Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: f
View:
• Any patient admitted for delivery by cesarean or vaginal delivery at 24 weeks gestation or greater with hypertension(HTN). Hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN. Following enrollment, treatment will be escalated at discretion of primary provider with the goal of normotension.
Locations
United States
Nebraska
Nebraska Methodist Women's Hospital
RECRUITING
Omaha
Contact Information
Primary
Todd Lovgren, MD
todd.lovgren@nmhs.org
4028151970
Backup
Joshua Dahlke, MD
joshua.dahlke@nmhs.org
4028151970
Time Frame
Start Date: 2022-06-20
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 600
Treatments
Active_comparator: Nifedipine
Patients randomized to Nifedipine will be started on Nifedipine XR 30mg BID. Escalation in therapy to be determined by primary provider. Maximum dose of Nifedipine is 120mg daily. All patients will be monitored for signs and symptoms of hypotension or medication side effect- severe HA, orthostasis, syncope.
Active_comparator: Labetalol
Patients randomized to Labetalol will be started on 200mg TID. Escalation in therapy to be determined by primary provider. Maximum dose is 2400mg in a day. All patients will be monitored for signs and symptoms of hypotension or medication side effect- orthostasis, syncope, bradycardia.
Related Therapeutic Areas
Sponsors
Leads: Nebraska Methodist Health System