Trial Outcomes & Findings for Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features (NCT NCT02911701)
NCT ID: NCT02911701
Last Updated: 2023-07-27
Results Overview
length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
duration of postpartum hospitalization (approximately 3-7 days)
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Acetaminophen
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
47
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Acetaminophen
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
Baseline characteristics by cohort
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
31.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Native American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
mode of delivery
Vaginal
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
mode of delivery
Operative vaginal
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
mode of delivery
Cesarean
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Parity
Nulliparous
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Parity
Multiparous
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
chronic hypertension requiring treatment
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
need for IV Antihypertensives before delivery
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Duration of Severe-range Hypertension After Delivery
|
38.0 hours
Interval 29.4 to 51.3
|
35.3 hours
Interval 27.2 to 47.5
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)number of days from delivery until hospital discharge
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Length of Hospitalization
|
4.0 days
Standard Deviation 1.3
|
3.8 days
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)computed mean arterial pressure using all measured blood pressures during postpartum hospitalization
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Mean Arterial Pressure Over the Entire Postpartum Hospitalization
|
97.3 mmHg
Standard Deviation 9.1
|
37.6 mmHg
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Population: Data not collected
computed mean arterial pressure using all measured blood pressures during postpartum hospitalization, stratified by postpartum day (1, 2, 3, etc.)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Population: Data not collected
mean total number of severe range blood pressure (defined as SBP \>160mmGh or DBP \>110mmHg) measurements in each study arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Severe-range hypertension (defined as SBP \> 160 mmHg or DBP \>1100 mmHg) during postpartum stay
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Proportion of Study Participants in Each Study Arm Who Have Any Postpartum Severe Range BPs
|
31 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg)
|
165 mm Hg
Standard Deviation 15
|
168 mm Hg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge
|
31 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Population: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Proportion in each arm who required one or more doses of antihypertensive medication given for acute lowering of BP
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Need for Antihypertensives (Either Oral or Intravenous) for Acute Lowering of Blood Pressure
|
26 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)The proportion of study participants in each study arm who require any IV antihypertensives to acutely lower blood pressure during their postpartum hospital stay.
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
The Proportion of Study Participants Requiring the Use of Intravenous Antihypertensives
|
26 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Population: Clinical ascertainment of pain level was of low quality and so was not analyzed.
Mean daily pain level, as reported by patient on scale from 1-10 (10 is most severe).
Outcome measures
| Measure |
Acetaminophen
n=47 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=44 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Mean Daily Pain Level, as Reported by Patient on Scale From 1-10, Stratified by Postpartum Day
|
2.4 units on a scale
Standard Deviation 2.3
|
1.8 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day
postpartum day 0
|
22.6 morphine equivalents, mg
Standard Deviation 13.9
|
22.1 morphine equivalents, mg
Standard Deviation 25.1
|
|
Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day
postpartum day 1
|
32.3 morphine equivalents, mg
Standard Deviation 30
|
27.5 morphine equivalents, mg
Standard Deviation 18.7
|
|
Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day
postpartum day 2
|
45.4 morphine equivalents, mg
Standard Deviation 32.3
|
28.9 morphine equivalents, mg
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Population: data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Population: Data not collected
Mean difference in hematocrit from pre-delivery to postpartum nadir prior to discharge
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Adverse events include seizure, stroke, posterior reversible encephalopathy syndrome, repeat course of IV magnesium sulfate for seizure prophylaxis.
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Composite of Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)AST: Aspartate aminotransferase; ALT: alanine aminotransferase
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Proportion of Study Participants in Each Study Arm With New Onset Postpartum Elevation of Liver Function Tests (AST, ALT) Above Twice the Normal Limit
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Acute kidney injury is defined as serum creatinine \> 1.1mg/dL or double the baseline value
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Proportion of Study Participants in Each Study Arm With New Onset Postpartum Acute Kidney Injury
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)Delayed postpartum hemorrhage is defined as \> 1000 mL of blood loss occuring \> 24 hours after delivery
Outcome measures
| Measure |
Acetaminophen
n=50 Participants
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 Participants
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Proportion of Study Participants in Each Study Arm With Delayed Postpartum Hemorrhage
|
0 Participants
|
0 Participants
|
Adverse Events
Acetaminophen
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acetaminophen
n=50 participants at risk
Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.
Acetaminophen
|
Ibuprofen
n=50 participants at risk
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Inpatient readmission
|
0.00%
0/50 • Duration of postpartum hospitalization, up to 2 weeks
|
6.0%
3/50 • Number of events 3 • Duration of postpartum hospitalization, up to 2 weeks
|
|
Gastrointestinal disorders
Acute postpartum elevation of liver function tests
|
2.0%
1/50 • Number of events 1 • Duration of postpartum hospitalization, up to 2 weeks
|
0.00%
0/50 • Duration of postpartum hospitalization, up to 2 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nathan Blue
University of New Mexico, Division of Maternal-Fetal Medicine
Phone: 505-272-6309
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place