Trial Outcomes & Findings for Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring (NCT NCT04823949)
NCT ID: NCT04823949
Last Updated: 2023-05-18
Results Overview
How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
202 participants
Primary outcome timeframe
10 days
Results posted on
2023-05-18
Participant Flow
The recruitment was conducted at Prisma Health (Greenville, SC, USA) and the Medical University of South Carolina (Charleston, SC, USA) between April 2021 and September 2021. The recruitment took place inpatient at the obstetric units of both hospitals.
Participant milestones
| Measure |
Standard Care
Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge
|
Intervention
Patient will receive a Babyscripts blood pressure cuff (brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
101
|
|
Overall Study
COMPLETED
|
101
|
96
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Standard Care
Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge
|
Intervention
Patient will receive a Babyscripts blood pressure cuff (brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring
Baseline characteristics by cohort
| Measure |
Standard Care
n=101 Participants
Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum
|
Intervention
n=96 Participants
Patient will receive a Babyscripts blood pressure cuff(brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.6 years
n=93 Participants
|
28.9 years
n=4 Participants
|
29.1 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
197 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
34 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=93 Participants
|
96 participants
n=4 Participants
|
197 participants
n=27 Participants
|
|
Insurance
Private
|
39 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Insurance
Medicaid
|
58 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
|
Insurance
None
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
BMI
|
34.0 kg/m^2
n=93 Participants
|
32.9 kg/m^2
n=4 Participants
|
33.3 kg/m^2
n=27 Participants
|
|
Tobacco use
None
|
59 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
127 Participants
n=27 Participants
|
|
Tobacco use
Former
|
28 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Tobacco use
Current
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Tobacco use
Unknown
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Chronic Hypertension
|
26 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Diabetes
Gestational diabetes
|
10 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Diabetes
Type 2 Diabetes
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Diabetes
Type 1 Diabetes
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Renal Disease
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Timing of Diagnosis
Antepartum
|
70 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
127 Participants
n=27 Participants
|
|
Timing of Diagnosis
Intrapartum
|
25 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Timing of Diagnosis
Postpartum
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Gestational Age at Delivery
|
37.3 Weeks
n=93 Participants
|
37.5 Weeks
n=4 Participants
|
37.3 Weeks
n=27 Participants
|
|
Hypertensive Disease Severity
Gestational hypertension
|
37 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Hypertensive Disease Severity
Preeclampsia without severe features
|
15 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Hypertensive Disease Severity
Preeclampsia with severe features
|
48 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Hypertensive Disease Severity
HELLP syndrome
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Hypertensive Disease Severity
Eclampsia
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 10 daysHow many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists
Outcome measures
| Measure |
Standard Care
n=101 Participants
Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge
|
Intervention
n=96 Participants
Patient will receive a Babyscripts blood pressure cuff (brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description
|
|---|---|---|
|
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum
|
59 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: 16 daysHow many participants required initiation of antihypertensive after discharge
Outcome measures
| Measure |
Standard Care
n=101 Participants
Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge
|
Intervention
n=96 Participants
Patient will receive a Babyscripts blood pressure cuff (brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description
|
|---|---|---|
|
Initiation of Antihypertensive After Discharge
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 16 daysNumber of participants with unscheduled visits
Outcome measures
| Measure |
Standard Care
n=101 Participants
Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge
|
Intervention
n=96 Participants
Patient will receive a Babyscripts blood pressure cuff (brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description
|
|---|---|---|
|
Unscheduled Visits
|
5 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 weeksNumber of participants readmitted postpartum
Outcome measures
| Measure |
Standard Care
n=101 Participants
Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge
|
Intervention
n=96 Participants
Patient will receive a Babyscripts blood pressure cuff (brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description
|
|---|---|---|
|
Readmission
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 weeksNumber of participants who attended their postpartum visit
Outcome measures
| Measure |
Standard Care
n=101 Participants
Patient will be scheduled for a blood pressure check in the office within 10 days of the postpartum discharge
|
Intervention
n=96 Participants
Patient will receive a Babyscripts blood pressure cuff (brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge
Home blood pressure monitoring: See arm description
|
|---|---|---|
|
Attended Postpartum Visit
|
71 Participants
|
75 Participants
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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
Dr. Matthew Finneran
The Medical University of South Carolina
Phone: (843) 792-4500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place