Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies, Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/2/2017 |
| Start Date: | September 2016 |
| End Date: | June 2018 |
NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure
over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the
setting of preeclampsia have not been well studied. This study aims to assess the effect of
avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with
preeclampsia with severe features. Eligible women will be randomized to receive either
acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies
for pain control although ibuprofen has better pain control than acetaminophen. The primary
outcome will be duration of postpartum severe-range hypertension.
over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the
setting of preeclampsia have not been well studied. This study aims to assess the effect of
avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with
preeclampsia with severe features. Eligible women will be randomized to receive either
acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies
for pain control although ibuprofen has better pain control than acetaminophen. The primary
outcome will be duration of postpartum severe-range hypertension.
The proposed study is a randomized, controlled, double-masked trial comparing the effect of
postpartum acetaminophen and ibuprofen on blood pressure among women with preeclampsia. Study
participants will be randomized to receive either acetaminophen or ibuprofen for mild
postpartum pain control. Study participants, study personnel and providers will be blinded to
randomization status of study participants.
Potential study participants will be enrolled when they are diagnosed with a severe
hypertensive disorder of pregnancy. This will usually occur prior to delivery, but may occur
up to 6 hours after delivery. Patients diagnosed with preeclampsia without severe features
will also be approached and enrolled at the time of diagnosis in anticipation for possible
progression to preeclampsia with severe features. Once enrolled, study participants will not
be randomized until delivery, at which time they will be randomized to receive either
acetaminophen or ibuprofen for mild postpartum pain. Both groups will have available
oxycodone for moderate to severe pain, per our routine. Study group allocation will only be
known by the investigational pharmacy. The ibuprofen and acetaminophen will be made to appear
identical to each other and will be unmarked through encapsulation. Block randomization will
be used to ensure equal allocation to the two study arms.
For the duration of study participation, study participants will undergo postpartum
monitoring with vital sign measurements (including blood pressure) every 4 hours, pain
assessment with each administration of study medication, as well as daily evaluation of
laboratory studies until they have normalized to the satisfaction of their provider. Study
participants will receive the study drug every 6 hours from the time of delivery until
hospital discharge, unless they refuse. Study participation will be complete upon hospital
discharge. Study participants will be contacted by a study team member 6 weeks after delivery
to ask about any additional complications or symptoms requiring visits to the emergency
department or hospital readmission. Descriptive factors and clinical outcomes will be
extracted from the medical record and de-identified by study personnel during each day of
study participation.
postpartum acetaminophen and ibuprofen on blood pressure among women with preeclampsia. Study
participants will be randomized to receive either acetaminophen or ibuprofen for mild
postpartum pain control. Study participants, study personnel and providers will be blinded to
randomization status of study participants.
Potential study participants will be enrolled when they are diagnosed with a severe
hypertensive disorder of pregnancy. This will usually occur prior to delivery, but may occur
up to 6 hours after delivery. Patients diagnosed with preeclampsia without severe features
will also be approached and enrolled at the time of diagnosis in anticipation for possible
progression to preeclampsia with severe features. Once enrolled, study participants will not
be randomized until delivery, at which time they will be randomized to receive either
acetaminophen or ibuprofen for mild postpartum pain. Both groups will have available
oxycodone for moderate to severe pain, per our routine. Study group allocation will only be
known by the investigational pharmacy. The ibuprofen and acetaminophen will be made to appear
identical to each other and will be unmarked through encapsulation. Block randomization will
be used to ensure equal allocation to the two study arms.
For the duration of study participation, study participants will undergo postpartum
monitoring with vital sign measurements (including blood pressure) every 4 hours, pain
assessment with each administration of study medication, as well as daily evaluation of
laboratory studies until they have normalized to the satisfaction of their provider. Study
participants will receive the study drug every 6 hours from the time of delivery until
hospital discharge, unless they refuse. Study participation will be complete upon hospital
discharge. Study participants will be contacted by a study team member 6 weeks after delivery
to ask about any additional complications or symptoms requiring visits to the emergency
department or hospital readmission. Descriptive factors and clinical outcomes will be
extracted from the medical record and de-identified by study personnel during each day of
study participation.
Inclusion Criteria:
- ability to give informed consent
- diagnosis of a "severe" hypertensive disorder of pregnancy:
- preeclampsia with severe features
- chronic hypertension with superimposed preeclampsia with severe features
- HELLP syndrome: hemolysis, elevated liver function tests, low platelets
- eclampsia
- not yet delivered or less than 6 hours after delivery
Exclusion Criteria:
- current incarceration
- serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury
- AST (aspartate aminotransferase) >200 unit/L
- ALT (alanine aminotransferase) > 200 unit/L
- known allergy or sensitivity to NSAIDs or acetaminophen
- delivery > 6 hours prior to enrollment
- chronic kidney disease
- chronic liver disease
- prior liver transplant
- chronic infectious hepatitis
- gastritis
- gastro-esophageal reflux disease (GERD)
- peptic ulcer disease
- bleeding disorder
- provider feels that participation is not in the best interest of the patient
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