Trial Outcomes & Findings for Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure (NCT NCT01029691)
NCT ID: NCT01029691
Last Updated: 2017-10-16
Results Overview
measured by a 24 hour cuff, averaged across the night;
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
baseline and 1 week after PAP treatment.
Results posted on
2017-10-16
Participant Flow
Pregnant women with hypertension were recruited from University of Michigan obstetric clinics and inpatient areas. Enrollment into the trial occurred between March 2010 and November 2013.
After signing consent, one participant decided not to have any sleep studies performed, explaining the difference between the 125 enrolled listed in the registration section and the 124 followed below.
Participant milestones
| Measure |
Compliant Users APAP
Women who used APAP at least 4 hours per night. Auto-titrating Positive Airway Pressure: Women will use APAP until delivery. Nocturnal blood pressure will be assessed at two time points: 1 week of APAP use and at regular intervals across pregnancy. Daytime blood pressure measurements across pregnancy will be obtained from medical records along with delivery information.
|
Non-Compliant APAP
Women who were in the APAP arm but who used less than 4 hours per night
|
Standard of Care
Women in the standard of care group will have clinical blood pressure measurements extracted from medical records. Delivery information will also be collected.
|
|---|---|---|---|
|
APAP Initiation to Week 1 or Delivery
STARTED
|
20
|
27
|
77
|
|
APAP Initiation to Week 1 or Delivery
Baseline Sleep Study
|
20
|
23
|
77
|
|
APAP Initiation to Week 1 or Delivery
Began Actual APAP Use
|
20
|
16
|
77
|
|
APAP Initiation to Week 1 or Delivery
COMPLETED
|
20
|
16
|
77
|
|
APAP Initiation to Week 1 or Delivery
NOT COMPLETED
|
0
|
11
|
0
|
|
Continued APAP to Delivery
STARTED
|
20
|
16
|
77
|
|
Continued APAP to Delivery
COMPLETED
|
20
|
16
|
76
|
|
Continued APAP to Delivery
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Compliant Users APAP
Women who used APAP at least 4 hours per night. Auto-titrating Positive Airway Pressure: Women will use APAP until delivery. Nocturnal blood pressure will be assessed at two time points: 1 week of APAP use and at regular intervals across pregnancy. Daytime blood pressure measurements across pregnancy will be obtained from medical records along with delivery information.
|
Non-Compliant APAP
Women who were in the APAP arm but who used less than 4 hours per night
|
Standard of Care
Women in the standard of care group will have clinical blood pressure measurements extracted from medical records. Delivery information will also be collected.
|
|---|---|---|---|
|
Continued APAP to Delivery
Death
|
0
|
0
|
1
|
Baseline Characteristics
Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure
Baseline characteristics by cohort
| Measure |
Compliant Autotitrating Positive Airway Pressure (APAP)
n=20 Participants
Women who used APAP for at least 4 hours/night
|
Non-compliant APAP
n=16 Participants
Women who did not use APAP for at least 4 hours/night
|
Standard Care
n=77 Participants
Non-APAP arm
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
32.3 Years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
31.1 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
31.8 Years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
113 Participants
n=4 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
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
77 participants
n=5 Participants
|
113 participants
n=4 Participants
|
|
Nocturnal blood pressure
Systolic
|
126.7 mmHg
STANDARD_DEVIATION 9.5 • n=5 Participants
|
124.5 mmHg
STANDARD_DEVIATION 8.9 • n=7 Participants
|
NA mmHg
STANDARD_DEVIATION NA • n=5 Participants
|
125.8 mmHg
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Nocturnal blood pressure
Diastolic
|
69.7 mmHg
STANDARD_DEVIATION 8.0 • n=5 Participants
|
68.8 mmHg
STANDARD_DEVIATION 8.3 • n=7 Participants
|
NA mmHg
STANDARD_DEVIATION NA • n=5 Participants
|
69.3 mmHg
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
sleep study apnea hypopnea index (AHI)
|
18.9 events per hour
STANDARD_DEVIATION 30.6 • n=5 Participants
|
4.2 events per hour
STANDARD_DEVIATION 6.0 • n=7 Participants
|
NA events per hour
STANDARD_DEVIATION NA • n=5 Participants
|
12.4 events per hour
STANDARD_DEVIATION 24.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 week after PAP treatment.Population: The standard of care group did not have nocturnal blood pressure monitoring as they were not assigned to use a positive airway pressure device
measured by a 24 hour cuff, averaged across the night;
Outcome measures
| Measure |
Positive Airway Pressure Adherent
n=20 Participants
Positive Airway Pressure: Women will use positive airway pressure until delivery
|
Positive Airway Pressure Non Adherent
n=16 Participants
Positive Airway Pressure: Women who used positive airway pressure for limited time
|
Standard Care
|
|---|---|---|---|
|
Nocturnal Blood Pressure
Baseline Nocturnal Systolic
|
128.2 mmHg
Standard Deviation 9.8
|
124.7 mmHg
Standard Deviation 8.9
|
—
|
|
Nocturnal Blood Pressure
Baseline Nocturnal Diastolic
|
70.6 mmHg
Standard Deviation 8.0
|
68.8 mmHg
Standard Deviation 8.3
|
—
|
|
Nocturnal Blood Pressure
1 week Systolic
|
127.7 mmHg
Standard Deviation 9.3
|
125.3 mmHg
Standard Deviation 8.5
|
—
|
|
Nocturnal Blood Pressure
1 week Diastolic
|
70.9 mmHg
Standard Deviation 8.4
|
69.3 mmHg
Standard Deviation 7.4
|
—
|
PRIMARY outcome
Timeframe: 1-6 months after enrollment.Population: One woman in the standard of care group died during pregnancy and is therefore not included in this analysis.
