Pre-EclampsiaPhase 2NCT04402385
Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE)
A Phase 2 study testing Aspirin 81 mg in people with Pre-Eclampsia and Stage 1 Hypertension, run by Yale University at 1 site in United States.
Trial summary
To determine if low dose aspirin reduces the incidence of hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome) in pregnant women with stage 1 hypertension and elevated blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia, Stage 1 Hypertension, Elevated Blood Pressure
- What is being tested?
- Aspirin 81 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 22 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 pregnancy
- Elevated blood pressure (At least 2 systolic BP 120-129 mm Hg within 1 year pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare encounters) or Stage 1 hypertension (At least 2 systolic BP 130-139 and/or diastolic BP 80-89 within 1 year pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare encounters)
- Speaks English or Spanish
- Informed and written consent
- Confirmed single live intrauterine pregnancy (confirmed by positive cardiac motion by transvaginal or transabdominal ultrasound)
Who cannot join
- Chronic hypertension
- Pre-gestational diabetes
- Chronic renal disease
- diagnosis of stage 1 chronic kidney disease or higher and/or GFR <60 mL/min with duration at least 3 months and/or history of kidney transplantation and/or undergoing peritoneal or hemodialysis
- Systemic lupus erythematous
- Antiphospholipid antibody syndrome (diagnosis made by having 1 or more clinical criteria and 1 or more laboratory criteria)
Show all 15Show fewer
- Clinical criteria: venous thrombosis, arterial thrombosis, obstetric complications (3 or more unexplained consecutive spontaneous abortions <10 weeks gestation, 1 or more unexplained deaths of a morphologically normal fetus after 10 weeks gestation, 1 or more premature births before 34 weeks gestation attributable to placental insufficiency, including severe preeclampsia or fetal growth restriction)
- Laboratory criteria: lupus anticoagulant, anti-cardiolipin IgG or IgM with titer >99th percentile, anti-beta 2 glycoprotein IgG or IgM with titer >99th percentile. Laboratory result must be positive twice at least 12 weeks apart
- Multifetal gestation
- 20 weeks gestation at time of randomization based on American College of Obstetricians and Gynecologists dating criteria. Dating will be based on last menstrual period (LMP) if regular, sure LMP is available that agrees with ultrasound dating. Otherwise, earliest ultrasound will be used for dating purposes.
- Prior history of hypertensive disorder of pregnancy
- Current pregnancy with known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy
- Women with contraindications to taking aspirin (bleeding diathesis such as Von Willebrand's disease, peptic ulcer disease, aspirin hypersensitivity, nasal polyps, asthma with aspirin-induced bronchospasm, severe liver disease).
- Concurrent participation in another study that influences risk of preeclampsia
- Women who do not plan to deliver within the YNHH system
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06512
About this study
To determine if low dose aspirin reduces the incidence of hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome) in pregnant women with stage 1 hypertension and elevated blood pressure.
Read the detailed description
At the baseline visit, women will go through informed consent and review of study eligibility. Objectives of the study, participation requirements, eligibility inclusion and exclusion will be reviewed in detail. If these are not met, the woman is excluded from the study. If she meets inclusion criteria, a checklist of exclusion criteria will be reviewed. If any exclusions are met, the woman is excluded from the study. The consent form will be reviewed in detail. If the woman consents and signs all pages of the form, randomization follows.
Randomization will be done in a 1:1 allocation ratio between the treatment and placebo arms, stratified by blood pressure group (elevated blood pressure and stage 1 hypertension). A computer algorithm will assign participant based on random permuted blocks design with block size between 2-4 within each strata. Each participant will have an assigned Study ID number that is linked to their random assignment.
Participants will be contacted by telephone 1 week after randomization. The purpose of this visit is to ensure the participant has received study medication and initiated the regimen.
The third encounter will be 6 weeks (+/- 1week) after randomization in person to coincide with routine prenatal visit or via telephone. The purpose of this study visit is to review their pregnancy course, use of study medications, any side effects, difficulties with the study, and have opportunities to make comments and/or ask questions. The participants will be asked to bring their study medication for pill count at the time of this encounter, if the study visit is able to be performed in person. Study participants will continue their routine prenatal care with pregnancy management performed routinely per their provider.
The fourth encounter will be 16 weeks (+/- 1week) after randomization in person to coincide with routine prenatal visit or via telephone. If the participant is already delivered by this time, the visit will be performed via telephone postpartum. The purpose of this study visit is to review their pregnancy course, use of study medications, any side effects, difficulties with the study, and have opportunities to make comments and/or ask questions. The participants will be asked to bring their study medication for pill count at the time of this encounter, if the study visit is able to be performed in person.
The rest of the study will be conducted via chart review. Each prenatal visit will be reviewed for blood pressure, evaluation of symptoms, review of any laboratory and/or imaging results. New diagnoses, medications, and hospital admissions will be documented.
