Postpartum NSAIDS and Maternal Hypertension
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| ClinicalTrials.gov Identifier: NCT03824119 |
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Recruitment Status :
Recruiting
First Posted : January 31, 2019
Last Update Posted : November 6, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Preeclampsia Gestational Hypertension Superimposed Preeclampsia Chronic Hypertension in Obstetric Context | Drug: Ibuprofen 600 mg Other: Standard Postpartum Care without NSAIDs | Phase 4 |
The objective of this study is to determine whether the withholding of NSAID use is associated with a clinically significant decrease in postpartum hypertension in women with antepartum hypertension. The investigators are interested in whether the use of NSAIDs elevates blood pressure to greater than or equal to 150/100 mmHg (by either systolic or diastolic parameters) more frequently in hypertensive women. The investigators hypothesize that among participants with hypertensive disease associated with pregnancy, those who have NSAIDs withheld from standard postpartum care (experimental arm) will be half as likely to have an increase of blood pressure of 150/100 mmHg in the first 24 hours postpartum compared to participants receiving standard care that includes NSAIDs (control arm).
This trial is a randomized, open label study investigating the effect of NSAID use on blood pressure during the immediate postpartum period in women with chronic hypertension (cHTN) or pregnancy induced hypertension (PIH). The experimental group in this study will be women randomized to withholding NSAIDs during the study period, as women with hypertension routinely receive NSAIDs postpartum. Women with a diagnosis of pregnancy induced hypertension [gestational hypertension (gHTN), preeclampsia, superimposed preeclampsia, ] or cHTN will be enrolled antepartum and will be separated into two groups by the route of delivery: vaginal vs. cesarean delivery. Participants in the control arm will be assigned to receive standard care, which includes NSAIDs (ketorolac, ibuprofen) and participants in the experimental arm will be assigned to receive standard care with NSAIDs withheld in the postpartum period for the duration of hospitalization. The intervention period will last approximately 2-4 days and will conclude at the time of hospital discharge.
Blood pressure measurements will be obtained and recorded routinely in the postpartum period until hospital discharge. More frequent measurements may be performed in the event of severe blood pressure elevations at the discretion of the provider and treating clinical team. Complete Blood Count (CBC) on postpartum Day 1 will be performed as part of standard care. Additional laboratory evaluations will be performed at the discretion of the provider. In addition to blood pressure measurement, pain scale scores will be recorded daily using a Numeric Pain Scale Score. Initiation of anti-hypertensive medication, severe hypertension (BP 160/110 mmHg), treatment with magnesium sulfate and adverse maternal outcomes (cerebrovascular accident, congestive heart failure, pulmonary edema, eclamptic seizure, death) will be documented and abstracted from the medical record.
A power calculation to estimate the appropriate number of subjects needed to detect a difference of 30% in the primary outcome, with an alpha level of 0.05 and 80% power demonstrates that approximately 100 subjects per group (50 in the experimental group and 50 in the control group) will be needed for each delivery route tested (vaginal and cesarean).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial |
| Actual Study Start Date : | December 11, 2018 |
| Estimated Primary Completion Date : | December 11, 2022 |
| Estimated Study Completion Date : | December 11, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard Postpartum Care
Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management.
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Drug: Ibuprofen 600 mg
Standard postpartum care (including administration of NSAIDs)
Other Name: Standard Postpartum Care |
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Active Comparator: Standard Postpartum Care without NSAIDs
Subjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider.
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Other: Standard Postpartum Care without NSAIDs
NSAID administration will be withheld from this group. |
- Proportion of participants with blood pressure elevation [ Time Frame: 24 hours postpartum ]Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
- Proportion of participants with blood pressure elevation [ Time Frame: 48, 72 and 96 hours postpartum ]Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
- Number of participants with eclamptic Seizure [ Time Frame: Through study completion, up to 6 weeks postpartum ]Documented occurrence of new onset generalized tonic-clonic seizure(s) or coma in a woman with preeclampsia
- Number of participants with stroke [ Time Frame: Through study completion, up to 6 weeks postpartum ]New onset neurologic deficit associated with neuroimaging (CT scan or MRI) evidence of brain infarction or bleeding
- Initiation of anti-hypertensive medication [ Time Frame: Randomization through hospital discharge, an average of 3-7 days ]Provider documentation of initiation of anti-hypertensive medication (e.g. nifedipine, labetalol)
- Pain numerical rating scale (NRS) score [ Time Frame: Randomization through hospital discharge, measured daily, an average of 3-7 days ]Numerical pain scale score 0-10; 0= no pain and 10=worst possible pain; total score reported
- Number of participants with renal failure [ Time Frame: Through study completion, up to 6 weeks postpartum ]Creatinine >1.1 or doubled
- Number of participants with pulmonary edema [ Time Frame: Through study completion, up to 6 weeks postpartum ]Evidence of lung infiltrates on chest radiograph or CT scan
- Number of participants who die [ Time Frame: From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum ]
- Length of hospital stay [ Time Frame: Through hospital discharge, an average of 3-7 days ]Number of days from delivery to hospital discharge
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824119
| Contact: Elizabeth Sasso, MD | (323)409-3306 | elizabeth.sasso@med.usc.edu | |
| Contact: Ian O'Donnell | (323)409-3306 | ian.odonnell@med.usc.edu |
| United States, California | |
| LA County Hospital/University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Elizabeth Sasso, MD 323-409-3306 elizabeth.sasso@med.usc.edu | |
| Principal Investigator: | Richard Lee, MD | University of Southern California |
| Responsible Party: | Richard H. Lee, Associate Professor, University of Southern California |
| ClinicalTrials.gov Identifier: | NCT03824119 |
| Other Study ID Numbers: |
HS-17-00959 |
| First Posted: | January 31, 2019 Key Record Dates |
| Last Update Posted: | November 6, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Pre-Eclampsia Hypertension, Pregnancy-Induced Hypertension Vascular Diseases Cardiovascular Diseases Pregnancy Complications Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |