- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06601439
Utilization of Maternal Healthcare Services and Infant Feeding Practices (HTHMCH)
Utilization of Maternal Healthcare Services and Infant Feeding Practices Among Slum-Dwelling Women in Pune, India
The goal of this observational study is to assess household food insecurity among slum-dwelling women in India and to explore if household food insecurity is associated with maternal healthcare services utilization and infant feeding practices
The main questions it aims to answer are:
- Is the utilization of maternal healthcare services antenatally, during delivery, and postnatally associated with household food insecurity among slum-dwelling women in Pune, India?
- Is household food insecurity associated with birth outcomes and infant growth in these women?
Participants will be asked:
- For information related to socio-demographic characteristics, healthcare services utilization, food insecurity experience, dietary intake, and infant feeding indicators using a questionnaire.
- Anthropometric measurements of the participant, her husband and her infant/s will be collected.
- Focus group discussions (FGDs) will also be conducted to gain insight into the perceptions of these women with respect to the utilization of maternal healthcare services.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The first target indicator of Sustainable Development Goal (SDG) 3 i.e. Good Health and Well-being for all at all ages is reducing the global maternal mortality ratio (MMR) to less than 70 per 100,000 live births by 2030. India, however, has been performing well on this indicator with progressive reduction in MMR from 130 deaths per 100,000 live births in 2014-16 to 97 deaths per 100,000 live births in 2018-2020, with eight Indian states achieving the SDG target of MMR to less than 70, where Maharashtra ranks 2nd amongst these states. It is well-known that the appropriate utilization of maternal healthcare services contributes to reduced maternal morbidity and mortality and improved offspring health. Women who availed of even one antenatal care (ANC) visit were more likely to opt for institutional deliveries and postnatal care. India provides comprehensive continuum of care in maternal and newborn health comprising quality ANC, delivery care, and postnatal care (PNC). However, there is considerable regional inequity in the utilization of these services. There are multiple factors that influence the utilization of maternal healthcare services which vary by region, religion, socio-economic status, and service delivery environment among many others. Thus, it is imperative to identify enablers, barriers and need gaps location wise so that appropriate interventions can be developed for promotion of healthcare service utilization. Pune has been reported to have an MMR of 49 per 100,000 live births, however, there are limited data on MMR among slum-dwelling women. Also, there are inadequate data on maternal healthcare utilization among slum-dwelling women in Pune. Given that need gaps in the continuum of care for maternal healthcare services are unique to socio-economic status and location, it is important to conduct a needs assessment for utilization of maternal healthcare services among slum-dwelling women in Pune. Moreover, as care in the antenatal period is linked not only to improved maternal health but also to newborn and infant survival and health, it is important to assess birth outcomes and infant growth in relation to maternal utilization of healthcare services. Food insecurity negatively impacts pregnant and lactating women as gender biases may interfere with their access to adequate food thus, affecting their health and the health of their offspring. Thus, it was deemed necessary to assess household food insecurity among slum-dwelling pregnant women in India and to explore if household food insecurity is associated with maternal healthcare services utilization.
Therefore, this study has been planned with the following objectives:
- To assess the utilization of antenatal and postnatal health care services by slum-dwelling women from Pune
- To assess infant feeding practices among slum-dwelling women from Pune
- To explore the association of utilization of maternal healthcare services ante and postnatally with birth outcomes and infant growth
- To examine the association of household food insecurity with maternal healthcare service utilization, birth outcomes and infant feeding and growth
- To create a Social and Behavioural Change Communication (SBCC) module aimed at improving the uptake of maternal services and promoting complementary feeding of infants.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Maharashtra
-
Pune, Maharashtra, India, 411001
- Hirabai Cowasji Jehangir Medical Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Participant
- is willing and able to give informed consent
- has been residing in a slum for a minimum of 3 years
- is aged between 18 to 49 years
- has a child or children less than 2 years of age
Exclusion Criteria:
- She is unwilling to consent to participate in the study
- The age of her child or children is greater than 2 years.
- The mother or child have any congenital / chronic conditions
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of women who consumed at least 100 Iron Folic Acid tablets
Time Frame: Through study completion, an average of 1 year
|
Percentage of women who consumed at least 100 Iron Folic Acid tablets
|
Through study completion, an average of 1 year
|
|
Percentage of women who consumed deworming tablets at least once during pregnancy
Time Frame: Through study completion, an average of 1 year
|
Percentage of women who consumed deworming tablets at least once during pregnancy
|
Through study completion, an average of 1 year
|
|
Percentage of women who underwent delivery preparedness
Time Frame: Through study completion, an average of 1 year
|
Percentage of women who underwent delivery preparedness
|
Through study completion, an average of 1 year
|
|
Percentage of women with knowledge of key danger signs during pregnancy
Time Frame: Through study completion, an average of 1 year
|
Percentage of women with knowledge of key danger signs during pregnancy such as vaginal bleeding, severe headaches
|
Through study completion, an average of 1 year
|
|
Percentage of women who delivered at institution
Time Frame: Through study completion, an average of 1 year
|
Percentage of women who delivered at institution
|
Through study completion, an average of 1 year
|
|
Percentage of women who stayed at a facility for at least 24 hours post-delivery
Time Frame: Through study completion, an average of 1 year
|
Percentage of women who stayed at a facility for at least 24 hours post-delivery
|
Through study completion, an average of 1 year
|
|
Percentage of women who received post-natal care within a week of delivery
Time Frame: Through study completion, an average of 1 year
|
Percentage of women who received post-natal care within a week of delivery
|
Through study completion, an average of 1 year
|
|
Percentage of women who availed at least three Antenatal Care (ANC) visits
Time Frame: Through study completion, an average of 1 year
|
Percentage of women who availed at least three Antenatal Care (ANC) visits
|
Through study completion, an average of 1 year
|
|
Percentage of women who had contact with ASHA worker during pregnancy
Time Frame: Through study completion, an average of 1 year
|
Percentage of women who had contact with Accredited Social Health Activist (ASHA) worker during pregnancy
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association of demographic characteristics and household food insecurity scores with the indicators of utilization of healthcare services
Time Frame: Through study completion, an average of 1 year
|
The association of demographic characteristics such as age of the participant, education of participant and her husband, occupation of participant and her husband, socio-economic status of the family, gender of the infant and household food insecurity scores will be investigated with each indicator of utilization of maternal healthcare service.
|
Through study completion, an average of 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of indicators of utilization of healthcare services with birth outcomes
Time Frame: Through study completion, an average of 1 year
|
Correlation of the indicators of utilization of healthcare services with birth outcomes such as 1. gestational age at birth - preterm or term birth 2. birth weight - low birth weight or appropriate birth weight 3. gestational size - small for gestational age / appropriate for gestational age 4. Neonatal complications
|
Through study completion, an average of 1 year
|
|
Correlation of indicators of utilization of healthcare services with infant growth
Time Frame: Through study completion, an average of 1 year
|
Correlation of the indicators of utilization of healthcare services with infant growth parameters such as 1. body weight 2. length 3. mid-upper arm circumference
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rubina M Mandlik, PhD, Hirabai Cowasji Jehangir Medical Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- JCDC/BHR/24/045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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