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NCT Number: NCT04236258

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

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.

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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Hypertension Hypertension, Pregnancy-Induced Postpartum Postpartum Preeclampsia Preeclampsia Severe Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

This is randomized controlled trial to investigate if enalapril is superior to nifedipine in terms of medical resources used in postpartum women with hypertension. These are both antihypertensives we commonly use in the postpartum period for women with hypertension in pregnancy but we do not know which medication works better at decreasing prolonged hospitalizations, the number of unscheduled medical visits and/or readmissions to the hospital.

Nifedipine is more traditionally used and well-validated by current medical literature. However, enalapril's mechanism of action is better suited to the dysregulation of blood pressure that can occur with hypertensive disorders of pregnancy. Therefore, we hypothesize that enalapril is superior to nifedipine in terms of medical resources used in the postpartum period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

NIFEdipine ER

Drug

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

Enalapril

Drug

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

Primary outcomes

  1. Prolonged Hospitalization

    Time frame: up to six weeks postpartum

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

  2. Unscheduled Clinic Appointment

    Time frame: up to six weeks postpartum

    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

  3. Visit to Labor and Delivery Triage for Evaluation

    Time frame: up to six weeks postpartum

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

  4. Postpartum Readmission

    Time frame: up to six weeks postpartum

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

Secondary outcomes

  1. Time to Blood Pressure Control

    Time frame: up to six weeks postpartum

    Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)

  2. Number of Participants Who Needed for Additional Antihypertensives

    Time frame: up to six weeks postpartum

    Any time a patient needs a second or third agent added to her antihypertensive regimen

  3. Time to Discharge

    Time frame: up to six weeks postpartum

    The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension

  4. Clinically Significant Hypotension or Hypertension

    Time frame: up to six weeks postpartum

    Any time a patient became symptomatic from her blood pressure as noted by her providers

  5. Creatinine Values at 1-2 Weeks After Discharge

    Time frame: 1-2 weeks

    Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)

  6. Continued Need for Antihypertensive

    Time frame: up to six weeks postpartum

    If a patient still needs the prescribed antihypertensives one week after discharge and six weeks after delivery to control her blood pressure as determined by her provider during her clinic visit

  7. Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received

    Time frame: up to six weeks postpartum

    A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication

  8. Patient Self-reported Compliance With Their Antihypertensive Regimen

    Time frame: up to six weeks postpartum

    The patient will complete a survey that self-assesses how compliant she has been with taking the prescribed antihypertensives ("difficulty remembering to take the medication")

  9. Creatinine Level Around 6 Weeks After Delivery

    Time frame: 6 weeks after delivery

    Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2020
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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