SMARThealth Pregnancy: Feasibility & Acceptability of a Complex Intervention for High-risk Pregnant Women in Rural India.

Anemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968952
• Other study ID #: 22-19
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: November 1, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Primary Health Centre cluster:

Inclusion Criteria:

• PHC serving population of greater than 30,000 people.

• Administrative lead for PHC consents for the PHC to participate in the study.

Exclusion Criteria:

• Administrative lead does not give consent for the PHC to participate in the study.

Pregnant women:

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anemia
• Diabetes, Gestational
• Eclampsia
• Gestational Diabetes
• Pre-Eclampsia

Intervention

Other:
• SMARThealth Pregnancy
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.

Locations

Country	Name	City	State
India	The George Institute for Global Health	Hyderabad	Telengana

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	The George Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of eligible pregnant women successfully recruited to study in 12 months.	12 months
Primary	Retention rate	Number of eligible participants who remain in study for entire duration up to and including the 6 week postpartum visit.	12 months
Primary	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.	12 months
Secondary	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.	12 months
Secondary	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.	18 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Mean postpartum haemoglobin	Haemoglobin values of postpartum women measured at 6 weeks postpartum.	12 months
Secondary	Mean postpartum Systolic Blood Pressure	Systolic blood pressure of postpartum women measured at 6 weeks postpartum.	12 months
Secondary	Mean postpartum Diastolic Blood Pressure	Diastolic blood pressure of postpartum women measured at 6 weeks postpartum.	12 months