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NCT03824119
Postpartum NSAIDS and Maternal Hypertension
Phase 4 trial testing Ibuprofen 600 mg in Preeclampsia in 200 participants. Status unknown.
11 December 2022
Quick facts
| Lead sponsor | University of Southern California |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 11 December 2018 |
| Primary completion | 11 December 2022 |
| Estimated completion | 11 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ibuprofen 600 mg — full drug profile →
- Standard Postpartum Care without NSAIDs
Conditions studied
- Preeclampsia — all drugs for Preeclampsia →
- Gestational Hypertension — all drugs for Gestational Hypertension →
- Superimposed Preeclampsia — all drugs for Superimposed Preeclampsia →
- Chronic Hypertension in Obstetric Context — all drugs for Chronic Hypertension in Obstetric Context →
Sponsor
University of Southern California
Who can join
18 and older, female only, with Preeclampsia or Gestational Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03824119
- Europe PMC full search
- ASCO Meeting Library
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03824119 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Southern California
- Last refreshed: 6 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03824119.
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