PregnancyI-SMARTNCT05709327
Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
A study testing Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART) in people with Pregnancy, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This study aims to test the following hypotheses in a single-arm observational study in 70-100 healthy pregnant multi-ethnic women who will be followed-up from the first trimester of pregnancy to the third trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Sep 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- From the first to third trimester of pregnancy (4-39 weeks of gestational age)
- Mobile phone's operating system supported by the smart ring application.
- Aged 21 and above
Who cannot join
- Can't read or speak English
- Below 21 years of age
- Below or above gestational age limit
- Limited mobility
- Diagnosed with severe unstable mental conditions
- Diagnosed with severe chronic disorders
- Mobile device not compatible with smart ring
Trial locations and contacts
1 site in 1 country.
Singapore1 site
KK Women's and Children's Hospital
Singapore, Singapore, 229899
About this study
This study aims to test the following hypotheses in a single-arm observational study in 70-100 healthy pregnant multi-ethnic women who will be followed-up from the first trimester of pregnancy to the third trimester of pregnancy.
Aim 1: To assess the applicability, acceptability and compliance with the use of a wearable smart ring together with smart digital devices (e.g., smart phone) during pregnancy.
Read more
Hypothesis 1: The investigators hypothesize that participants will respond favorably to the use of the smart ring to monitor their physical activity and sleep during pregnancy.
Aim 2: To assess the association between maternal characteristics (age, pre-pregnancy BMI, pregnancy weight gain, stress, anxiety and depression symptoms) with physical activity markers (energy expenditure, and step count) and sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability) collected from the smart ring in the second trimester of pregnancy.
Hypothesis 2: The investigators hypothesize that specific maternal characteristics will be associated with physical activity markers (energy expenditure, and step count), as well as sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability).
Read the detailed description
Wearable sensor and other smart technologies may play an important part in the early detection of adverse pregnancy-related health events along with motivating improvement in patient and provider interactions for effective pregnancy health management. The use of wearable sensors, more specifically, wearable smart rings can potentially be used to offer remote, unobtrusive personalized care, encourage preventive care and provide the necessary context for self-help based just-intime adaptive interventions (feedback loops utilizing digital phenotyping data to trigger in-app interventions). Studies on the use of wearable smart rings and health outcomes are scarce, and currently there is no available data of the use of wearable smart rings together with smart digital devices (i.e., smart phone) for tracking pregnancy health in women. This study aims to be the first to generate preliminary pilot data to support it's use in this specific group of women.
An observational period for up to 37 weeks, single-center, one-armed intervention study involving 70-100 healthy pregnant women from a multi-ethnic population (Chinese, Malay, Indian, others) aged between 21 and 45 years.
All participants included into the study will be provided an Oura Ring to wear for the rest of the pregnancy period.
Data will be collected through questionnaires and each time a participant opens up their mobile application, the uploaded data will be automatically transferred via Bluetooth connection to the study database in the smart ring cloud service. The questionnaires include socio-economic factors, maternal anxiety and depression, maternal sleep, and maternal physical activity. The participants data will be collected from the moment join the study up till delivery.
- Conditions
- Pregnancy
- Being tested
- Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)Other
Single-arm observational study where all participants in the study will be given a smart ring (Oura Ring) to wear throughout the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm observational study | Other | All participants in the study will be provided a smart ring to wear for the entire duration of the pregnancy. Receives: Other: Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and applicability of smart ring usage during pregnancy
The feasibility and applicability of a commercial smart ring (Oura Ring) use assessed by a feedback survey.
Measured: At the end of pregnancy
Secondary outcomes (11)
Objective change in sleep quality across the entire pregnancy
The smart ring (Oura Ring) will issued to capture durations of deep sleep, rapid eye movement (REM) sleep, light sleep and nightly heart rate. Sleep Score ranges from 0-100, where a higher score reflects better sleep outcome.
Measured: up to 37 weeks from recruitment
Self-reported change in sleep quality
Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Measured: First trimester of pregnancy between 0-12 weeks gestational age
Self-reported change in sleep quality
Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Measured: Second trimester of pregnancy between 13-27 weeks gestational age
Self-reported change in sleep quality
Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index Questionnaire (PSQI). Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Measured: Third trimester of pregnancy between 28-40 weeks gestational age
Objective change in physical activity across the entire pregnancy
The smart ring (Oura Ring) will be issued to capture durations of activity, inactivity and rest. Activity score ranges from 0-100, where a higher score reflects better balance between activity and rest.
Measured: up to 37 weeks from recruitment
Self-reported change in physical activity
Self-reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Data collected with International Physical Activity Questionnaire (IPAQ) can be reported as a continuous measure and reported as median metabolic equivalent of task (MET) minutes. A higher score will indicated higher physical activity involvement.
Measured: First trimester of pregnancy between 0-12 weeks gestational age
Self-reported change in physical activity
Self-reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Data collected with International Physical Activity Questionnaire (IPAQ) can be reported as a continuous measure and reported as median metabolic equivalent of task (MET) minutes. A higher score will indicated higher physical activity involvement.
Measured: Second trimester of pregnancy between 13-27 weeks gestational age
Self-reported change in physical activity
Self-reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Data collected with International Physical Activity Questionnaire (IPAQ) can be reported as a continuous measure and reported as median metabolic equivalent of task (MET) minutes. A higher score will indicated higher physical activity involvement.
Measured: Third trimester of pregnancy between 28-40 weeks gestational age
Anxiety and depression symptoms
The Depression Anxiety Stress Scales (DASS) will be used to capture self-reported anxiety and depression symptoms across pregnancy. The minimum score is 0 and the maximum score is 63. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms.
