Recruiting

NSAIDS

Sponsor:

University of Southern California

Code:

NCT03824119

Conditions

Preeclampsia

Gestational Hypertension

Superimposed Preeclampsia

Chronic Hypertension in Obstetric Context

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ibuprofen 600 mg

Standard Postpartum Care without NSAIDs

Study Details

Brief summary:

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.

Conditions

Preeclampsia

Gestational Hypertension

Superimposed Preeclampsia

Chronic Hypertension in Obstetric Context

Study ID

NCT03824119

Start date

Dec 11, 2018

Status verified date

Nov, 2020

Completion date

Dec 11, 2022

Anticipated

Primary completion date

Dec 11, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Postpartum Care

Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management.

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.

Interventions

Ibuprofen 600 mg

Standard postpartum care (including administration of NSAIDs)

Standard Postpartum Care without NSAIDs

NSAID administration will be withheld from this group.

Primary outcome measure

  • Proportion of participants with blood pressure elevation [ Time Frame: 24 hours postpartum ]

Central Contacts and Locations

Central contacts

Elizabeth Sasso, MD

(323)409-3306elizabeth.sasso@med.usc.edu

Ian O'Donnell

(323)409-3306ian.odonnell@med.usc.edu

Locations

LA County Hospital/University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Elizabeth Sasso, MD

323-409-3306elizabeth.sasso@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Nov 6, 2020

Last verified

Nov, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2020-11-06.