NCT05551104 Safest Choice of Antihypertensive Regimen for Postpartum Hypertension
| NCT ID | NCT05551104 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Loma Linda University |
| Condition | Postpartum Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-05-08 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2023-05-08 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this investigator-initiated randomized control trial is to determine whether oral Nifedipine versus oral Labetalol is superior in controlling high blood pressures in the postpartum period.
Eligibility Criteria
Inclusion Criteria: * Female * Women who develop postpartum hypertension\* after delivery of the placenta or chronic hypertensive postpartum women who require medication for blood pressure control. * Postpartum hypertension requiring treatment are defined as systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than or equal to 90mmHg on at least 2 occasions at least 4 hours apart, or systolic blood pressure greater than or equal to 160mmHg or diastolic blood pressure greater than 110mmHg sustained for more than 15 minutes. Exclusion Criteria: * History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema * Contraindication to either Nifedipine or Labetalol * HR \<60 or \>110 * Native language other than English or Spanish
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05551104 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05551104 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT05551104 currently recruiting?
Yes, NCT05551104 is actively recruiting participants. Contact the research team at atugung@llu.edu for enrollment information.
Where is the NCT05551104 trial being conducted?
This trial is being conducted at Loma Linda, United States.
Who is sponsoring the NCT05551104 clinical trial?
NCT05551104 is sponsored by Loma Linda University. The trial plans to enroll 500 participants.