Trial Outcomes & Findings for Low Doses of Aspirin in the Prevention of Preeclampsia (NCT NCT04070573)

NCT ID: NCT04070573

Last Updated: 2025-03-13

Results Overview

The incidence of preterm (\<37 weeks) preeclampsia in high risk pregnant women treated with either 81 mg or 162 mg of daily aspirin during pregnancy.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 400 participants
• Primary outcome timeframe: 9 months for each patient (from recruitment until 6 weeks postpartum)
• Results posted on: 2025-03-13

Participant Flow

Participant milestones

Measure	81mg ASA Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Overall Study STARTED	200	200
Overall Study COMPLETED	181	184
Overall Study NOT COMPLETED	19	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Doses of Aspirin in the Prevention of Preeclampsia

Baseline characteristics by cohort

Measure	81mg ASA n=200 Participants Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=200 Participants Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	Total n=400 Participants Total of all reporting groups
Age, Continuous	35 years n=5 Participants	35 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	200 Participants n=5 Participants	200 Participants n=7 Participants	400 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	32 Participants n=5 Participants	46 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	150 Participants n=5 Participants	140 Participants n=7 Participants	290 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	41 Participants n=5 Participants	31 Participants n=7 Participants	72 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	43 Participants n=5 Participants	38 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	77 Participants n=7 Participants	138 Participants n=5 Participants
Race (NIH/OMB) More than one race	26 Participants n=5 Participants	39 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	15 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months for each patient (from recruitment until 6 weeks postpartum)

Population: Intention to treat analysis of all participants with pregnancy progressing beyond 20 weeks with delivery data available

The incidence of preterm (<37 weeks) preeclampsia in high risk pregnant women treated with either 81 mg or 162 mg of daily aspirin during pregnancy.

Outcome measures

Measure	81mg ASA n=181 Participants Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=184 Participants Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Incidence of Preterm (<37 Weeks) Preeclampsia	22 Participants	16 Participants

PRIMARY outcome

Timeframe: 9 months for each patient (from recruitment until 6 weeks postpartum)

Population: Intention to treat analysis of all participants with pregnancy progressing beyond 20 weeks with delivery data available

The incidence of preeclampsia with severe features (American College of Obstetricians and Gynecologists 2019 definition) in high-risk pregnant women treated with either 81 mg or 162 mg of daily aspirin during pregnancy.

Outcome measures

Measure	81mg ASA n=181 Participants Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=184 Participants Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Incidence of Preeclampsia With Severe Features	26 Participants	20 Participants

PRIMARY outcome

Timeframe: 9 months for each participant

Population: Intention to treat analysis of all participants with pregnancy progressing beyond 20 weeks with delivery data available

Composite of preterm preeclampsia and/or preeclampsia with severe features

Outcome measures

Measure	81mg ASA n=181 Participants Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=184 Participants Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Composite Primary Outcome	28 Participants	25 Participants

SECONDARY outcome

Timeframe: 9 months for each patient (from recruitment until 6 weeks postpartum)

Population: Intention to treat analysis of all participants with pregnancy progressing beyond 20 weeks with delivery data available for adjudication and with SMAQ data available

Evaluate and compare the adherence of pregnant women to 81mg and 162mg of daily low-dose aspirin using a validated, Simplified Medication Adherence Questionnaire (SMAQ).

Outcome measures

Measure	81mg ASA n=181 Participants Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=184 Participants Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Aspirin Adherence 20 weeks	106 Participants	122 Participants
Aspirin Adherence 26 weeks	124 Participants	126 Participants
Aspirin Adherence 36 weeks	107 Participants	101 Participants

SECONDARY outcome

Timeframe: 9 months for each patient (from recruitment until 6 weeks postpartum)

Population: Intention to treat analysis of all participants with pregnancy progressing beyond 20 weeks with delivery data available

Compare maternal and fetal outcomes in pregnant women at a high risk for preeclampsia who are treated with either 81mg or 162mg of daily aspirin during pregnancy, including gestational hypertension, postpartum hypertension, preterm delivery <37 weeks, fetal growth restriction (IUGR) or low birthweight (<2000g), placental abruption, ICU admission (maternal and neonatal), and maternal/fetal mortality.

