Neonatal Sleep Intervention to Improve Postpartum Hypertension

May 16, 2023 updated by: Alisse Hauspurg

The Impact of a Neonatal Sleep Intervention on Postpartum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Magee-Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years old
  • Have a singleton, full-term (37 or greater weeks of gestation), live birth of a non-anomalous fetus
  • Diagnosis of gestational hypertension or pre-eclampsia by American College of Obstetricians and Gynecologists criteria
  • Enrolled in the institution's postpartum blood pressure remote monitoring program
  • Willing to undergo randomization
  • Willing to use the SNOO for their neonate in the postpartum period if randomized to that study arm

Exclusion Criteria:

  • <18 years old
  • Non-English speaking
  • Diagnosis of chronic hypertension
  • Diagnosis of pre-gestational diabetes
  • Diagnosis of cardiac disease
  • Diagnosis of kidney disease
  • Diagnosis of liver disease
  • Infant admitted to the neonatal intensive care unit
  • Intend to use the SNOO prior to study enrollment
  • Not willing to be randomized
  • Not willing to use the SNOO if randomized to that study arm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: 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.
Other: Safe sleep education in the postpartum period
Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
Active Comparator: Usual Care
Will receive the current standard of care of safe sleep education in the postpartum period
Other: Safe sleep education in the postpartum period
Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure
Time Frame: 6 weeks postpartum
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS Sleep Disturbance Questionnaire
Time Frame: 6 weeks postpartum
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
Mean Arterial Pressure
Time Frame: 1 week postpartum
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
Time Frame: 1 week postpartum
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
Time Frame: 1 week postpartum
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)
Time Frame: 1 week postpartum
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)
Time Frame: 1 week postpartum
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
Time Frame: 1 week postpartum
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
Time Frame: 1 week postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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)
Time Frame: 6 weeks postpartum
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)
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 4 months postpartum
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
Time Frame: 4 months postpartum
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
Time Frame: 4 months postpartum
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)
Time Frame: 4 months postpartum
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)
Time Frame: 4 months postpartum
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
Time Frame: 4 months postpartum
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
Time Frame: 4 months postpartum
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
Time Frame: 6 weeks postpartum
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
Epworth Sleepiness Scale Score
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 4 months postpartum
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
Time Frame: 4 months postpartum
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
Time Frame: 4 months postpartum
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
Time Frame: 4 months postpartum
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alisse Hauspurg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Happiest Baby, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alisse Hauspurg, MD, University of Pittsburgh, Magee-Womens Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY20070054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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