Hypertension In Postpartum Preeclampsia Study

NCT ID: NCT03011567

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-10-31

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).

Conditions

Hypertension, Pregnancy-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Severe HDP- NSAID

This arm will be assigned a postpartum analgesic regimen with ibuprofen.

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

Participants will receive ibuprofen for postpartum mild pain relief

Mild HDP- NSAID

This arm will be assigned a postpartum analgesic regimen with ibuprofen.

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

Participants will receive ibuprofen for postpartum mild pain relief

Severe HDP- No NSAID

This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Participants will receive acetaminophen for postpartum mild pain relief

Mild HDP- No NSAID

This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Participants will receive acetaminophen for postpartum mild pain relief

Interventions

Acetaminophen

Participants will receive acetaminophen for postpartum mild pain relief

Intervention Type: DRUG

Ibuprofen

Participants will receive ibuprofen for postpartum mild pain relief

Intervention Type: DRUG

Other Intervention Names

Tylenol; Motrin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MemorialCare Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer McNulty, MD

Role: PRINCIPAL_INVESTIGATOR

Long Beach Memorial Medical Center

Locations

Miller Children and Women Hospital Long Beach

Long Beach, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31764732 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

663-15

Identifier Type: -

Identifier Source: org_study_id