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Postpartum NSAIDS and Maternal Hypertension

NCT03824119 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-11-06

No results posted yet for this study

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

Interventions

DRUG

Ibuprofen 600 mg

Standard postpartum care (including administration of NSAIDs)

OTHER

Standard Postpartum Care without NSAIDs

NSAID administration will be withheld from this group.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Richard Lee, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2022-12-11
Completion
2022-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824119 on ClinicalTrials.gov