Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| N023548 | Other Grant/Funding Number | ResMed Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ResMed Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see whether the presence of night-time breathing disturbances ("sleep-disordered breathing") in pregnant women is related to fetal growth patterns. The hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in fetal growth.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto-PAP Therapy | Experimental |
| |
| No Therapy | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto-PAP | Device | Women will be using the Auto-PAP device nightly from randomization to end of pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester | A slowing of fetal growth will be defined as a slowing of fetal growth by >=33% during the last trimester | 3rd trimester |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or Absence of Placental Hypoxia | The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia | At delivery the placenta will be collected and processed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Louise M O'Brien, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Heath System | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Auto-PAP Therapy | Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy |
| FG001 | No Therapy | No treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Auto-PAP Therapy | Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy |
| BG001 | No Therapy | No treatment |
| 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 | Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester | A slowing of fetal growth will be defined as a slowing of fetal growth by >=33% during the last trimester | Because the latter part of the study was overlapping March 2020, some women did not get all of their research ultrasounds. Data below is shared for all women for whom at least one 3rd trimester ultrasound is available. | Posted | Count of Participants | Participants | 3rd trimester |
|
through delivery up to a maximum of 33 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auto-PAP Therapy | Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Demise | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Fetal/infant demise |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louise O'Brien | University of Michigan | 734 647-9064 | louiseo@med.umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2020 | Dec 17, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| gestational age at enrollment | Mean | Standard Deviation | weeks |
|
No treatment
|
|
|
| Secondary | Presence or Absence of Placental Hypoxia | The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia | Some placentas were not collected and sent to pathology as intended, perhaps in part because of fewer staff available during the COVID inflected months. | Posted | Count of Participants | Participants | At delivery the placenta will be collected and processed. |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | No Therapy | No treatment | 0 | 22 | 2 | 22 | 0 | 22 |
|
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |