Trial Outcomes & Findings for Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE) (NCT NCT04402385)

NCT ID: NCT04402385

Last Updated: 2023-07-11

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: after 20 weeks gestation until 6 weeks postpartum
• Results posted on: 2023-07-11

Participant Flow

Participant milestones

Measure	Aspirin Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Overall Study STARTED	25	25
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Aspirin Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Overall Study Withdrawal by Subject	4	4
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	0	1

Baseline Characteristics

Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE)

Baseline characteristics by cohort

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily	Total n=39 Participants Total of all reporting groups
Age, Continuous	28.0 years STANDARD_DEVIATION 6.4 • n=5 Participants	29.8 years STANDARD_DEVIATION 6.6 • n=7 Participants	28.9 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: after 20 weeks gestation until 6 weeks postpartum

Population: All enrolled participants that successfully delivered.

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.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Development of Hypertensive Disorder Yes	5 Participants	4 Participants
Development of Hypertensive Disorder No	15 Participants	15 Participants

SECONDARY outcome

Timeframe: after 20 weeks gestation until 6 weeks postpartum

Population: All enrolled participants that successfully delivered.

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.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Development of Gestational Hypertension Yes	3 Participants	4 Participants
Development of Gestational Hypertension No	17 Participants	15 Participants

SECONDARY outcome

Timeframe: after 20 weeks gestation until 6 weeks postpartum

Population: All enrolled participants that successfully delivered.

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.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Development of Preeclampsia Yes	2 Participants	0 Participants
Development of Preeclampsia No	18 Participants	19 Participants

SECONDARY outcome

Timeframe: up to 37 weeks gestation

Population: All enrolled participants that successfully delivered.

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.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Development of Preeclampsia- 37 Weeks Yes	0 Participants	0 Participants
Development of Preeclampsia- 37 Weeks No	20 Participants	19 Participants

SECONDARY outcome

Timeframe: up to 34 weeks gestation

Population: All enrolled participants that successfully delivered while on study.

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.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Development of Preeclampsia- 34 Weeks Yes	0 Participants	0 Participants
Development of Preeclampsia- 34 Weeks No	20 Participants	19 Participants

SECONDARY outcome

Timeframe: after 20 weeks gestation until 6 weeks postpartum

Population: All enrolled participants that successfully delivered while on study.

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.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Development of Eclampsia Yes	0 Participants	0 Participants
Development of Eclampsia No	20 Participants	19 Participants

SECONDARY outcome

Timeframe: after 20 weeks gestation until 6 weeks postpartum

Population: All enrolled participants that successfully delivered while on study.

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.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Development of HELLP Syndrome Yes	0 Participants	0 Participants
Development of HELLP Syndrome No	20 Participants	19 Participants

SECONDARY outcome

Timeframe: Up to 37 weeks

Population: All enrolled participants that successfully delivered while on study.

This measure is operationally defined as a yes/no response to a spontaneous preterm delivery up to 37 weeks of pregnancy.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Spontaneous Preterm Delivery Yes	0 Participants	2 Participants
Spontaneous Preterm Delivery No	20 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to 34 weeks

Population: All enrolled participants that successfully delivered while on study.

This measure is operationally defined as a yes/no response to a spontaneous preterm delivery up to 34 weeks of pregnancy.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Spontaneous Preterm Delivery Yes	0 Participants	1 Participants
Spontaneous Preterm Delivery No	20 Participants	18 Participants

SECONDARY outcome

Timeframe: after 20 weeks gestation until delivery

Population: All infants born to enrolled participants that successfully delivered while on study.

Fetal growth restriction is estimated fetal weight <10th percentile for gestational age by Hadlock criteria with Yale New Haven Health practice-specific growth curves.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Fetal Growth Restriction Yes	0 Participants	2 Participants
Fetal Growth Restriction No	20 Participants	17 Participants

SECONDARY outcome

Timeframe: day of life 0

Population: All infants born from enrolled participants that successfully delivered while on study.

Birthweight small for gestational age (<10% by sex-specific World Health Organization growth charts)

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Birthweight	3320.95 weight in grams Standard Deviation 390.47	3271.57 weight in grams Standard Deviation 609.29

SECONDARY outcome

Timeframe: Birth until 1 year of age

Neonatal ICU admission is operationally defined as a yes/no to whether a newborn was admitted to the neonatal ICU admission.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Neonatal ICU Admission NICU Admission = Yes	1 Participants	3 Participants
Neonatal ICU Admission NICU Admission = No	19 Participants	16 Participants

SECONDARY outcome

Timeframe: after 20 weeks gestation until delivery

Stillbirth is operationally defined as a fetal death before or during delivery (corrected when results were entered)

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Stillbirth Yes	0 Participants	0 Participants
Stillbirth No	20 Participants	19 Participants

SECONDARY outcome

Timeframe: Birth until 1 year of age

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.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Neonatal Adverse Events Yes	3 Participants	2 Participants
Neonatal Adverse Events No	17 Participants	17 Participants

SECONDARY outcome

Timeframe: after 20 weeks gestation until delivery

Placental abruption is operationally defined as a yes/no response to a placental abruption verified either clinically or as seen on pathologic placental examination.

Outcome measures

Measure	Aspirin n=20 Participants Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo n=19 Participants Participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Placental Abruption Yes	0 Participants	0 Participants
Placental Abruption No	20 Participants	19 Participants

Adverse Events

Aspirin - Parent

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Aspirin - Infant

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo - Parent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo - Infant

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aspirin - Parent n=20 participants at risk Participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Aspirin - Infant n=20 participants at risk Children of participants randomized to 81 mg of Aspirin daily Aspirin 81 mg: Participants randomized to 81 mg of Aspirin daily	Placebo - Parent n=19 participants at risk Participants randomized to placebo daily Placebo: Participants randomized to placebo daily	Placebo - Infant n=19 participants at risk Children of participants randomized to placebo daily Placebo: Participants randomized to placebo daily
Pregnancy, puerperium and perinatal conditions Postpartum Hemorrhage	5.0% 1/20 • Number of events 1 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/20 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.
Blood and lymphatic system disorders Hyperbilirubinemia	0.00% 0/20 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	5.0% 1/20 • Number of events 1 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.
Congenital, familial and genetic disorders Microcephaly	0.00% 0/20 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	5.0% 1/20 • Number of events 1 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.
Respiratory, thoracic and mediastinal disorders Respiratory Syncytial Virus	0.00% 0/20 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	5.0% 1/20 • Number of events 1 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	5.3% 1/19 • Number of events 1 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.
Infections and infestations Laryngomalacia	0.00% 0/20 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/20 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	5.3% 1/19 • Number of events 1 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.
Blood and lymphatic system disorders Nosebleed	5.0% 1/20 • Number of events 1 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/20 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.	0.00% 0/19 • From 20 weeks gestational up to 1 year following birth Adverse event reporting only for parents that delivered while on study and their children born on study.

Other adverse events

Adverse event data not reported

Additional Information

Olga Grechukhina, MD: Assistant Professor of Obstetrics, Gynecology & Reproductive Sciences

Yale School of Medicine

Phone: (203) 785-3091

Email: olga.grechukhina@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place