Pregnancy ComplicationsSTEPNCT04173559
Sleep and Tracking Effects in Pregnancy Study
A study testing Activity Intervention in people with Pregnancy Complications and Pregnancy Related, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Pregnancy Related, Weight Gain
- What is being tested?
- Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2023to 14 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 51 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At high risk for adverse pregnancy outcomes, due to either body mass index ≥ 30 kg/m^2, or a prior history of preeclampsia, intrauterine growth restriction or preterm birth prior to 37 weeks' gestation in a previous pregnancy and a perceived stress score of >/= 14 (10-question scale)
- Gestational age of 8.0 to 19.9 weeks' gestation using American College of Obstetricians and Gynecologists dating criteria (combination of ultrasound and menstrual dating, as available)
- Current singleton viable intrauterine pregnancy. Spontaneous reduction of twin to singleton gestation is allowable provided it occurred prior to 14 weeks' gestation.
- No structural abnormalities or aneuploidy
- Ability to communicate in and provide consent in English
- Maternal age 18 to 51 years of age
- Owns smartphone compatible with wrist-based activity tracker (over 200 devices supported)
Who cannot join
- Women pregnant with multifetal gestations
- Women who have a medical condition where a modest increase in low-impact activity is contraindicated (at the discretion of the woman's treating physician)
- Planned delivery prior to 36 weeks' of gestation
- Unwilling to wear wrist-based activity tracker for at least 6 out of 7 days per week
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Improving Perinatal Outcomes Through Activity and Sleep Tracking
Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy.
Participants: Pregnant women enrolled in prenatal care at the University of North Carolina who have a documented moderate or high level of perceived stress ( ≥ 14) and are at high risk for adverse pregnancy outcomes due to body mass index of ≥ 30 kg/m2 or history of gestational hypertension, preeclampsia, intrauterine growth restriction, or preterm birth <37 weeks' in a prior pregnancy.
Procedures: Women meeting inclusion criteria will be recruited through the University of North Carolina prenatal care clinics. They will be contacted for possible participation at regularly scheduled prenatal visits and/or ultrasound. They may also be contacted for possible participation by remote methods (e.g., Telehealth). Women who are enrolled will complete validated dietary, stress, sleep, and body image questionnaires. Enrolled women will then be randomized to receive standard obstetrical care or enhanced counseling. All participants will receive a wrist-based activity tracker. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Maternal and neonatal outcomes will be compared between groups.
Read the detailed description
During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to minimize stress and optimize weight gain, nutrition, and activity, positively impacting outcomes and lifelong health. The overarching hypothesis of this study is that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women increase their activity level during pregnancy, reduce stress, and optimize gestational weight gain and biometric parameters. Importantly, the investigators propose that women can be engaged in care via a simple, personalized text-message based intervention.
Women will be enrolled early in pregnancy and followed prospectively. All women will receive a wrist-based activity tracker. Some women (those randomized to receive individualized counseling) will receive weekly text messages based on their activity and sleep in the prior week. Other women will not receive any specific instructions regarding activity level. The investigators will follow their outcomes prospectively. Biologic samples (including blood, urine, vaginal swabs, placental tissue) will be collected at enrollment and at delivery.
- Conditions
- Pregnancy Complications, Pregnancy Related, Weight Gain, Weight Change Trajectory, High Risk Pregnancy, Stress, Emotional
- Being tested
- Activity Intervention
- Medical subject headings
- Pregnancy Complications, Weight Gain, Body-Weight Trajectory, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity InterventionBehavioural
After 1 week of baseline activity is obtained, participants will be contacted with personalized activity goals that are 10% higher than their previous weeks' activity levels. They will also receive feedback regarding sleep if they are not averaging at least 6 hours per night or if they are waking more than twice per night. Participants will also receive weekly text reminders and encouraging feedback, and will receive additional counseling in person at regularly scheduled prenatal visits until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy. |
| Activity Intervention | Experimental | Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. . Receives: Behavioral: Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Perceived Maternal Stress
Perceived stress score will be calculated using a validated 10-question stress scale; score = 14 indicates moderate stress
Measured: through delivery, an average of 7 months per participant
Proportion of women with adverse perinatal outcomes
The investigators will define adverse pregnancy outcomes as a composite of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups.
