Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions

Study Overview
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Brief Summary
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This study aims to examine the relation between iron status and maternal-child interactions as well as maternal depressive symptoms in mothers from central Pennsylvania.

Detailed Description
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Investigators aim to follow mothers and their infants from 6 weeks to 6 months in the postpartum to understand the relation between iron status and mother-child interactions and depressive symptoms. During this period, iron deficient anemic mothers will receive an intervention with iron with the scope of improving iron status, reducing their depressive symptoms, and in turn, increasing the quality of parenting behaviors during mother-child interactions. The control group will be iron sufficient mothers who will receive a placebo.

Official Title
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Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: Iron
* Dietary Supplement: Gelatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women between 18 - 40 years. Mother expects to be the primary caregiver for the infant for study duration and will allow infant to be enrolled in the study.. Mother has no history of gastrointestinal or hematological disorders and not taking medications that interfere with hematopoiesis or absorption. After birth, the mother and baby are healthy, delivery was of one infant only, infant gestational age ≥ 38 weeks, infant weight ≥ 2500 g (5.5 lbs), neither the mom nor the infant received a blood transfusion at or since delivery, and mom agrees to discontinue use of any iron containing medications. Exclusion Criteria: Maternal age ≤ 18 and > 40 years Evidence of a history of gastrointestinal or hematological disorders and evidence of taking medications that interfere with hematopoiesis or absorption. Severely anemic (Hemoglobin < 90 g/L) Iron deficient but not anemic women Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Iron deficient anemic (IDA) mothers will be given an iron supplement versus iron sufficient (control; CN) mothers will be given a placebo (gelatin pill) daily.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron Intervention<br>IDA mothers will receive a 65 mg of iron (ferrous sulfate) daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery). | Dietary Supplement: Iron<br>* 65 mg of iron (ferrous sulfate)<br>* Other names: Iron, Spring Valley;|
| Placebo Comparator: Placebo<br>IS mothers will receive 600 mg of gelatin daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery). | Dietary Supplement: Gelatin<br>* 600 mg gelatin<br>* Other names: 21st Century;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mother-child interaction scores in the postpartum period | Mother child-interactions will be measured via the Emotional Availability Scales and microanalytic coding. Scores will be compared between iron deficient and iron sufficient women. Investigators will also examine change in scores within group from baseline to endline. The Emotional Availability Scales consist of 6 subscales, 4 for the mother and 2 for the child. Maternal subscales include sensitivity, structuring, non-intrusiveness, and non-hostility; child subscales include involvement and responsiveness. All are scored on a scale of 1 - 7 with higher scores indicating a more optimal score. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency anemia (IDA), iron status, mother-infant interactions, intervention study, postpartum depressive symptoms