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

Pre-eclampsia Clinical Trial

Official title:

A Randomized-controlled Trial to Assess the Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891174
• Other study ID #: HUM00117154
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2016
• Est. completion date: June 20, 2018

Study information

• Verified date: May 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 20, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-eclampsia
• Toxemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Systolic Blood Pressure (SBP)	The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.	24 hours following intervention
Secondary	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.	At the time of first dose of study drug and 2 hours after
Secondary	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.	0-24 hours and 24-48 hours after initial study medication administration
Secondary	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.	24 hours and 48 hours after initial study medication administration