Preeclampsia, Hypertension
Conditions
Keywords
Sleep disordered breathing, Preeclampsia, Positive Airway Pressure
Brief summary
The purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure.
Detailed description
Initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. Part way through the study, IRB granted approval to expand recruitment to include other hypertensive diagnoses. So, in effect, a more accurate post hoc title would be Study of Positive Airway Pressure to Reduce Blood Pressure in Hypertensive Pregnancies.
Interventions
DEVICEPositive Airway Pressure
Women will use positive airway pressure until delivery
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with preeclampsia who receive care at the University of Michigan Hospitals * No current use of PAP therapy. * Willing and able to provide informed consent.
Exclusion criteria
* Current PAP therapy * Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma). * Cognitively impaired and unable to understand informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal Blood Pressure | baseline and 1 week after PAP treatment. | measured by a 24 hour cuff, averaged across the night; |
| Number of Participants With Worsening of Hypertension | 1-6 months after enrollment. | 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. |
| Severity of Sleep Disordered Breathing | at baseline | 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. |
| Number of Participants With Sleep-disordered Breathing (SDB) | Baseline night 1 | Presence or absence of SDB (defined as an apnea/hypopnea index; AHI\>=5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth Weight | At delivery (within 6 months of enrollment) | — |
| NICU Admission | at delivery (within 6 months of enrollment) | Number of mothers who had one (or more) babies admitted to NICU |
| Gestational Age at Delivery | At delivery (within 6 months of enrollment). | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Compliant Autotitrating Positive Airway Pressure (APAP) Women who used APAP for at least 4 hours/night | 20 |
| Non-compliant APAP Women who did not use APAP for at least 4 hours/night | 16 |
| Standard Care Non-APAP arm | 77 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Continued APAP to Delivery | Death | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Standard Care | Non-compliant APAP | Compliant Autotitrating Positive Airway Pressure (APAP) |
|---|---|---|---|---|
| Age, Continuous | 31.8 Years STANDARD_DEVIATION 6.1 | 31.1 Years STANDARD_DEVIATION 6.6 | 32.3 Years STANDARD_DEVIATION 3.8 | 34.3 Years STANDARD_DEVIATION 4.8 |
| Nocturnal blood pressure Diastolic | 69.3 mmHg STANDARD_DEVIATION 8.2 | NA mmHg | 68.8 mmHg STANDARD_DEVIATION 8.3 | 69.7 mmHg STANDARD_DEVIATION 8 |
| Nocturnal blood pressure Systolic | 125.8 mmHg STANDARD_DEVIATION 9.3 | NA mmHg | 124.5 mmHg STANDARD_DEVIATION 8.9 | 126.7 mmHg STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized African American | 33 Participants | 19 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 72 Participants | 52 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized Mixed Race | 6 Participants | 4 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 113 participants | 77 participants | 16 participants | 20 participants |
| Sex: Female, Male Female | 113 Participants | 77 Participants | 16 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| sleep study apnea hypopnea index (AHI) | 12.4 events per hour STANDARD_DEVIATION 24 | NA events per hour | 4.2 events per hour STANDARD_DEVIATION 6 | 18.9 events per hour STANDARD_DEVIATION 30.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 1 / 77 |
| other Total, other adverse events | 0 / 36 | 0 / 77 |
| serious Total, serious adverse events | 2 / 36 | 1 / 77 |
Outcome results
Primary
Nocturnal Blood Pressure
measured by a 24 hour cuff, averaged across the night;
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Airway Pressure Adherent | Nocturnal Blood Pressure | Baseline Nocturnal Systolic | 128.2 mmHg | Standard Deviation 9.8 |
| Positive Airway Pressure Adherent | Nocturnal Blood Pressure | Baseline Nocturnal Diastolic | 70.6 mmHg | Standard Deviation 8 |
| Positive Airway Pressure Adherent | Nocturnal Blood Pressure | 1 week Systolic | 127.7 mmHg | Standard Deviation 9.3 |
| Positive Airway Pressure Adherent | Nocturnal Blood Pressure | 1 week Diastolic | 70.9 mmHg | Standard Deviation 8.4 |
| Positive Airway Pressure Non Adherent | Nocturnal Blood Pressure | 1 week Diastolic | 69.3 mmHg | Standard Deviation 7.4 |
| Positive Airway Pressure Non Adherent | Nocturnal Blood Pressure | Baseline Nocturnal Systolic | 124.7 mmHg | Standard Deviation 8.9 |
| Positive Airway Pressure Non Adherent | Nocturnal Blood Pressure | 1 week Systolic | 125.3 mmHg | Standard Deviation 8.5 |
| Positive Airway Pressure Non Adherent | Nocturnal Blood Pressure | Baseline Nocturnal Diastolic | 68.8 mmHg | Standard Deviation 8.3 |
Comparison: unadjusted systolic blood pressure at baseline between groupsp-value: 0.45t-test, 2 sided
Comparison: Unadjusted diastolic blood pressure at baseline between groupsp-value: 0.66t-test, 2 sided
Comparison: Unadjusted systolic blood pressure at week 1p-value: 0.61t-test, 2 sided
Comparison: Unadjusted diastolic blood pressure at week 1p-value: 0.75t-test, 2 sided
Primary
Number of Participants With Sleep-disordered Breathing (SDB)
Presence or absence of SDB (defined as an apnea/hypopnea index; AHI\>=5)
Time frame: Baseline night 1
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Airway Pressure Adherent | Number of Participants With Sleep-disordered Breathing (SDB) | 14 Participants |
| Positive Airway Pressure Non Adherent | Number of Participants With Sleep-disordered Breathing (SDB) | 3 Participants |
Primary
Number of Participants With Worsening of Hypertension
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positive Airway Pressure Adherent | Number of Participants With Worsening of Hypertension | 11 participants |
| Positive Airway Pressure Non Adherent | Number of Participants With Worsening of Hypertension | 9 participants |
| Standard Care | Number of Participants With Worsening of Hypertension | 57 participants |
p-value: 0.085Chi-squared
Primary
Severity of Sleep Disordered Breathing
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.
Time frame: at baseline
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Airway Pressure Adherent | Severity of Sleep Disordered Breathing | 15.6 apnea/hypopnea index | Standard Deviation 25.9 |
| Positive Airway Pressure Non Adherent | Severity of Sleep Disordered Breathing | 2.7 apnea/hypopnea index | Standard Deviation 1.9 |
p-value: 0.012t-test, 2 sided
Secondary
Birth Weight
Time frame: At delivery (within 6 months of enrollment)
Population: There is one extra baby in each arm to represent the twins born in each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Airway Pressure Adherent | Birth Weight | 2804.3 grams | Standard Deviation 1037.4 |
| Positive Airway Pressure Non Adherent | Birth Weight | 2749.7 grams | Standard Deviation 870 |
| Standard Care | Birth Weight | 2957.5 grams | Standard Deviation 909.3 |
Secondary
Gestational Age at Delivery
Time frame: At delivery (within 6 months of enrollment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Airway Pressure Adherent | Gestational Age at Delivery | 36.7 weeks | Standard Deviation 3.7 |
| Positive Airway Pressure Non Adherent | Gestational Age at Delivery | 36.0 weeks | Standard Deviation 3.6 |
| Standard Care | Gestational Age at Delivery | 36.9 weeks | Standard Deviation 3 |
Secondary
NICU Admission
Number of mothers who had one (or more) babies admitted to NICU
Time frame: at delivery (within 6 months of enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Airway Pressure Adherent | NICU Admission | 1 Participants |
| Positive Airway Pressure Non Adherent | NICU Admission | 3 Participants |
| Standard Care | NICU Admission | 13 Participants |
p-value: 0.4Fisher Exact