Pre-EclampsiaNCT04864249

Neonatal Sleep Intervention to Improve Postpartum Hypertension

A study testing SNOO and Safe sleep education in the postpartum period in people with Pre-Eclampsia and Gestational Hypertension, run by Alisse Hauspurg at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pre-Eclampsia, Gestational Hypertension, Sleep
What is being tested?: SNOO and Safe sleep education in the postpartum period
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 9 Jul 2021to 30 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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

Who cannot join

<18 years old
Non-English speaking
Diagnosis of chronic hypertension
Diagnosis of pre-gestational diabetes
Diagnosis of cardiac disease
Diagnosis of kidney disease

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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.

Conditions: Pre-Eclampsia, Gestational Hypertension, Sleep
Being tested: SNOO, Safe sleep education in the postpartum period
Keywords: Pre-Eclampsia, Gestational Hypertension, Postpartum Sleep, SNOO
Medical subject headings: Pre-Eclampsia, Hypertension, Pregnancy-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04864249
Study group	Role	What they receive
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 Receives: Device: SNOO; Other: 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 Receives: Other: Safe sleep education in the postpartum period

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks postpartum

Secondary outcomes (35)

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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jul 202130 Sep 2022

First posted28 Apr 2021
Study start9 Jul 2021
Primary completion11 May 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04864249
Sponsor's protocol ID: STUDY20070054
Status last verified: May 2023
First submitted: 24 Apr 2021
Last updated: 8 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 38072236

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingEarly Phase 1
Daily Aspirin Treatment After Preeclampsia
Preeclampsia
RecruitingEarly Phase 1
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Preeclampsia, Endothelial Function
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia

All Pre-Eclampsia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of a Neonatal Sleep Intervention on Postpartum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
ClinicalTrials.gov ID: NCT04864249
Acronym / sponsor ID: STUDY20070054
Conditions: Pre-Eclampsia, Gestational Hypertension, Sleep
Keywords: Pre-Eclampsia, Gestational Hypertension, Postpartum Sleep, SNOO
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Alisse HauspurgUniversity, hospital or other
Collaborators: Happiest Baby, Inc.
Study start: 9 Jul 2021 (actual)
Primary completion: 11 May 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 28 Apr 2021 (actual)
Results: Posted 8 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SNOO Responsive Bassinet	Experimental	Device: SNOO, Other: Safe sleep education in the postpartum periodWill 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	Other: Safe sleep education in the postpartum periodWill receive the current standard of care of safe sleep education in the postpartum period

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥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

Key exclusion criteria (11 listed)

<18 years old
Non-English speaking
Diagnosis of chronic hypertension
Diagnosis of pre-gestational diabetes
Diagnosis of cardiac disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SNOOThe 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.	Device	SNOO Responsive Bassinet
Safe sleep education in the postpartum periodComprised of education from the postpartum clinical nurse with a corresponding educational handout to take home	Other	SNOO Responsive Bassinet, Usual Care

Primary outcome

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.

35 secondary outcomes

Mean Arterial Pressure
Time frame: 1 week postpartum
Systolic Blood Pressure
Time frame: 1 week postpartum
Diastolic Blood Pressure
Time frame: 1 week postpartum
Number of Participants on Antihypertensive Medication(s)
Time frame: 1 week postpartum
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
Time frame: 1 week postpartum
Maternal Weight in Kilograms
Time frame: 1 week postpartum
Body Mass Index in kg/m^2
Time frame: 1 week postpartum
Systolic Blood Pressure
Time frame: 6 weeks postpartum
Diastolic Blood Pressure
Time frame: 6 weeks postpartum
Number of Participants on Antihypertensive Medication(s)
Time frame: 6 weeks postpartum
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
Time frame: 6 weeks postpartum
Maternal Weight in Kilograms
Time frame: 6 weeks postpartum
Body Mass Index
Time frame: 6 weeks postpartum
Mean Arterial Pressure
Time frame: 4 months postpartum
Systolic Blood Pressure
Time frame: 4 months postpartum
Diastolic Blood Pressure
Time frame: 4 months postpartum
Number of Participants on Antihypertensive Medication(s)
Time frame: 4 months postpartum
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
Time frame: 4 months postpartum
Maternal Weight in Kilograms
Time frame: 4 months postpartum
Body Mass Index in kg/m^2
Time frame: 4 months postpartum
Pittsburgh Sleep Quality Index Score
Time frame: 6 weeks postpartum
PROMIS Sleep Disturbance Questionnaire
Time frame: 6 weeks postpartum
Epworth Sleepiness Scale Score
Time frame: 6 weeks postpartum
Edinburgh Postnatal Depression Scale Score
Time frame: 6 weeks postpartum
Generalized Anxiety Disorder 2-item Score
Time frame: 6 weeks postpartum
Perceived Stress Scale 4 Score
Time frame: 6 weeks postpartum
Breslau 7-Item Screen for Post-traumatic Stress Disorder Score
Time frame: 6 weeks postpartum
Median Infant Total Daily Sleep
Time frame: 6 weeks postpartum
Median Infant Daily Longest Sleep Duration
Time frame: 6 weeks postpartum
Median Maternal Total Daily Sleep
Time frame: 6 weeks postpartum
Median Maternal Daily Longest Sleep Duration
Time frame: 6 weeks postpartum
Median Infant Total Daily Sleep
Time frame: 4 months postpartum
Median Infant Daily Longest Sleep Duration
Time frame: 4 months postpartum
Median Maternal Total Daily Sleep
Time frame: 4 months postpartum
Median Maternal Daily Longest Sleep Duration
Time frame: 4 months postpartum

Results and safety

Results posted to the registry on 8 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SNOO Responsive Bassinet	54	45
Usual Care	56	31

Primary outcome: Mean Arterial Pressure

Time frame: 6 weeks postpartum. Mean (Standard Deviation). Unit: mm Hg

Measure	SNOO Responsive Bassinet n = 53	Usual Care n = 51
Value	93 (8)	94 (8)

SNOO Responsive Bassinet vs Usual Care: p = 0.54, t-test, 2 sided

Population analysed: Some participants lost to follow-up and/or did not complete this outcome measure

35 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SNOO Responsive Bassinet	0 of 54 (0%)	0 of 54 (0%)	0 of 54
Usual Care	0 of 56 (0%)	0 of 56 (0%)	0 of 56

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38072236Wang 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.
Individual participant dataSharing planned: No

Related trials for Pre-Eclampsia

Active, not recruitingEarly Phase 1
Daily Aspirin Treatment After Preeclampsia
Preeclampsia
RecruitingEarly Phase 1
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Preeclampsia, Endothelial Function
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alisse Hauspurg, MD principal investigator

University of Pittsburgh, Magee-Womens Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SNOO and Safe sleep education in the postpartum period in people with Pre-Eclampsia and Gestational Hypertension, run by Alisse Hauspurg at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Arterial Pressure (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04864249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023; AzTrials last refreshed its copy on 1 Nov 2026.