Measured: First trimester of pregnancy between 0-12 weeks gestational age
Change in anxiety and depression symptoms across the first, second and third trimesters
The Depression Anxiety Stress Scales (DASS) will be used to capture self-reported anxiety and depression symptoms across pregnancy. The minimum score is 0 and the maximum score is 63. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms.
Measured: Second trimester of pregnancy between 13-27 weeks gestational age
Change in anxiety and depression symptoms across the first, second and third trimesters
The Depression Anxiety Stress Scales (DASS) will be used to capture self-reported anxiety and depression symptoms across pregnancy. The minimum score is 0 and the maximum score is 63. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms.
Measured: Third trimester of pregnancy between 28-40 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start3 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm observational study
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tan Kok Hian, KK Women's and Children's Hospital
- Investigators
- Kok Hian Tan, MD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709327
- Sponsor's protocol ID
- 2021/2515
- Acronym
- I-SMART
- Status last verified
- Aug 2026
- First submitted
- 26 Dec 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
- ClinicalTrials.gov ID
- NCT05709327
- Acronym / sponsor ID
- I-SMART / 2021/2515
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Feb 2023 (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.
This study aims to test the following hypotheses in a single-arm observational study in 70-100 healthy pregnant multi-ethnic women who will be followed-up from the first trimester of pregnancy to the third trimester of pregnancy.
Aim 1: To assess the applicability, acceptability and compliance with the use of a wearable smart ring together with smart digital devices (e.g., smart phone) during pregnancy.
Hypothesis 1: The investigators hypothesize that participants will respond favorably to the use of the smart ring to monitor their physical activity and sleep during pregnancy.
Aim 2: To assess the association between maternal characteristics (age, pre-pregnancy BMI, pregnancy weight gain, stress, anxiety and depression symptoms) with physical activity markers (energy expenditure, and step count) and sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability) collected from the smart ring in the second trimester of pregnancy.
Hypothesis 2: The investigators hypothesize that specific maternal characteristics will be associated with physical activity markers (energy expenditure, and step count), as well as sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability).
Detailed description
Wearable sensor and other smart technologies may play an important part in the early detection of adverse pregnancy-related health events along with motivating improvement in patient and provider interactions for effective pregnancy health management. The use of wearable sensors, more specifically, wearable smart rings can potentially be used to offer remote, unobtrusive personalized care, encourage preventive care and provide the necessary context for self-help based just-intime adaptive interventions (feedback loops utilizing digital phenotyping data to trigger in-app interventions). Studies on the use of wearable smart rings and health outcomes are scarce, and currently there is no available data of the use of wearable smart rings together with smart digital devices (i.e., smart phone) for tracking pregnancy health in women. This study aims to be the first to generate preliminary pilot data to support it's use in this specific group of women.
An observational period for up to 37 weeks, single-center, one-armed intervention study involving 70-100 healthy pregnant women from a multi-ethnic population (Chinese, Malay, Indian, others) aged between 21 and 45 years.
All participants included into the study will be provided an Oura Ring to wear for the rest of the pregnancy period.
Data will be collected through questionnaires and each time a participant opens up their mobile application, the uploaded data will be automatically transferred via Bluetooth connection to the study database in the smart ring cloud service. The questionnaires include socio-economic factors, maternal anxiety and depression, maternal sleep, and maternal physical activity. The participants data will be collected from the moment join the study up till delivery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm observational study
| Arm | Type | Receives |
|---|---|---|
| Single-arm observational study | Other | Other: Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)All participants in the study will be provided a smart ring to wear for the entire duration of the pregnancy. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- From the first to third trimester of pregnancy (4-39 weeks of gestational age)
- Mobile phone's operating system supported by the smart ring application.
- Aged 21 and above
Key exclusion criteria (7 listed)
- Can't read or speak English
- Below 21 years of age
- Below or above gestational age limit
- Limited mobility
- Diagnosed with severe unstable mental conditions
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 |
|---|---|---|
| Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)Single-arm observational study where all participants in the study will be given a smart ring (Oura Ring) to wear throughout the duration of the study. | Other | Single-arm observational study |
Primary outcome
Feasibility and applicability of smart ring usage during pregnancy
Time frame: At the end of pregnancy
The feasibility and applicability of a commercial smart ring (Oura Ring) use assessed by a feedback survey.
11 secondary outcomes
Objective change in sleep quality across the entire pregnancy
Time frame: up to 37 weeks from recruitment
Self-reported change in sleep quality
Time frame: First trimester of pregnancy between 0-12 weeks gestational age
Self-reported change in sleep quality
Time frame: Second trimester of pregnancy between 13-27 weeks gestational age
Self-reported change in sleep quality
Time frame: Third trimester of pregnancy between 28-40 weeks gestational age
Objective change in physical activity across the entire pregnancy
Time frame: up to 37 weeks from recruitment
Self-reported change in physical activity
Time frame: First trimester of pregnancy between 0-12 weeks gestational age
Self-reported change in physical activity
Time frame: Second trimester of pregnancy between 13-27 weeks gestational age
Self-reported change in physical activity
Time frame: Third trimester of pregnancy between 28-40 weeks gestational age
Anxiety and depression symptoms
Time frame: First trimester of pregnancy between 0-12 weeks gestational age
Change in anxiety and depression symptoms across the first, second and third trimesters
Time frame: Second trimester of pregnancy between 13-27 weeks gestational age
Change in anxiety and depression symptoms across the first, second and third trimesters
Time frame: Third trimester of pregnancy between 28-40 weeks gestational age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Kok Hian Tan, MD principal investigator
KK Women's and Children's 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 Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART) in people with Pregnancy, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility and applicability of smart ring usage during pregnancy (time frame: At the end of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.