Delivery records will be abstracted for outcomes listed below. Neonatal records will be reviewed from birth until 1 year of age. Neonatal and infant chart abstraction will include birthweight, Apgar scores, hospital course, problem visit, diagnoses, medications, emergency department visits, and hospitalizations. Participant's postpartum course will be reviewed for 1 year postpartum, including outpatient visits, emergency department visits, and any hospitalizations.
The study will be performed by an intent-to-treat analysis. Thus, even women who discontinue study medication will be included in final analyses.
- Conditions
- Pre-Eclampsia, Stage 1 Hypertension, Elevated Blood Pressure
- Being tested
- Aspirin 81 mg, Placebo
- Keywords
- 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 81 mgDrug
Participants randomized to 81 mg of Aspirin daily
PlaceboDrug
Participants randomized to placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Participants randomized to 81 mg of Aspirin daily Receives: Drug: Aspirin 81 mg |
| Placebo | Placebo comparator | Participants randomized to placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Hypertensive Disorder
This measure is operationally defined as a yes/no response to the development of any hypertensive disorder of pregnancy (gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome). This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.
Measured: after 20 weeks gestation until 6 weeks postpartum
Secondary outcomes (14)
Development of Gestational Hypertension
This measure is operationally defined as a yes/no response to the development of gestational hypertension. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.
Measured: after 20 weeks gestation until 6 weeks postpartum
Development of Preeclampsia
This measure is operationally defined as a yes/no response to the development of preeclampsia. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.
Measured: after 20 weeks gestation until 6 weeks postpartum
Development of Preeclampsia- 37 Weeks
This measure is operationally defined as a yes/no response to the development of preeclampsia at less than 37 weeks of pregnancy. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.
Measured: up to 37 weeks gestation
Development of Preeclampsia- 34 Weeks
This measure is operationally defined as a yes/no response to the development of preeclampsia at less than 34 weeks of pregnancy. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.
Measured: up to 34 weeks gestation
Development of Eclampsia
This measure is operationally defined as a yes/no response to the development of eclampsia. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.
Measured: after 20 weeks gestation until 6 weeks postpartum
Development of HELLP Syndrome
This measure is operationally defined as a yes/no response to the development of HELLP syndrome. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.
Measured: after 20 weeks gestation until 6 weeks postpartum
Spontaneous Preterm Delivery
This measure is operationally defined as a yes/no response to a spontaneous preterm delivery up to 37 weeks of pregnancy.
Measured: Up to 37 weeks
Spontaneous Preterm Delivery
This measure is operationally defined as a yes/no response to a spontaneous preterm delivery up to 34 weeks of pregnancy.
Measured: Up to 34 weeks
Fetal Growth Restriction
Fetal growth restriction is estimated fetal weight <10th percentile for gestational age by Hadlock criteria with Yale New Haven Health practice-specific growth curves.
Measured: after 20 weeks gestation until delivery
Birthweight
Birthweight small for gestational age (<10% by sex-specific World Health Organization growth charts)
Measured: day of life 0
Neonatal ICU Admission
Neonatal ICU admission is operationally defined as a yes/no to whether a newborn was admitted to the neonatal ICU admission.
Measured: Birth until 1 year of age
Stillbirth
Stillbirth is operationally defined as a fetal death before or during delivery (corrected when results were entered)
Measured: after 20 weeks gestation until delivery
Neonatal Adverse Events
Neonatal adverse events are operationally defined as a composite yes/no response of any of the following: need for respiratory support, necrotizing enterocolitis, neonatal sepsis, retinopathy of prematurity, intraventricular hemorrhage, neonatal death.
Measured: Birth until 1 year of age
Placental Abruption
Placental abruption is operationally defined as a yes/no response to a placental abruption verified either clinically or as seen on pathologic placental examination.
Measured: after 20 weeks gestation until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start6 Aug 2020
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Why it stopped: Unable to recruit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Grechukhina, MD, Principal investigator, Yale UniversityHillart Hosier, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402385
- Sponsor's protocol ID
- 2000028023
- Status last verified
- Jun 2023
- First submitted
- 22 May 2020
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE)
- ClinicalTrials.gov ID
- NCT04402385
- Acronym / sponsor ID
- 2000028023
- Conditions
- Pre-Eclampsia, Stage 1 Hypertension, Elevated Blood Pressure
- Keywords
- Aspirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if low dose aspirin reduces the incidence of hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome) in pregnant women with stage 1 hypertension and elevated blood pressure.
Detailed description
At the baseline visit, women will go through informed consent and review of study eligibility. Objectives of the study, participation requirements, eligibility inclusion and exclusion will be reviewed in detail. If these are not met, the woman is excluded from the study. If she meets inclusion criteria, a checklist of exclusion criteria will be reviewed. If any exclusions are met, the woman is excluded from the study. The consent form will be reviewed in detail. If the woman consents and signs all pages of the form, randomization follows.
