Trial Outcomes & Findings for The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy (NCT NCT02891174)
NCT ID: NCT02891174
Last Updated: 2019-05-23
Results Overview
The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.
COMPLETED
PHASE4
74 participants
24 hours following intervention
2019-05-23
Participant Flow
74 women were consented prior to delivery. Women were subsequently excluded due to cesarean delivery (n=20), severe features of preeclampsia (n=7), additional anesthesia (n=2), and delivery physician preference (n=2). 43 women were randomized. Six women declined study medication and were not included in intention-to-treat analysis.
Participant milestones
| Measure |
Ibuprofen Followed by Acetaminophen
Period 1: Ibuprofen 600 mg every 6 hours for 24 hours Period 2: Acetaminophen 650 mg every 6 hours for 24 hours. No washout
|
Acetaminophen Followed by Ibuprofen
Period 1: Acetaminophen 650 mg every 6 hours for 24 hours Period 2: Ibuprofen 600 mg every 6 hours for 24 hours. No washout
|
|---|---|---|
|
First Intervention (24 Hours)
STARTED
|
20
|
23
|
|
First Intervention (24 Hours)
Received First Intervention
|
19
|
18
|
|
First Intervention (24 Hours)
COMPLETED
|
17
|
10
|
|
First Intervention (24 Hours)
NOT COMPLETED
|
3
|
13
|
|
Second Intervention (24 Hours)
STARTED
|
17
|
10
|
|
Second Intervention (24 Hours)
COMPLETED
|
11
|
3
|
|
Second Intervention (24 Hours)
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Ibuprofen Followed by Acetaminophen
Period 1: Ibuprofen 600 mg every 6 hours for 24 hours Period 2: Acetaminophen 650 mg every 6 hours for 24 hours. No washout
|
Acetaminophen Followed by Ibuprofen
Period 1: Acetaminophen 650 mg every 6 hours for 24 hours Period 2: Ibuprofen 600 mg every 6 hours for 24 hours. No washout
|
|---|---|---|
|
First Intervention (24 Hours)
Declined any study medication
|
1
|
5
|
|
First Intervention (24 Hours)
Discharged prior to cross-over
|
0
|
2
|
|
First Intervention (24 Hours)
Withdrew after receiving study drug
|
2
|
6
|
|
Second Intervention (24 Hours)
No blood pressure after cross-over
|
1
|
0
|
|
Second Intervention (24 Hours)
Discharged during second intervention
|
3
|
5
|
|
Second Intervention (24 Hours)
Withdrew after receiving study drug
|
2
|
1
|
|
Second Intervention (24 Hours)
Protocol Violation
|
0
|
1
|
Baseline Characteristics
The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
Baseline characteristics by cohort
| Measure |
Ibuprofen Followed by Acetaminophen
n=19 Participants
Ibuprofen administered immediately post-partum, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours followed by acetaminophen, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours.
Ibuprofen: At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with ibuprofen followed by acetaminophen.
Acetaminophen: At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with acetaminophen followed by ibuprofen.
|
Acetaminophen Followed by Ibuprofen
n=18 Participants
Acetaminophen administered immediately post-partum, 650 mg (2 x 325 mg tablets) every 6 hours for 24 hours followed by ibuprofen, 600 mg (3 x 200 mg tablets) every 6 hours for 24 hours.
Ibuprofen: At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with ibuprofen followed by acetaminophen.
Acetaminophen: At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with acetaminophen followed by ibuprofen.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
31.1 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
31.0 years
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
BMI
|
33.5 kg/m^2
n=99 Participants
|
31.7 kg/m^2
n=107 Participants
|
32.3 kg/m^2
n=206 Participants
|
|
Marital Status
Single
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Marital Status
Lives with partner
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Marital Status
Married
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Marital Status
Not reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Insurance
Commercial
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Insurance
Public/Medicaid
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Nulliparous
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Gestational Age
|
39.4 weeks
STANDARD_DEVIATION 1.5 • n=99 Participants
|
38.6 weeks
STANDARD_DEVIATION 1.5 • n=107 Participants
|
38.9 weeks
STANDARD_DEVIATION 1.5 • n=206 Participants
|
|
Gestational Hypertension
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Systolic Blood Pressure
|
132.5 mmHg
STANDARD_DEVIATION 5.3 • n=99 Participants
|
131.2 mmHg
STANDARD_DEVIATION 7.3 • n=107 Participants
|
131.6 mmHg
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Maximum Systolic Blood Pressure Prior to Delivery
|
153.2 mmHg
STANDARD_DEVIATION 8.8 • n=99 Participants
|
149.8 mmHg
STANDARD_DEVIATION 8.6 • n=107 Participants
|
151.5 mmHg
STANDARD_DEVIATION 8.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours following interventionPopulation: 37 women who received \>=1 dose of study drug were included in intention-to-treat analyses. 35 women had blood pressure recorded in the intended ibuprofen period; 2 excluded due to discharge prior to cross-over. 36 women had blood pressure recorded in the intended acetaminophen period; 1 excluded with no blood pressure measured after cross-over.
