Study Summary
This trial tests if adding nonsteroidal anti-inflammatory drugs to preeclampsia treatment helps prevent postpartum hypertension.
Eligible Conditions
- Postpartum preeclampsia
- Pre-Eclampsia, Severe
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: at the end of hospitalization, up to 7 days after randomization
Week 6
Hospital readmission
Mean arterial blood pressure
Postpartum opioid use
Postpartum pain scores
Day 7
postpartum antihypertensive requirements
Day 4
End organ damage
up to 6 weeks
Continued anti-hypertensive requirement
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
NSAID free analgesic bundle
1 of 2
NSAID Analgesic bundle
1 of 2
Active Control
Experimental Treatment
286 Total Participants · 2 Treatment Groups
Primary Treatment: Ketorolac · No Placebo Group · Phase 2
NSAID Analgesic bundleExperimental Group · 4 Interventions: Oxycodone, Ibuprofen 600 mg, Acetaminophen, Ketorolac · Intervention Types: Drug, Drug, Drug, Drug
NSAID free analgesic bundleActiveComparator Group · 2 Interventions: Oxycodone, Acetaminophen · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxycodone
FDA approved
Ibuprofen
FDA approved
Acetaminophen
FDA approved
Ketorolac
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at the end of hospitalization, up to 7 days after randomization
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,822 Previous Clinical Trials
2,283,722 Total Patients Enrolled
Eligibility Criteria
Age Any Age · Female Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Lo JO, Mission JF, Caughey AB. Hypertensive disease of pregnancy and maternal mortality. Curr Opin Obstet Gynecol. 2013 Apr;25(2):124-32. doi: 10.1097/GCO.0b013e32835e0ef5. Review.
- “Hypertension in Pregnancy”. 2013. “Hypertension in Pregnancy”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.aog.0000437382.03963.88.
- Mogos, Mulubrhan F., Jason L. Salemi, Kiara K. Spooner, Barbara L. McFarlin, and Hamisu H. Salihu. 2018. “Hypertensive Disorders of Pregnancy and Postpartum Readmission in the United States”. Journal of Hypertension. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/hjh.0000000000001594.
- Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. Review.
- Viteri, Oscar A., Joey A. England, Mesk A. Alrais, Kayla A. Lash, Maria I. Villegas, Olaide A. Ashimi Balogun, Suneet P. Chauhan, and Baha M. Sibai. 2017. “Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women with Preeclampsia with Severe Features”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002247.
- Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Lo JO, Mission JF, Caughey AB. Hypertensive disease of pregnancy and maternal mortality. Curr Opin Obstet Gynecol. 2013 Apr;25(2):124-32. doi: 10.1097/GCO.0b013e32835e0ef5.
- Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.
- Jonathan (Jake) Hirshberg 2019. "Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03978767.