Postpartum NSAIDS and Maternal Hypertension
Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2018
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 11, 2018
CompletedFirst Submitted
Initial submission to the registry
January 4, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2022
CompletedNovember 6, 2020
November 1, 2020
4 years
January 4, 2019
November 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants with blood pressure elevation
Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
24 hours postpartum
Secondary Outcomes (9)
Proportion of participants with blood pressure elevation
48, 72 and 96 hours postpartum
Number of participants with eclamptic Seizure
Through study completion, up to 6 weeks postpartum
Number of participants with stroke
Through study completion, up to 6 weeks postpartum
Initiation of anti-hypertensive medication
Randomization through hospital discharge, an average of 3-7 days
Pain numerical rating scale (NRS) score
Randomization through hospital discharge, measured daily, an average of 3-7 days
- +4 more secondary outcomes
Study Arms (2)
Standard Postpartum Care
ACTIVE COMPARATORSubjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management.
Standard Postpartum Care without NSAIDs
ACTIVE COMPARATORSubjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider.
Interventions
Standard postpartum care (including administration of NSAIDs)
NSAID administration will be withheld from this group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LA County Hospital/University of Southern California
Los Angeles, California, 90033, United States
Related Publications (11)
Pope JE, Anderson JJ, Felson DT. A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med. 1993 Feb 22;153(4):477-84.
PMID: 8435027BACKGROUNDJohnson AG, Nguyen TV, Day RO. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med. 1994 Aug 15;121(4):289-300. doi: 10.7326/0003-4819-121-4-199408150-00011.
PMID: 8037411BACKGROUNDCurhan GC, Willett WC, Rosner B, Stampfer MJ. Frequency of analgesic use and risk of hypertension in younger women. Arch Intern Med. 2002 Oct 28;162(19):2204-8. doi: 10.1001/archinte.162.19.2204.
PMID: 12390063BACKGROUNDMakris A, Thornton C, Hennessy A. Postpartum hypertension and nonsteroidal analgesia. Am J Obstet Gynecol. 2004 Feb;190(2):577-8. doi: 10.1016/j.ajog.2003.08.030.
PMID: 14981414BACKGROUNDSchoenfeld A, Freedman S, Hod M, Ovadia Y. Antagonism of antihypertensive drug therapy in pregnancy by indomethacin? Am J Obstet Gynecol. 1989 Nov;161(5):1204-5. doi: 10.1016/0002-9378(89)90666-2.
PMID: 2589441BACKGROUNDWasden SW, Ragsdale ES, Chasen ST, Skupski DW. Impact of non-steroidal anti-inflammatory drugs on hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Oct;4(4):259-63. doi: 10.1016/j.preghy.2014.06.001. Epub 2014 Jul 11.
PMID: 26104814BACKGROUNDViteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.
PMID: 28885417BACKGROUNDVigil-De Gracia P, Solis V, Ortega N. Ibuprofen versus acetaminophen as a post-partum analgesic for women with severe pre-eclampsia: randomized clinical study. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1279-1282. doi: 10.1080/14767058.2016.1210599. Epub 2016 Aug 2.
PMID: 27384376BACKGROUNDWalters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589.
PMID: 3769407BACKGROUNDHypertension 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.
PMID: 24150027BACKGROUNDSibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16.
PMID: 21963308BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Lee, MD
University of Southern California
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 4, 2019
First Posted
January 31, 2019
Study Start
December 11, 2018
Primary Completion
December 11, 2022
Study Completion
December 11, 2022
Last Updated
November 6, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share