Preeclampsia Clinical Trial
Official title:
Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 11, 2022 |
Est. primary completion date | December 11, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | LA County Hospital/University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California |
United States,
American College of Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-31. doi: 10.1097/01.AOG.0000437382.03963.88. — View Citation
Curhan 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. — View Citation
Johnson 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. — View Citation
Makris A, Thornton C, Hennessy A. Postpartum hypertension and nonsteroidal analgesia. Am J Obstet Gynecol. 2004 Feb;190(2):577-8. — View Citation
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. — View Citation
Schoenfeld 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. — View Citation
Sibai 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. Review. — View Citation
Vigil-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. — View Citation
Viteri 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. — View Citation
Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. — View Citation
Wasden 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Proportion of participants with blood pressure elevation | Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above | 48, 72 and 96 hours postpartum | |
Secondary | Number of participants with eclamptic Seizure | Documented occurrence of new onset generalized tonic-clonic seizure(s) or coma in a woman with preeclampsia | Through study completion, up to 6 weeks postpartum | |
Secondary | Number of participants with stroke | New onset neurologic deficit associated with neuroimaging (CT scan or MRI) evidence of brain infarction or bleeding | Through study completion, up to 6 weeks postpartum | |
Secondary | Initiation of anti-hypertensive medication | Provider documentation of initiation of anti-hypertensive medication (e.g. nifedipine, labetalol) | Randomization through hospital discharge, an average of 3-7 days | |
Secondary | Pain numerical rating scale (NRS) score | Numerical pain scale score 0-10; 0= no pain and 10=worst possible pain; total score reported | Randomization through hospital discharge, measured daily, an average of 3-7 days | |
Secondary | Number of participants with renal failure | Creatinine >1.1 or doubled | Through study completion, up to 6 weeks postpartum | |
Secondary | Number of participants with pulmonary edema | Evidence of lung infiltrates on chest radiograph or CT scan | Through study completion, up to 6 weeks postpartum | |
Secondary | Number of participants who die | From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum | ||
Secondary | Length of hospital stay | Number of days from delivery to hospital discharge | Through hospital discharge, an average of 3-7 days |
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