Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features (NCT02911701) | Clinical Trial Compass
CompletedPhase 4
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
United States100 participantsStarted 2016-09
Plain-language summary
NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the setting of preeclampsia have not been well studied. This study aims to assess the effect of avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with preeclampsia with severe features. Eligible women will be randomized to receive either acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies for pain control although ibuprofen has better pain control than acetaminophen. The primary outcome will be duration of postpartum severe-range hypertension.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ability to give informed consent
* diagnosis of a "severe" hypertensive disorder of pregnancy:
* preeclampsia with severe features
* chronic hypertension with superimposed preeclampsia with severe features
* HELLP syndrome: hemolysis, elevated liver function tests, low platelets
* eclampsia
* not yet delivered or less than 6 hours after delivery
Exclusion Criteria:
* current incarceration
* serum creatinine \> 1.0 mg/dL or suspicion of acute kidney injury
* AST (aspartate aminotransferase) \>200 unit/L
* ALT (alanine aminotransferase) \> 200 unit/L
* known allergy or sensitivity to NSAIDs or acetaminophen
* delivery \> 6 hours prior to enrollment
* chronic kidney disease
* chronic liver disease
* prior liver transplant
* chronic infectious hepatitis
* gastritis
* gastro-esophageal reflux disease (GERD)
* peptic ulcer disease
* bleeding disorder
* provider feels that participation is not in the best interest of the patient
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of Severe-range Hypertension After Delivery
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)