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Completed

NCT Number: NCT03011567

Hypertension In Postpartum Preeclampsia Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Miller Children and Women Hospital Long Beach

Long Beach, California, 90806, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

Participants will receive acetaminophen for postpartum mild pain relief

Other names: Tylenol

Ibuprofen

Drug

Participants will receive ibuprofen for postpartum mild pain relief

Other names: Motrin

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Patient Satisfaction

    Time frame: Through study completion, an average of 3 days

    Number of patients reporting "High level of satisfaction with pain medications"

  4. Length of Hospital Stay

    Time frame: Through study completion, an average of 3 days

    Length of Hospital Stay after delivery

  5. Diuresis

    Time frame: Through study completion, an average of 3 days

    Achievement of average 200ml/hour for 4 consecutive hours

  6. Average Mean Arterial Blood Pressures During Hospital Stay

    Time frame: Averaged from all blood pressures measured through study completion, an average of 3 days

Sponsors and collaborators

Lead sponsor

MemorialCare Health System

Other

Registry information

Official study title

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

Acronym: HIPPS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2017
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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