AnemiaIDA & NIDANCT04708665
Iron Deficiency Anemia and Non-iron Deficiency Anemia in Pregnancy in India
An observational study of Anemia and Anemia, Iron Deficiency, run by Boston University Charles River Campus at 1 site in India.
Trial summary
This is a sub-study nested into the existing NICHD Global Network for Women's \& Children's Health Research Maternal Newborn Health (MNH) registry that is a prospective, observational population-based registry in Eastern Maharashtra, India. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Anemia, Iron Deficiency, Anemia of Pregnancy
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 23 Nov 2020to 31 Jan 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 200 pregnant women and their infants in Eastern Maharashtra, India. Mothers will be enrolled in the first trimester of pregnancy and mothers and infants will be followed up until 6 weeks post-partum.
Who may be able to join
- A pregnant women in the first trimester of pregnancy
- Enrolled in the Maternal \& Newborn Health Registry
- At least 18 years of age
- Residing in the area of a selected Primary Health Center with the intention to remain in the area through child birth and 6-weeks post-partum
Who cannot join
- Having multiple fetuses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron-deficiency and Non-iron-deficiency Anemia in Pregnancy and Infant Health in India
This is a sub-study nested into the existing NICHD Global Network for Women's \& Children's Health Research Maternal Newborn Health (MNH) registry that is a prospective, observational population-based registry in Eastern Maharashtra, India. This study will assess the prevalence of iron deficiency anemia (IDA) and non-iron deficiency anemia (NIDA) in Eastern Maharashtra and will assess the association between both conditions and neo-natal and infant health outcomes (birth weight, gestational age at birth, weight-for-gestational-age z-score and infant hemoglobin concentration at 6 weeks). The investigators will also assess the relative strength of the association between anemia in the 1st trimester and 3rd trimester (after iron needs have increased but mothers may have been taking iron folic acid (IFA) supplements for several months) and infant health outcomes.
- Conditions
- Anemia, Anemia, Iron Deficiency, Anemia of Pregnancy
- Keywords
- Anemia of Pregnancy
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Birthweight
Measured: 0-48 hours
Secondary outcomes (3)
gestational age at birth
Measured: <48 hours
weight-for-gestational-age z-score
Measured: <48 hours
infant hemoglobin at 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start23 Nov 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Lata Medical Research Foundation
- Responsible party
- Principal investigator, Lindsey Locks, Boston University Charles River Campus
- Investigators
- Lindsey M Locks, ScD MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708665
- Sponsor's protocol ID
- 55207436
- Acronym
- IDA & NIDA
- Status last verified
- Aug 2024
- First submitted
- 8 Jan 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron-deficiency and Non-iron-deficiency Anemia in Pregnancy and Infant Health in India
- ClinicalTrials.gov ID
- NCT04708665
- Acronym / sponsor ID
- IDA & NIDA / 55207436
- Conditions
- Anemia, Anemia, Iron Deficiency, Anemia of Pregnancy
- Keywords
- Anemia of Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Lata Medical Research Foundation
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 Jan 2021 (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.
This is a sub-study nested into the existing NICHD Global Network for Women's \& Children's Health Research Maternal Newborn Health (MNH) registry that is a prospective, observational population-based registry in Eastern Maharashtra, India. This study will assess the prevalence of iron deficiency anemia (IDA) and non-iron deficiency anemia (NIDA) in Eastern Maharashtra and will assess the association between both conditions and neo-natal and infant health outcomes (birth weight, gestational age at birth, weight-for-gestational-age z-score and infant hemoglobin concentration at 6 weeks). The investigators will also assess the relative strength of the association between anemia in the 1st trimester and 3rd trimester (after iron needs have increased but mothers may have been taking iron folic acid (IFA) supplements for several months) and infant health outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 200 pregnant women and their infants in Eastern Maharashtra, India. Mothers will be enrolled in the first trimester of pregnancy and mothers and infants will be followed up until 6 weeks post-partum.
Key inclusion criteria (4 listed)
- A pregnant women in the first trimester of pregnancy
- Enrolled in the Maternal \& Newborn Health Registry
- At least 18 years of age
- Residing in the area of a selected Primary Health Center with the intention to remain in the area through child birth and 6-weeks post-partum
Key exclusion criteria (1 listed)
- Having multiple fetuses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Birthweight
Time frame: 0-48 hours
3 secondary outcomes
gestational age at birth
Time frame: <48 hours
weight-for-gestational-age z-score
Time frame: <48 hours
infant hemoglobin at 6 weeks
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Lindsey M Locks, ScD MPH principal investigator
Boston University
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 Anemia and Anemia, Iron Deficiency, run by Boston University Charles River Campus 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 6 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Birthweight (time frame: 0-48 hours). 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 6 Aug 2024.