Trial Outcomes & Findings for Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia (NCT NCT03893630)
NCT ID: NCT03893630
Last Updated: 2025-08-29
Results Overview
Uterine artery doppler is used to assess impedance to flow in the uterine artery three times: 11-16 weeks gestation(baseline), 18-22 weeks gestation (event 2), 28-32 weeks gestation (event 3). Data reported as change between 11-16 weeks gestation (baseline) and either 18-22 weeks gestation (event 2) or 28-32 weeks gestation (event 3). difference in uterine artery pulsatility index (PI) is calculated as the difference in PI for each patient between each trimester visit. PI at each visit will be calculated by averaging left-side and right-side PIs from each of three (or all available) images on each side for each patient using ultrasound technology. Unit of measure is a ratio: difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity Relative change in uterine artery pulsatility index is a measure of flow to the uterus. A greater difference from the baseline value represents a greater improvement in placental perfusion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Three times between 11 and 32 weeks of gestation.
Results posted on
2025-08-29
Participant Flow
Participant milestones
| Measure |
Control Group
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
68
|
75
|
|
Overall Study
COMPLETED
|
57
|
54
|
68
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
7
|
Reasons for withdrawal
| Measure |
Control Group
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
3
|
|
Overall Study
Discontinued Intervention
|
0
|
4
|
2
|
Baseline Characteristics
Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia
Baseline characteristics by cohort
| Measure |
Control Group
n=65 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=68 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=75 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 6.3 • n=39 Participants
|
29.6 years
STANDARD_DEVIATION 5.9 • n=41 Participants
|
29.8 years
STANDARD_DEVIATION 6.1 • n=35 Participants
|
29.7 years
STANDARD_DEVIATION 6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=39 Participants
|
68 Participants
n=41 Participants
|
75 Participants
n=35 Participants
|
208 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=39 Participants
|
59 Participants
n=41 Participants
|
66 Participants
n=35 Participants
|
182 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
29 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=39 Participants
|
52 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
146 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=39 Participants
|
68 participants
n=41 Participants
|
75 participants
n=35 Participants
|
208 participants
n=31 Participants
|
|
BMI at enrollment
|
29.2 kg/m2
STANDARD_DEVIATION 7.9 • n=39 Participants
|
35.7 kg/m2
STANDARD_DEVIATION 10.0 • n=41 Participants
|
34.1 kg/m2
STANDARD_DEVIATION 8.5 • n=35 Participants
|
33.1 kg/m2
STANDARD_DEVIATION 9.2 • n=31 Participants
|
|
Method of Conception
Natural
|
60 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
195 Participants
n=31 Participants
|
|
Method of Conception
Assisted by Ovulation Drugs
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Method of Conception
In Vitro Fertilization
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Three times between 11 and 32 weeks of gestation.Population: Participants delivered or lost to follow up not included
Uterine artery doppler is used to assess impedance to flow in the uterine artery three times: 11-16 weeks gestation(baseline), 18-22 weeks gestation (event 2), 28-32 weeks gestation (event 3). Data reported as change between 11-16 weeks gestation (baseline) and either 18-22 weeks gestation (event 2) or 28-32 weeks gestation (event 3). difference in uterine artery pulsatility index (PI) is calculated as the difference in PI for each patient between each trimester visit. PI at each visit will be calculated by averaging left-side and right-side PIs from each of three (or all available) images on each side for each patient using ultrasound technology. Unit of measure is a ratio: difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity Relative change in uterine artery pulsatility index is a measure of flow to the uterus. A greater difference from the baseline value represents a greater improvement in placental perfusion.
Outcome measures
| Measure |
Control Group
n=55 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=52 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=66 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Change in Pulsatility Index (PI)
Baseline to Event 2
|
-0.56 ratio
Standard Deviation 0.55
|
-0.53 ratio
Standard Deviation 0.34
|
-0.43 ratio
Standard Deviation 0.34
|
|
Change in Pulsatility Index (PI)
Baseline to Event 3
|
-0.88 ratio
Standard Deviation 0.56
|
-0.72 ratio
Standard Deviation 0.41
|
-0.58 ratio
Standard Deviation .54
|
SECONDARY outcome
Timeframe: From enrollment at 11 weeks throughout pregnancy and postpartum ( 6 weeks after delivery), approximately 35 weeksPopulation: Participants delivered or lost to follow up not included
Frequency of Disease during pregnancy and postpartum as defined by American College of Obstetrics and Gynecology (ACOG) criteria
Outcome measures
| Measure |
Control Group
n=58 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=61 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=73 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Onset of Pre-eclampsia
|
1 Participants
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From enrollment at 11 weeks throughout pregnancy and immediate postpartum ( 6 weeks after delivery), approximately 35 weeksPopulation: Participants delivered or lost to follow up not included
Frequency women are identified with Severe Features of the disease
Outcome measures
| Measure |
Control Group
n=58 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=62 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=73 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Severity of Pre-eclampsia
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Neonatal period ( first 28 days after birth)Population: Participants lost to follow up not included
Frequency of adverse neonatal outcomes
Outcome measures
| Measure |
Control Group
n=57 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=59 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=70 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Composite Neonatal Outcomes Including Frequency of Intraventricular Hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome (RDS), Necrotising Enterocolitis(NEC)
|
5 Participants
|
17 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Three times between 11 and 32 weeks of gestationPopulation: Serum specimens were not collected for all patients at individual timepoints related to issues such as patient refusal for venipuncture. Some elected to discontinue participation
Serial biologic samples will be obtained in the first (baseline), second (event 2), and third (event 3) trimesters to measure changes in soluble Intercellular Adhesion Molecule (s-ICAM) levels over time.
