150 mg/day vs. (3) aspirin 75 mg/day with metformin 1.5 g/day from the first trimester to compare the incidence of preterm preeclampsia with delivery at <37 week's gestation between the treatment arms, in order to determine the optimal therapeutic intervention for the prevention of preterm preeclampsia among Chinese women at high-risk of preeclampsia.
Read the detailed description
All women with singleton pregnancies who are attending for their routine hospital visit at 11-13 weeks' gestation will be invited to undergo screening for preeclampsia. We use a Bayes theorem-based method that combines maternal characteristics, medical and obstetric history together with mean arterial pressure (MAP) and serum placental growth factor (PlGF) level. Women who are deemed high-risk following first trimester combined screening (cutoff corresponding to a screen positive rate of 10%, e.g ≥1 in 80) will be invited to participate in the 3-arm randomized controlled trial.
- Conditions
- Preeclampsia
- Being tested
- 75 mg acetylsalicylic acid, 1.5g Metformin, 150 mg acetylsalicylic acid, Placebo of acetylsalicylic acid and Metformin
- Keywords
- Preterm preeclampsia, Aspirin, Metformin
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75 mg acetylsalicylic acidDrug
Also called 75mg Aspirin
75 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral
1.5g MetforminDrug
Also called 1.5g Glucophage
up to 1.5 g metformin (C4H11N5, CAS number 657-24-9) daily, Oral Dose increases from 0.5g to 1.0g to 1.5g
150 mg acetylsalicylic acidDrug
Also called 150mg Aspirin
150 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral
Placebo of acetylsalicylic acid and MetforminDrug
Pills with shape, color and smell same with acetylsalicylic acid and metformin, daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 75 mg and placebo | Experimental | A capsule of 75 mg aspirin plus an aspirin identical-appearing capsule of placebo to be taken orally once per night from enrolment until 36 weeks' gestation and metformin identical-appearing placebo capsules to be taken orally twice per day from enrolment until delivery. Receives: Drug: 75 mg acetylsalicylic acid; Drug: Placebo of acetylsalicylic acid and Metformin |
| Aspirin 150 mg and placebo | Experimental | Two capsules of 75 mg aspirin to be taken orally once per night from enrolment until 36 weeks' gestation and metformin identical-appearing placebo capsules to be taken orally twice per day from enrolment until delivery. Receives: Drug: 150 mg acetylsalicylic acid; Drug: Placebo of acetylsalicylic acid and Metformin |
| Aspirin 75 mg and Metformin 1.5 g | Experimental | A capsule of 75 mg aspirin plus an aspirin identical-appearing capsule of placebo to be taken orally once per night from enrolment until 36 weeks' gestation and metformin capsules (up to 750 mg) to be taken twice per day from enrolment until delivery Receives: Drug: 75 mg acetylsalicylic acid; Drug: 1.5g Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preterm preeclampsia(<37 weeks)
Preeclampsia will be defined as per the International Society for the Study of Hypertension in Pregnancy.The Proportions of delivery with preterm-preeclampsia between different intervention groups will be measured.
Measured: ≥20 weeks to <37 weeks of gestation
Secondary outcomes (9)
Adverse outcome of pregnancy at <37 weeks.
including preeclampsia requiring delivery, gestational age (SGA; <5th percentile) requiring delivery, miscarriage or still birth or placental abruption.
Measured: <37 weeks of gestation
Adverse outcome of pregnancy at <34 weeks.
including preeclampsia requiring delivery, gestational age (SGA; <5th percentile) requiring delivery, miscarriage or still birth or placental abruption.
Measured: <34 weeks of gestation
Adverse outcome of pregnancy at ≥37 weeks
including preeclampsia requiring delivery, gestational age (SGA; <5th percentile) requiring delivery, stillbirth or placental abruption.
Measured: ≥37 weeks of gestation
Neonatal mortality
A neonatal death is a death during 0-27 days of life.
