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Unable to continue recruiting
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This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.
Study groups will include a treatment with nifedipine extended release or no treatment. Subjects will be randomized 1:1. Subjects randomized to the treatment group will be provided the study drug (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply. The control group will not receive any drug for blood pressure control. the primary outcome is systolic blood pressure at 1 week postpartum.
Subjects in both groups will be scheduled for a 1-week postpartum blood pressure check and routine 4 week postpartum visit. Medication compliance in the treatment group will be assessed via validated questionnaire. The primary outcome of this study is average systolic blood pressure at 1 week postpartum. Patients will be given instructions on blood pressure ranges and specific symptoms when they should contact study staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Other | The treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. |
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| Control Group | No Intervention | The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine Extended-Release Tablets | Drug | Antihypertensive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Systolic Blood Pressure at 1 Week Postpartum | 1 week postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Average Systolic Blood Pressure at 4 Weeks Postpartum | 4 weeks postpartum | |
| Average Diastolic Blood Pressure at 1 Week Postpartum | 1 week postpartum | |
| Average Diastolic Blood Pressure at 4 Weeks Postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenna Hughes, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | The treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. Nifedipine Extended-Release Tablets: Antihypertensive |
| FG001 | Control Group | The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | The treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. Nifedipine Extended-Release Tablets: Antihypertensive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Average Systolic Blood Pressure at 1 Week Postpartum | Data not collected on 3 participants. | Posted | Mean | Standard Deviation | mmHg | 1 week postpartum |
|
up to 4 weeks postpartum
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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 | Treatment Group | The treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. Nifedipine Extended-Release Tablets: Antihypertensive |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenna Hughes, M.D. | Duke University | 919-668-0843 | brenna.hughes@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2021 | Jan 6, 2023 | Prot_SAP_000.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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Treatment Arm vs Active Control Arm
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| 4 weeks postpartum |
| Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum | 1 week postpartum |
| Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum | 4 weeks postpartum |
| Method of Feeding | up to 4 weeks postpartum |
| Number of Participants With ED/Triage Visits | up to 4 weeks postpartum |
| Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum | 1 week postpartum |
| Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum | 1 week postpartum |
| Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum | 1 week postpartum |
| Number of Participants With Hospital Readmission | up to 4 weeks postpartum |
| BG001 | Control Group | The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. |
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| Secondary | Average Systolic Blood Pressure at 4 Weeks Postpartum | Data not collected on 3 participants. | Posted | Mean | Standard Deviation | mmHg | 4 weeks postpartum |
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| Secondary | Average Diastolic Blood Pressure at 1 Week Postpartum | Data not collected on 3 participants. | Posted | Mean | Standard Deviation | mmHg | 1 week postpartum |
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| Secondary | Average Diastolic Blood Pressure at 4 Weeks Postpartum | Data not collected on 3 participants. | Posted | Mean | Standard Deviation | mmHg | 4 weeks postpartum |
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| Secondary | Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum | Data not collected on 3 participants. | Posted | Count of Participants | Participants | 1 week postpartum |
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| Secondary | Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum | Data not collected on 3 participants. | Posted | Count of Participants | Participants | 4 weeks postpartum |
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| Secondary | Method of Feeding | Posted | Count of Participants | Participants | up to 4 weeks postpartum |
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| Secondary | Number of Participants With ED/Triage Visits | Posted | Count of Participants | Participants | up to 4 weeks postpartum |
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| Secondary | Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum | Posted | Count of Participants | Participants | 1 week postpartum |
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| Secondary | Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum | Posted | Count of Participants | Participants | 1 week postpartum |
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| Secondary | Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum | Posted | Count of Participants | Participants | 1 week postpartum |
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| Secondary | Number of Participants With Hospital Readmission | Posted | Count of Participants | Participants | up to 4 weeks postpartum |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control Group | The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Participants pumping and formula |
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| Participants pumping |
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| Participants breastfeeding |
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