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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

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hypertension, Pregnancy-Induced Pre-eclampsia Drug: Ibuprofen Drug: Acetaminophen Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized-controlled Trial to Assess the Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : June 20, 2018


Arm Intervention/treatment
Active Comparator: Ibuprofen followed by acetaminophen
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
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.
Other Names:
  • Advil
  • Motrin

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 acetaminophen followed by ibuprofen.
Other Name: Tylenol

Active Comparator: 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.
Drug: 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.
Other Names:
  • Advil
  • Motrin

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 acetaminophen followed by ibuprofen.
Other Name: Tylenol




Primary Outcome Measures :
  1. Difference in Systolic Blood Pressure (SBP) [ Time Frame: 24 hours following intervention ]
    The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.


Secondary Outcome Measures :
  1. Change in Self-reported Pain Score 2 Hours After First Intervention [ Time Frame: At the time of first dose of study drug and 2 hours after ]
    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.

  2. Mean Pain Score by Nursing Assessment [ Time Frame: 0-24 hours and 24-48 hours after initial study medication administration ]
    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.

  3. Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen [ Time Frame: 24 hours and 48 hours after initial study medication administration ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Antepartum women
  • Diagnosis of Gestational Hypertension or Pre-eclampsia by blood pressure ≥140 systolic or ≥90 diastolic, on at least 2 measurements ≥ 4 hours apart; with or without proteinuria (urine protein-creatinine ratio ≥0.3 or 24 hour-urine protein ≥300 mg).
  • Taking one or fewer oral medications for blood pressure control.
  • Singleton gestation.
  • English-speaking

Exclusion Criteria:

  • Allergy to nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen
  • More than 1 severe range blood pressure (≥160 systolic or ≥110 diastolic) prior to enrollment.
  • Neurologic symptoms attributed to hypertension (headache, visual changes) prior to enrollment.
  • Pulmonary edema.
  • Elevated AST (>60 international units/L) or ALT (>70 international units/L) prior to enrollment.
  • Low platelet count (<100,000/microliter) prior to enrollment.
  • Renal insufficiency (creatinine > 1.1 or double the baseline creatinine if known) prior to enrollment.
  • Chronic hypertension defined as hypertension pre-existing pregnancy or diagnosed prior to 20-weeks' gestation.
  • Moderate- or severe-persistent asthma.
  • Therapeutic anticoagulation.
  • Chronic opiate use during the pregnancy (opiate therapy given daily for > 2 weeks).
  • Lactose intolerance or allergy due to placebo containing lactose.
  • Cesarean delivery.
  • Additional anesthesia at time of delivery (spinal anesthesia, sedation) that would change routine pain management.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891174


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Jourdan Triebwasser, MD University of Michigan
Principal Investigator: Elizabeth Langen, MD University of Michigan
Principal Investigator: Alexander Tsodikov, PhD University of Michigan
  Study Documents (Full-Text)

Documents provided by Elizabeth Langen, University of Michigan:

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Responsible Party: Elizabeth Langen, Assistant Professor of Obstetrics and Gynecology, University of Michigan
ClinicalTrials.gov Identifier: NCT02891174     History of Changes
Other Study ID Numbers: HUM00117154
First Posted: September 7, 2016    Key Record Dates
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elizabeth Langen, University of Michigan:
ibuprofen
acetaminophen
blood pressure
post-partum
pain control
pre-eclampsia
gestational hypertension
Additional relevant MeSH terms:
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Toxemia
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Infection
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action