Hypertension in Pregnancy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGNifedipine Extended-Release Tablets
Antihypertensive
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Treatment Arm vs Active Control Arm
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Antepartum diagnosis of gestational hypertension * preeclampsia * superimposed preeclampsia without antepartum chronic hypertension medication * Delivery at 23 weeks or greater * Persistent elevation in BP \>24 hours postpartum (\>140/90 mm Hg) (2 or more BP \>4 hours apart) * 18 years or older * English speaking
Exclusion criteria
* Need for continuation of antepartum antihypertensive medication * Contraindication of calcium channel blocker use * Severe range (160/110 mm Hg) blood pressure requiring treatment \>24 hours after delivery * Requires a 2nd oral antihypertensive medication for blood pressure control inpatient * Acute cardiomyopathy or heart failure * Creatinine ≥1.5 * Blood pressure \<90/60 within 24 hours of discharge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Systolic Blood Pressure at 1 Week Postpartum | 1 week postpartum |
Secondary
| Measure | Time frame |
|---|---|
| Average Diastolic Blood Pressure at 1 Week Postpartum | 1 week postpartum |
| Average Diastolic Blood Pressure at 4 Weeks Postpartum | 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 |
| Average Systolic Blood Pressure at 4 Weeks Postpartum | 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 |
| Number of Participants With ED/Triage Visits | up to 4 weeks postpartum |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Treatment Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 30 years | 28.5 years | 27 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 9 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Average Systolic Blood Pressure at 1 Week Postpartum
Time frame: 1 week postpartum
Population: Data not collected on 3 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Average Systolic Blood Pressure at 1 Week Postpartum | 137.0 mmHg | Standard Deviation 14.5 |
| Control Group | Average Systolic Blood Pressure at 1 Week Postpartum | 127.3 mmHg | Standard Deviation 7.1 |
Secondary
Average Diastolic Blood Pressure at 1 Week Postpartum
Time frame: 1 week postpartum
Population: Data not collected on 3 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Average Diastolic Blood Pressure at 1 Week Postpartum | 89.8 mmHg | Standard Deviation 10.7 |
| Control Group | Average Diastolic Blood Pressure at 1 Week Postpartum | 86.3 mmHg | Standard Deviation 9.2 |
Secondary
Average Diastolic Blood Pressure at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Population: Data not collected on 3 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Average Diastolic Blood Pressure at 4 Weeks Postpartum | 84.5 mmHg | Standard Deviation 9.8 |
| Control Group | Average Diastolic Blood Pressure at 4 Weeks Postpartum | 83.2 mmHg | Standard Deviation 10.3 |
Secondary
Average Systolic Blood Pressure at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Population: Data not collected on 3 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Average Systolic Blood Pressure at 4 Weeks Postpartum | 130.3 mmHg | Standard Deviation 13.7 |
| Control Group | Average Systolic Blood Pressure at 4 Weeks Postpartum | 126.0 mmHg | Standard Deviation 15.6 |
Secondary
Method of Feeding
Time frame: up to 4 weeks postpartum
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Method of Feeding | Participants breastfeeding and pumping | 1 Participants |
| Treatment Group | Method of Feeding | Participants pumping | 1 Participants |
| Treatment Group | Method of Feeding | Participants pumping and formula | 1 Participants |
| Treatment Group | Method of Feeding | Participants breastfeeding | 0 Participants |
| Treatment Group | Method of Feeding | Participants breastfeeding and formula | 2 Participants |
| Control Group | Method of Feeding | Participants breastfeeding | 1 Participants |
| Control Group | Method of Feeding | Participants breastfeeding and formula | 2 Participants |
| Control Group | Method of Feeding | Participants breastfeeding and pumping | 1 Participants |
| Control Group | Method of Feeding | Participants pumping and formula | 0 Participants |
| Control Group | Method of Feeding | Participants pumping | 1 Participants |
Secondary
Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum
Time frame: 1 week postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum | 0 Participants |
| Control Group | Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum | 0 Participants |
Secondary
Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum
Time frame: 1 week postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum | 0 Participants |
| Control Group | Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum | 0 Participants |
Secondary
Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum
Time frame: 1 week postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum | 0 Participants |
| Control Group | Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum | 0 Participants |
Secondary
Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
Time frame: 1 week postpartum
Population: Data not collected on 3 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum | Yes | 1 Participants |
| Treatment Group | Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum | No | 4 Participants |
| Control Group | Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum | Yes | 1 Participants |
| Control Group | Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum | No | 3 Participants |
Secondary
Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Population: Data not collected on 3 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum | Yes | 1 Participants |
| Treatment Group | Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum | No | 3 Participants |
| Control Group | Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum | Yes | 2 Participants |
| Control Group | Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum | No | 3 Participants |
Secondary
Number of Participants With ED/Triage Visits
Time frame: up to 4 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants With ED/Triage Visits | 2 Participants |
| Control Group | Number of Participants With ED/Triage Visits | 0 Participants |
Secondary
Number of Participants With Hospital Readmission
Time frame: up to 4 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants With Hospital Readmission | 0 Participants |
| Control Group | Number of Participants With Hospital Readmission | 0 Participants |