Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Happiest Baby, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The investigators are conducting a single center, randomized controlled trial testing the impact of a neonatal sleep intervention, the SNOO, on reducing maternal blood pressure (BP) in the postpartum period in women with hypertensive disorders of pregnancy. The SNOO is a responsive bassinet designed to automatically calm and consolidate infants by responding to their cries. Use of the SNOO has been demonstrated to improve infant sleep by 1-2 hours nightly, thus increasing maternal sleep time. The investigators plan for 110 women with pregnancies complicated by gestational hypertension or pre-eclampsia to be randomized 1:1 to either receive and use the SNOO responsive bassinet for their infants, or to receive the usual care of safe sleep education. Women will be followed longitudinally through 6 months postpartum with serial BPs, weights, mood assessments, and subjective and objective sleep assessments. The investigators hypothesize that for women with pregnancies complicated by gestational hypertension or preeclampsia, that poor maternal sleep quality contributes to increased BP in the postpartum period. The investigators further propose that compared to usual care (safe sleep education), an intervention targeted to improve neonatal sleep (the SNOO), and thus maternal sleep, will improve postpartum BP for these women.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNOO Responsive Bassinet | Experimental | Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period |
|
| Usual Care | Active Comparator | Will receive the current standard of care of safe sleep education in the postpartum period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNOO | Device | The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure | Mean arterial pressure will be calculated from the systolic and diastolic blood pressures [(2 * diastolic blood pressure + systolic blood pressure) / 3] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit. | 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure | Mean arterial pressure will be calculated from the systolic and diastolic blood pressures [(2 * diastolic blood pressure + systolic blood pressure) / 3] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | 1 week postpartum |
| Systolic Blood Pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alisse Hauspurg, MD | University of Pittsburgh, Magee-Womens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38072236 | Derived | Wang TL, Quinn BA, Hart R, Wiener AA, Facco FL, Simhan HN, Hauspurg AK. The effect of a neonatal sleep intervention on maternal postpartum hypertension: a randomized trial. Am J Obstet Gynecol MFM. 2024 Feb;6(2):101239. doi: 10.1016/j.ajogmf.2023.101239. Epub 2023 Dec 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SNOO Responsive Bassinet | Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion. Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home |
| FG001 | Usual Care | Will receive the current standard of care of safe sleep education in the postpartum period Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SNOO Responsive Bassinet | Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion. Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home |
| 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 | Mean Arterial Pressure | Mean arterial pressure will be calculated from the systolic and diastolic blood pressures [(2 * diastolic blood pressure + systolic blood pressure) / 3] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 6 weeks postpartum |
|
6 months
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 | SNOO Responsive Bassinet | Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion. Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alisse Hauspurg | University of Pittsburgh Medical Center, Magee-Womens Hospital | 412-641-1381 | janickia@upmc.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 | Mar 18, 2023 | Mar 19, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Safe sleep education in the postpartum period | Other | Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home |
|
Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit |
| 1 week postpartum |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | 1 week postpartum |
| Number of Participants on Antihypertensive Medication(s) | Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. | 1 week postpartum |
| Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80. | 1 week postpartum |
| Maternal Weight in Kilograms | Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit | 1 week postpartum |
| Body Mass Index in kg/m^2 | Body mass index in kg/m^2 will be assessed at the time of the study follow-up visit | 1 week postpartum |
| Systolic Blood Pressure | Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | 6 weeks postpartum |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | 6 weeks postpartum |
| Number of Participants on Antihypertensive Medication(s) | Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. | 6 weeks postpartum |
| Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80. | 6 weeks postpartum |
| Maternal Weight in Kilograms | Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit | 6 weeks postpartum |