Measured: outcome will be ascertained at delivery
Secondary outcomes (17)
Number of activity goals met by personalized activity level group
Proportion of weekly activity goals that were successfully met by women randomized to personalized activity group
Measured: through delivery, an average of 7 months per participant
Mean Daily steps
Mean number of daily steps; amount will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Median Daily steps
median number of daily steps; amount will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Mean 'Moderate' or greater physical activity
Mean number of weekly minutes of 'moderate' or 'intense' physical activity as registered by the wrist-based activity monitor; amount will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Median 'Moderate' or greater physical activity
median number of weekly minutes of 'moderate' or 'intense' physical activity as registered by the wrist-based activity monitor; amount will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Mean Nightly sleep minutes
Mean number of sleep minutes per night; amount will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Median Nightly sleep minutes
median number of sleep minutes per night; amount will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Median resting heart rate parameters
The change in the median resting heart rate level and nadir of the resting heart rate (in beats per minute), between enrollment and delivery ; amount will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Mean Resting heart rate parameters
The change in the mean resting heart rate level and nadir of the resting heart rate (in beats per minute), between enrollment and delivery ; amount will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Median Body composition change during study - total body water
The change in median total body water measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.
Measured: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Mean Body composition change during study - total body water
The change in mean total body water measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.
Measured: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Median Body composition change during study - percent body fat
The change in median percent body fat measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.
Measured: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Mean Body composition change during study - percent body fat
The change in mean percent body fat measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.
Measured: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Gestational weight gain
The amount of weight gained by each participant during pregnancy, in pounds. outcomes will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Gestational weight gain, per week after study enrollment
The amount of weight gained per week by each participant, in pounds, between study enrollment and delivery. outcomes will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant
Proportion of women with gestational diabetes mellitus
The diagnosis of gestational diabetes mellitus during pregnancy, using standard criteria as set forth by American College of Obstetricians and Gynecologists. outcomes will be compared between randomization groups.
Measured: through delivery, an average of 7 months per participant.
Proportion of women with hypertensive complications of pregnancy
The diagnosis of gestational hypertension, preeclampsia, or eclampsia, using standard American College of Obstetricians and Gynecologists diagnostic criteria. outcomes will be compared between randomization groups.
Measured: through 6 weeks' postpartum, an average of 7 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study startMay 2023 (estimated)
- Primary completion14 May 2025 (estimated)
- Study completion14 May 2025 (estimated)
Why it stopped: Lack of available staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy A Manuck, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173559
- Sponsor's protocol ID
- 18-2434
- Acronym
- STEP
- Status last verified
- Aug 2024
- First submitted
- 20 Nov 2019
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Publications
Olson CM, Strawderman MS, Reed RG. Efficacy of an intervention to prevent excessive gestational weight gain. Am J Obstet Gynecol. 2004 Aug;191(2):530-6. doi: 10.1016/j.ajog.2004.01.027.
PubMed 15343232Muktabhant B, Lumbiganon P, Ngamjarus C, Dowswell T. Interventions for preventing excessive weight gain during pregnancy. Cochrane Database Syst Rev. 2012 Apr 18;4(4):CD007145. doi: 10.1002/14651858.CD007145.pub2.
PubMed 22513947Muktabhant B, Lawrie TA, Lumbiganon P, Laopaiboon M. Diet or exercise, or both, for preventing excessive weight gain in pregnancy. Cochrane Database Syst Rev. 2015 Jun 15;2015(6):CD007145. doi: 10.1002/14651858.CD007145.pub3.
PubMed 26068707Wolf HT, Owe KM, Juhl M, Hegaard HK. Leisure time physical activity and the risk of pre-eclampsia: a systematic review. Matern Child Health J. 2014 May;18(4):899-910. doi: 10.1007/s10995-013-1316-8.
