COMPLETED

Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial

Conditions

Preeclampsia Severe Preeclampsia Postpartum NSAIDs Ibuprofen

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.

Official Title

Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial

Quick Facts

Study Start:2019-06-10

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03978767

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.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Women at \> 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with: * An antepartum diagnosis of preeclampsia with severe features * Pre-eclampsia with severe features will be defined as: * Elevated blood pressure ≥ 160/110, or * Pre-eclampsia in the setting of thrombocytopenia (platelet count \< 100,000), or * Impaired liver function (AST elevated to twice upper limit of normal), or * Persistent epigastric pain, or * Renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or * Pulmonary edema, or * New onset visual disturbance or headache unresponsive to therapy.	* NSAID allergy * Allergy to acetaminophen * Antihypertensive use in this pregnancy prior to 20 weeks gestation * Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60 mL/min * Inability to obtain consent * Opioid abuse disorder * Peptic ulcer disease.

Inclusion Criteria

Exclusion Criteria

* Women at \> 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with:
* An antepartum diagnosis of preeclampsia with severe features
* Pre-eclampsia with severe features will be defined as:
* Elevated blood pressure ≥ 160/110, or
* Pre-eclampsia in the setting of thrombocytopenia (platelet count \< 100,000), or
* Impaired liver function (AST elevated to twice upper limit of normal), or
* Persistent epigastric pain, or
* Renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or
* Pulmonary edema, or
* New onset visual disturbance or headache unresponsive to therapy.

* NSAID allergy
* Allergy to acetaminophen
* Antihypertensive use in this pregnancy prior to 20 weeks gestation
* Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60 mL/min
* Inability to obtain consent
* Opioid abuse disorder
* Peptic ulcer disease.

Contacts and Locations

Study Locations (Sites)

Barnes Jewish Hospital

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

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 Registration Dates

Study Start Date2019-06-10

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2019-06-10

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

NSAIDs
Ibuprofen

Additional Relevant MeSH Terms

Preeclampsia Severe
Preeclampsia Postpartum