The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.
Outcome measures
| Measure |
Ibuprofen
n=35 Participants
Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended ibuprofen period.
|
Acetaminophen
n=36 Participants
Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended acetaminophen period.
|
|---|---|---|
|
Difference in Systolic Blood Pressure (SBP)
Baseline systolic blood pressure
|
131.8 mmHg
Standard Deviation 6.3
|
132.0 mmHg
Standard Deviation 6.4
|
|
Difference in Systolic Blood Pressure (SBP)
Systolic blood pressure after exposure
|
129.1 mmHg
Standard Deviation 8.3
|
129.1 mmHg
Standard Deviation 8.5
|
|
Difference in Systolic Blood Pressure (SBP)
Observed Difference in systolic blood pressure
|
-2.7 mmHg
Standard Deviation 8.1
|
-2.9 mmHg
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: At the time of first dose of study drug and 2 hours afterPopulation: 14 women in the ibuprofen first group and 8 women in the the acetaminophen first group completed pain surveys before and 2 hours after 1st dose of study drug.
Prior to the first dose of pain medication, participants will take a brief, self-administered survey to assess abdominal and overall pain using a 0-10 scale. Two hours after the first dose of study drug, participants will repeat the self-administered survey to assess abdominal, perineal, and overall pain using a 0-10 scale. Clinical Pain Scale: 0=no pain to 10=worst pain.
Outcome measures
| Measure |
Ibuprofen
n=14 Participants
Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended ibuprofen period.
|
Acetaminophen
n=8 Participants
Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended acetaminophen period.
|
|---|---|---|
|
Change in Self-reported Pain Score 2 Hours After First Intervention
Abdominal pain
|
-0.6 score on a scale
Standard Deviation 1.6
|
-0.3 score on a scale
Standard Deviation 1.2
|
|
Change in Self-reported Pain Score 2 Hours After First Intervention
Perineal pain
|
-1.1 score on a scale
Standard Deviation 1.6
|
1.0 score on a scale
Standard Deviation 0.6
|
|
Change in Self-reported Pain Score 2 Hours After First Intervention
Overall pain
|
-0.7 score on a scale
Standard Deviation 1.8
|
-0.6 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 0-24 hours and 24-48 hours after initial study medication administrationPopulation: Of 37 women in intention-to-treat analyses, 35 were analyzed in ibuprofen treatment; 2 of those women had no recorded nursing pain score in ibuprofen period (n=33). 36 women were analyzed in acetaminophen treatment, but 1 of those women had no recorded nursing pain score in acetaminophen period (n=35).
Pain scores using a 0-10 scale as assessed by nursing during the 48 hours from initial study medication administration will be abstracted from the participant's medical record. Clinical Pain Scale: 0=no pain to 10=worst pain. All pain scores during the first intervention (0-24 hours) and second intervention (24-48) are included according to intention-to-treat principles.
Outcome measures
| Measure |
Ibuprofen
n=33 Participants
Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended ibuprofen period.
|
Acetaminophen
n=35 Participants
Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended acetaminophen period.
|
|---|---|---|
|
Mean Pain Score by Nursing Assessment
|
2.2 score on a scale
Standard Deviation 1.1
|
2.3 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 24 hours and 48 hours after initial study medication administrationPopulation: 11 women in the ibuprofen first group and 6 women in the the acetaminophen first group completed the satisfaction survey prior to discharge.
A brief survey on satisfaction with pain control during the first 24 hours post-partum and the second 24 hours post-partum, as well as overall during post-partum stay will be administered prior to discharge using a 1-5 Likert scale: 1=not satisfied to 5=extremely satisfied.
Outcome measures
| Measure |
Ibuprofen
n=11 Participants
Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended ibuprofen period.
|
Acetaminophen
n=6 Participants
Intention to treat population: received at least 1 dose of study medication in the first intervention period (either ibuprofen or acetaminophen), and had a blood pressure measured during the intended acetaminophen period.
|
|---|---|---|
|
Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen
Period 1
|
3 units on a scale
Interval 2.0 to 4.0
|
4 units on a scale
Interval 4.0 to 5.0
|
|
Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen
Period 2
|
3 units on a scale
Interval 2.0 to 4.0
|
4.5 units on a scale
Interval 4.0 to 5.0
|
|
Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen
Overall
|
3 units on a scale
Interval 2.0 to 4.0
|
4.5 units on a scale
Interval 4.0 to 5.0
|
Adverse Events
Ibuprofen
Acetaminophen
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place