Measured: During the first 28 days of life (0-27days)
Neonatal morbidity
Composite neonatal morbidity (any one of the following): >grade II intra-ventricular hemorrhage; neonatal sepsis confirmed by cultures; neonatal anemia requiring transfusion; respiratory distress syndrome requiring surfactant and ventilation; necrotising enterocolitis requiring surgical intervention.
Measured: During the first 28 days of life (0-27days)
Neonatal birthweight below the 3rd,5th and 10th centile.
Birthweight and birthweight percentile for gestational age at delivery is calculated using a normal range derived in a Chinese population.
Measured: At delivery
Stillbirth or neonatal death
Stillbirth: the death of a baby before or during birth after 24 weeks of gestation. Neonatal death: the death of a baby within the first 28 days of life.
Measured: At delivery
<34 weeks and <37 weeks spontaneous preterm delivery
Spontaneous delivery at <34 weeks(early preterm) and at <37 weeks(total preterm) includes those with spontaneous onset of labor and those with preterm pre-labor rupture of membranes (PPROM).
Measured: At spontaneous delivery
Gestational age
Gestation is the period of time between conception and birth. During this time, the baby grows and develops inside the mother's womb. Gestational age is the common term used during pregnancy to describe how far along the pregnancy is. It is measured in weeks, from the first day of the woman's last menstrual cycle to the current date. A normal pregnancy can range from 38 to 42 weeks.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start3 Jul 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University, Shanghai First Maternity and Infant Hospital, West China Second University Hospital, Peking University First Hospital
- Responsible party
- Principal investigator, Chiu Yee Liona Poon, Chinese University of Hong Kong
- Investigators
- Chiu Yee, Liona Poon, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580523
- Sponsor's protocol ID
- MOST-AVERT
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Women's Heart Health Group of Chinese Society of Cardiology of Chinese Medical Association; Hypertension Group of Chinese Society of Cardiology of Chinese Medical Association. [Expert consensus on blood pressure management in hypertensive disorders of pregnancy (2019)]. Zhonghua Xin Xue Guan Bing Za Zhi. 2020 Mar 24;48(3):195-204. doi: 10.3760/cma.j.cn112148-20191024-00652. Chinese.
PubMed 32234176Witlin AG, Saade GR, Mattar F, Sibai BM. Predictors of neonatal outcome in women with severe preeclampsia or eclampsia between 24 and 33 weeks' gestation. Am J Obstet Gynecol. 2000 Mar;182(3):607-11. doi: 10.1067/mob.2000.104224.
PubMed 10739516Irgens HU, Reisaeter L, Irgens LM, Lie RT. Long term mortality of mothers and fathers after pre-eclampsia: population based cohort study. BMJ. 2001 Nov 24;323(7323):1213-7. doi: 10.1136/bmj.323.7323.1213.
PubMed 11719411von Dadelszen P, Magee LA, Roberts JM. Subclassification of preeclampsia. Hypertens Pregnancy. 2003;22(2):143-8. doi: 10.1081/PRG-120021060.
PubMed 12908998Chaemsaithong P, Pooh RK, Zheng M, Ma R, Chaiyasit N, Tokunaka M, Shaw SW, Seshadri S, Choolani M, Wataganara T, Yeo GSH, Wright A, Leung WC, Sekizawa A, Hu Y, Naruse K, Saito S, Sahota D, Leung TY, Poon LC. Prospective evaluation of screening performance of first-trimester prediction models for preterm preeclampsia in an Asian population. Am J Obstet Gynecol. 2019 Dec;221(6):650.e1-650.e16. doi: 10.1016/j.ajog.2019.09.041. Epub 2019 Oct 4.
PubMed 31589866Akolekar R, Syngelaki A, Sarquis R, Zvanca M, Nicolaides KH. Prediction of early, intermediate and late pre-eclampsia from maternal factors, biophysical and biochemical markers at 11-13 weeks. Prenat Diagn. 2011 Jan;31(1):66-74. doi: 10.1002/pd.2660.
