Pre-EclampsiaNCT03968952
SMARThealth Pregnancy: Feasibility & Acceptability of a Complex Intervention for High-risk Pregnant Women in Rural India.
A study testing SMARThealth Pregnancy in people with Pre-Eclampsia and Gestational Diabetes, run by University of Oxford at 1 site in India.
Trial summary
Background: Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Gestational Diabetes, Anemia
- What is being tested?
- SMARThealth Pregnancy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2019to 1 Nov 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PHC serving population of greater than 30,000 people.
- Administrative lead for PHC consents for the PHC to participate in the study.
- Age above 18 years.
- Participant is recruited between 28-36 weeks gestation.
- Participant is willing and able to give informed consent for participation in the study AND is:
- Living in the villages affiliated to the PHC included in the study.
Who cannot join
- Administrative lead does not give consent for the PHC to participate in the study.
- Pregnant women:
- Pregnant women who are younger than 18 years and;
- Pregnant women who are not recruited between 28-36 weeks' gestation
- Pregnant women not living in villages affiliated to the study PHCs will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SMARThealth Pregnancy: A Pilot Cluster Randomised Study to Assess Feasibility & Acceptability of a Complex Intervention Using Mobile Decision Support to Detect, Refer & Manage Pregnant Women at High Risk of Future Cardiometabolic Disorders in Rural India.
Background: Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention.
Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India.
Read more
Study design: Cluster randomised pilot study of 4 primary care centres (PHCs) in two diverse areas of rural India.
Outcome: The primary objective of this pilot study is to address the feasibility of the SMARThealth Pregnancy intervention.
Read the detailed description
Background: Cardiovascular disease (CVD) is the leading cause of death in women in India, and the prevalence of cardiometabolic disorders is rising. Women in rural India (where two-thirds of the population live), are particularly vulnerable due to limited knowledge and healthcare access. Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention. Innovative solutions are required to address the needs of rural women, particularly during the transitions between antenatal and postpartum care and adult health services.
Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India.
Study design: This is a pilot study, using an un-blinded, parallel group, cluster randomised controlled study design.
Study Sites: Jhajjar District, Haryana and Guntur District, Andhra Pradesh, India.
Primary outcome: The primary objective of this pilot study is to address the uncertainties around feasibility: (i) how many PHCs accepted the invitation to participate in a trial; (ii) whether the intervention is feasible with respect to participant recruitment rates, (iii) retention of pregnant women in the trial to 6 weeks postpartum; (iv) acceptability and feasibility of outcomes measures (to measure the efficacy within a definitive trial); (v) fidelity to the study protocol.
Secondary outcomes include: (i) Acceptability of the intervention. (ii) Process evaluation measures including rates of detection, referral and follow-up of high-risk pregnant women. (iii) Clinical outcomes of mean haemoglobin and mean systolic and diastolic blood pressures at 6 weeks postpartum.
Randomisation: Cluster randomisation will be conducted at the level of the PHC. Staff related to each PHC will be allocated to either intervention or control groups. The study will recruit 200 pregnant women across all 4 PHC clusters; 100 CHWs (known as ASHAs and ANMs) and; up to 8 Primary Care Physicians (affiliated to the PHC clusters). The villages selected under each intervention and control PHC will be non-contiguous to avoid contamination.
- Conditions
- Pre-Eclampsia, Gestational Diabetes, Anemia
- Being tested
- SMARThealth Pregnancy
- Keywords
- Digital health, Gestational Diabetes, Hypertension, Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia, Diabetes, Gestational, Anemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARThealth PregnancyOther
Education and Training package on high-risk pregnancies and the associated long-term cardiometabolic risks; An mHealth platform providing mobile decision support to Community Health Workers.
| Study group | Role | What they receive |
|---|---|---|
| SMARThealth Pregnancy | Active comparator | The components of the SMARThealth Pregnancy intervention include:
1. Educational and Training component on high-risk pregnancy conditions, focusing on; Anaemia, Hypertensive Disorders of Pregnancy (HDPs) and Gestational diabetes mellitus (GDM).
2. An mHealth platform providing clinical decision support, lifestyle advice, recall and reminder system for Community Health Workers (CHWs) and Primary Care Physicians (PCPs).
Pregnant women in the intervention group will receive 3 visits at home by their CHW, in addition to their standard antenatal and postnatal care. One visit during the third trimester of pregnancy; one during Week 1 postpartum and; one visit during Week 6 postpartum. Receives: Other: SMARThealth Pregnancy |
| Enhanced Standard Care | No intervention | The control group will receive enhanced standard antenatal and postnatal care, involving: 1. An awareness programme for pregnant women, Community Health Workers (CHWs) and Primary Care Physicians (PCPs), held at the villages within the control group Primary Health Centre (PHC) cluster (Enhanced Standard Care). The community and health professionals will receive information on the high-risk conditions of anaemia in pregnancy, HDPs and GDM as part of the awareness programme. 2. Standard antenatal and postnatal care (consisting of free monthly antenatal care, and up to 7 postnatal visits), delivered by CHWs in partnership with their PHC doctor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of eligible pregnant women successfully recruited to study in 12 months.