This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.
Outcome measures
| Measure |
Positive Airway Pressure Adherent
n=20 Participants
Positive Airway Pressure: Women will use positive airway pressure until delivery
|
Positive Airway Pressure Non Adherent
n=16 Participants
Positive Airway Pressure: Women who used positive airway pressure for limited time
|
Standard Care
n=76 Participants
|
|---|---|---|---|
|
Number of Participants With Worsening of Hypertension
|
11 participants
|
9 participants
|
57 participants
|
PRIMARY outcome
Timeframe: at baselinePopulation: This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).
Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.
Outcome measures
| Measure |
Positive Airway Pressure Adherent
n=29 Participants
Positive Airway Pressure: Women will use positive airway pressure until delivery
|
Positive Airway Pressure Non Adherent
n=14 Participants
Positive Airway Pressure: Women who used positive airway pressure for limited time
|
Standard Care
|
|---|---|---|---|
|
Severity of Sleep Disordered Breathing
|
15.6 apnea/hypopnea index
Standard Deviation 25.9
|
2.7 apnea/hypopnea index
Standard Deviation 1.9
|
—
|
PRIMARY outcome
Timeframe: Baseline night 1Population: This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).
Presence or absence of SDB (defined as an apnea/hypopnea index; AHI\>=5)
Outcome measures
| Measure |
Positive Airway Pressure Adherent
n=29 Participants
Positive Airway Pressure: Women will use positive airway pressure until delivery
|
Positive Airway Pressure Non Adherent
n=14 Participants
Positive Airway Pressure: Women who used positive airway pressure for limited time
|
Standard Care
|
|---|---|---|---|
|
Number of Participants With Sleep-disordered Breathing (SDB)
|
14 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: At delivery (within 6 months of enrollment).Outcome measures
| Measure |
Positive Airway Pressure Adherent
n=20 Participants
Positive Airway Pressure: Women will use positive airway pressure until delivery
|
Positive Airway Pressure Non Adherent
n=16 Participants
Positive Airway Pressure: Women who used positive airway pressure for limited time
|
Standard Care
n=75 Participants
|
|---|---|---|---|
|
Gestational Age at Delivery
|
36.7 weeks
Standard Deviation 3.7
|
36.0 weeks
Standard Deviation 3.6
|
36.9 weeks
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: At delivery (within 6 months of enrollment)Population: There is one extra baby in each arm to represent the twins born in each group.
Outcome measures
| Measure |
Positive Airway Pressure Adherent
n=21 babies
Positive Airway Pressure: Women will use positive airway pressure until delivery
|
Positive Airway Pressure Non Adherent
n=17 babies
Positive Airway Pressure: Women who used positive airway pressure for limited time
|
Standard Care
n=76 babies
|
|---|---|---|---|
|
Birth Weight
|
2804.3 grams
Standard Deviation 1037.4
|
2749.7 grams
Standard Deviation 870.0
|
2957.5 grams
Standard Deviation 909.3
|
SECONDARY outcome
Timeframe: at delivery (within 6 months of enrollment)Number of mothers who had one (or more) babies admitted to NICU
Outcome measures
| Measure |
Positive Airway Pressure Adherent
n=20 Participants
Positive Airway Pressure: Women will use positive airway pressure until delivery
|
Positive Airway Pressure Non Adherent
n=16 Participants
Positive Airway Pressure: Women who used positive airway pressure for limited time
|
Standard Care
n=75 Participants
|
|---|---|---|---|
|
NICU Admission
|
1 Participants
|
3 Participants
|
13 Participants
|
Adverse Events
Positive Airway Pressure
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Positive Airway Pressure
n=36 participants at risk
Positive Airway Pressure: Women will use positive airway pressure until delivery
|
Standard Care
n=77 participants at risk
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
5.6%
2/36 • from start of intervention until 30 days after intervention (generally 30 days after delivery)
NOTE: All cause mortality table reflects maternal death only - as babies were not participants. Inpatient hospitalizations were not collected as data for adverse event collection (and therefore are not included in Serious Adverse Events reporting) because this was a study of high risk pregnancies, so recruitment came from inpatient candidates as well as from the community. For non-serious adverse events: study did not collect ordinary aspects of pregnancy such as nausea.
|
0.00%
0/77 • from start of intervention until 30 days after intervention (generally 30 days after delivery)
NOTE: All cause mortality table reflects maternal death only - as babies were not participants. Inpatient hospitalizations were not collected as data for adverse event collection (and therefore are not included in Serious Adverse Events reporting) because this was a study of high risk pregnancies, so recruitment came from inpatient candidates as well as from the community. For non-serious adverse events: study did not collect ordinary aspects of pregnancy such as nausea.
|
|
Pregnancy, puerperium and perinatal conditions
medical abortion
|
0.00%
0/36 • from start of intervention until 30 days after intervention (generally 30 days after delivery)
NOTE: All cause mortality table reflects maternal death only - as babies were not participants. Inpatient hospitalizations were not collected as data for adverse event collection (and therefore are not included in Serious Adverse Events reporting) because this was a study of high risk pregnancies, so recruitment came from inpatient candidates as well as from the community. For non-serious adverse events: study did not collect ordinary aspects of pregnancy such as nausea.
|
1.3%
1/77 • from start of intervention until 30 days after intervention (generally 30 days after delivery)
NOTE: All cause mortality table reflects maternal death only - as babies were not participants. Inpatient hospitalizations were not collected as data for adverse event collection (and therefore are not included in Serious Adverse Events reporting) because this was a study of high risk pregnancies, so recruitment came from inpatient candidates as well as from the community. For non-serious adverse events: study did not collect ordinary aspects of pregnancy such as nausea.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place