PubMed 23836014Sorensen TK, Williams MA, Lee IM, Dashow EE, Thompson ML, Luthy DA. Recreational physical activity during pregnancy and risk of preeclampsia. Hypertension. 2003 Jun;41(6):1273-80. doi: 10.1161/01.HYP.0000072270.82815.91. Epub 2003 Apr 28.
PubMed 12719446
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Perinatal Outcomes Through Activity and Sleep Tracking
- ClinicalTrials.gov ID
- NCT04173559
- Acronym / sponsor ID
- STEP / 18-2434
- Conditions
- Pregnancy Complications, Pregnancy Related, Weight Gain, Weight Change Trajectory, High Risk Pregnancy, Stress, Emotional
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of available staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- 14 May 2025 (estimated)
- Study completion
- 14 May 2025 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy.
Participants: Pregnant women enrolled in prenatal care at the University of North Carolina who have a documented moderate or high level of perceived stress ( ≥ 14) and are at high risk for adverse pregnancy outcomes due to body mass index of ≥ 30 kg/m2 or history of gestational hypertension, preeclampsia, intrauterine growth restriction, or preterm birth <37 weeks' in a prior pregnancy.
Procedures: Women meeting inclusion criteria will be recruited through the University of North Carolina prenatal care clinics. They will be contacted for possible participation at regularly scheduled prenatal visits and/or ultrasound. They may also be contacted for possible participation by remote methods (e.g., Telehealth). Women who are enrolled will complete validated dietary, stress, sleep, and body image questionnaires. Enrolled women will then be randomized to receive standard obstetrical care or enhanced counseling. All participants will receive a wrist-based activity tracker. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Maternal and neonatal outcomes will be compared between groups.
Detailed description
During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to minimize stress and optimize weight gain, nutrition, and activity, positively impacting outcomes and lifelong health. The overarching hypothesis of this study is that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women increase their activity level during pregnancy, reduce stress, and optimize gestational weight gain and biometric parameters. Importantly, the investigators propose that women can be engaged in care via a simple, personalized text-message based intervention.
Women will be enrolled early in pregnancy and followed prospectively. All women will receive a wrist-based activity tracker. Some women (those randomized to receive individualized counseling) will receive weekly text messages based on their activity and sleep in the prior week. Other women will not receive any specific instructions regarding activity level. The investigators will follow their outcomes prospectively. Biologic samples (including blood, urine, vaginal swabs, placental tissue) will be collected at enrollment and at delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy. |
| Activity Intervention | Experimental | Behavioral: Activity InterventionWomen randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. . |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- At high risk for adverse pregnancy outcomes, due to either body mass index ≥ 30 kg/m^2, or a prior history of preeclampsia, intrauterine growth restriction or preterm birth prior to 37 weeks' gestation in a previous pregnancy and a perceived stress score of >/= 14 (10-question scale)
- Gestational age of 8.0 to 19.9 weeks' gestation using American College of Obstetricians and Gynecologists dating criteria (combination of ultrasound and menstrual dating, as available)
- Current singleton viable intrauterine pregnancy. Spontaneous reduction of twin to singleton gestation is allowable provided it occurred prior to 14 weeks' gestation.
- No structural abnormalities or aneuploidy
- Ability to communicate in and provide consent in English
Key exclusion criteria (4 listed)
- Women pregnant with multifetal gestations
- Women who have a medical condition where a modest increase in low-impact activity is contraindicated (at the discretion of the woman's treating physician)
- Planned delivery prior to 36 weeks' of gestation
- Unwilling to wear wrist-based activity tracker for at least 6 out of 7 days per week
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 |
|---|---|---|
| Activity InterventionAfter 1 week of baseline activity is obtained, participants will be contacted with personalized activity goals that are 10% higher than their previous weeks' activity levels. They will also receive feedback regarding sleep if they are not averaging at least 6 hours per night or if they are waking more than twice per night. Participants will also receive weekly text reminders and encouraging feedback, and will receive additional counseling in person at regularly scheduled prenatal visits until delivery. | Behavioural | Activity Intervention |
Primary outcome
Reduction in Perceived Maternal Stress
Time frame: through delivery, an average of 7 months per participant
Perceived stress score will be calculated using a validated 10-question stress scale; score = 14 indicates moderate stress
Proportion of women with adverse perinatal outcomes
Time frame: outcome will be ascertained at delivery
The investigators will define adverse pregnancy outcomes as a composite of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups.
