Trial Outcomes & Findings for Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy (NCT NCT05849103)
NCT ID: NCT05849103
Last Updated: 2025-10-09
Results Overview
Proportion of participants with blood pressure values recorded in the office
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
343 participants
Primary outcome timeframe
7-10 days post delivery
Results posted on
2025-10-09
Participant Flow
Participant milestones
| Measure |
A) Standard BP Control, Clinician Monitoring
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
C) Standard BP Control, Care Navigation
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
D) Tight BP Control, Care Navigation
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
86
|
85
|
|
Overall Study
COMPLETED
|
84
|
83
|
82
|
85
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
Baseline characteristics by cohort
| Measure |
A) Standard BP Control, Clinician Monitoring
n=84 Participants
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
n=82 Participants
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
C) Standard BP Control, Care Navigation
n=83 Participants
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
D) Tight BP Control, Care Navigation
n=85 Participants
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.0 years
n=93 Participants
|
30.5 years
n=4 Participants
|
30.0 years
n=27 Participants
|
30.0 years
n=483 Participants
|
30.0 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
85 Participants
n=483 Participants
|
334 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race or Ethnicity · Asian
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race or Ethnicity · Hispanic
|
11 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race or Ethnicity · Multi-racial
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race or Ethnicity · Non-Hispanic Black
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
89 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race or Ethnicity · Non-Hispanic White
|
43 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
184 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race or Ethnicity · Unknown
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=93 Participants
|
82 participants
n=4 Participants
|
83 participants
n=27 Participants
|
85 participants
n=483 Participants
|
334 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 7-10 days post deliveryProportion of participants with blood pressure values recorded in the office
Outcome measures
| Measure |
A) Standard BP Control, Clinician Monitoring
n=84 Participants
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
n=82 Participants
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
C) Standard BP Control, Care Navigation
n=83 Participants
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
D) Tight BP Control, Care Navigation
n=85 Participants
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
|---|---|---|---|---|
|
Proportion of Participants With Recorded Blood Pressure Values in Office
|
43 Participants
|
44 Participants
|
49 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 7-10 days post deliveryProportion of participants with blood pressure values recorded through any means
Outcome measures
| Measure |
A) Standard BP Control, Clinician Monitoring
n=84 Participants
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
n=82 Participants
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
C) Standard BP Control, Care Navigation
n=83 Participants
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
D) Tight BP Control, Care Navigation
n=85 Participants
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
|---|---|---|---|---|
|
Proportion of Participants With Recorded Blood Pressure Values, Any Reporting
|
48 participants
|
47 participants
|
76 participants
|
78 participants
|
SECONDARY outcome
Timeframe: 7-10 days post deliveryMean difference in systolic blood pressure from baseline, 7-10 days
Outcome measures
| Measure |
A) Standard BP Control, Clinician Monitoring
n=84 Participants
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
n=82 Participants
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
C) Standard BP Control, Care Navigation
n=83 Participants
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
D) Tight BP Control, Care Navigation
n=85 Participants
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
|---|---|---|---|---|
|
Systolic Blood Pressure, 7-10 Days
|
130 mmHg
Interval 122.0 to 139.0
|
132 mmHg
Interval 125.0 to 138.0
|
128 mmHg
Interval 123.0 to 136.0
|
128 mmHg
Interval 120.0 to 137.0
|
SECONDARY outcome
Timeframe: 7-10 days post deliveryPopulation: Participants
Mean difference in diastolic blood pressure from baseline, 7-10 days
Outcome measures
| Measure |
A) Standard BP Control, Clinician Monitoring
n=84 Participants
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
n=82 Participants
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
C) Standard BP Control, Care Navigation
n=83 Participants
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
D) Tight BP Control, Care Navigation
n=85 Participants
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
|---|---|---|---|---|
|
Diastolic Blood Pressure
|
84 mmHg
Interval 78.0 to 90.0
|
82 mmHg
Interval 78.0 to 90.0
|
84 mmHg
Interval 78.0 to 89.0
|
84 mmHg
Interval 78.0 to 90.0
|
SECONDARY outcome
Timeframe: 4-6 weeks post deliveryMean difference in systolic blood pressure from baseline, 4-6 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4-6 weeks post deliveryMean difference in diastolic blood pressure from baseline, 4-6 weeks after delivery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7-10 daysPopulation: Participants
Initiated new antihypertensive medications by 7-10 days postpartum
Outcome measures
| Measure |
A) Standard BP Control, Clinician Monitoring
n=41 Participants
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
n=45 Participants
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
C) Standard BP Control, Care Navigation
n=49 Participants
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
D) Tight BP Control, Care Navigation
n=53 Participants
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
|---|---|---|---|---|
|
Initiated New Medications
|
9 Participants
|
7 Participants
|
4 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 7-10 days postpartumPopulation: Participants
Proportion of participants with two blood pressures \>=160/100 at least 15 minutes apart
Outcome measures
| Measure |
A) Standard BP Control, Clinician Monitoring
n=80 Participants
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
n=75 Participants
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
C) Standard BP Control, Care Navigation
n=80 Participants
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
D) Tight BP Control, Care Navigation
n=81 Participants
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
|---|---|---|---|---|
|
Sustained Severe Hypertension, 7-10 Days
|
6 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 7-10 daysPopulation: Participants
Proportion of patients with obstetric triage visits, emergency department visits, or hospital readmission
Outcome measures
| Measure |
A) Standard BP Control, Clinician Monitoring
n=84 Participants
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
|
B) Tight BP Control, Clinician Monitoring
n=82 Participants
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
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C) Standard BP Control, Care Navigation
n=83 Participants
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
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D) Tight BP Control, Care Navigation
n=85 Participants
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Blood Pressure Control Targets: This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Hypertension Management: This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
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Unplanned Visits
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13 Participants
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10 Participants
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10 Participants
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12 Participants
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SECONDARY outcome
Timeframe: 3-6 weeks post deliveryProportion of patients with postpartum visit attendance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post deliveryProportion of patients with primary care visit attendance
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeks post deliveryProportion of patients who respond 'yes' to feeling that their voice is heard
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeks post deliverymean T-score (Range 1-100) using NIH Toolbox
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeks post deliverymean T-score (Range 1-100) on Self-efficacy PROMIS measure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks post deliverymean score (range 14-84) for the Mothers on Respect Index Score
Outcome measures
Outcome data not reported
Adverse Events
A) Standard BP Control, Clinician Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B) Tight BP Control, Clinician Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C) Standard BP Control, Care Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D) Tight BP Control, Care Navigation
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
Sarah Osmundson, MD, MS
Vanderbilt University Medical Center
Phone: 6158752231
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place