Clinical trial NCT03968952: SMARThealth Pregnancy: Feasibility & Acceptability of a Complex Intervention for High-risk Pregnant Women in Rural India.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Gestational Diabetes
Anemia
Keywords: Digital health
Gestational Diabetes
Hypertension
Pre-Eclampsia
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: The George Institute
First posted: 2019-05-30
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 12 months
measure: Retention rate
timeFrame: 12 months
measure: Number of home visits completed by Community Health Worker
timeFrame: 12 months
Secondary outcomes:
measure: Number of pregnant women diagnosed with gestational diabetes.
timeFrame: 12 months
measure: Postpartum follow-up of pregnant women with gestational diabetes
timeFrame: 18 months
measure: Number of pregnant women diagnosed with a hypertensive disorder of pregnancy.
timeFrame: 12 months
measure: Number of pregnant women diagnosed with severe anaemia.
timeFrame: 12 months
measure: Mean postpartum haemoglobin
timeFrame: 12 months
measure: Mean postpartum Systolic Blood Pressure
timeFrame: 12 months
measure: Mean postpartum Diastolic Blood Pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: The George Institute for Global Health
state: Telengana
Study officials:
References:
citation: Nagraj 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.