A Phase 4 interventional study of Ibuprofen and Acetaminophen in Hypertension, Pregnancy-Induced and Pre-eclampsia, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by University of Michigan · Phase 4, Interventional, and Treatment
To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).
Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for post-partum analgesia. This use is supported by limited data on post-partum pain specifically; however, ibuprofen and other NSAIDs are superior to acetaminophen in ameliorating uterine pain and cramping in dysmenorrhea. The effect of NSAIDs on blood pressure (BP) in women post-partum is less well-known. In non-pregnant hypertensive patients NSAIDs are associated with increased BP over short courses of days to months, though effects of various NSAIDs differ. Pooled analyses suggest changes in mean BP of up to 3-6 mm Hg depending on the measurement method.There are case reports of hypertensive crises after NSAID administration post-partum in both normotensive and hypertensive women. A larger, recent retrospective cohort study found no difference in mean arterial pressure (MAP) or need for antihypertensive therapy in women with severe hypertensive disorders of pregnancy who were exposed to NSAIDs post-partum.
In light of the potential for worsening blood pressure in women with hypertensive disorders of pregnancy, the Task Force on Hypertension in Pregnancy of American College of Obstetricians and Gynecologists stated that "providers should be reminded of the contribution of nonsteroidal anti-inflammatory agents to increased BP." Additionally the task force recommends that NSAIDS "be replaced by other analgesics in women with hypertension that persists for more than 1 day postpartum". However, provider practices since the publication of these guidelines have varied.
Hypothesis: When compared to acetaminophen, ibuprofen does not increase post-partum systolic blood pressure (SBP) above baseline to a clinically relevant degree (≥10 mmHg) in women with gHTN and preE.
Aim 1: To assess the mean difference in SBP during 24 hours of exposure to ibuprofen and acetaminophen.
Aim 2: To assess whether ibuprofen results in higher satisfaction with pain control in the immediate post-partum period (48 hours) compared to acetaminophen.
Aim 3: To prospectively assess the need for post-partum anti-hypertensive therapy and readmission for blood pressure control in women with gHTN and preE. The post-partum period is defined as delivery through 6 weeks after delivery.
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Exclusion Criteria:
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.
Drug: Ibuprofen · Drug: Acetaminophen
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.
Drug: Ibuprofen · Drug: 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 ibuprofen followed by acetaminophen.
Also known as: Advil, Motrin
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.
Also known as: Tylenol
Difference in Systolic Blood Pressure (SBP)
The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.
Time frame: 24 hours following intervention
Change in Self-reported Pain Score 2 Hours After First Intervention
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
Mean Pain Score by Nursing Assessment
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
Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen
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
| Milestone | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen |
|---|---|---|
| Started | 20 | 23 |
| Received first intervention | 19 | 18 |
| Completed | 17 | 10 |
| Not completed | 3 | 13 |
| Withdrew: Declined any study medication | 1 | 5 |
| Withdrew: Discharged prior to cross-over | 0 | 2 |
| Withdrew: Withdrew after receiving study drug | 2 | 6 |
| Milestone | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen |
|---|---|---|
| Started | 17 | 10 |
| Completed | 11 | 3 |
| Not completed | 6 | 7 |
| Withdrew: No blood pressure after cross-over | 1 | 0 |
| Withdrew: Discharged during second intervention | 3 | 5 |
| Withdrew: Withdrew after receiving study drug | 2 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.
| mmHg | Ibuprofen | Acetaminophen |
|---|---|---|
| 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 |
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.
| score on a scale | Ibuprofen | Acetaminophen |
|---|---|---|
| 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 |
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.
| score on a scale | Ibuprofen | Acetaminophen |
|---|---|---|
| Mean Pain Score by Nursing Assessment | 2.2 ± 1.1 | 2.3 ± 1.3 |
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.
| units on a scale | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen |
|---|---|---|
| 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) |
Collected over 48 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibuprofen | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Acetaminophen | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
Baseline characteristics were measured after the first milestone, after 6 total participants who were initially randomized declined the study medication.
| Age, Continuous(years) | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen | Total |
|---|---|---|---|
| Mean | 30.9 ± 6.9 | 31.1 ± 6.3 | 31.0 ± 6.5 |
| Sex: Female, Male(Participants) | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen | Total |
|---|---|---|---|
| Female | 19 | 18 | 37 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen | Total |
|---|---|---|---|
| Race/Ethnicity — Non-Hispanic White | 17 | 17 | 34 |
| Race/Ethnicity — Black | 1 | 0 | 1 |
| Race/Ethnicity — Hispanic | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen | Total |
|---|---|---|---|
| United States | 19 | 18 | 37 |
| BMI(kg/m^2) | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen | Total |
|---|---|---|---|
| Median | 33.5 (30 to 41) | 31.7 (28 to 36) | 32.3 (29.2 to 36.9) |
| Marital Status(Participants) | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen | Total |
|---|---|---|---|
| Single | 4 | 5 | 9 |
| Lives with partner | 1 | 1 | 2 |
| Married | 14 | 11 | 25 |
| Not reported | 0 | 1 | 1 |
| Insurance(Participants) | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen | Total |
|---|---|---|---|
| Commercial | 17 | 14 | 31 |
| Public/Medicaid | 2 | 4 | 6 |
| Nulliparous(Participants) | Ibuprofen Followed by Acetaminophen | Acetaminophen Followed by Ibuprofen | Total |
|---|---|---|---|
| Count of participants | 10 | 11 | 21 |
4 further baseline measures are reported on the registry.
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