Impact of Food Insecurity on Utilization of Maternal Healthcare Services and Birth Outcomes in Slums in Pune, India

NCT06313112 | Active Not Recruiting

• 1 other identifier: JCDC/BHR/23/036
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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 utilization of maternal healthcare services, birth outcomes and infant growth. 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.
• Two focused 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. One FGD will be conducted for women who availed all the healthcare services and the other for those who did not adequately avail of the antenatal and postnatal services.

Conditions

Prenatal Care; Food Insecurity; Pregnancy Outcome

Keywords

Prenatal Care; Antenatal Care; Healthcare; Postnatal Care; Household Food Insecurity; Birth Outcomes

Outcome Measures

Primary Outcomes (9)

• Percentage of women who availed at least three Antenatal Care (ANC) visits

  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 Accredited Social Health Activist (ASHA) worker during pregnancy

  Percentage of women who had contact with ASHA worker during pregnancy

  Through study completion, an average of 1 year

• Percentage of women who consumed at least 100 Iron Folic Acid tablets

  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

  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

  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

  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

  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

  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

  Percentage of women who received post-natal care within a week of delivery

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Association of demographic characteristics and household food insecurity scores with the indicators of utilization of healthcare services

  Through study completion, an average of 1 year

Other Outcomes (2)

• Correlation of indicators of utilization of healthcare services with birth outcomes

  Through study completion, an average of 1 year

• Correlation of indicators of utilization of healthcare services with infant growth

  Through study completion, an average of 1 year

Interventions

Observational study OTHER

Observational study

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Slum dwelling women who have infants aged 1.5 months to 6 months

You may qualify if:

• A woman will be recruited in the study if she
• is willing and able to give an informed consent
• has been residing in a slum for a minimum of 2 years
• is aged between 18 to 49 years
• has an infant or infants between 1.5 to 6 months of age

You may not qualify if:

• She is unwilling to consent to participate in the study
• The age of her infant is less than 1.5 months or greater than 6 months.
• Her infant has any congenital conditions

Sponsors & Collaborators

• Hirabai Cowasji Jehangir Medical Research Institute: lead

Study Sites (1)

Hirabai Cowasji Jehangir Medical Research Institute

Pune, Maharashtra, 411001, India

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Rubina M Mandlik, PhD

  Hirabai Cowasji Jehangir Medical Research Institute Pune

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Directors

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 15, 2024
• Study Start: October 9, 2023
• Primary Completion: July 16, 2024
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IN (1)