NCT05752955Completed
SMART Health Pregnancy 2 - Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth
A Cluster-randomised Trial of a Complex Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth in Women Living in Rural India (SMART Health Pregnancy 2)
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
The goal of this clinical trial is to determine if a complex intervention called SMARThealth Pregnancy can improve the detection and management of high-risk conditions during pregnancy and in the first year after birth in women living in rural India. The main questions it aims to answer are: * Can screening of pregnant and postpartum women using the SMARThealth Pregnancy intervention decrease anaemia prevalence at 1 year after birth? * Can the SMARThealth Pregnancy intervention improve postnatal testing after a pregnancy affected by hypertension and diabetes? Participants in the intervention group will be screened by their community health worker at several timepoints during pregnancy, and in the first year after birth using the SMARThealth Pregnancy tablet App. The community health worker will ask about each woman about her medical and obstetric history, then measure her blood pressure, haemoglobin (using a point of care device), and offer a referral for a glucose tolerance test when indicated. Women who screen positive for anaemia, hypertension or diabetes will be given advice and referred to the primary care doctor. The primary care doctor will have a complimentary tablet app to facilitate electronic referral and evidence-based prescribing when indicated. The comparison group will have usual antenatal and postnatal care.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 3446 (actual)
- First submitted
- 21 Dec 2022
- Start date
- 6 Jun 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- The George Institute
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT05752955
What you commit to
- Study type: Interventional
- Participants enrolled: 3446
- From 6 Jun 2022 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- women who plan to move away and not return to the same village for the next 12 months
- women unable to understand the local study language
- Women who do not give consent
Who the study is looking for
- For Primary health Centres:
- located in the selected districts
- provide pregnancy care
- chief doctor (or equivalent) agrees to participate
- For women \>12 weeks pregnant
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The George Institute for Global Health Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.