Hypertension In Postpartum Preeclampsia Study (HIPPS)

December 13, 2023 updated by: MemorialCare Health System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Miller Children and Women Hospital Long Beach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Mean Arterial Blood Pressure- Mild Group
Time Frame: Averaged from all blood pressures measured through study completion, an average of 3 days
Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group
Averaged from all blood pressures measured through study completion, an average of 3 days
Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group
Time Frame: 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
Through study completion, an average of 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: Through study completion, an average of 3 days
Length of Hospital Stay after delivery
Through study completion, an average of 3 days
Pain Control During Hospital Stay
Time Frame: Through study completion, an average of 3 days
Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay Minimum 0, maximum 10. 10 means the highest level of pain
Through study completion, an average of 3 days
Outpatient Blood Pressure Measurement
Time Frame: 6 weeks after discharge from the hospital
Outpatient postpartum blood pressure measurement (represented in mean arterial pressure (MAP) within 6 weeks after discharge
6 weeks after discharge from the hospital
Patient Satisfaction
Time Frame: Through study completion, an average of 3 days
Number of patients reporting "High level of satisfaction with pain medications"
Through study completion, an average of 3 days
Diuresis
Time Frame: Through study completion, an average of 3 days
Achievement of average 200ml/hour for 4 consecutive hours
Through study completion, an average of 3 days
Average Mean Arterial Blood Pressures During Hospital Stay
Time Frame: Averaged from all blood pressures measured through study completion, an average of 3 days
Averaged from all blood pressures measured through study completion, an average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MemorialCare Health System

Investigators

  • Principal Investigator: Jennifer McNulty, MD, Long Beach Memorial Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimated)

January 5, 2017

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 663-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available on request

IPD Sharing Time Frame

Can be available on request

IPD Sharing Access Criteria

Can be available on request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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