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Trial record 4 of 118 for:    Recruiting, Not yet recruiting, Available Studies | "Hypertension, Pregnancy-Induced"

Hypertension In Postpartum Preeclampsia Study (HIPPS)

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ClinicalTrials.gov Identifier: NCT03011567
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
MemorialCare Health System

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.

Condition or disease Intervention/treatment Phase
Hypertension, Pregnancy-Induced Drug: Acetaminophen Drug: Ibuprofen Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy
Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


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 Name: 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 Name: 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 Name: 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 Name: Tylenol




Primary Outcome Measures :
  1. Average Mean Arterial Blood Pressure [ Time Frame: Averaged from all blood pressures measured through study completion, an average of 3 days ]
    Primary outcome for HDP-Mild Study Group

  2. Antihypertensive Treatment During Inpatient Postpartum Hospitalization [ Time Frame: Through study completion, an average of 3 days ]
    Primary outcome for HDP- Severe Study Group


Secondary Outcome Measures :
  1. Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay [ Time Frame: Through study completion, an average of 3 days ]
  2. Outpatient Blood Pressure Measurement [ Time Frame: 3 days after discharge from the hospital ]
    Outpatient postpartum blood pressure measurement within 3 days after discharge

  3. Patient Satisfaction/Side Effects [ Time Frame: Through study completion, an average of 3 days ]
  4. Length of Hospital Stay [ Time Frame: Through study completion, an average of 3 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011567


Contacts
Contact: Christina A Penfield, MD, MPH christina.penfield@uci.edu

Locations
United States, California
Miller Children and Women Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Christina Penfield, MD       cpenfield@uci.edu   
Contact: Deysi Caballero       dcaballero@memorialcare.org   
Sponsors and Collaborators
MemorialCare Health System
Investigators
Principal Investigator: Jennifer McNulty, MD Long Beach Memorial Medical Center

Responsible Party: MemorialCare Health System
ClinicalTrials.gov Identifier: NCT03011567     History of Changes
Other Study ID Numbers: 663-15
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by MemorialCare Health System:
Postpartum

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action