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The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

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ClinicalTrials.gov Identifier: NCT02891174
Recruitment Status : Completed
First Posted : September 7, 2016
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Langen, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hypertension, Pregnancy-Induced
Pre-eclampsia
Interventions Drug: Ibuprofen
Drug: Acetaminophen
Enrollment 74
Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Ibuprofen Followed by Acetaminophen Acetaminophen Followed by Ibuprofen
Hide Arm/Group Description Period 1: Ibuprofen 600 mg every 6 hours for 24 hours Period 2: Acetaminophen 650 mg every 6 hours for 24 hours. No washout Period 1: Acetaminophen 650 mg every 6 hours for 24 hours Period 2: Ibuprofen 600 mg every 6 hours for 24 hours. No washout
Period Title: First Intervention (24 Hours)
Started 20 23
Received First Intervention 19 18
Completed 17 10
Not Completed 3 13
Reason Not Completed
Declined any study medication             1             5
Discharged prior to cross-over             0             2
Withdrew after receiving study drug             2             6
Period Title: Second Intervention (24 Hours)
Started 17 10
Completed 11 3
Not Completed 6 7
Reason Not Completed
No blood pressure after cross-over             1             0
Discharged during second intervention             3             5
Withdrew after receiving study drug             2             1
Protocol Violation             0             1
Arm/Group Title Ibuprofen Followed by Acetaminophen Acetaminophen Followed by Ibuprofen Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 19 18 37
Hide Baseline Analysis Population Description
Baseline characteristics were measured after the first milestone, after 6 total participants who were initially randomized declined the study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 18 participants 37 participants
30.9  (6.9) 31.1  (6.3) 31.0  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 37 participants
Female
19
 100.0%
18
 100.0%
37
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 19 participants 18 participants 37 participants
Non-Hispanic White
17
  89.5%
17
  94.4%
34
  91.9%
Black
1
   5.3%
0
   0.0%
1
   2.7%
Hispanic
1
   5.3%
1
   5.6%
2
   5.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 18 participants 37 participants
19
 100.0%
18
 100.0%
37
 100.0%
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants 18 participants 37 participants
33.5
(30 to 41)
31.7
(28 to 36)
32.3
(29.2 to 36.9)
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 37 participants
Single
4
  21.1%
5
  27.8%
9
  24.3%
Lives with partner
1
   5.3%
1
   5.6%
2
   5.4%
Married
14
  73.7%
11
  61.1%
25
  67.6%
Not reported
0
   0.0%
1
   5.6%
1
   2.7%
Insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 37 participants
Commercial
17
  89.5%
14
  77.8%
31
  83.8%
Public/Medicaid
2
  10.5%
4
  22.2%
6
  16.2%
Nulliparous  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 37 participants
10
  52.6%
11
  61.1%
21
  56.8%
Gestational Age  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 19 participants 18 participants 37 participants
39.4  (1.5) 38.6  (1.5) 38.9  (1.5)
Gestational Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 37 participants
15
  78.9%
17
  94.4%
32
  86.5%
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 19 participants 18 participants 37 participants
132.5  (5.3) 131.2  (7.3) 131.6  (10.9)
Maximum Systolic Blood Pressure Prior to Delivery   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 19 participants 18 participants 37 participants
153.2  (8.8) 149.8  (8.6) 151.5  (8.0)
[1]
Measure Description: The maximum systolic blood pressure between admission and delivery for each participant was recorded. The mean of the maximum systolic blood pressures was calculated for each group.
1.Primary Outcome
Title Difference in Systolic Blood Pressure (SBP)
Hide Description The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.
Time Frame 24 hours following intervention
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ibuprofen Acetaminophen
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline systolic blood pressure 131.8  (6.3) 132.0  (6.4)
Systolic blood pressure after exposure 129.1  (8.3) 129.1  (8.5)
Observed Difference in systolic blood pressure -2.7  (8.1) -2.9  (8.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen, Acetaminophen
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments margin=10 mmHg
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-3.7 to 5.7
Estimation Comments The adjusted mean difference between ibuprofen and acetaminophen is presented here. The adjusted mean difference was calculated using a linear mixed model adjusting for time period by intention-to-treat principles.
2.Secondary Outcome
Title Change in Self-reported Pain Score 2 Hours After First Intervention
Hide Description 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.
Time Frame At the time of first dose of study drug and 2 hours after
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ibuprofen Acetaminophen
Hide Arm/Group Description:
Ibuprofen was the first intervention and pain scales were administered only during this first period.
Acetaminophen was the first intervention and pain scales were administered only during this first period.
Overall Number of Participants Analyzed 14 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
Abdominal pain -0.6  (1.6) -0.3  (1.2)
Perineal pain -1.1  (1.6) 1.0  (0.6)
Overall pain -0.7  (1.8) -0.6  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen, Acetaminophen
Comments Change in abdominal pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments Abdominal pain
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen, Acetaminophen
Comments Change in perineal pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments Perineal pain
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen, Acetaminophen
Comments Change in overall pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments Overall pain
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Pain Score by Nursing Assessment
Hide Description 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.
Time Frame 0-24 hours and 24-48 hours after initial study medication administration
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ibuprofen Acetaminophen
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.2  (1.1) 2.3  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen, Acetaminophen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen
Hide Description 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.
Time Frame 24 hours and 48 hours after initial study medication administration
Hide Outcome Measure Data
Hide Analysis Population Description
11 women in the ibuprofen first group and 6 women in the the acetaminophen first group completed the satisfaction survey prior to discharge.
Arm/Group Title Ibuprofen Followed by Acetaminophen Acetaminophen Followed by Ibuprofen
Hide Arm/Group Description:
Period 1: Ibuprofen 600 mg every 6 hours for 24 hours. Period 2: Acetaminophen 650 mg every 6 hours for 24 hours. No washout period.
Period 1: Acetaminophen 650 mg every 6 hours for 24 hours. Period 2: Ibuprofen 600 mg every 6 hours for 24 hours. No washout period.
Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Period 1
3
(2 to 4)
4
(4 to 5)
Period 2
3
(2 to 4)
4.5
(4 to 5)
Overall
3
(2 to 4)
4.5
(4 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen Followed by Acetaminophen, Acetaminophen Followed by Ibuprofen
Comments First intervention (24 hours)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen Followed by Acetaminophen, Acetaminophen Followed by Ibuprofen
Comments Second intervention (24 hours)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen Followed by Acetaminophen
Comments Overall satisfaction with pain control during study period
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 48 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibuprofen Acetaminophen
Hide Arm/Group Description Women who received ibuprofen intervention Women who received acetaminophen intervention
All-Cause Mortality
Ibuprofen Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/34 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ibuprofen Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ibuprofen Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/34 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elizabeth Langen
Organization: University of Michigan
Phone: 734-764-3406
EMail: elangen@med.umich.edu
Layout table for additonal information
Responsible Party: Elizabeth Langen, University of Michigan
ClinicalTrials.gov Identifier: NCT02891174     History of Changes
Other Study ID Numbers: HUM00117154
First Submitted: August 26, 2016
First Posted: September 7, 2016
Results First Submitted: March 19, 2019
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019