Overview
The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
Status:
Completed
Completed
Trial end date:
2018-06-20
2018-06-20
Target enrollment:
0
0
Participant gender:
Female
Female
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).Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of MichiganTreatments:
Acetaminophen
Ibuprofen
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.