Clinical trial NCT03011567: Hypertension In Postpartum Preeclampsia Study
Official title: A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pregnancy-Induced
Keywords: Postpartum
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs) administered during the postpartum period influence blood pressure in women with hypertensive disorders of pregnancy. The study design is a prospective double blinded randomized control trial with participants randomized to receive postpartum analgesic regimens with and without NSAIDs.

Detailed description: Non-steroidal antiinflammatory drugs (NSAIDs) are effective agents for the management of pain in the postpartum period. The addition of NSAIDs to post-cesarean analgesic regimen has been shown to improve post-cesarean pain and reduce opioid requirements. However, concern has been raised over use of NSAIDs in hypertensive pregnant patients, as recent evidence suggests the potential for increased blood pressure in patients with chronic hypertensive disorders receiving these agents. Notably, these studies were conducted on patients with longstanding chronic hypertension, which included males and non-pregnant females, and it is therefore unclear whether this recommendation is appropriate for patients with transient hypertensive disorders of pregnancy.

This protocol describes a randomized trial to evaluate whether NSAIDs influence blood pressure parameters in patients with hypertensive disorders of pregnancy. Patients with severe hypertensive disorders of pregnancy (Severe HDP) will be studied separately from women with mild hypertensive disorders of pregnancy (Mild HDP).

Eligibility criteria: Inclusion Criteria:

* Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
* Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
* Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
* Gestational hypertension
* Preeclampsia without severe features
* Preeclampsia with severe features
* Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome
* Eclampsia

Exclusion Criteria:

* Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
* Severe hypertension: Patients with at least one severe blood pressure measurement (systolic \>160mmHg or diastolic \>105mmHg) prior to randomization
* Renal dysfunction (Serum creatinine measurement \>1.3mg/dL during the current pregnancy)
* Low platelet count (recorded measurement \<50,000 during hospital admission)
* Significant liver dysfunction (AST or ALT \>500)
* Known sensitivities to ibuprofen or acetaminophen
* Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable)
* Postpartum hemorrhage requiring transfusion

Primary outcomes:
measure: Average Mean Arterial Blood Pressure- Mild Group
timeFrame: Averaged from all blood pressures measured through study completion, an average of 3 days
measure: Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group
timeFrame: Through study completion, an average of 3 days
Secondary outcomes:
measure: Pain Control During Hospital Stay
timeFrame: Through study completion, an average of 3 days
measure: Outpatient Blood Pressure Measurement
timeFrame: 6 weeks after discharge from the hospital
measure: Patient Satisfaction
timeFrame: Through study completion, an average of 3 days
measure: Length of Hospital Stay
timeFrame: Through study completion, an average of 3 days
measure: Diuresis
timeFrame: Through study completion, an average of 3 days
measure: Average Mean Arterial Blood Pressures During Hospital Stay
timeFrame: Averaged from all blood pressures measured through study completion, an average of 3 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Miller Children and Women Hospital Long Beach
state: California
Study officials:
affiliation: Long Beach Memorial Medical Center
name: Jennifer McNulty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penfield CA, McNulty JA, Oakes MC, Nageotte MP. Ibuprofen and Postpartum Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1219-1226. doi: 10.1097/AOG.0000000000003553.