PubMed 21210481Askie LM, Duley L, Henderson-Smart DJ, Stewart LA; PARIS Collaborative Group. Antiplatelet agents for prevention of pre-eclampsia: a meta-analysis of individual patient data. Lancet. 2007 May 26;369(9575):1791-1798. doi: 10.1016/S0140-6736(07)60712-0.
PubMed 17512048Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
PubMed 28657417Bujold E, Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, Forest JC, Giguere Y. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis. Obstet Gynecol. 2010 Aug;116(2 Pt 1):402-414. doi: 10.1097/AOG.0b013e3181e9322a.
PubMed 20664402Roberge S, Villa P, Nicolaides K, Giguere Y, Vainio M, Bakthi A, Ebrashy A, Bujold E. Early administration of low-dose aspirin for the prevention of preterm and term preeclampsia: a systematic review and meta-analysis. Fetal Diagn Ther. 2012;31(3):141-6. doi: 10.1159/000336662. Epub 2012 Mar 21.
PubMed 22441437Roberge S, Nicolaides K, Demers S, Hyett J, Chaillet N, Bujold E. The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Feb;216(2):110-120.e6. doi: 10.1016/j.ajog.2016.09.076. Epub 2016 Sep 15.
PubMed 27640943Caron N, Rivard GE, Michon N, Morin F, Pilon D, Moutquin JM, Rey E. Low-dose ASA response using the PFA-100 in women with high-risk pregnancy. J Obstet Gynaecol Can. 2009 Nov;31(11):1022-1027. doi: 10.1016/S1701-2163(16)34346-8.
PubMed 20175340Rey E, Rivard GE. Is testing for aspirin response worthwhile in high-risk pregnancy? Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):38-42. doi: 10.1016/j.ejogrb.2011.02.026. Epub 2011 Mar 25.
PubMed 21440360Hypertensive Disorders in Pregnancy Subgroup, Chinese Society of Obstetrics and Gynecology, Chinese Medical Association. [Diagnosis and treatment of hypertension and pre-eclampsia in pregnancy: a clinical practice guideline in China（2020）]. Zhonghua Fu Chan Ke Za Zhi. 2020 Apr 25;55(4):227-238. doi: 10.3760/cma.j.cn112141-20200114-00039. Chinese.
PubMed 32375429Brownfoot FC, Hastie R, Hannan NJ, Cannon P, Tuohey L, Parry LJ, Senadheera S, Illanes SE, Kaitu'u-Lino TJ, Tong S. Metformin as a prevention and treatment for preeclampsia: effects on soluble fms-like tyrosine kinase 1 and soluble endoglin secretion and endothelial dysfunction. Am J Obstet Gynecol. 2016 Mar;214(3):356.e1-356.e15. doi: 10.1016/j.ajog.2015.12.019. Epub 2015 Dec 22.
PubMed 26721779
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Versus Metformin in Pregnancies at High Risk of Preterm Preeclampsia: a 3-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05580523
- Acronym / sponsor ID
- MOST-AVERT
- Conditions
- Preeclampsia
- Keywords
- Preterm preeclampsia, Aspirin, Metformin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University, Shanghai First Maternity and Infant Hospital, West China Second University Hospital, Peking University First Hospital
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized controlled, double-blind trial of three treatment arms: (1) aspirin 75 mg/day vs. (2) aspirin 150 mg/day vs. (3) aspirin 75 mg/day with metformin 1.5 g/day from the first trimester to compare the incidence of preterm preeclampsia with delivery at <37 week's gestation between the treatment arms, in order to determine the optimal therapeutic intervention for the prevention of preterm preeclampsia among Chinese women at high-risk of preeclampsia.
Detailed description
All women with singleton pregnancies who are attending for their routine hospital visit at 11-13 weeks' gestation will be invited to undergo screening for preeclampsia. We use a Bayes theorem-based method that combines maternal characteristics, medical and obstetric history together with mean arterial pressure (MAP) and serum placental growth factor (PlGF) level. Women who are deemed high-risk following first trimester combined screening (cutoff corresponding to a screen positive rate of 10%, e.g ≥1 in 80) will be invited to participate in the 3-arm randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin 75 mg and placebo | Experimental | Drug: 75 mg acetylsalicylic acid, Drug: Placebo of acetylsalicylic acid and MetforminA capsule of 75 mg aspirin plus an aspirin identical-appearing capsule of placebo to be taken orally once per night from enrolment until 36 weeks' gestation and metformin identical-appearing placebo capsules to be taken orally twice per day from enrolment until delivery. |
| Aspirin 150 mg and placebo | Experimental | Drug: 150 mg acetylsalicylic acid, Drug: Placebo of acetylsalicylic acid and MetforminTwo capsules of 75 mg aspirin to be taken orally once per night from enrolment until 36 weeks' gestation and metformin identical-appearing placebo capsules to be taken orally twice per day from enrolment until delivery. |
| Aspirin 75 mg and Metformin 1.5 g | Experimental | Drug: 75 mg acetylsalicylic acid, Drug: 1.5g MetforminA capsule of 75 mg aspirin plus an aspirin identical-appearing capsule of placebo to be taken orally once per night from enrolment until 36 weeks' gestation and metformin capsules (up to 750 mg) to be taken twice per day from enrolment until delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancies
- Live fetus at 11-13 weeks' gestation
- High-risk for preterm preeclampsia at 11-13 weeks by the algorithm combining maternal characteristics, medical and obstetric history, MAP and serum PlGF
- Informed and written consent
Key exclusion criteria (14 listed)
- Age <18 years old
- Multiple pregnancies
- Treatment with low-dose aspirin and metformin at the time of screening
- Pregnancies complicated by major fetal abnormality identified during the first trimester
- Women with learning difficulties, or serious mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 75 mg acetylsalicylic acidAlso: 75mg Aspirin75 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral | Drug | Aspirin 75 mg and Metformin 1.5 g, Aspirin 75 mg and placebo |
| 1.5g MetforminAlso: 1.5g Glucophageup to 1.5 g metformin (C4H11N5, CAS number 657-24-9) daily, Oral Dose increases from 0.5g to 1.0g to 1.5g | Drug | Aspirin 75 mg and Metformin 1.5 g |
| 150 mg acetylsalicylic acidAlso: 150mg Aspirin150 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral | Drug | Aspirin 150 mg and placebo |
| Placebo of acetylsalicylic acid and MetforminPills with shape, color and smell same with acetylsalicylic acid and metformin, daily, oral | Drug | Aspirin 150 mg and placebo, Aspirin 75 mg and placebo |
Primary outcome
Incidence of preterm preeclampsia(<37 weeks)
Time frame: ≥20 weeks to <37 weeks of gestation
Preeclampsia will be defined as per the International Society for the Study of Hypertension in Pregnancy.The Proportions of delivery with preterm-preeclampsia between different intervention groups will be measured.
9 secondary outcomes
Adverse outcome of pregnancy at <37 weeks.
Time frame: <37 weeks of gestation
Adverse outcome of pregnancy at <34 weeks.
Time frame: <34 weeks of gestation
Adverse outcome of pregnancy at ≥37 weeks
Time frame: ≥37 weeks of gestation
Neonatal mortality
Time frame: During the first 28 days of life (0-27days)
Neonatal morbidity
Time frame: During the first 28 days of life (0-27days)
Neonatal birthweight below the 3rd,5th and 10th centile.
Time frame: At delivery
Stillbirth or neonatal death
Time frame: At delivery
<34 weeks and <37 weeks spontaneous preterm delivery
Time frame: At spontaneous delivery
Gestational age
Time frame: At delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 32234176Women's Heart Health Group of Chinese Society of Cardiology of Chinese Medical Association; Hypertension Group of Chinese Society of Cardiology of Chinese Medical Association. [Expert consensus on blood pressure management in hypertensive disorders of pregnancy (2019)]. Zhonghua Xin Xue Guan Bing Za Zhi. 2020 Mar 24;48(3):195-204. doi: 10.3760/cma.j.cn112148-20191024-00652. Chinese.
