Postpartum NSAIDS and Maternal Hypertension

November 4, 2020 updated by: Richard H. Lee, University of Southern California

Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial

Previous studies have suggested that NSAID use causes an increase in blood pressure. Further, blood pressure elevation has been noted in women with pregnancy related hypertensive disease during the postpartum period. NSAIDs remain part of standard postpartum care in women with hypertensive disease. The objective of this study is to determine whether postpartum standard care withholding NSAID use is associated with a clinically significant reduction in postpartum hypertension in women with pregnancy induced hypertension. The investigators hypothesize that women with pregnancy induced hypertensive disease will be half as likely to have blood pressure elevation of 150/100 mmHg in the first 24 hours postpartum.

This study is an open label randomized trial of women with antepartum hypertension. Women will be randomized to receive standard postpartum care or standard postpartum care without NSAIDs. Blood pressure measurements and patient outcomes will be recorded. The study period will begin at the time of delivery and will end at the time of hospital discharge.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to determine whether the withholding of NSAID use is associated with a clinically significant decrease in postpartum hypertension in women with antepartum hypertension. The investigators are interested in whether the use of NSAIDs elevates blood pressure to greater than or equal to 150/100 mmHg (by either systolic or diastolic parameters) more frequently in hypertensive women. The investigators hypothesize that among participants with hypertensive disease associated with pregnancy, those who have NSAIDs withheld from standard postpartum care (experimental arm) will be half as likely to have an increase of blood pressure of 150/100 mmHg in the first 24 hours postpartum compared to participants receiving standard care that includes NSAIDs (control arm).

This trial is a randomized, open label study investigating the effect of NSAID use on blood pressure during the immediate postpartum period in women with chronic hypertension (cHTN) or pregnancy induced hypertension (PIH). The experimental group in this study will be women randomized to withholding NSAIDs during the study period, as women with hypertension routinely receive NSAIDs postpartum. Women with a diagnosis of pregnancy induced hypertension [gestational hypertension (gHTN), preeclampsia, superimposed preeclampsia, ] or cHTN will be enrolled antepartum and will be separated into two groups by the route of delivery: vaginal vs. cesarean delivery. Participants in the control arm will be assigned to receive standard care, which includes NSAIDs (ketorolac, ibuprofen) and participants in the experimental arm will be assigned to receive standard care with NSAIDs withheld in the postpartum period for the duration of hospitalization. The intervention period will last approximately 2-4 days and will conclude at the time of hospital discharge.

Blood pressure measurements will be obtained and recorded routinely in the postpartum period until hospital discharge. More frequent measurements may be performed in the event of severe blood pressure elevations at the discretion of the provider and treating clinical team. Complete Blood Count (CBC) on postpartum Day 1 will be performed as part of standard care. Additional laboratory evaluations will be performed at the discretion of the provider. In addition to blood pressure measurement, pain scale scores will be recorded daily using a Numeric Pain Scale Score. Initiation of anti-hypertensive medication, severe hypertension (BP 160/110 mmHg), treatment with magnesium sulfate and adverse maternal outcomes (cerebrovascular accident, congestive heart failure, pulmonary edema, eclamptic seizure, death) will be documented and abstracted from the medical record.

A power calculation to estimate the appropriate number of subjects needed to detect a difference of 30% in the primary outcome, with an alpha level of 0.05 and 80% power demonstrates that approximately 100 subjects per group (50 in the experimental group and 50 in the control group) will be needed for each delivery route tested (vaginal and cesarean).

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

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
      • Los Angeles, California, United States, 90033
        • Recruiting
        • LA County Hospital/University of Southern California
        • Contact:

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18 years or older delivering at LAC/USC Hospital
  • Delivery occurring at or after 20 weeks gestation
  • Diagnosis of antenatal hypertensive disorder: gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, eclampsia, chronic hypertension

Exclusion Criteria:

  • HELLP Syndrome
  • Renal dysfunction (Serum Creatinine >1.1 in current pregnancy)
  • Known liver disease
  • Low platelet count (<50,000 during hospital admission)
  • Known sensitivity or allergy to ibuprofen or acetaminophen
  • Use of therapeutic doses of anticoagulation
  • Postpartum hemorrhage requiring blood transfusion
  • Neonate with platelet disorder or thrombocytopenia in breastfeeding mother

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Postpartum Care
Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management.
Drug: Ibuprofen 600 mg
Standard postpartum care (including administration of NSAIDs)
Other Names:
  • Standard Postpartum Care
Active Comparator: Standard Postpartum Care without NSAIDs
Subjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider.
Other: Standard Postpartum Care without NSAIDs
NSAID administration will be withheld from this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with blood pressure elevation
Time Frame: 24 hours postpartum
Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
24 hours postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with blood pressure elevation
Time Frame: 48, 72 and 96 hours postpartum
Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
48, 72 and 96 hours postpartum
Number of participants with eclamptic Seizure
Time Frame: Through study completion, up to 6 weeks postpartum
Documented occurrence of new onset generalized tonic-clonic seizure(s) or coma in a woman with preeclampsia
Through study completion, up to 6 weeks postpartum
Number of participants with stroke
Time Frame: Through study completion, up to 6 weeks postpartum
New onset neurologic deficit associated with neuroimaging (CT scan or MRI) evidence of brain infarction or bleeding
Through study completion, up to 6 weeks postpartum
Initiation of anti-hypertensive medication
Time Frame: Randomization through hospital discharge, an average of 3-7 days
Provider documentation of initiation of anti-hypertensive medication (e.g. nifedipine, labetalol)
Randomization through hospital discharge, an average of 3-7 days
Pain numerical rating scale (NRS) score
Time Frame: Randomization through hospital discharge, measured daily, an average of 3-7 days
Numerical pain scale score 0-10; 0= no pain and 10=worst possible pain; total score reported
Randomization through hospital discharge, measured daily, an average of 3-7 days
Number of participants with renal failure
Time Frame: Through study completion, up to 6 weeks postpartum
Creatinine >1.1 or doubled
Through study completion, up to 6 weeks postpartum
Number of participants with pulmonary edema
Time Frame: Through study completion, up to 6 weeks postpartum
Evidence of lung infiltrates on chest radiograph or CT scan
Through study completion, up to 6 weeks postpartum
Number of participants who die
Time Frame: From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum
From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum
Length of hospital stay
Time Frame: Through hospital discharge, an average of 3-7 days
Number of days from delivery to hospital discharge
Through hospital discharge, an average of 3-7 days

Collaborators and Investigators

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

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Richard Lee, MD, University of Southern California

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)

December 11, 2018

Primary Completion (Anticipated)

December 11, 2022

Study Completion (Anticipated)

December 11, 2022

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-17-00959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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