| Body Mass Index | Body mass index in kg/m^2 will be assessed at the time of the study follow-up visit | 6 weeks postpartum |
| Mean Arterial Pressure | Mean arterial pressure will be calculated from the systolic and diastolic blood pressures [(2 * diastolic blood pressure + systolic blood pressure) / 3] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | 4 months postpartum |
| Systolic Blood Pressure | Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | 4 months postpartum |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | 4 months postpartum |
| Number of Participants on Antihypertensive Medication(s) | Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. | 4 months postpartum |
| Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80. | 4 months postpartum |
| Maternal Weight in Kilograms | Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit | 4 months postpartum |
| Body Mass Index in kg/m^2 | Body mass index in kg/m^2 will be assessed at the time of the study follow-up visit | 4 months postpartum |
| Pittsburgh Sleep Quality Index Score | The Pittsburgh Sleep Quality Index contains 19 self-rated questions and 5 questions rated by the bed partner or roommate if one is available; only the self-rated questions are included in the scoring. Scores range from 0 (indicating no difficulties in any aspect of sleep) to 21 (indicating severe difficulties in all areas). | 6 weeks postpartum |
| PROMIS Sleep Disturbance Questionnaire | The PROMIS Sleep Disturbance Questionnaire contains 27 self-rated questions on subjective sleep quality. Scores range from 27 (indicating excellent sleep quality) to 135 (indicating poor sleep quality). | 6 weeks postpartum |
| Epworth Sleepiness Scale Score | The Epworth Sleepiness Scale contains 8 self-rated questions to determine the level of daytime sleepiness in individuals. Scores range from 0 to 24. A score of 10 or more is concerning for excessive daytime sleepiness. | 6 weeks postpartum |
| Edinburgh Postnatal Depression Scale Score | The Edinburgh Postnatal Depression Scale contains 10 self-rated questions to assess for major depression in the postnatal period. Scores range from 0 to 30. A score of 13 or greater is concerning for major depression. | 6 weeks postpartum |
| Generalized Anxiety Disorder 2-item Score | The Generalized Anxiety Disorder 2-item contains 2 self-rated questions to screen for generalized anxiety disorder. Scores range from 0 to 6. A score of 3 or greater is concerning for generalized anxiety disorder. | 6 weeks postpartum |
| Perceived Stress Scale 4 Score | The Perceived Stress Scale 4 contains 4 self-rated questions regarding stress levels. Scores range from 0 to 16. Higher scores a correlated to more stress. | 6 weeks postpartum |
| Breslau 7-Item Screen for Post-traumatic Stress Disorder Score | The Breslau 7-Item Screen for Posttraumatic Stress Disorder contains 7 self-rated questions assessing symptoms of post-traumatic stress disorder. Scores range from 0 to 7. Scores of 4 or above are concerning for post-traumatic stress disorder. | 6 weeks postpartum |
| Median Infant Total Daily Sleep | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. | 6 weeks postpartum |
| Median Infant Daily Longest Sleep Duration | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. | 6 weeks postpartum |
| Median Maternal Total Daily Sleep | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. | 6 weeks postpartum |
| Median Maternal Daily Longest Sleep Duration | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. | 6 weeks postpartum |
| Median Infant Total Daily Sleep | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. | 4 months postpartum |
| Median Infant Daily Longest Sleep Duration | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. | 4 months postpartum |
| Median Maternal Total Daily Sleep | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. | 4 months postpartum |
| Median Maternal Daily Longest Sleep Duration | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. | 4 months postpartum |
| BG001 | Usual Care | Will receive the current standard of care of safe sleep education in the postpartum period Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Partner status | Count of Participants | Participants |
|
| Annual household income | Count of Participants | Participants |
|
| Insurance status during pregnancy | Count of Participants | Participants |
|
| Other children also living at home | Count of Participants | Participants |
|
| Smoking within the past 2 years | Count of Participants | Participants |
|
| Pre-delivery diagnosis of depression | Count of Participants | Participants |
|
| Ever breastfeed | Count of Participants | Participants |
|
| Gestational age at delivery | Median | Inter-Quartile Range | weeks |
|
| Mode of delivery | Count of Participants | Participants |
|
| Blood loss during delivery | Median | Inter-Quartile Range | mL |
|
| Neonatal birthweight | Median | Inter-Quartile Range | g |
|
| Type of hypertensive disorder | The diagnoses of gestational hypertension, preeclampsia without severe features, and preeclampsia with severe features were based on criteria established by the American College of Obstetricians and Gynecologists (ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1.) | Count of Participants | Participants |
|
| Gestational age at diagnosis of hypertensive disorder | Median | Inter-Quartile Range | weeks |
|
