Pre-EclampsiaPhase 4NCT04908982
Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension
A Phase 4 study testing Aspirin 81mg in people with Pre-Eclampsia, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Aspirin 81mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2021to 31 May 2023
- Phase
- Phase 4
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women from 6 0/7 to 13 6/7 weeks gestation
- 18-50 years old
- Systolic blood pressure of 130-139 mmHg or Diastolic blood pressure of 80-89 mmHg
Who cannot join
- History of preeclampsia
- Multifetal gestation
- Chronic hypertension
- Pre-gestational diabetes
- Renal disease
- Autoimmune disease
Show all 9Show fewer
- Aspirin allergy or hypersensitivity
- Presence of nasal polyps
- History of aspirin-induced bronchospasm
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School
Norfolk, Virginia, 23507
Tetsuya Kawakita, MD, 757-446-7900, kawakit@evms.edu
Kristin Ayers, MPH, 7574460579, ayerskl@evms.edu
About this study
Official title: Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension: A Pilot Study
In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Based on new criteria, stage 1 hypertension is associated with a 2-3 fold increased risk of preeclampsia. There are no data regarding prevention of preeclampsia in women with stage 1 hypertension. Low-dose aspirin has been used during pregnancy to prevent preeclampsia for women at high-risk for preeclampsia. Although the precise mechanism remains uncertain, it is possible that low-dose aspirin improves placental perfusion, which results in a decreased rate of preeclampsia. A study that examines the effect of low-dose aspirin on placenta vasculature and tissue elastography by using novel ultrasound tools would be useful. The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening. They found a significant decrease in the rate of preterm preeclampsia (4.3% vs. 1.6%; P <0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability in the U.S. women with stage 1 hypertension is limited. Our pilot study will examine 1) the effect of low-dose aspirin 81 mg in women with stage 1 hypertension on placental vasculature and shear-wave elastography; 2) the rate of preterm preeclampsia in women with stage 1 hypertension in a control group and in pregnancies treated with low-dose aspirin 81 mg; 3) feasibility of conducting a larger multicenter randomized controlled trial on this subject.
Read the detailed description
In 2017, the American College of Cardiology (ACC) and the American Heart Association (AHA) changed the diagnostic criteria for hypertension in non-pregnant adults.1 The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg.2 Stage 1 hypertension based on the new criteria is associated with an increased risk of preeclampsia compared to normal BP (15-16% vs. 5-7%).3, 4 However, the American College of Obstetricians and Gynecologists (ACOG) continues to diagnose chronic hypertension in pregnancy as a systolic BP above 140 mm Hg and a diastolic BP of 90 mm Hg since there are no data regarding prevention of preeclampsia in women with stage 1 hypertension.5
Preeclampsia is a multi-organ, progressive disorder characterized by the new onset of hypertension with proteinuria or end-organ dysfunction.6 Preeclampsia is a major cause of morbidity such as eclampsia, pulmonary edema, myocardial infarction, stroke, coagulopathy, and renal failure and a leading cause of iatrogenic preterm birth and maternal mortality.7 Preeclampsia is also an economic burden to the health care system. The mean combined maternal and infant medical care costs for women with preeclampsia are significantly higher than those of uncomplicated women ($41,790 vs. $13,187 in 2015 dollars) with the main cost drivers being infant health care costs due to prematurity.8
It is hypothesized that preeclampsia is caused by an imbalance in prostacyclin and thromboxane A2 (TXA2) resulting in vascular disturbances and coagulation defects. Low-dose aspirin (60-150 mg/day) irreversibly acetylates cyclooxygenase (COX)-1, which results in decreased platelet synthesis of TXA2 without affecting vascular wall production of prostacyclin.9. 10 However, it is likely that preeclampsia is a result of poor placentation. In this pilot study, we will examine the effect of low-dose aspirin on placental perfusion by using novel ultrasound tools (Superb Micro-Vascular Imaging [SMI], Shear Wave Elastography [SWE], intensity analysis [IA], and Attenuation Imaging [ATI]). Superb Micro-Vascular Imaging (SMI) is a novel Doppler technique designed to improve the visualization of microscopic vessels, through a new adaptive algorithm, which dramatically enhances microvascular flow and removes artifacts. Shear Wave Elastography (SWE) is a new noninvasive ultrasound-based technology for the evaluation of soft tissue stiffness. Intensity Analysis (IA) is a technique that analyzes tissue homogeneity. Attenuation Imagining (ATI) measures beam attenuation by quantifying an attenuation coefficient (AC db/cm/MHz). Our group has developed longitudinal nomograms on placental vasculature to include uterine and spiral arteries on the maternal side and fetal placental arterioles and umbilical artery on the fetal side.11 Furthermore, longitudinal nomograms related to placental tissue structure, including shear wave elastography has been developed.12
Although the precise mechanism is uncertain, low-dose aspirin has been used during pregnancy to prevent or delay the onset of preeclampsia for women at high-risk for preeclampsia.13 The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening.14 They found a significant decrease in the rate of preterm preeclampsia less than 37 weeks of gestation (4.3% vs. 1.6%; P <0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability of aspirin preeclampsia prevention in the U.S. women with stage 1 hypertension is limited.
