Prenatal CareMCHNCT06313112
Impact of Food Insecurity on Utilization of Maternal Healthcare Services and Birth Outcomes in Slums in Pune, India
An observational study of Prenatal Care and Food Insecurity, run by Hirabai Cowasji Jehangir Medical Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Care, Food Insecurity, Pregnancy Outcome
- What is being tested?
- Observational study
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 9 Oct 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Slum dwelling women who have infants aged 1.5 months to 6 months
Who may be able to join
- 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
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Hirabai Cowasji Jehangir Medical Research Institute
Pune, Maharashtra, 411001
About this study
Official title: Utilization of Maternal Health Services, Birth Outcomes and Infant Growth and Its Linkage With Food Insecurity 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 utilization of maternal healthcare services, birth outcomes and infant growth.
The main questions it aims to answer are:
Read more
- 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.
Read the detailed description
The first target indicator of Sustainable Development Goals (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. While there had been a significant reduction in the MMR globally from 385 maternal deaths per 100,000 live births in 1990 to 211 maternal deaths per 100,000 live births in 2017, the MMR increased slightly to 223 deaths per 100,000 live births in 2020. 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 < 70. Maharashtra ranks 2nd among these eight states with an MMR of 33 in 2018-2020. In spite of the stellar progress made by India, together with Nigeria it still accounted for one-third of the global MMR contributing to 8% of the total maternal deaths in 2020, and India also accounted for nearly two-thirds of the MMR in the South East Asia region.
It is well-known that the appropriate utilization of maternal healthcare services contributes to reduced maternal morbidity and mortality and improved offspring health. It has also been established that utilization of one of the services in the continuum of care for maternal and child health greatly increases the likelihood of utilization of the subsequent services. For example, women who availed of even one 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 antenatal care (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.
Considering the rapid proliferation of the slum population in India, and also Pune, household food insecurity is proving to be a major challenge due to competition among the informal workforce residing in slums for basic life necessities. In particular, 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. Food insecurity may cause people to prioritize activities that enable them to gain access to food over health seeking. This may result in poor utilization of maternal healthcare services which may be difficult to access or may involve costs and time in accessing them. Thus, the investigators deemed it necessary 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.
The objectives of the study are as follows:
- To assess the utilization of antenatal and postnatal health care services by 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 growth
- Conditions
- Prenatal Care, Food Insecurity, Pregnancy Outcome
- Being tested
- Observational study
- Keywords
- Prenatal Care, Antenatal Care, Healthcare, Postnatal Care, Household Food Insecurity, Birth Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women who availed at least three Antenatal Care (ANC) visits
Percentage of women who availed at least three Antenatal Care (ANC) visits
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Percentage of women who underwent delivery preparedness
Percentage of women who underwent delivery preparedness
Measured: 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
Measured: Through study completion, an average of 1 year
Percentage of women who delivered at institution
Percentage of women who delivered at institution
Measured: 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
Measured: 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
Measured: 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
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start9 Oct 2023
- Primary completion16 Jul 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hirabai Cowasji Jehangir Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anuradha Khadilkar, Hirabai Cowasji Jehangir Medical Research Institute
- Investigators
- Rubina M Mandlik, PhD, Principal investigator, Hirabai Cowasji Jehangir Medical Research Institute Pune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313112
- Sponsor's protocol ID
- JCDC/BHR/23/036
- Acronym
- MCH
- Status last verified
- Sep 2024
- First submitted
- 23 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Maternal Health Services, Birth Outcomes and Infant Growth and Its Linkage With Food Insecurity Among Slum-Dwelling Women in Pune, India
- ClinicalTrials.gov ID
- NCT06313112
- Acronym / sponsor ID
- MCH / JCDC/BHR/23/036
- Conditions
- Prenatal Care, Food Insecurity, Pregnancy Outcome
- Keywords
- Prenatal Care, Antenatal Care, Healthcare, Postnatal Care, Household Food Insecurity, Birth Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hirabai Cowasji Jehangir Medical Research InstituteUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The first target indicator of Sustainable Development Goals (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. While there had been a significant reduction in the MMR globally from 385 maternal deaths per 100,000 live births in 1990 to 211 maternal deaths per 100,000 live births in 2017, the MMR increased slightly to 223 deaths per 100,000 live births in 2020. 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 < 70. Maharashtra ranks 2nd among these eight states with an MMR of 33 in 2018-2020. In spite of the stellar progress made by India, together with Nigeria it still accounted for one-third of the global MMR contributing to 8% of the total maternal deaths in 2020, and India also accounted for nearly two-thirds of the MMR in the South East Asia region.
It is well-known that the appropriate utilization of maternal healthcare services contributes to reduced maternal morbidity and mortality and improved offspring health. It has also been established that utilization of one of the services in the continuum of care for maternal and child health greatly increases the likelihood of utilization of the subsequent services. For example, women who availed of even one 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 antenatal care (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.
Considering the rapid proliferation of the slum population in India, and also Pune, household food insecurity is proving to be a major challenge due to competition among the informal workforce residing in slums for basic life necessities. In particular, 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. Food insecurity may cause people to prioritize activities that enable them to gain access to food over health seeking. This may result in poor utilization of maternal healthcare services which may be difficult to access or may involve costs and time in accessing them. Thus, the investigators deemed it necessary 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.
The objectives of the study are as follows:
- To assess the utilization of antenatal and postnatal health care services by 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 growth
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Slum dwelling women who have infants aged 1.5 months to 6 months
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyObservational study | Other | – |
Primary outcome
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
Percentage of women who had contact with Accredited Social Health Activist (ASHA) worker during pregnancy
Time frame: Through study completion, an average of 1 year
Percentage of women who had contact with ASHA worker during pregnancy
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
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
Percentage of women who underwent delivery preparedness
Time frame: Through study completion, an average of 1 year
Percentage of women who underwent delivery preparedness
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
Percentage of women who delivered at institution
Time frame: Through study completion, an average of 1 year
Percentage of women who delivered at institution
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
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubina M Mandlik, PhD principal investigator
Hirabai Cowasji Jehangir Medical Research Institute Pune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prenatal Care and Food Insecurity, run by Hirabai Cowasji Jehangir Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women who availed at least three Antenatal Care (ANC) visits (time frame: Through study completion, an average of 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.