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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIFEdipine ER | Drug | Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Blood Pressure Control | Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours) | up to six weeks postpartum |
| Number of Participants Who Needed for Additional Antihypertensives |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas McElrath, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37806651 | Derived | 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. |
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De-identified individual participant data will be made available to other researchers for all primary and secondary outcomes as well as demographic data.
The data will be available for approximately six months after the study's conclusion.
Data access requests will be reviewed by the internal Institutional Review Board.
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We aimed for 90 participants as part of the protocol but ended up oversampling at 94 due to concern over potential drop out.
We enrolled 94 participants in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nifedipine | 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. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive. |
| FG001 | Enalapril | 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. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nifedipine | Participants in the nifedipine group were assigned nifedipine ER 30mg daily as their initial antihypertensive. |
| BG001 | Enalapril | Participants in the nifedipine group were assigned enalapril 10mg daily as their initial antihypertensive. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prolonged Hospitalization | Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
Data were collected for each patient over a period of 6 weeks after their delivery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nifedipine | 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. Nifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive. |
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The trial was conducted during the COVID pandemic which fundamentally changed the way patients interact with the medical system.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Yoselevsky | Brigham and Women's Hospital | 314-413-1254 | eyoselevsky@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2021 | Feb 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2022 | Feb 28, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D004656 | Enalapril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Enalapril | Drug | Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive. |
|
Any time a patient needs a second or third agent added to her antihypertensive regimen
| up to six weeks postpartum |
| Time to Discharge | The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension | up to six weeks postpartum |
| Clinically Significant Hypotension or Hypertension | Any time a patient became symptomatic from her blood pressure as noted by her providers | up to six weeks postpartum |
| Creatinine Values at 1-2 Weeks After Discharge | Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn) | 1-2 weeks |
| Continued Need for Antihypertensive | 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 | up to six weeks postpartum |
| Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received | A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication | up to six weeks postpartum |
| Patient Self-reported Compliance With Their Antihypertensive Regimen | 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") | up to six weeks postpartum |
| Creatinine Level Around 6 Weeks After Delivery | Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn) | 6 weeks after delivery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | all participants in the study were female | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | This is self-identified race and/or ethnicity as derived from the electronic medical record. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insurance | Count of Participants | Participants |
|
| Parity | number of live children a participant has | Mean | Standard Deviation | para |
|
| Twin gestation | Count of Participants | Participants |
|
| Delivery type | Count of Participants | Participants |
|
| Gestational age at delivery | Mean | Standard Deviation | weeks |
|
| Hypertensive diagnosis | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
|
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| Primary | Postpartum Readmission | Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
|
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| Secondary | Time to Blood Pressure Control | Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours) | Posted | Mean | Standard Deviation | days | up to six weeks postpartum |
|
|
|
| Secondary | Number of Participants Who Needed for Additional Antihypertensives | Any time a patient needs a second or third agent added to her antihypertensive regimen | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
|
|
| Secondary | Time to Discharge | The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension | Posted | Mean | Standard Deviation | days | up to six weeks postpartum |
|
|
|
| Secondary | Clinically Significant Hypotension or Hypertension | Any time a patient became symptomatic from her blood pressure as noted by her providers | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
|
|
| Secondary | Creatinine Values at 1-2 Weeks After Discharge | Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn) | This is the population of participants who attended a 1-2 week clinic visit after discharge and had a creatinine level drawn | Posted | Mean | Standard Deviation | mg/dL | 1-2 weeks |
|
|
|
| Secondary | Continued Need for Antihypertensive | 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 | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
|
|
| Secondary | Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received | A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
|
|
| Secondary | Patient Self-reported Compliance With Their Antihypertensive Regimen | 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") | Posted | Count of Participants | Participants | up to six weeks postpartum |
|
|
|
| Secondary | Creatinine Level Around 6 Weeks After Delivery | Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn) | This is the population who attended their 6 week postpartum visit and had a creatinine level drawn at that time | Posted | Mean | Standard Deviation | mg/dL | 6 weeks after delivery |
|
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Enalapril | 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. Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |