Anemia, Gestational Diabetes Mellitus (GDM), Pregnancy Induced Hypertension (PIH)
Conditions
Keywords
Antenatal care, Pregnancy care, Pregnancy complications, Pregnancy Induced Hypertension, Gestational Diabetes Mellitus, Anemia
Brief summary
Our research aims to address a critical gap in the provision of quality antenatal care (ANC) in India and Nepal, by developing and evaluating an intervention comprising of a tablet-based electronic decision support system (EDSS). This intervention -"mIRA" - is an mHealth integrated model of hypertension, diabetes, and antenatal care in primary care settings. mIRA aims to (a) prompt frontline health workers (FHWs) to provide evidence-based routine ANC, and also enhance the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia, whilst improving adherence to National ANC guidelines; (b) facilitate record-keeping and reporting and; (c) link providers across various levels of care to improve continuity of care. A cluster randomized controlled (cRCT) to assess the effectiveness of the mIRA EDSS in improving ANC and enhancing the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia will be conducted in Telangana, India. A mixed-methods process evaluation will be conducted in both India and Nepal. The process evaluation will contribute to our understanding of the mechanisms contributing to changes (improvement) in the quality of ANC by using the EDSS intervention.
Detailed description
The cRCT aims to evaluate the effectiveness of a tablet-based EDSS in improving the quality of ANC and enhancing the detection and management of PIH, GDM, and anemia at primary care level health facilities in five districts of Telangana State: Medak, Rangareddy, Siddipet, Vikarabad, and Yadadri Bhuvangiri. The EDSS will use evidence-based algorithms to suggest recommendations to the FHWs for providing ANC, based on the pregnant woman's history, examination, and investigations, as well as incorporate reminders to ensure all relevant components of ANC are recorded. The aim is to ensure that ANC components received during multiple visits from multiple healthcare providers are captured and contribute to coordinated care. FHWs, primarily Auxiliary Nurse Midwives (ANMs), will use the EDSS during ANC consultations with pregnant women at Sub-Centres, while at the Primary Health Centres (PHCs), this will be used by Medical Officers (MOs) and staff nurses. In these selected districts, which are predominantly rural, 66 clusters with each cluster comprising a PHC and its two reporting Sub-Centres, will be randomized with a 1:1 allocation ratio to the intervention arm (providing ANC using the mIRA EDSS intervention) and the control arm (providing usual care), using a computer-generated randomization schedule stratified by the district. Covariate constrained randomization will be used to balance the arms on the following baseline covariates: the presence of a laboratory and laboratory technician (yes/no); more than three staff providing ANC (yes/no); facility type (PHCs that are open 24/7 or those not open 24/7). The cRCT will not be conducted In Nepal, however, the mIRA EDSS will be implemented at government Health Posts (HP), government Primary Health Care Centers (PHCCs), and Dhulikhel Hospital Outreach Centers (DHORCs), in four catchment districts (Kavrepalanchok, Sindhupalchowk, Sindhuli, and Dolakha) of Dhulikhel Hospital. A pre-post EDSS implementation outcome evaluation will be conducted. The process evaluation research activities conducted in India and Nepal will be the same (including a baseline facility survey, routine monitoring, and audit of record-keeping), except for a longitudinal case study and a time-motion study that will be conducted only in Nepal. Additionally, endline qualitative in-depth interviews with healthcare providers, facility managers, district and state health officials and policymakers, and with members of the Public Health Foundation of India team (intervention implementors) will be conducted only in India.
Interventions
OTHERmHealth Integrated Model of Antenatal Care
In the intervention facilities, antenatal care (ANC) will be provided to all pregnant women using the mIRA electronic decision support system (EDSS) by ANMs (Auxiliary Nurse Midwife), Staff nurses, or Medical Officers (MOs). These frontline healthcare workers (FHWs) will be trained to use the EDSS and will also be provided "refresher" training on the guideline-recommended processes of ANC. This training will enable them to use the mIRA EDSS in the provision of ANC. Non-physician FHWs (ANMs and staff nurses) will screen, detect, and refer PIH, GDM, and severe anemia cases. They will not prescribe treatments, but will carry out all other duties including diagnosis, referral to the MO to prescribe drugs, provide lifestyle advice, follow-up, and subsequently support adherence to management plans.
Sponsors
Public Health Foundation of India
London School of Hygiene and Tropical Medicine
Kathmandu University School of Medical Sciences
Bill and Melinda Gates Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women visiting a trial facility up to the end of the 28th week of gestation * Women who are planning to remain within the five study districts until at least one-month post-partum OR women whose mothers reside in the selected districts
Exclusion criteria
• Women coming to the trial facility for a non-routine ANC visit (for example, to get a laboratory investigation, to collect a report or her medicine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of four selected ANC components delivered by the healthcare providers per visit, observed over two visits- the trial enrolment visit and the next routine ANC appointment. | Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months | This will be a composite score calculated as per the performance of the number of selected ANC components delivered or completed by the healthcare provider. The four selected components are: 1) the measurement and recording of systolic and diastolic blood pressure; 2) measurement of blood glucose, 3) performing urinary dipstick test for proteinuria and 4) conducting hemoglobin tests. The action of completing each of the aforementioned components by the healthcare provider will count as a score of one. Thus, completion of all four components will account to a score of four. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who were told by the provider that they had PIH, GDM or severe anemia | Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months | Conditions diagnosed as: hypertension (SBP≥ 140 mmHg and DBP≥90 mmHg), GDM (venous blood glucose: fasting \>92 mg/dL, 1 h OGTT (Oral Glucose Tolerance Test) \>180 mg/dL, 2 h OGTT \>153-199 mg/dL; glucometer test values: fasting \>92 mg/dL, 1 h OGTT \>198 mg/dL, 2 h OGTT \>168 mg/dL) or severe anemia (\<7g/dL) |
| Mean number of quality antenatal care components delivered in the enrolment visit | Up to 28 weeks of gestation | The components are as follows: tests completed: blood pressure; blood glucose; urinary dipstick; hemoglobin tests Provider: symptom check: nausea; vomiting; vaginal bleeding; severe headache, decreased or absent foetal movement, severe abdominal pain, blurred vision warning about: severe vomiting; vaginal bleeding; severe headache; decreased or no foetal movement: severe abdominal pain; blurred vision counseling on diet enquiring about mental health recording ANC related information on the women-held MCP (Maternal and Chlid Protection) card |
| Mean number of the danger signs mentioned to each participant by the healthcare provider for which she is advised to return for help | Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months | Danger signs include severe vomiting, vaginal bleeding, severe headache, decreased or no foetal movement, severe abdominal pain, blurred vision |
| Proportion of providers who took the appropriate action (as defined by the EDSS) in response to aforementioned current pregnancy symptoms or who were told that they had hypertension in pregnancy, GDM or anemia | Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months | Symptoms for which a response is expected from the provider: vomiting, vaginal bleeding, severe headache, decreased or absent foetal movement, severe abdominal pain or blurred vision or who were told that they had hypertension in pregnancy, GDM or anemia |
| Mean number of the four selected ANC components delivered by the healthcare provider observed at the trial enrolment visit | Up to 28 weeks of gestation | This will be a composite score calculated as per the performance of the number of selected ANC components delivered or completed by the healthcare provider. The four selected components are: 1) the measurement and recording of systolic and diastolic blood pressure; 2) measurement of blood glucose, 3) performing urinary dipstick test for proteinuria and 4) conducting hemoglobin tests. The action of completing each of the aforementioned components by the healthcare provider will count as a score of one. Thus, completion of all four components will account to a score of four. |
| Proportion of participants with clinical parameters indicative of PIH, GDM or severe anemia | Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months | Conditions diagnosed as: hypertension (SBP≥ 140 mmHg and DBP≥90 mmHg), GDM (venous blood glucose: fasting \>92 mg/dL, 1 h OGTT (Oral Glucose Tolerance Test) \>180 mg/dL, 2 h OGTT \>153-199 mg/dL; glucometer test values: fasting \>92 mg/dL, 1 h OGTT \>198 mg/dL, 2 h OGTT \>168 mg/dL) or severe anemia (\<7g/dL) |
| Mean number of the current pregnancy symptoms discussed with participants (either by the provider asking or the woman mentioning), observed over the two visits. | Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months | Symptoms include: nausea, vomiting, vaginal bleeding, severe headache, decreased or absent fetal movement, severe abdominal pain, blurred vision |
Countries
India, Nepal
Contacts
PRINCIPAL_INVESTIGATORDorairaj Prabhakaran, DM
Vice President, Research and Policy
Outcome results
None listed