17 secondary outcomes
Number of activity goals met by personalized activity level group
Time frame: through delivery, an average of 7 months per participant
Mean Daily steps
Time frame: through delivery, an average of 7 months per participant
Median Daily steps
Time frame: through delivery, an average of 7 months per participant
Mean 'Moderate' or greater physical activity
Time frame: through delivery, an average of 7 months per participant
Median 'Moderate' or greater physical activity
Time frame: through delivery, an average of 7 months per participant
Mean Nightly sleep minutes
Time frame: through delivery, an average of 7 months per participant
Median Nightly sleep minutes
Time frame: through delivery, an average of 7 months per participant
Median resting heart rate parameters
Time frame: through delivery, an average of 7 months per participant
Mean Resting heart rate parameters
Time frame: through delivery, an average of 7 months per participant
Median Body composition change during study - total body water
Time frame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Mean Body composition change during study - total body water
Time frame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Median Body composition change during study - percent body fat
Time frame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Mean Body composition change during study - percent body fat
Time frame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Gestational weight gain
Time frame: through delivery, an average of 7 months per participant
Gestational weight gain, per week after study enrollment
Time frame: through delivery, an average of 7 months per participant
Proportion of women with gestational diabetes mellitus
Time frame: through delivery, an average of 7 months per participant.
Proportion of women with hypertensive complications of pregnancy
Time frame: through 6 weeks' postpartum, an average of 7 months per participant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 15343232Olson CM, Strawderman MS, Reed RG. Efficacy of an intervention to prevent excessive gestational weight gain. Am J Obstet Gynecol. 2004 Aug;191(2):530-6. doi: 10.1016/j.ajog.2004.01.027.
- Background: PubMed 22513947Muktabhant B, Lumbiganon P, Ngamjarus C, Dowswell T. Interventions for preventing excessive weight gain during pregnancy. Cochrane Database Syst Rev. 2012 Apr 18;4(4):CD007145. doi: 10.1002/14651858.CD007145.pub2.
- Background: PubMed 26068707Muktabhant B, Lawrie TA, Lumbiganon P, Laopaiboon M. Diet or exercise, or both, for preventing excessive weight gain in pregnancy. Cochrane Database Syst Rev. 2015 Jun 15;2015(6):CD007145. doi: 10.1002/14651858.CD007145.pub3.
- Background: PubMed 23836014Wolf HT, Owe KM, Juhl M, Hegaard HK. Leisure time physical activity and the risk of pre-eclampsia: a systematic review. Matern Child Health J. 2014 May;18(4):899-910. doi: 10.1007/s10995-013-1316-8.
- Background: PubMed 12719446Sorensen TK, Williams MA, Lee IM, Dashow EE, Thompson ML, Luthy DA. Recreational physical activity during pregnancy and risk of preeclampsia. Hypertension. 2003 Jun;41(6):1273-80. doi: 10.1161/01.HYP.0000072270.82815.91. Epub 2003 Apr 28.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Related trials for Pregnancy Complications
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
RecruitingObservational study
Heart Failure in Women: Epidemiological and Prognostic Insights
Heart Failure
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruiting
Foot Reflexology for Anxiety in Women Hospitalized With High-Risk Pregnancy
Anxiety, Pregnancy, High-Risk
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
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.
Tracy A Manuck, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Intervention in people with Pregnancy Complications and Pregnancy Related, run by University of North Carolina, Chapel Hill 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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Feb 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction in Perceived Maternal Stress (time frame: through delivery, an average of 7 months per participant). The study lists 2 primary outcomes in all. 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 NCT04173559, which also lists 5 linked publications.
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 10 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.