search
Back to results

Hypertension In Postpartum Preeclampsia Study (HIPPS)

Primary Purpose

Hypertension, Pregnancy-Induced

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Ibuprofen
Sponsored by
MemorialCare Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pregnancy-Induced focused on measuring Postpartum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Miller Children and Women Hospital Long Beach

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Severe HDP- NSAID

Mild HDP- NSAID

Severe HDP- No NSAID

Mild HDP- No NSAID

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Average Mean Arterial Blood Pressure
Primary outcome for HDP-Mild Study Group
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

Secondary Outcome Measures

Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay
Pain control
Outpatient Blood Pressure Measurement
Outpatient postpartum blood pressure measurement within 3 days after discharge
Patient Satisfaction/Side Effects
Patient satisfaction
Length of Hospital Stay
Length of Hospital Stay after delivery
Diuresis
Hourly urine output

Full Information

First Posted
January 2, 2017
Last Updated
August 31, 2020
Sponsor
MemorialCare Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT03011567
Brief Title
Hypertension In Postpartum Preeclampsia Study
Acronym
HIPPS
Official Title
A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MemorialCare Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy-Induced
Keywords
Postpartum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Severe HDP- NSAID
Arm Type
Experimental
Arm Description
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Arm Title
Mild HDP- NSAID
Arm Type
Experimental
Arm Description
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Arm Title
Severe HDP- No NSAID
Arm Type
Experimental
Arm Description
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Arm Title
Mild HDP- No NSAID
Arm Type
Experimental
Arm Description
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Participants will receive acetaminophen for postpartum mild pain relief
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Motrin
Intervention Description
Participants will receive ibuprofen for postpartum mild pain relief
Primary Outcome Measure Information:
Title
Average Mean Arterial Blood Pressure
Description
Primary outcome for HDP-Mild Study Group
Time Frame
Averaged from all blood pressures measured through study completion, an average of 3 days
Title
Proportion of participants with at least one episode of severe blood pressure postpartum (systolic >=160 or diastolic >=105mmHg) during inpatient postpartum hospitalization
Description
Primary outcome for HDP- Severe Study Group
Time Frame
Through study completion, an average of 3 days
Secondary Outcome Measure Information:
Title
Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay
Description
Pain control
Time Frame
Through study completion, an average of 3 days
Title
Outpatient Blood Pressure Measurement
Description
Outpatient postpartum blood pressure measurement within 3 days after discharge
Time Frame
3 days after discharge from the hospital
Title
Patient Satisfaction/Side Effects
Description
Patient satisfaction
Time Frame
Through study completion, an average of 3 days
Title
Length of Hospital Stay
Description
Length of Hospital Stay after delivery
Time Frame
Through study completion, an average of 3 days
Title
Diuresis
Description
Hourly urine output
Time Frame
Through study completion, an average of 3 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer McNulty, MD
Organizational Affiliation
Long Beach Memorial Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miller Children and Women Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31764732
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.
Results Reference
derived

Learn more about this trial

Hypertension In Postpartum Preeclampsia Study

We'll reach out to this number within 24 hrs