| Mean arterial pressure at first prenatal visit | The mean arterial pressure at the first prenatal visit represents a baseline measure assessing one component of the participant's health early in pregnancy prior to the onset of any hypertensive disorder of pregnancy. | Some participant data not available in chart review | Mean | Standard Deviation | mm Hg |
|
| Systolic blood pressure at first prenatal visit | The systolic blood pressure at the first prenatal visit represents a baseline measure assessing one component of the participant's health early in pregnancy prior to the onset of any hypertensive disorder of pregnancy. | Some participant data not available in chart review | Mean | Standard Deviation | mm Hg |
|
| Diastolic blood pressure at first prenatal visit | The diastolic blood pressure at the first prenatal visit represents a baseline measure assessing one component of the participant's health early in pregnancy prior to the onset of any hypertensive disorder of pregnancy. | Some participant data not available in chart review | Mean | Standard Deviation | mm Hg |
|
| Weight in kg at first prenatal visit | The weight at the first prenatal visit represents a baseline measure assessing one component of the participant's health early in pregnancy prior to the onset of any hypertensive disorder of pregnancy. | Some participant data not available in chart review | Median | Inter-Quartile Range | kg |
|
| Body Mass Index in kg/m^2 at first prenatal visit | The Body Mass Index at the first prenatal visit represents a baseline measure assessing one component of the participant's health early in pregnancy prior to the onset of any hypertensive disorder of pregnancy. | Some participant data not available in chart review | Median | Inter-Quartile Range | kg/m^2 |
|
| Mean arterial pressure on Labor and Delivery admission | Mean | Standard Deviation | mm Hg |
|
| Systolic blood pressure on Labor and Delivery admission | Mean | Standard Deviation | mm Hg |
|
| Diastolic blood pressure on Labor and Delivery admission | Mean | Standard Deviation | mm Hg |
|
| Weight on Labor and Delivery admission in kg | Median | Inter-Quartile Range | kg |
|
| Body Mass Index on Labor and Delivery admission in kg/m^2 | Median | Inter-Quartile Range | kg/m^2 |
|
| Mean arterial pressure at postpartum enrollment | Mean | Standard Deviation | mm Hg |
|
| Systolic blood pressure at postpartum enrollment | Mean | Standard Deviation | mm Hg |
|
| Diastolic blood pressure at postpartum enrollment | Mean | Standard Deviation | mm Hg |
|
| Number of participants on antihypertensive medication(s) at postpartum enrollment | Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of postpartum enrollment. | Count of Participants | Participants |
|
| Number of participants with Stage 1+ hypertension or on antihypertensive medication(s) | Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of postpartum enrollment. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80. | Count of Participants | Participants |
|
| Weight at postpartum enrollment in kg | Median | Inter-Quartile Range | kg |
|
| Body Mass Index at postpartum enrollment in kg/m^2 | Median | Inter-Quartile Range | kg/m^2 |
|
| OG001 | Usual Care | Will receive the current standard of care of safe sleep education in the postpartum period Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home |
|
|
|
| Secondary | Mean Arterial Pressure | Mean arterial pressure will be calculated from the systolic and diastolic blood pressures [(2 * diastolic blood pressure + systolic blood pressure) / 3] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 1 week postpartum |
|
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 1 week postpartum |
|
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 1 week postpartum |
|
|
|
|
| Secondary | Number of Participants on Antihypertensive Medication(s) | Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Count of Participants | Participants | 1 week postpartum |
|
|
|
|
| Secondary | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Count of Participants | Participants | 1 week postpartum |
|
|
|
|
| Secondary | Maternal Weight in Kilograms | Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | kg | 1 week postpartum |
|
|
|
|
| Secondary | Body Mass Index in kg/m^2 | Body mass index in kg/m^2 will be assessed at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | kg/m^2 | 1 week postpartum |
|
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 6 weeks postpartum |
|
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 6 weeks postpartum |
|
|
|
|
| Secondary | Number of Participants on Antihypertensive Medication(s) | Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Count of Participants | Participants | 6 weeks postpartum |
|
|
|
|
| Secondary | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Count of Participants | Participants | 6 weeks postpartum |
|
|
|
|
| Secondary | Maternal Weight in Kilograms | Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | kg | 6 weeks postpartum |
|
|
|
|
| Secondary | Body Mass Index | Body mass index in kg/m^2 will be assessed at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | kg/m^2 | 6 weeks postpartum |
|
|
|
|
| Secondary | Mean Arterial Pressure | Mean arterial pressure will be calculated from the systolic and diastolic blood pressures [(2 * diastolic blood pressure + systolic blood pressure) / 3] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 4 months postpartum |