Our long-term goal is to reduce preterm preeclampsia in women with stage 1 hypertension. We hypothesize that 1) spiral artery Pulsatility Index (PI) and Peak Systolic Velocity (PSV) and SWE is lower in women with stage 1 hypertension who receive low-dose aspirin 81 mg compared to those who do not receive low-dose aspirin; 2) Women with stage 1 hypertension who receive low-dose aspirin 81 mg have a lower rate of preterm preeclampsia compared to those who do not receive low-dose aspirin. To examine these hypotheses in a future, large randomized, controlled trial, our aims for this pilot study include the following:
Aim 1. To examine the change in placental vasculature and tissue elastography in women with stage 1 hypertension who receive low-dose aspirin 81 mg and those who do not receive low-dose aspirin.
Aim 2. To examine rates of preterm preeclampsia in women with stage 1 hypertension who receive low-dose aspirin 81 mg and those who do not receive low-dose aspirin.
Aim 3. To examine eligibility rate, recruitment rate, study compliance, and loss of follow-up rate. This information will be useful to assess feasibility of a future multicenter randomized controlled trial.
In summary, women with stage 1 hypertension are at an increased risk of preeclampsia. Low-dose aspirin may reduce the rate of preterm preeclampsia in women with stage 1 hypertension. In this pilot study, we will conduct an open label randomized controlled trial and obtain necessary information for a future multicenter randomized controlled trial.
- Conditions
- Pre-Eclampsia
- Being tested
- Aspirin 81mg
- Keywords
- Preeclampsia, Hypertension, Stage 1 Hypertension, Pregnancy, Aspirin, Low Dose Aspirin
- Medical subject headings
- Pre-Eclampsia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81mgDrug
81mg aspirin daily beginning between 12 and 16 weeks of pregnancy and continuing until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Participants in this arm will be instructed to take 1 81mg aspirin daily beginning between weeks 12 and 16 of pregnancy and continuing until delivery. Receives: Drug: Aspirin 81mg |
| No Aspirin | No intervention | Participants in this arm will receive no aspirin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Preeclampsia
Preeclampsia developed before 37 weeks
Measured: Prior to 37 weeks
Secondary outcomes (4)
Preeclampsia
Systolic blood pressure of 140 mmHg or more or diastolic blood pressure of 90 mmHg or more on two occasions at least four hours apart or a systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 110 mmHg or more; and Proteinuria of 300mg or more per 24-hour urine collection or protein/creatinine ratio of 0.3 or more; or in the absence of proteinuria, new-onset hypertension with the new onset of any of the following severe features: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, new-onset headache unresponsive to medication.
Measured: After 37 weeks
Gestational Hypertension
Systolic blood pressure of 140 mmHg or more or diastolic blood pressure of 90 mmHg or more on two occasions at least four hours apart with no proteinuria or severe features.
Measured: After 20 weeks gestation
HELLP Syndrome
Hemolysis, elevated liver enzymes, and low platelet count syndrome
Measured: After 20 weeks gestation
Eclampsia
New-onset tonic-clonic, focal, or multifocal seizure in the absence of other causative conditions
Measured: After 20 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start28 May 2021
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either receive 81mg of aspirin daily beginning between 12 and 16 weeks of pregnancy or to receive no aspirin.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Tetsuya Kawakita, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908982
- Sponsor's protocol ID
- AS1H
- Status last verified
- May 2021
- First submitted
- 26 May 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
PubMed 29133354Topel ML, Duncan EM, Krishna I, Badell ML, Vaccarino V, Quyyumi AA. Estimated Impact of the 2017 American College of Cardiology/American Heart Association Blood Pressure Guidelines on Reproductive-Aged Women. Hypertension. 2018 Oct;72(4):e39-e42. doi: 10.1161/HYPERTENSIONAHA.118.11660.