- Background: PubMed 10739516Witlin AG, Saade GR, Mattar F, Sibai BM. Predictors of neonatal outcome in women with severe preeclampsia or eclampsia between 24 and 33 weeks' gestation. Am J Obstet Gynecol. 2000 Mar;182(3):607-11. doi: 10.1067/mob.2000.104224.
- Background: PubMed 11719411Irgens HU, Reisaeter L, Irgens LM, Lie RT. Long term mortality of mothers and fathers after pre-eclampsia: population based cohort study. BMJ. 2001 Nov 24;323(7323):1213-7. doi: 10.1136/bmj.323.7323.1213.
- Background: PubMed 12908998von Dadelszen P, Magee LA, Roberts JM. Subclassification of preeclampsia. Hypertens Pregnancy. 2003;22(2):143-8. doi: 10.1081/PRG-120021060.
- Background: PubMed 31589866Chaemsaithong P, Pooh RK, Zheng M, Ma R, Chaiyasit N, Tokunaka M, Shaw SW, Seshadri S, Choolani M, Wataganara T, Yeo GSH, Wright A, Leung WC, Sekizawa A, Hu Y, Naruse K, Saito S, Sahota D, Leung TY, Poon LC. Prospective evaluation of screening performance of first-trimester prediction models for preterm preeclampsia in an Asian population. Am J Obstet Gynecol. 2019 Dec;221(6):650.e1-650.e16. doi: 10.1016/j.ajog.2019.09.041. Epub 2019 Oct 4.
- Background: PubMed 21210481Akolekar R, Syngelaki A, Sarquis R, Zvanca M, Nicolaides KH. Prediction of early, intermediate and late pre-eclampsia from maternal factors, biophysical and biochemical markers at 11-13 weeks. Prenat Diagn. 2011 Jan;31(1):66-74. doi: 10.1002/pd.2660.
- Background: PubMed 17512048Askie LM, Duley L, Henderson-Smart DJ, Stewart LA; PARIS Collaborative Group. Antiplatelet agents for prevention of pre-eclampsia: a meta-analysis of individual patient data. Lancet. 2007 May 26;369(9575):1791-1798. doi: 10.1016/S0140-6736(07)60712-0.
- Background: PubMed 28657417Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
- Background: PubMed 20664402Bujold E, Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, Forest JC, Giguere Y. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis. Obstet Gynecol. 2010 Aug;116(2 Pt 1):402-414. doi: 10.1097/AOG.0b013e3181e9322a.
- Background: PubMed 22441437Roberge S, Villa P, Nicolaides K, Giguere Y, Vainio M, Bakthi A, Ebrashy A, Bujold E. Early administration of low-dose aspirin for the prevention of preterm and term preeclampsia: a systematic review and meta-analysis. Fetal Diagn Ther. 2012;31(3):141-6. doi: 10.1159/000336662. Epub 2012 Mar 21.
- Background: PubMed 27640943Roberge S, Nicolaides K, Demers S, Hyett J, Chaillet N, Bujold E. The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Feb;216(2):110-120.e6. doi: 10.1016/j.ajog.2016.09.076. Epub 2016 Sep 15.
- Background: PubMed 20175340Caron N, Rivard GE, Michon N, Morin F, Pilon D, Moutquin JM, Rey E. Low-dose ASA response using the PFA-100 in women with high-risk pregnancy. J Obstet Gynaecol Can. 2009 Nov;31(11):1022-1027. doi: 10.1016/S1701-2163(16)34346-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiu Yee, Liona Poon, MD principal investigator
Chinese University of Hong Kong
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 75 mg acetylsalicylic acid, 1.5g Metformin and 150 mg acetylsalicylic acid in people with Preeclampsia, run by Chinese University of Hong Kong at 6 sites 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiu Yee, Liona Poon, MD ((852) 3505 1290, liona.poon@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preterm preeclampsia(<37 weeks) (time frame: ≥20 weeks to <37 weeks of gestation). 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 NCT05580523, which also lists 21 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 8 Nov 2023.