Trial Outcomes & Findings for Persistent Postpartum Hypertension Pilot Trial (NCT NCT04349124)
NCT ID: NCT04349124
Last Updated: 2023-04-03
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
1 week postpartum
Results posted on
2023-04-03
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Persistent Postpartum Hypertension Pilot Trial
Baseline characteristics by cohort
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=5 Participants
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.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
27 years
n=7 Participants
|
28.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week postpartumPopulation: Data not collected on 3 participants.
Outcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=4 Participants
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.
|
|---|---|---|
|
Average Systolic Blood Pressure at 1 Week Postpartum
|
137.0 mmHg
Standard Deviation 14.5
|
127.3 mmHg
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 4 weeks postpartumPopulation: Data not collected on 3 participants.
Outcome measures
| Measure |
Treatment Group
n=4 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Average Systolic Blood Pressure at 4 Weeks Postpartum
|
130.3 mmHg
Standard Deviation 13.7
|
126.0 mmHg
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Data not collected on 3 participants.
Outcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=4 Participants
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.
|
|---|---|---|
|
Average Diastolic Blood Pressure at 1 Week Postpartum
|
89.8 mmHg
Standard Deviation 10.7
|
86.3 mmHg
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: 4 weeks postpartumPopulation: Data not collected on 3 participants.
Outcome measures
| Measure |
Treatment Group
n=4 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Average Diastolic Blood Pressure at 4 Weeks Postpartum
|
84.5 mmHg
Standard Deviation 9.8
|
83.2 mmHg
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 1 week postpartumPopulation: Data not collected on 3 participants.
Outcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=4 Participants
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.
|
|---|---|---|
|
Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
Yes
|
1 Participants
|
1 Participants
|
|
Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
No
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 weeks postpartumPopulation: Data not collected on 3 participants.
Outcome measures
| Measure |
Treatment Group
n=4 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
Yes
|
1 Participants
|
2 Participants
|
|
Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
No
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeks postpartumOutcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=5 Participants
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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|---|---|---|
|
Method of Feeding
Participants breastfeeding and formula
|
2 Participants
|
2 Participants
|
|
Method of Feeding
Participants breastfeeding and pumping
|
1 Participants
|
1 Participants
|
|
Method of Feeding
Participants pumping and formula
|
1 Participants
|
0 Participants
|
|
Method of Feeding
Participants pumping
|
1 Participants
|
1 Participants
|
|
Method of Feeding
Participants breastfeeding
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeks postpartumOutcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Number of Participants With ED/Triage Visits
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 week postpartumOutcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 week postpartumOutcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 week postpartumOutcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeks postpartumOutcome measures
| Measure |
Treatment Group
n=5 Participants
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
|
Control Group
n=5 Participants
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.
|
|---|---|---|
|
Number of Participants With Hospital Readmission
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place