PubMed 30354726Hauspurg A, Parry S, Mercer BM, Grobman W, Hatfield T, Silver RM, Parker CB, Haas DM, Iams JD, Saade GR, Wapner RJ, Reddy UM, Simhan H. Blood pressure trajectory and category and risk of hypertensive disorders of pregnancy in nulliparous women. Am J Obstet Gynecol. 2019 Sep;221(3):277.e1-277.e8. doi: 10.1016/j.ajog.2019.06.031. Epub 2019 Jun 27.
PubMed 31255629Sutton EF, Hauspurg A, Caritis SN, Powers RW, Catov JM. Maternal Outcomes Associated With Lower Range Stage 1 Hypertension. Obstet Gynecol. 2018 Oct;132(4):843-849. doi: 10.1097/AOG.0000000000002870.
PubMed 30204698Battarbee AN, Sinkey RG, Harper LM, Oparil S, Tita ATN. Chronic hypertension in pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):532-541. doi: 10.1016/j.ajog.2019.11.1243. Epub 2019 Nov 9.
PubMed 31715148Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2.
PubMed 20598363ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
PubMed 30575675Hao J, Hassen D, Hao Q, Graham J, Paglia MJ, Brown J, Cooper M, Schlieder V, Snyder SR. Maternal and Infant Health Care Costs Related to Preeclampsia. Obstet Gynecol. 2019 Dec;134(6):1227-1233. doi: 10.1097/AOG.0000000000003581.
PubMed 31764733Clarke RJ, Mayo G, Price P, FitzGerald GA. Suppression of thromboxane A2 but not of systemic prostacyclin by controlled-release aspirin. N Engl J Med. 1991 Oct 17;325(16):1137-41. doi: 10.1056/NEJM199110173251605.
PubMed 1891022Patrono C. Aspirin as an antiplatelet drug. N Engl J Med. 1994 May 5;330(18):1287-94. doi: 10.1056/NEJM199405053301808. No abstract available.
PubMed 8145785Horgan R, Sinkovskaya E, Saade G, Kalafat E, Rice MM, Heeze A, Abuhamad A. Longitudinal assessment of spiral and uterine arteries in normal pregnancy using novel ultrasound tool. Ultrasound Obstet Gynecol. 2023 Dec;62(6):860-866. doi: 10.1002/uog.26312.
PubMed 37470712Abuhamad A, Sinkovskaya E, Heeze A, et al. Longitudinal assessment of placental shear-wave elastography and correlation with placental circulation in normal pregnancies. Am J Obstet Gynecol. 2020;222(1)S67
ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.
PubMed 29939940Rolnik 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 28657417Muntner P, Carey RM, Gidding S, Jones DW, Taler SJ, Wright JT Jr, Whelton PK. Potential US Population Impact of the 2017 ACC/AHA High Blood Pressure Guideline. Circulation. 2018 Jan 9;137(2):109-118. doi: 10.1161/CIRCULATIONAHA.117.032582. Epub 2017 Nov 13.
PubMed 29133599
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension: A Pilot Study
- ClinicalTrials.gov ID
- NCT04908982
- Acronym / sponsor ID
- AS1H
- Conditions
- Pre-Eclampsia
- Keywords
- Preeclampsia, Hypertension, Stage 1 Hypertension, Pregnancy, Aspirin, Low Dose Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Study start
- 28 May 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 1 Jun 2021 (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.
In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Based on new criteria, stage 1 hypertension is associated with a 2-3 fold increased risk of preeclampsia. There are no data regarding prevention of preeclampsia in women with stage 1 hypertension. Low-dose aspirin has been used during pregnancy to prevent preeclampsia for women at high-risk for preeclampsia. Although the precise mechanism remains uncertain, it is possible that low-dose aspirin improves placental perfusion, which results in a decreased rate of preeclampsia. A study that examines the effect of low-dose aspirin on placenta vasculature and tissue elastography by using novel ultrasound tools would be useful. The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening. They found a significant decrease in the rate of preterm preeclampsia (4.3% vs. 1.6%; P <0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability in the U.S. women with stage 1 hypertension is limited. Our pilot study will examine 1) the effect of low-dose aspirin 81 mg in women with stage 1 hypertension on placental vasculature and shear-wave elastography; 2) the rate of preterm preeclampsia in women with stage 1 hypertension in a control group and in pregnancies treated with low-dose aspirin 81 mg; 3) feasibility of conducting a larger multicenter randomized controlled trial on this subject.
