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Phase 4 Completed N=94 Randomized Treatment

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

Hypertension in Pregnancy · Preeclampsia Severe · Hypertension · Postpartum Preeclampsia
Source: ClinicalTrials.gov NCT04236258 ↗
Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Prolonged Hospitalization — 13; 17 Participants
◆ Published Evidence
Emerging
8citations · ~3 / year
A randomized controlled trial comparing the efficacy of nifedipine and enalapril in the postpartum period.
American journal of obstetrics & gynecology MFM · 2023 · Likely link

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.

Linked Publications

  • A randomized controlled trial comparing the efficacy of nifedipine and enalapril in the postpartum period.
    American journal of obstetrics & gynecology MFM · 2023 · 8 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Prolonged Hospitalization
13; 17
PRIMARY
Unscheduled Clinic Appointment
19; 17
PRIMARY
Visit to Labor and Delivery Triage for Evaluation
13; 17
PRIMARY
Postpartum Readmission
3; 4
SECONDARY
Time to Blood Pressure Control
0.7; 1.9
SECONDARY
Number of Participants Who Needed for Additional Antihypertensives
6; 16
SECONDARY
Time to Discharge
3.2; 3.3
SECONDARY
Clinically Significant Hypotension or Hypertension
0; 0
SECONDARY
Creatinine Values at 1-2 Weeks After Discharge
0.68; 0.75
SECONDARY
Continued Need for Antihypertensive
41; 36
SECONDARY
Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received
1; 1
SECONDARY
Patient Self-reported Compliance With Their Antihypertensive Regimen
0; 2
SECONDARY
Creatinine Level Around 6 Weeks After Delivery
0.82; 0.88

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04236258) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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