Trial Outcomes & Findings for Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida (NCT NCT03961360)

NCT ID: NCT03961360

Last Updated: 2024-05-08

Results Overview

based on American College Obstetrics and Gynecology (ACOG) guidelines

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 220 participants
• Primary outcome timeframe: 3-7 months
• Results posted on: 2024-05-08

Participant Flow

Participant milestones

Measure	162 mg/Day Aspirin Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Overall Study STARTED	110	110
Overall Study COMPLETED	107	102
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida

Baseline characteristics by cohort

Measure	162 mg/Day Aspirin n=110 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=110 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	Total n=220 Participants Total of all reporting groups
Age, Continuous	30 years n=93 Participants	29 years n=4 Participants	29 years n=27 Participants
Sex: Female, Male Female	110 Participants n=93 Participants	110 Participants n=4 Participants	220 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized African American	52 Participants n=93 Participants	59 Participants n=4 Participants	111 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic/Latina	34 Participants n=93 Participants	25 Participants n=4 Participants	59 Participants n=27 Participants
Race/Ethnicity, Customized White	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Race/Ethnicity, Customized Unknown or not reported	16 Participants n=93 Participants	19 Participants n=4 Participants	35 Participants n=27 Participants
Region of Enrollment United States	110 participants n=93 Participants	110 participants n=4 Participants	220 participants n=27 Participants
Insurance Type Private	10 Participants n=93 Participants	11 Participants n=4 Participants	21 Participants n=27 Participants
Insurance Type Government assisted (Medicaid, Medicare or other federal or state funded assistance program)	99 Participants n=93 Participants	99 Participants n=4 Participants	198 Participants n=27 Participants
Insurance Type Self pay	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Gestational age at enrollment	15.9 weeks n=93 Participants	15.6 weeks n=4 Participants	15.64 weeks n=27 Participants
Body Mass Index	37 kg/m^2 n=93 Participants	38 kg/m^2 n=4 Participants	37.88 kg/m^2 n=27 Participants
Number of Participants who are Nulliparous	19 Participants n=93 Participants	27 Participants n=4 Participants	46 Participants n=27 Participants
Number of Participants with Systemic Lupus Erythematosus	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Number of Participants who use tobacco during pregnancy	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
History of preeclampsia in prior pregnancy	37 Participants n=93 Participants	30 Participants n=4 Participants	67 Participants n=27 Participants
Number of participants with Type 1 diabetes	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Number of participants with type 2 diabetes	41 Participants n=93 Participants	43 Participants n=4 Participants	84 Participants n=27 Participants
Number of participants diagnosed with gestational diabetes before 20 weeks	3 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants
Number of participants enrolled prior to 16 weeks	55 Participants n=93 Participants	58 Participants n=4 Participants	113 Participants n=27 Participants
Number of participants on aspirin prior to enrollment	23 Participants n=93 Participants	21 Participants n=4 Participants	44 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3-7 months

based on American College Obstetrics and Gynecology (ACOG) guidelines

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis	37 Participants	41 Participants

SECONDARY outcome

Timeframe: less than 37 weeks gestational age (GA)

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features	22 Participants	21 Participants

SECONDARY outcome

Timeframe: 3-7 months

development of hypertension anytime during pregnancy based on ACOG guidelines

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Maternal Outcomes-Number of Participants With Gestational Hypertension	13 Participants	20 Participants

SECONDARY outcome

Timeframe: 1 day

Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Maternal Outcomes- Number of Participants With Placenta Abruption	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 20 weeks

onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Maternal Outcomes- Number of Participants With Eclampsia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

group of symptoms that occur in pregnant women who have: hemolysis(H): (the breakdown of red blood cells)elevated liver enzymes (EL). low platelet (LP) count. Assessed by ACOG guidelines and measured in urine and blood samples

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Maternal Outcomes- Number of Participants With HELLP Syndrome	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-24 hrs post delivery

excessive bleeding following the birth of a baby

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Maternal Outcomes- Number of Participants With Postpartum Hemorrhage	11 Participants	9 Participants

SECONDARY outcome

Timeframe: during labor to 24 hrs post delivery

any other bleeding associated with birth not otherwise categorized

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Maternal Outcomes- Number of Participants With Other Maternal Bleeding	0 Participants	0 Participants

SECONDARY outcome

Timeframe: during delivery

peripartum

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Maternal Outcomes- Number of Participants That Required Blood Transfusion	8 Participants	6 Participants

SECONDARY outcome

Timeframe: at delivery

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Neonatal Outcome- Gestational Age at Delivery	36.30 weeks Interval 34.4 to 37.4	37.20 weeks Interval 35.1 to 38.2

SECONDARY outcome

Timeframe: at delivery

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Neonatal Outcomes-Delivery at < 37 Weeks	58 Participants	45 Participants

SECONDARY outcome

Timeframe: 5 minutes post delivery

The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Neonatal Outcomes-Apgar Score < 5 at 5 Minutes	4 Participants	3 Participants

SECONDARY outcome

Timeframe: at delivery

Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile.

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Neonatal Outcome-Small for Gestational Age	7 Participants	3 Participants

SECONDARY outcome

Timeframe: from birth until discharge from NICU (about 1 to 4 weeks)

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay	10 days Interval 4.0 to 17.0	10.5 days Interval 3.75 to 21.5

SECONDARY outcome

Timeframe: from birth until discharge from NICU (about 1 to 4 weeks)

bleeding inside or around the ventricles in the brain.

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from birth until discharge from NICU (about 1 to 4 weeks)

chronic lung disease that affects newborns (mostly premature) and infants.

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from birth until discharge from NICU (about 1 to 4 weeks)

medical condition where a portion of the bowel dies

Outcome measures

Measure	162 mg/Day Aspirin n=107 Participants Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=102 Participants Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis	1 Participants	0 Participants

Adverse Events

162 mg/Day Aspirin

Serious events: 24 serious events

Other events: 51 other events

Deaths: 0 deaths

81 mg/Day Aspirin

Serious events: 19 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Measure	162 mg/Day Aspirin n=110 participants at risk Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=110 participants at risk Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Pregnancy, puerperium and perinatal conditions Placenta Abruption	2.7% 3/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum	2.7% 3/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum
Pregnancy, puerperium and perinatal conditions Postpartum hemorrhage	10.0% 11/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum	8.2% 9/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum
Pregnancy, puerperium and perinatal conditions Maternal blood transfusion	7.3% 8/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum	5.5% 6/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum
Congenital, familial and genetic disorders Fetal Heart Defect	1.8% 2/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum	0.00% 0/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum
Congenital, familial and genetic disorders Kidney Malformation	0.00% 0/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum	0.91% 1/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum

Other adverse events

Measure	162 mg/Day Aspirin n=110 participants at risk Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia	81 mg/Day Aspirin n=110 participants at risk Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Pregnancy, puerperium and perinatal conditions Preeclampsia	33.6% 37/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum	37.3% 41/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum
Pregnancy, puerperium and perinatal conditions Gestational hypertension	11.8% 13/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum	18.2% 20/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum
Gastrointestinal disorders Necrotizing Enterocolitis	0.91% 1/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum	0.00% 0/110 • From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum

Additional Information

Farah Amro, MD

The University of Texas Health Science Center at Houston

Phone: 713-500-6421

Email: farah.h.amro@uth.tmc.edu

Results disclosure agreements

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