Trial Outcomes & Findings for Hypertension In Postpartum Preeclampsia Study (NCT NCT03011567)
NCT ID: NCT03011567
Last Updated: 2024-01-03
Results Overview
Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
202 participants
Primary outcome timeframe
Averaged from all blood pressures measured through study completion, an average of 3 days
Results posted on
2024-01-03
Participant Flow
Participant milestones
| Measure |
Severe Hypertensive Disorders of Pregnancy (HDP)- NSAID
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy (HDP)- NSAID
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Severe Hypertensive Disorders of Pregnancy (HDP)- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy (HDP)- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
31
|
70
|
31
|
|
Overall Study
Randomized
|
70
|
31
|
70
|
31
|
|
Overall Study
COMPLETED
|
70
|
31
|
70
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypertension In Postpartum Preeclampsia Study
Baseline characteristics by cohort
| Measure |
Severe HDP- NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild HDP- NSAID
n=31 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Severe HDP- No NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
n=31 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
202 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
28 years
STANDARD_DEVIATION 6 • n=7 Participants
|
29.2 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
28 years
STANDARD_DEVIATION 5 • n=4 Participants
|
28.5 years
STANDARD_DEVIATION 6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
202 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
31 participants
n=7 Participants
|
70 participants
n=5 Participants
|
31 participants
n=4 Participants
|
202 participants
n=21 Participants
|
|
Gestational age
|
36.4 weeks
STANDARD_DEVIATION 4 • n=5 Participants
|
37 weeks
STANDARD_DEVIATION 3 • n=7 Participants
|
35.4 weeks
STANDARD_DEVIATION 3.7 • n=5 Participants
|
38 weeks
STANDARD_DEVIATION 3 • n=4 Participants
|
37 weeks
STANDARD_DEVIATION 1 • n=21 Participants
|
PRIMARY outcome
Timeframe: Averaged from all blood pressures measured through study completion, an average of 3 daysPrimary outcome for Hypertensive disorders of pregnancy-Mild Study Group
Outcome measures
| Measure |
Mild Hypertensive Disorders of Pregnancy- NSAID
n=31 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy- No NSAID
n=30 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Severe HDP- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Average Mean Arterial Blood Pressure- Mild Group
|
93 mmHg
Standard Deviation 8
|
93 mmHg
Standard Deviation 7
|
—
|
—
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 daysProportion of participants with at least one episode of severe blood pressure postpartum (systolic \>=160 or diastolic \>=105mmHg) during inpatient postpartum hospitalization
Outcome measures
| Measure |
Mild Hypertensive Disorders of Pregnancy- NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy- No NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Severe HDP- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group
|
27 Participants
|
29 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 daysWong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay Minimum 0, maximum 10. 10 means the highest level of pain
Outcome measures
| Measure |
Mild Hypertensive Disorders of Pregnancy- NSAID
n=64 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy- No NSAID
n=27 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Severe HDP- No NSAID
n=68 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
n=30 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Pain Control During Hospital Stay
|
6.1 score on a scale
Standard Deviation 1.5
|
6.4 score on a scale
Standard Deviation 1.4
|
5.6 score on a scale
Standard Deviation 1.9
|
6.0 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 6 weeks after discharge from the hospitalPopulation: There was a large attrition in participants for this outpatient outcome
Outpatient postpartum blood pressure measurement (represented in mean arterial pressure (MAP) within 6 weeks after discharge
Outcome measures
| Measure |
Mild Hypertensive Disorders of Pregnancy- NSAID
n=8 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy- No NSAID
n=9 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Severe HDP- No NSAID
n=17 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
n=20 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Outpatient Blood Pressure Measurement
|
99 mmHg
Interval 89.3 to 108.8
|
95 mmHg
Interval 84.5 to 104.5
|
97.8 mmHg
Interval 90.2 to 105.4
|
102.7 mmHg
Interval 96.9 to 108.4
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 daysNumber of patients reporting "High level of satisfaction with pain medications"
Outcome measures
| Measure |
Mild Hypertensive Disorders of Pregnancy- NSAID
n=64 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy- No NSAID
n=30 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Severe HDP- No NSAID
n=68 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
n=29 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Patient Satisfaction
|
58 Participants
|
22 Participants
|
65 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 daysLength of Hospital Stay after delivery
Outcome measures
| Measure |
Mild Hypertensive Disorders of Pregnancy- NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy- No NSAID
n=23 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Severe HDP- No NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
n=23 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Length of Hospital Stay
|
4.3 days
Interval 1.9 to 6.7
|
2.0 days
Interval 1.71 to 2.3
|
3.7 days
Interval 2.7 to 4.7
|
1.8 days
Interval 1.56 to 1.95
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 daysAchievement of average 200ml/hour for 4 consecutive hours
Outcome measures
| Measure |
Mild Hypertensive Disorders of Pregnancy- NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy- No NSAID
n=31 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Severe HDP- No NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
n=30 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Diuresis
|
45 Participants
|
19 Participants
|
46 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Averaged from all blood pressures measured through study completion, an average of 3 daysOutcome measures
| Measure |
Mild Hypertensive Disorders of Pregnancy- NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
|
Mild Hypertensive Disorders of Pregnancy- No NSAID
n=70 Participants
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Severe HDP- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
Mild HDP- No NSAID
This arm will be assigned a postpartum analgesic regimen with acetaminophen.
Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
|
|---|---|---|---|---|
|
Average Mean Arterial Blood Pressures During Hospital Stay
|
95.7 mmHG
Standard Deviation 8.2
|
95.9 mmHG
Standard Deviation 9.5
|
—
|
—
|
Adverse Events
Severe HDP- NSAID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild HDP- NSAID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Severe HDP- No NSAID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild HDP- No NSAID
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