|
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 4 months postpartum |
|
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | mm Hg | 4 months postpartum |
|
|
|
|
| Secondary | Number of Participants on Antihypertensive Medication(s) | Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Count of Participants | Participants | 4 months postpartum |
|
|
|
|
| Secondary | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Count of Participants | Participants | 4 months postpartum |
|
|
|
|
| Secondary | Maternal Weight in Kilograms | Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | kg | 4 months postpartum |
|
|
|
|
| Secondary | Body Mass Index in kg/m^2 | Body mass index in kg/m^2 will be assessed at the time of the study follow-up visit | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | kg/m^2 | 4 months postpartum |
|
|
|
|
| Secondary | Pittsburgh Sleep Quality Index Score | The Pittsburgh Sleep Quality Index contains 19 self-rated questions and 5 questions rated by the bed partner or roommate if one is available; only the self-rated questions are included in the scoring. Scores range from 0 (indicating no difficulties in any aspect of sleep) to 21 (indicating severe difficulties in all areas). | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postpartum |
|
|
|
|
| Secondary | PROMIS Sleep Disturbance Questionnaire | The PROMIS Sleep Disturbance Questionnaire contains 27 self-rated questions on subjective sleep quality. Scores range from 27 (indicating excellent sleep quality) to 135 (indicating poor sleep quality). | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | units on a scale | 6 weeks postpartum |
|
|
|
|
| Secondary | Epworth Sleepiness Scale Score | The Epworth Sleepiness Scale contains 8 self-rated questions to determine the level of daytime sleepiness in individuals. Scores range from 0 to 24. A score of 10 or more is concerning for excessive daytime sleepiness. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postpartum |
|
|
|
|
| Secondary | Edinburgh Postnatal Depression Scale Score | The Edinburgh Postnatal Depression Scale contains 10 self-rated questions to assess for major depression in the postnatal period. Scores range from 0 to 30. A score of 13 or greater is concerning for major depression. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks postpartum |
|
|
|
|
| Secondary | Generalized Anxiety Disorder 2-item Score | The Generalized Anxiety Disorder 2-item contains 2 self-rated questions to screen for generalized anxiety disorder. Scores range from 0 to 6. A score of 3 or greater is concerning for generalized anxiety disorder. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks postpartum |
|
|
|
|
| Secondary | Perceived Stress Scale 4 Score | The Perceived Stress Scale 4 contains 4 self-rated questions regarding stress levels. Scores range from 0 to 16. Higher scores a correlated to more stress. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks postpartum |
|
|
|
|
| Secondary | Breslau 7-Item Screen for Post-traumatic Stress Disorder Score | The Breslau 7-Item Screen for Posttraumatic Stress Disorder contains 7 self-rated questions assessing symptoms of post-traumatic stress disorder. Scores range from 0 to 7. Scores of 4 or above are concerning for post-traumatic stress disorder. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks postpartum |
|
|
|
|
| Secondary | Median Infant Total Daily Sleep | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | hours per day | 6 weeks postpartum |
|
|
|
|
| Secondary | Median Infant Daily Longest Sleep Duration | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | hours per day | 6 weeks postpartum |
|
|
|
|
| Secondary | Median Maternal Total Daily Sleep | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | hours per day | 6 weeks postpartum |
|
|
|
|
| Secondary | Median Maternal Daily Longest Sleep Duration | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | hours per day | 6 weeks postpartum |
|
|
|
|
| Secondary | Median Infant Total Daily Sleep | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | hours per day | 4 months postpartum |
|
|
|
|
| Secondary | Median Infant Daily Longest Sleep Duration | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | hours per day | 4 months postpartum |
|
|
|
|
| Secondary | Median Maternal Total Daily Sleep | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | hours per day | 4 months postpartum |
|
|
|
|
| Secondary | Median Maternal Daily Longest Sleep Duration | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. | Some participants lost to follow-up and/or did not complete this outcome measure | Posted | Median | Inter-Quartile Range | hours per day | 4 months postpartum |
|
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Usual Care | Will receive the current standard of care of safe sleep education in the postpartum period Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home | 0 | 56 | 0 | 56 | 0 | 56 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Unknown or Not Reported |
|
| Asian or Pacific Islander |
|
| Other |
|
| Single |
|
| Prefer not to answer |
|
| Other |
|
| No insurance |
|
| Vacuum-assisted vaginal delivery |
|
| Cesarean delivery |
|
| Preeclampsia with severe features |
|