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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL095739-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Airway Pressure (compliant) | Experimental | This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night |
|
| Standard care | No Intervention | ||
| Positive Airway Pressure (non-compliant) | Experimental | No one was assigned to this arm, but for results data quality purposes, women assigned to PAP who were explicitly non-compliant (used less than 4 hours per night), were analyzed separately from women who were compliant with the PAP assignment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure | Device | Women will use positive airway pressure until delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal Blood Pressure | measured by a 24 hour cuff, averaged across the night; | baseline and 1 week after PAP treatment. |
| 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. | 1-6 months after enrollment. |
| 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. | at baseline |
| Number of Participants With Sleep-disordered Breathing (SDB) | Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5) | Baseline night 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age at Delivery | At delivery (within 6 months of enrollment). | |
| Birth Weight | At delivery (within 6 months of enrollment) | |
| NICU Admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise M O'Brien, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24888772 | Result | O'Brien LM, Bullough AS, Chames MC, Shelgikar AV, Armitage R, Guilleminualt C, Sullivan CE, Johnson TR, Chervin RD. Hypertension, snoring, and obstructive sleep apnoea during pregnancy: a cohort study. BJOG. 2014 Dec;121(13):1685-93. doi: 10.1111/1471-0528.12885. Epub 2014 May 30. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Non-Compliant APAP | Women who were in the APAP arm but who used less than 4 hours per night |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| APAP Initiation to Week 1 or Delivery |
| |||||||||||||||||||
| Continued APAP to Delivery |
|
These data are for those who initiated APAP only and do not include the standard of care arm as they did not have nocturnal blood pressure
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| ID | Title | Description |
|---|---|---|
| BG000 | Compliant Autotitrating Positive Airway Pressure (APAP) | Women who used APAP for at least 4 hours/night |
| BG001 | Non-compliant APAP | Women who did not use APAP for at least 4 hours/night |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nocturnal Blood Pressure | measured by a 24 hour cuff, averaged across the night; | The standard of care group did not have nocturnal blood pressure monitoring as they were not assigned to use a positive airway pressure device | Posted | Mean | Standard Deviation | mmHg | baseline and 1 week after PAP treatment. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive Airway Pressure | Positive Airway Pressure: Women will use positive airway pressure until delivery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonatal death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | pre-existing severe fetal growth restrictions involved in both cases; IRB approved determination that these are unrelated to study participation or intervention. Neonatal deaths not tracked in standard of care arm |
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These tables represent full basic analysis of all the participants enrolled without adjustment for confounding variables. Future publications will present more complex subsequent analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louise O'Brien | University of Michigan | 734 647-9064 | louiseo@med.umich.edu |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D006973 | Hypertension |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
Number of mothers who had one (or more) babies admitted to NICU |
| at delivery (within 6 months of enrollment) |
| NOT COMPLETED |
|
|
| BG002 | Standard Care | Non-APAP arm |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Nocturnal blood pressure | Mean | Standard Deviation | mmHg |
|
| sleep study apnea hypopnea index (AHI) | Number of respiratory events per hour of sleep | Mean | Standard Deviation | events per hour |
|
| OG002 |
| Standard Care |
|
|
|
| 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. | One woman in the standard of care group died during pregnancy and is therefore not included in this analysis. | Posted | Number | participants | 1-6 months after enrollment. |
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | apnea/hypopnea index | at baseline |
|
|
|
|
| Primary | Number of Participants With Sleep-disordered Breathing (SDB) | Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5) | 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). | Posted | Count of Participants | Participants | Baseline night 1 |
|
|
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| Secondary | Gestational Age at Delivery | Posted | Mean | Standard Deviation | weeks | At delivery (within 6 months of enrollment). |
|
|
|
| Secondary | Birth Weight | There is one extra baby in each arm to represent the twins born in each group. | Posted | Mean | Standard Deviation | grams | At delivery (within 6 months of enrollment) | babies | babies |
|
|
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| Secondary | NICU Admission | Number of mothers who had one (or more) babies admitted to NICU | Posted | Count of Participants | Participants | at delivery (within 6 months of enrollment) |
|
|
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|
| 0 |
| 36 |
| 2 |
| 36 |
| 0 |
| 36 |
| EG001 | Standard Care | 1 | 77 | 1 | 77 | 0 | 77 |
|
| medical abortion | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | severe growth restriction of fetus with no interval growth on serial ultrasounds as well as oligohydramnios |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |