Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period

NCT04236258 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019P002981
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. Half of participants will receive enalapril while the other half will receive enalapril. We will compare the two groups in the amount of medical resources used which we are defining as prolonged hospitalizations, unscheduled medical visits and/or hospital readmissions in the postpartum period.

Conditions

Hypertension in Pregnancy; Preeclampsia Severe; Gestational Hypertension; Postpartum Preeclampsia; Postpartum

Outcome Measures

Primary Outcomes (4)

• Prolonged Hospitalization

  Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery

  up to six weeks postpartum

• Unscheduled Clinic Appointment

  Participants who have any additional clinic appointments for any clinical reason in the postpartum period beyond the two appointments (around 1 week and 6 weeks postpartum) that are routinely scheduled

  up to six weeks postpartum

• Visit to Labor and Delivery Triage for Evaluation

  Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason

  up to six weeks postpartum

• Postpartum Readmission

  Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period

  up to six weeks postpartum

Secondary Outcomes (9)

• Time to Blood Pressure Control

  up to six weeks postpartum

• Number of Participants Who Needed for Additional Antihypertensives

  up to six weeks postpartum

• Time to Discharge

  up to six weeks postpartum

• Clinically Significant Hypotension or Hypertension

  up to six weeks postpartum

• Creatinine Values at 1-2 Weeks After Discharge

  1-2 weeks

Study Arms (2)

Nifedipine

ACTIVE COMPARATOR

This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive.

Drug: NIFEdipine ER

Enalapril

ACTIVE COMPARATOR

This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.

Drug: Enalapril

Interventions

NIFEdipine ER DRUG

Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.

Nifedipine

Enalapril DRUG

Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.

Enalapril

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension
• provider wanting to initiate antihypertensive in the postpartum period
• the patient is not currently on \>1 antihypertensive
• plans to receive postpartum care at the hospital or affiliated clinic

You may not qualify if:

• sustained pulse \<60 or \>120 BPM over four hours
• allergy to any of the antihypertensives
• creatinine greater than or equal to 1.5
• strict contraindication to any of the antihypertensives
• history of failed treatment with any of the antihypertensives

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Yoselevsky EM, Seely EW, Celi AC, Robinson JN, McElrath TF. A randomized controlled trial comparing the efficacy of nifedipine and enalapril in the postpartum period. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101178. doi: 10.1016/j.ajogmf.2023.101178. Epub 2023 Oct 6.

  PMID: 37806651 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Enalapril

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The trial was conducted during the COVID pandemic which fundamentally changed the way patients interact with the medical system.

Results Point of Contact

• Title: Dr. Elizabeth Yoselevsky
• Organization: Brigham and Women's Hospital

eyoselevsky@bwh.harvard.edu

314-413-1254

Study Officials

• Thomas McElrath, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 22, 2020
• Study Start: January 24, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 30, 2022
• Results First Posted: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available for approximately six months after the study's conclusion.
• Access Criteria: Data access requests will be reviewed by the internal Institutional Review Board.

Locations

US (1)