Outcome measures
| Measure |
Control Group
n=57 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=53 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=64 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Change in s-ICAM Levels Over Time
Baseline and Event 2
|
6.1 ng/ml
Standard Deviation 12.6
|
1.6 ng/ml
Standard Deviation 30.8
|
7.9 ng/ml
Standard Deviation 28.5
|
|
Change in s-ICAM Levels Over Time
Baseline and Event 3
|
-29.6 ng/ml
Standard Deviation 15.0
|
-43.6 ng/ml
Standard Deviation 32.2
|
-34.1 ng/ml
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: Three times between 11 and 32 weeks of gestationPopulation: Serum specimens were not collected for all patients at individual timepoints related to issues such as patient refusal for venipuncture. Some elected to discontinue participation
Serial biologic samples will be obtained in the first (baseline), second (event 2), and third (event 3) trimesters to measure changes in placental growth factor (PIGF) levels over time.
Outcome measures
| Measure |
Control Group
n=57 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=53 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=64 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Change in PIGF Levels Over Time
Baseline and Event 2
|
570.6 pg/ml
Standard Deviation 377.8
|
568.3 pg/ml
Standard Deviation 545.8
|
509.7 pg/ml
Standard Deviation 457.8
|
|
Change in PIGF Levels Over Time
Baseline and Event 3
|
-36.4 pg/ml
Standard Deviation 69.3
|
1.0 pg/ml
Standard Deviation 136.0
|
-16.7 pg/ml
Standard Deviation 44.1
|
SECONDARY outcome
Timeframe: Three times between 11 and 32 weeks of gestationPopulation: Serum specimens were not collected for all patients at individual timepoints related to issues such as patient refusal for venipuncture. Some elected to discontinue participation.
Serial biologic samples will be obtained in the first, second, and third trimesters to measure changes in C-reactive protein (CRP) levels over time.
Outcome measures
| Measure |
Control Group
n=57 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=53 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=64 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Change in CRP Levels Over Time
Baseline and Follow Up 1
|
-0.5 mg/L
Standard Deviation 8.8
|
0.2 mg/L
Standard Deviation 9.3
|
-2.7 mg/L
Standard Deviation 8.8
|
|
Change in CRP Levels Over Time
Baseline and Delivery
|
-10.6 mg/L
Standard Deviation 11.9
|
-13.4 mg/L
Standard Deviation 12.4
|
-11.9 mg/L
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Three times between 11 and 32 weeks of gestationPopulation: Not enough serum from samples to run these measures
Serial biologic samples will be obtained in the first, second, and third trimesters to measure changes in interleukin 6 (IL-6) levels over time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three times between 11 and 32 weeks of gestationPopulation: Not enough serum from samples to run these measures
Serial biologic samples will be obtained in the first, second, and third trimesters to measure changes in tumor necrosis factor (TNFα) levels over time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Delivery, up to 41 weeksmeasured in weeks, from the first day of the last menstrual cycle to delivery
Outcome measures
| Measure |
Control Group
n=65 Participants
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=68 Participants
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=75 Participants
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Gestational Age at Delivery
|
38.8 weeks
Standard Deviation 1.3
|
36.0 weeks
Standard Deviation 4.3
|
36.2 weeks
Standard Deviation 4.7
|
Adverse Events
Control Group
Serious events: 8 serious events
Other events: 3 other events
Deaths: 0 deaths
Acetylsalicylic Acid 81mg
Serious events: 12 serious events
Other events: 3 other events
Deaths: 0 deaths
Acetylsalicylic Acid 162mg
Serious events: 15 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=65 participants at risk
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=68 participants at risk
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=75 participants at risk
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Hemorrhage
|
12.3%
8/65 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
10.3%
7/68 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
12.0%
9/75 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
|
Pregnancy, puerperium and perinatal conditions
Intrauterine Fetal Demise
|
0.00%
0/65 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
2.9%
2/68 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
1.3%
1/75 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
|
Pregnancy, puerperium and perinatal conditions
Placental Abruption
|
0.00%
0/65 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
1.5%
1/68 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
2.7%
2/75 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
|
Pregnancy, puerperium and perinatal conditions
Previable Delivery
|
0.00%
0/65 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
2.9%
2/68 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
4.0%
3/75 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
Other adverse events
| Measure |
Control Group
n=65 participants at risk
Patients will receive standard of care.
Control: Standard of Care
|
Acetylsalicylic Acid 81mg
n=68 participants at risk
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 81 mg: Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
Acetylsalicylic Acid 162mg
n=75 participants at risk
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Acetylsalicylic Acid 162 mg: Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
|
|---|---|---|---|
|
Nervous system disorders
headaches
|
3.1%
2/65 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
0.00%
0/68 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
0.00%
0/75 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
|
Blood and lymphatic system disorders
Nose bleeds
|
0.00%
0/65 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
1.5%
1/68 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
0.00%
0/75 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/65 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
1.5%
1/68 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
0.00%
0/75 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
|
Gastrointestinal disorders
Emesis
|
1.5%
1/65 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
1.5%
1/68 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
2.7%
2/75 • 29 weeks
Adverse Events were assessed from enrollment until delivery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place