Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial

NCT05309460 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: NebraskaMethodistHS
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.

Conditions

Postpartum Preeclampsia; Hypertension in Pregnancy

Keywords

Nifedipine; Labetalol; Postpartum; Hypertension; Preeclampsia; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Readmission

  Patients will be monitored following delivery for readmission to the hospital. To improve patient capture, all patients will be called at 6 months to identify complications or if hospital admission occured in the 6 months following delivery

  6 months

Secondary Outcomes (2)

• Medication failure

  Any time during the 6 months following delivery

• Medication change or discontinuation

  Any time during the 6 months following delivery

Study Arms (2)

Nifedipine

ACTIVE COMPARATOR

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.

Drug: NIFEdipine ER

Labetalol

ACTIVE COMPARATOR

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.

Drug: Labetalol Oral Tablet

Interventions

Labetalol Oral Tablet DRUG

See Labetalol arm.

Also known as: Normodyne, Trandate

Labetalol

NIFEdipine ER DRUG

See Nifedipine arm.

Also known as: Procardia XL

Nifedipine

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nebraska Methodist Health System: lead

Study Sites (1)

Nebraska Methodist Women's Hospital

Omaha, Nebraska, 68022, United States

RECRUITING

Related Publications (2)

• Lovgren T, Connealy B, Yao R, Dahlke JD. Postpartum management of hypertension and effect on readmission rates. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100517. doi: 10.1016/j.ajogmf.2021.100517. Epub 2021 Oct 30.

  PMID: 34757235 BACKGROUND

• Lovgren T, Connealy B, Yao R, D Dahlke J. Postpartum medical management of hypertension and risk of readmission for hypertensive complications. J Hypertens. 2023 Feb 1;41(2):351-355. doi: 10.1097/HJH.0000000000003340. Epub 2022 Dec 13.

  PMID: 36511111 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension; Pre-Eclampsia

Interventions

Labetalol; Nifedipine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Todd Lovgren, MD

  Nebraska Methodist Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd Lovgren, MD

CONTACT

4028151970; todd.lovgren@nmhs.org

Joshua Dahlke, MD

CONTACT

4028151970; joshua.dahlke@nmhs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arm, block randomized Arm A: Nifedipine Arm B: Labetalol

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: June 20, 2022
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: On completion of study for 12 months.
• Access Criteria: TBD by primary author.

Locations

US (1)