Measured: 12 months
Retention rate
Number of eligible participants who remain in study for entire duration up to and including the 6 week postpartum visit.
Measured: 12 months
Number of home visits completed by Community Health Worker
Number of home visits completed by Community Health Worker using the SMARThealth Pregnancy mHealth platform in line with study protocol.
Measured: 12 months
Secondary outcomes (7)
Number of pregnant women diagnosed with gestational diabetes.
Number of participants correctly diagnosed with gestational diabetes mellitus using antenatal oral glucose tolerance test, in accordance with Government of India guidelines for Gestational Diabetes Mellitus, 2018.
Measured: 12 months
Postpartum follow-up of pregnant women with gestational diabetes
Number of participants diagnosed with gestational diabetes who received postnatal 6 week oral glucose tolerance test, in accordance with Government of India guidelines for Gestational Diabetes Mellitus, 2018.
Measured: 18 months
Number of pregnant women diagnosed with a hypertensive disorder of pregnancy.
Number of participants diagnosed with a hypertensive disorder of pregnancy using International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria.
Measured: 12 months
Number of pregnant women diagnosed with severe anaemia.
Number of participants diagnosed with severe anaemia (haemoglobin of <7g/dL) during pregnancy, in accordance with Government of India guidelines for Anaemia, 2018.
Measured: 12 months
Mean postpartum haemoglobin
Haemoglobin values of postpartum women measured at 6 weeks postpartum.
Measured: 12 months
Mean postpartum Systolic Blood Pressure
Systolic blood pressure of postpartum women measured at 6 weeks postpartum.
Measured: 12 months
Mean postpartum Diastolic Blood Pressure
Diastolic blood pressure of postpartum women measured at 6 weeks postpartum.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Oct 2019
- Primary completion14 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group cluster will use the SMARThealth Pregnancy training package and mHealth platform. The Control group will have enhanced standard antenatal and postnatal care.
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- The George Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968952
- Sponsor's protocol ID
- 22-19
- Status last verified
- Nov 2020
- First submitted
- 23 May 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagraj S, Kennedy S, Jha V, Norton R, Hinton L, Billot L, Rajan E, Mohammed Abdul A, Phalswal A, Arora V, Praveen D, Hirst J. A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial. JMIR Form Res. 2023 Jul 20;7:e44362. doi: 10.2196/44362.
PubMed 37471135Nagraj S, Kennedy SH, Jha V, Norton R, Hinton L, Billot L, Rajan E, Arora V, Praveen D, Hirst JE. SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial. Front Glob Womens Health. 2021 May 28;2:620759. doi: 10.3389/fgwh.2021.620759. eCollection 2021.
PubMed 34816187
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMARThealth Pregnancy: A Pilot Cluster Randomised Study to Assess Feasibility & Acceptability of a Complex Intervention Using Mobile Decision Support to Detect, Refer & Manage Pregnant Women at High Risk of Future Cardiometabolic Disorders in Rural India.
- ClinicalTrials.gov ID
- NCT03968952
- Acronym / sponsor ID
- 22-19
- Conditions
- Pre-Eclampsia, Gestational Diabetes, Anemia
- Keywords
- Digital health, Gestational Diabetes, Hypertension, Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- The George Institute
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 30 May 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.
Background: Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention.
Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India.
Study design: Cluster randomised pilot study of 4 primary care centres (PHCs) in two diverse areas of rural India.
Outcome: The primary objective of this pilot study is to address the feasibility of the SMARThealth Pregnancy intervention.
Detailed description
Background: Cardiovascular disease (CVD) is the leading cause of death in women in India, and the prevalence of cardiometabolic disorders is rising. Women in rural India (where two-thirds of the population live), are particularly vulnerable due to limited knowledge and healthcare access. Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention. Innovative solutions are required to address the needs of rural women, particularly during the transitions between antenatal and postpartum care and adult health services.
Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India.
Study design: This is a pilot study, using an un-blinded, parallel group, cluster randomised controlled study design.
Study Sites: Jhajjar District, Haryana and Guntur District, Andhra Pradesh, India.
Primary outcome: The primary objective of this pilot study is to address the uncertainties around feasibility: (i) how many PHCs accepted the invitation to participate in a trial; (ii) whether the intervention is feasible with respect to participant recruitment rates, (iii) retention of pregnant women in the trial to 6 weeks postpartum; (iv) acceptability and feasibility of outcomes measures (to measure the efficacy within a definitive trial); (v) fidelity to the study protocol.