Detailed description
In 2017, the American College of Cardiology (ACC) and the American Heart Association (AHA) changed the diagnostic criteria for hypertension in non-pregnant adults.1 The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg.2 Stage 1 hypertension based on the new criteria is associated with an increased risk of preeclampsia compared to normal BP (15-16% vs. 5-7%).3, 4 However, the American College of Obstetricians and Gynecologists (ACOG) continues to diagnose chronic hypertension in pregnancy as a systolic BP above 140 mm Hg and a diastolic BP of 90 mm Hg since there are no data regarding prevention of preeclampsia in women with stage 1 hypertension.5
Preeclampsia is a multi-organ, progressive disorder characterized by the new onset of hypertension with proteinuria or end-organ dysfunction.6 Preeclampsia is a major cause of morbidity such as eclampsia, pulmonary edema, myocardial infarction, stroke, coagulopathy, and renal failure and a leading cause of iatrogenic preterm birth and maternal mortality.7 Preeclampsia is also an economic burden to the health care system. The mean combined maternal and infant medical care costs for women with preeclampsia are significantly higher than those of uncomplicated women ($41,790 vs. $13,187 in 2015 dollars) with the main cost drivers being infant health care costs due to prematurity.8
It is hypothesized that preeclampsia is caused by an imbalance in prostacyclin and thromboxane A2 (TXA2) resulting in vascular disturbances and coagulation defects. Low-dose aspirin (60-150 mg/day) irreversibly acetylates cyclooxygenase (COX)-1, which results in decreased platelet synthesis of TXA2 without affecting vascular wall production of prostacyclin.9. 10 However, it is likely that preeclampsia is a result of poor placentation. In this pilot study, we will examine the effect of low-dose aspirin on placental perfusion by using novel ultrasound tools (Superb Micro-Vascular Imaging [SMI], Shear Wave Elastography [SWE], intensity analysis [IA], and Attenuation Imaging [ATI]). Superb Micro-Vascular Imaging (SMI) is a novel Doppler technique designed to improve the visualization of microscopic vessels, through a new adaptive algorithm, which dramatically enhances microvascular flow and removes artifacts. Shear Wave Elastography (SWE) is a new noninvasive ultrasound-based technology for the evaluation of soft tissue stiffness. Intensity Analysis (IA) is a technique that analyzes tissue homogeneity. Attenuation Imagining (ATI) measures beam attenuation by quantifying an attenuation coefficient (AC db/cm/MHz). Our group has developed longitudinal nomograms on placental vasculature to include uterine and spiral arteries on the maternal side and fetal placental arterioles and umbilical artery on the fetal side.11 Furthermore, longitudinal nomograms related to placental tissue structure, including shear wave elastography has been developed.12
Although the precise mechanism is uncertain, low-dose aspirin has been used during pregnancy to prevent or delay the onset of preeclampsia for women at high-risk for preeclampsia.13 The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening.14 They found a significant decrease in the rate of preterm preeclampsia less than 37 weeks of gestation (4.3% vs. 1.6%; P <0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability of aspirin preeclampsia prevention in the U.S. women with stage 1 hypertension is limited.
Our long-term goal is to reduce preterm preeclampsia in women with stage 1 hypertension. We hypothesize that 1) spiral artery Pulsatility Index (PI) and Peak Systolic Velocity (PSV) and SWE is lower in women with stage 1 hypertension who receive low-dose aspirin 81 mg compared to those who do not receive low-dose aspirin; 2) Women with stage 1 hypertension who receive low-dose aspirin 81 mg have a lower rate of preterm preeclampsia compared to those who do not receive low-dose aspirin. To examine these hypotheses in a future, large randomized, controlled trial, our aims for this pilot study include the following:
Aim 1. To examine the change in placental vasculature and tissue elastography in women with stage 1 hypertension who receive low-dose aspirin 81 mg and those who do not receive low-dose aspirin.
Aim 2. To examine rates of preterm preeclampsia in women with stage 1 hypertension who receive low-dose aspirin 81 mg and those who do not receive low-dose aspirin.
Aim 3. To examine eligibility rate, recruitment rate, study compliance, and loss of follow-up rate. This information will be useful to assess feasibility of a future multicenter randomized controlled trial.
In summary, women with stage 1 hypertension are at an increased risk of preeclampsia. Low-dose aspirin may reduce the rate of preterm preeclampsia in women with stage 1 hypertension. In this pilot study, we will conduct an open label randomized controlled trial and obtain necessary information for a future multicenter randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either receive 81mg of aspirin daily beginning between 12 and 16 weeks of pregnancy or to receive no aspirin.
