Hypertension Clinical Trial
Official title:
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)
NCT number | NCT05752955 |
Other study ID # | 27-21 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 6, 2022 |
Est. completion date | December 2024 |
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 | Recruiting |
Enrollment | 3240 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - For Primary health Centres: - located in the selected districts - provide pregnancy care - chief doctor (or equivalent) agrees to participate - For women >12 weeks pregnant Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
India | The George Institute for Global Health | Hyderabad | Telangana |
Lead Sponsor | Collaborator |
---|---|
The George Institute | University of Oxford |
India,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Differences in quality of life scores | Differences in EuroQuol 5D (EQ5D) score between baseline and at 12 months | 10-12 months after delivery | |
Other | Differences in depression scores | Differences in Patient Health Questionnaire 9 (PHQ9) scores between baseline and at 12 months | 10-12 months after delivery | |
Other | Differences in anxiety scores | Differences in Generalised Anxiety and Depression score 7 (GAD7) scores between baseline and at 12 months | 10-12 months after delivery | |
Other | Infant feeding | World Health Organization Infant and Young Feeding Assessment | 6 weeks after delivery and 12 months after delivery] | |
Other | Pregnancy intention | Difference in London Measure of Unplanned pregnancy scores | 10-12 months post natal | |
Other | Cost of care | Direct and indirect costs of care during pregnancy and for the first six weeks after birth | 6 - 10 weeks after birth | |
Primary | Decrease anaemia prevalence in women | Proportion of participants with any degree of anaemia (non-pregnant definition Hb < 12g/dL) between the intervention and control clusters | 10-12 months after delivery | |
Secondary | Decrease the proportion of women with moderate and severe anaemia | Proportion of participants with moderate anaemia (Hb < 10g /dL) and severe anaemia (Hb < 8g /dL) between the intervention and control clusters | 10-12 months after delivery | |
Secondary | Postnatal screening for type 2 diabetes after GDM | Proportion of women with GDM who undergo screening for type 2 diabetes in the first year after delivery | 10-12 months after delivery | |
Secondary | Postnatal screening for hypertension after hypertensive disorder of pregnancy | Proportion of women with a hypertensive disorder of pregnancy screened for hypertension in the first year after delivery | 10-12 months after delivery | |
Secondary | Compliance with iron-folic acid supplements during pregnancy and breastfeeding | Self reported compliance with iron folic acid supplementation | 10-12 months after delivery | |
Secondary | De-worming treatment | Proportion of women during pregnancy who receive de-worming treatment | during pregnancy | |
Secondary | Point of care Haemoglobin (Hb) testing | Proportion of women who have a point of care Hb test during pregnancy and in the post natal period | 10-12 months after delivery | |
Secondary | Referral of high risk conditions | The proportion of women detected with anaemia, hypertension or GDM correctly referred to primary or secondary care | Six weeks post delivery | |
Secondary | Hypertension after hypertensive disorder of pregnancy | Differences in systolic and diastolic blood pressure in women who were diagnosed during pregnancy with hypertensive disorder of pregnancy | 10-12 months after delivery | |
Secondary | Dysglycaemia after a pregnancy affected by GDM | Difference in HbA1c, fasting and 2-hour glucose venous samples post 75 gram glucose load in those who developed GDM during pregnancy | 10-12 months after delivery |
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