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=99 Participants
|
28.9 years
n=107 Participants
|
29.1 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
34 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=99 Participants
|
96 participants
n=107 Participants
|
197 participants
n=206 Participants
|
|
Insurance
Private
|
39 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Insurance
Medicaid
|
58 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Insurance
None
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
BMI
|
34.0 kg/m^2
n=99 Participants
|
32.9 kg/m^2
n=107 Participants
|
33.3 kg/m^2
n=206 Participants
|
|
Tobacco use
None
|
59 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Tobacco use
Former
|
28 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Tobacco use
Current
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Tobacco use
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Chronic Hypertension
|
26 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Diabetes
Gestational diabetes
|
10 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Diabetes
Type 2 Diabetes
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Diabetes
Type 1 Diabetes
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Renal Disease
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Timing of Diagnosis
Antepartum
|
70 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Timing of Diagnosis
Intrapartum
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Timing of Diagnosis
Postpartum
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Gestational Age at Delivery
|
37.3 Weeks
n=99 Participants
|
37.5 Weeks
n=107 Participants
|
37.3 Weeks
n=206 Participants
|
|
Hypertensive Disease Severity
Gestational hypertension
|
37 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Hypertensive Disease Severity
Preeclampsia without severe features
|
15 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Hypertensive Disease Severity
Preeclampsia with severe features
|
48 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Hypertensive Disease Severity
HELLP syndrome
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Hypertensive Disease Severity
Eclampsia
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 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