Hypertension In Postpartum Preeclampsia Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy

Conditions
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Hypertension, Pregnancy-Induced

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe HDP- NSAID<br>This arm will be assigned a postpartum analgesic regimen with ibuprofen. | Drug: Ibuprofen<br>* Participants will receive ibuprofen for postpartum mild pain relief<br>* Other names: Motrin;|
| Experimental: Mild HDP- NSAID<br>This arm will be assigned a postpartum analgesic regimen with ibuprofen. | Drug: Ibuprofen<br>* Participants will receive ibuprofen for postpartum mild pain relief<br>* Other names: Motrin;|
| Experimental: Severe HDP- No NSAID<br>This arm will be assigned a postpartum analgesic regimen with acetaminophen. | Drug: Acetaminophen<br>* Participants will receive acetaminophen for postpartum mild pain relief<br>* Other names: Tylenol;|
| Experimental: Mild HDP- No NSAID<br>This arm will be assigned a postpartum analgesic regimen with acetaminophen. | Drug: Acetaminophen<br>* Participants will receive acetaminophen for postpartum mild pain relief<br>* Other names: Tylenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Mean Arterial Blood Pressure | Primary outcome for HDP-Mild Study Group | Averaged from all blood pressures measured through study completion, an average of 3 days | 
| Proportion of participants with at least one episode of severe blood pressure postpartum (systolic >=160 or diastolic >=105mmHg) during inpatient postpartum hospitalization | Primary outcome for HDP- Severe Study Group | Through study completion, an average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay | Pain control | Through study completion, an average of 3 days | 
| Outpatient Blood Pressure Measurement | Outpatient postpartum blood pressure measurement within 3 days after discharge | 3 days after discharge from the hospital | 
| Patient Satisfaction/Side Effects | Patient satisfaction | Through study completion, an average of 3 days | 
| Length of Hospital Stay | Length of Hospital Stay after delivery | Through study completion, an average of 3 days | 
| Diuresis | Hourly urine output | Through study completion, an average of 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum