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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
258
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.
The George Institute for Global Health
Hyderabad, Telangana, India
Recruitment rate
Number of eligible pregnant women successfully recruited to study in 12 months.
Time frame: 12 months
Retention rate
Number of eligible participants who remain in study for entire duration up to and including the 6 week postpartum visit.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Mean postpartum haemoglobin
Haemoglobin values of postpartum women measured at 6 weeks postpartum.
Time frame: 12 months
Mean postpartum Systolic Blood Pressure
Systolic blood pressure of postpartum women measured at 6 weeks postpartum.
Time frame: 12 months
Mean postpartum Diastolic Blood Pressure
Diastolic blood pressure of postpartum women measured at 6 weeks postpartum.
Time frame: 12 months
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