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Completed

NCT Number: NCT04864249

Neonatal Sleep Intervention to Improve Postpartum Hypertension

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.

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Key information

Conditions

Pre-eclampsia Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Sleep Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Safe sleep education in the postpartum period

Other

Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. 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

  20. 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

  21. 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).

  22. 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).

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

Sponsors and collaborators

Lead sponsor

Alisse Hauspurg

Other

Collaborators

  • Happiest Baby, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2021
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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