Outcome measures

Measure	81mg ASA n=181 Participants Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=184 Participants Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Maternal and Fetal Outcomes gestational Hypertension	36 Participants	36 Participants
Maternal and Fetal Outcomes maternal ICU admission	2 Participants	1 Participants
Maternal and Fetal Outcomes Placental abruption	0 Participants	8 Participants
Maternal and Fetal Outcomes preterm delivery (<37 week)	50 Participants	57 Participants
Maternal and Fetal Outcomes IUGR or low birthweight	21 Participants	16 Participants
Maternal and Fetal Outcomes NICU admissions	27 Participants	33 Participants
Maternal and Fetal Outcomes postpartum Hypertension	23 Participants	22 Participants

SECONDARY outcome

Timeframe: 9 months for each patient (from recruitment until 6 weeks postpartum)

Population: Intention to treat analysis of all participants with pregnancy progressing beyond 20 weeks with delivery data available

Compare the time-to-event for developing preeclampsia for women treated with 81mg vs 162mg of aspirin per day. The time to event analysis will be made using the gestational age at the onset of preeclampsia as a variable

Outcome measures

Measure	81mg ASA n=181 Participants Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=184 Participants Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Time-to-event for Preeclampsia: Gestational Age at Onset of Preeclampsia	34.1 weeks to developing preeclampsia Standard Deviation 5.08	34.3 weeks to developing preeclampsia Standard Deviation 5.59

SECONDARY outcome

Timeframe: 9 months for each patient (from recruitment until 6 weeks postpartum)

Population: All available SMAQ adherence questionnaires are considered from all timepoints cumulatively

To assess the adherence to low dose aspirin in pregnant women that are at high risk for preeclampsia and compare compliance rates for women on 81mg vs 162mg of aspirin per day using urine studies for salicylates and serum analysis. All time points together

Outcome measures

Measure	81mg ASA n=369 Surveys Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=387 Surveys Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Aspirin Adherence- All Time Points Together	337 surveys reporting adherence	349 surveys reporting adherence

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months for each patient (from recruitment until 6 weeks postpartum)

Assess the impact of specific co-morbidities (diabetes, chronic hypertension, renal disease and autoimmune disease), blood pressure control, age and race on the relationship between treatment group (81mg vs 162mg aspirin per day) and preeclampsia incidence.

Outcome measures

Outcome data not reported

Adverse Events

81mg ASA

Serious events: 2 serious events

Other events: 55 other events

Deaths: 0 deaths

162mg ASA

Serious events: 4 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Measure	81mg ASA n=181 participants at risk Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=184 participants at risk Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Pregnancy, puerperium and perinatal conditions Antepartum Fetal demise after 20 weeks	1.1% 2/181 • Number of events 2 • 9 months	1.6% 3/184 • Number of events 3 • 9 months
Congenital, familial and genetic disorders Perinatal demise	0.00% 0/181 • 9 months	0.54% 1/184 • Number of events 1 • 9 months

Other adverse events

Measure	81mg ASA n=181 participants at risk Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.	162mg ASA n=184 participants at risk Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day. acetylsalicylic acid: High risk pregnant women will be treated with daily aspirin during pregnancy.
Cardiac disorders Hypertension	16.0% 29/181 • Number of events 29 • 9 months	25.5% 47/184 • Number of events 47 • 9 months
Pregnancy, puerperium and perinatal conditions Fetal concerns	3.9% 7/181 • Number of events 7 • 9 months	10.3% 19/184 • Number of events 19 • 9 months
Pregnancy, puerperium and perinatal conditions Vaginal Spotting	4.4% 8/181 • Number of events 8 • 9 months	9.8% 18/184 • Number of events 18 • 9 months
Infections and infestations COVID	2.2% 4/181 • Number of events 4 • 9 months	7.6% 14/184 • Number of events 14 • 9 months
Infections and infestations Infection	3.9% 7/181 • Number of events 7 • 9 months	6.0% 11/184 • Number of events 11 • 9 months

Additional Information

Dr Line Malha

Weill Cornell Medicine

Phone: 6469622606

Email: lim9120@med.cornell.edu

Results disclosure agreements

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