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: Aspirin 81mgParticipants in this arm will be instructed to take 1 81mg aspirin daily beginning between weeks 12 and 16 of pregnancy and continuing until delivery. |
| No Aspirin | No intervention | –Participants in this arm will receive no aspirin. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women from 6 0/7 to 13 6/7 weeks gestation
- 18-50 years old
- Systolic blood pressure of 130-139 mmHg or Diastolic blood pressure of 80-89 mmHg
Key exclusion criteria (9 listed)
- History of preeclampsia
- Multifetal gestation
- Chronic hypertension
- Pre-gestational diabetes
- Renal disease
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 |
|---|---|---|
| Aspirin 81mg81mg aspirin daily beginning between 12 and 16 weeks of pregnancy and continuing until delivery. | Drug | Aspirin |
Primary outcome
Preterm Preeclampsia
Time frame: Prior to 37 weeks
Preeclampsia developed before 37 weeks
4 secondary outcomes
Preeclampsia
Time frame: After 37 weeks
Gestational Hypertension
Time frame: After 20 weeks gestation
HELLP Syndrome
Time frame: After 20 weeks gestation
Eclampsia
Time frame: After 20 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Background: PubMed 29133354Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
- Background: PubMed 30354726Topel ML, Duncan EM, Krishna I, Badell ML, Vaccarino V, Quyyumi AA. Estimated Impact of the 2017 American College of Cardiology/American Heart Association Blood Pressure Guidelines on Reproductive-Aged Women. Hypertension. 2018 Oct;72(4):e39-e42. doi: 10.1161/HYPERTENSIONAHA.118.11660.
- Background: PubMed 31255629Hauspurg A, Parry S, Mercer BM, Grobman W, Hatfield T, Silver RM, Parker CB, Haas DM, Iams JD, Saade GR, Wapner RJ, Reddy UM, Simhan H. Blood pressure trajectory and category and risk of hypertensive disorders of pregnancy in nulliparous women. Am J Obstet Gynecol. 2019 Sep;221(3):277.e1-277.e8. doi: 10.1016/j.ajog.2019.06.031. Epub 2019 Jun 27.
- Background: PubMed 30204698Sutton EF, Hauspurg A, Caritis SN, Powers RW, Catov JM. Maternal Outcomes Associated With Lower Range Stage 1 Hypertension. Obstet Gynecol. 2018 Oct;132(4):843-849. doi: 10.1097/AOG.0000000000002870.
- Background: PubMed 31715148Battarbee AN, Sinkey RG, Harper LM, Oparil S, Tita ATN. Chronic hypertension in pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):532-541. doi: 10.1016/j.ajog.2019.11.1243. Epub 2019 Nov 9.
- Background: PubMed 20598363Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2.
- Background: PubMed 30575675ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
- Background: PubMed 31764733Hao J, Hassen D, Hao Q, Graham J, Paglia MJ, Brown J, Cooper M, Schlieder V, Snyder SR. Maternal and Infant Health Care Costs Related to Preeclampsia. Obstet Gynecol. 2019 Dec;134(6):1227-1233. doi: 10.1097/AOG.0000000000003581.
- Background: PubMed 1891022Clarke RJ, Mayo G, Price P, FitzGerald GA. Suppression of thromboxane A2 but not of systemic prostacyclin by controlled-release aspirin. N Engl J Med. 1991 Oct 17;325(16):1137-41. doi: 10.1056/NEJM199110173251605.
- Background: PubMed 8145785Patrono C. Aspirin as an antiplatelet drug. N Engl J Med. 1994 May 5;330(18):1287-94. doi: 10.1056/NEJM199405053301808. No abstract available.
- Background: PubMed 37470712Horgan R, Sinkovskaya E, Saade G, Kalafat E, Rice MM, Heeze A, Abuhamad A. Longitudinal assessment of spiral and uterine arteries in normal pregnancy using novel ultrasound tool. Ultrasound Obstet Gynecol. 2023 Dec;62(6):860-866. doi: 10.1002/uog.26312.
- BackgroundAbuhamad A, Sinkovskaya E, Heeze A, et al. Longitudinal assessment of placental shear-wave elastography and correlation with placental circulation in normal pregnancies. Am J Obstet Gynecol. 2020;222(1)S67
- Individual participant dataSharing planned: Undecided
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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.
Tetsuya Kawakita, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin 81mg in people with Pre-Eclampsia, run by Eastern Virginia Medical School at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2021. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tetsuya Kawakita, MD (7574467900, kawakit@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm Preeclampsia (time frame: Prior to 37 weeks). 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 NCT04908982, which also lists 24 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 28 Jun 2021.