Phase 4
N=94
Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Hypertension in Pregnancy · Preeclampsia Severe · Gestational Hypertension · Postpartum Preeclampsia · Postpartum
Bottom Line
View on ClinicalTrials.gov: NCT04236258 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Prolonged Hospitalization — 13; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- NIFEdipine ER (Drug); Enalapril (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04236258). 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.