Randomization will be done in a 1:1 allocation ratio between the treatment and placebo arms, stratified by blood pressure group (elevated blood pressure and stage 1 hypertension). A computer algorithm will assign participant based on random permuted blocks design with block size between 2-4 within each strata. Each participant will have an assigned Study ID number that is linked to their random assignment.
Participants will be contacted by telephone 1 week after randomization. The purpose of this visit is to ensure the participant has received study medication and initiated the regimen.
The third encounter will be 6 weeks (+/- 1week) after randomization in person to coincide with routine prenatal visit or via telephone. The purpose of this study visit is to review their pregnancy course, use of study medications, any side effects, difficulties with the study, and have opportunities to make comments and/or ask questions. The participants will be asked to bring their study medication for pill count at the time of this encounter, if the study visit is able to be performed in person. Study participants will continue their routine prenatal care with pregnancy management performed routinely per their provider.
The fourth encounter will be 16 weeks (+/- 1week) after randomization in person to coincide with routine prenatal visit or via telephone. If the participant is already delivered by this time, the visit will be performed via telephone postpartum. The purpose of this study visit is to review their pregnancy course, use of study medications, any side effects, difficulties with the study, and have opportunities to make comments and/or ask questions. The participants will be asked to bring their study medication for pill count at the time of this encounter, if the study visit is able to be performed in person.
The rest of the study will be conducted via chart review. Each prenatal visit will be reviewed for blood pressure, evaluation of symptoms, review of any laboratory and/or imaging results. New diagnoses, medications, and hospital admissions will be documented.
Delivery records will be abstracted for outcomes listed below. Neonatal records will be reviewed from birth until 1 year of age. Neonatal and infant chart abstraction will include birthweight, Apgar scores, hospital course, problem visit, diagnoses, medications, emergency department visits, and hospitalizations. Participant's postpartum course will be reviewed for 1 year postpartum, including outpatient visits, emergency department visits, and any hospitalizations.
The study will be performed by an intent-to-treat analysis. Thus, even women who discontinue study medication will be included in final analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: Aspirin 81 mgParticipants randomized to 81 mg of Aspirin daily |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to placebo daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Elevated blood pressure (At least 2 systolic BP 120-129 mm Hg within 1 year pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare encounters) or Stage 1 hypertension (At least 2 systolic BP 130-139 and/or diastolic BP 80-89 within 1 year pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare encounters)
- Speaks English or Spanish
- Informed and written consent
- Confirmed single live intrauterine pregnancy (confirmed by positive cardiac motion by transvaginal or transabdominal ultrasound)
Key exclusion criteria (15 listed)
- Chronic hypertension
- Pre-gestational diabetes
- Chronic renal disease
- Systemic lupus erythematous
- Antiphospholipid antibody syndrome (diagnosis made by having 1 or more clinical criteria and 1 or more laboratory criteria)
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 81 mgParticipants randomized to 81 mg of Aspirin daily | Drug | Aspirin |
| PlaceboParticipants randomized to placebo daily | Drug | Placebo |
Primary outcome
Development of Hypertensive Disorder
Time frame: after 20 weeks gestation until 6 weeks postpartum
This measure is operationally defined as a yes/no response to the development of any hypertensive disorder of pregnancy (gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome). This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.
14 secondary outcomes
Development of Gestational Hypertension
Time frame: after 20 weeks gestation until 6 weeks postpartum
Development of Preeclampsia
Time frame: after 20 weeks gestation until 6 weeks postpartum
Development of Preeclampsia- 37 Weeks
Time frame: up to 37 weeks gestation
Development of Preeclampsia- 34 Weeks
Time frame: up to 34 weeks gestation
Development of Eclampsia
Time frame: after 20 weeks gestation until 6 weeks postpartum
Development of HELLP Syndrome
Time frame: after 20 weeks gestation until 6 weeks postpartum
Spontaneous Preterm Delivery
Time frame: Up to 37 weeks
Spontaneous Preterm Delivery
Time frame: Up to 34 weeks
Fetal Growth Restriction
Time frame: after 20 weeks gestation until delivery
Birthweight
Time frame: day of life 0
Neonatal ICU Admission
Time frame: Birth until 1 year of age
Stillbirth
Time frame: after 20 weeks gestation until delivery
Neonatal Adverse Events
Time frame: Birth until 1 year of age
Placental Abruption
Time frame: after 20 weeks gestation until delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Olga Grechukhina, MD principal investigator
Yale University
Hillart Hosier, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin 81 mg in people with Pre-Eclampsia and Stage 1 Hypertension, run by Yale University 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 11 Jul 2023. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Development of Hypertensive Disorder (time frame: after 20 weeks gestation until 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2023.