Secondary outcomes include: (i) Acceptability of the intervention. (ii) Process evaluation measures including rates of detection, referral and follow-up of high-risk pregnant women. (iii) Clinical outcomes of mean haemoglobin and mean systolic and diastolic blood pressures at 6 weeks postpartum.
Randomisation: Cluster randomisation will be conducted at the level of the PHC. Staff related to each PHC will be allocated to either intervention or control groups. The study will recruit 200 pregnant women across all 4 PHC clusters; 100 CHWs (known as ASHAs and ANMs) and; up to 8 Primary Care Physicians (affiliated to the PHC clusters). The villages selected under each intervention and control PHC will be non-contiguous to avoid contamination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group cluster will use the SMARThealth Pregnancy training package and mHealth platform. The Control group will have enhanced standard antenatal and postnatal care.
| Arm | Type | Receives |
|---|---|---|
| SMARThealth Pregnancy | Active comparator | Other: SMARThealth PregnancyThe components of the SMARThealth Pregnancy intervention include: 1. Educational and Training component on high-risk pregnancy conditions, focusing on; Anaemia, Hypertensive Disorders of Pregnancy (HDPs) and Gestational diabetes mellitus (GDM). 2. An mHealth platform providing clinical decision support, lifestyle advice, recall and reminder system for Community Health Workers (CHWs) and Primary Care Physicians (PCPs). Pregnant women in the intervention group will receive 3 visits at home by their CHW, in addition to their standard antenatal and postnatal care. One visit during the third trimester of pregnancy; one during Week 1 postpartum and; one visit during Week 6 postpartum. |
| Enhanced Standard Care | No intervention | –The control group will receive enhanced standard antenatal and postnatal care, involving: 1. An awareness programme for pregnant women, Community Health Workers (CHWs) and Primary Care Physicians (PCPs), held at the villages within the control group Primary Health Centre (PHC) cluster (Enhanced Standard Care). The community and health professionals will receive information on the high-risk conditions of anaemia in pregnancy, HDPs and GDM as part of the awareness programme. 2. Standard antenatal and postnatal care (consisting of free monthly antenatal care, and up to 7 postnatal visits), delivered by CHWs in partnership with their PHC doctor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PHC serving population of greater than 30,000 people.
- Administrative lead for PHC consents for the PHC to participate in the study.
- Age above 18 years.
- Participant is recruited between 28-36 weeks gestation.
- Participant is willing and able to give informed consent for participation in the study AND is:
Key exclusion criteria (5 listed)
- Administrative lead does not give consent for the PHC to participate in the study.
- Pregnant women who are younger than 18 years and;
- Pregnant women who are not recruited between 28-36 weeks' gestation
- Pregnant women not living in villages affiliated to the study PHCs will be excluded from the study.
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 |
|---|---|---|
| SMARThealth PregnancyEducation and Training package on high-risk pregnancies and the associated long-term cardiometabolic risks; An mHealth platform providing mobile decision support to Community Health Workers. | Other | SMARThealth Pregnancy |
Primary outcome
Recruitment rate
Time frame: 12 months
Number of eligible pregnant women successfully recruited to study in 12 months.
Retention rate
Time frame: 12 months
Number of eligible participants who remain in study for entire duration up to and including the 6 week postpartum visit.
Number of home visits completed by Community Health Worker
Time frame: 12 months
Number of home visits completed by Community Health Worker using the SMARThealth Pregnancy mHealth platform in line with study protocol.
7 secondary outcomes
Number of pregnant women diagnosed with gestational diabetes.
Time frame: 12 months
Postpartum follow-up of pregnant women with gestational diabetes
Time frame: 18 months
Number of pregnant women diagnosed with a hypertensive disorder of pregnancy.
Time frame: 12 months
Number of pregnant women diagnosed with severe anaemia.
Time frame: 12 months
Mean postpartum haemoglobin
Time frame: 12 months
Mean postpartum Systolic Blood Pressure
Time frame: 12 months
Mean postpartum Diastolic Blood Pressure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 37471135Nagraj S, Kennedy S, Jha V, Norton R, Hinton L, Billot L, Rajan E, Mohammed Abdul A, Phalswal A, Arora V, Praveen D, Hirst J. A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial. JMIR Form Res. 2023 Jul 20;7:e44362. doi: 10.2196/44362.
- Derived from this study: PubMed 34816187Nagraj S, Kennedy SH, Jha V, Norton R, Hinton L, Billot L, Rajan E, Arora V, Praveen D, Hirst JE. SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial. Front Glob Womens Health. 2021 May 28;2:620759. doi: 10.3389/fgwh.2021.620759. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMARThealth Pregnancy in people with Pre-Eclampsia and Gestational Diabetes, run by University of Oxford at 1 site in India.
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 5 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 4 Nov 2020. 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 India. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment rate (time frame: 12 months). The study lists 3 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 NCT03968952, which also lists 2 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 4 Nov 2020.