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New treatment option for Iron Deficiency (ID)
Official title Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females
ClinicalTrials.gov ID: NCT07076849
What this study is testing
- What it's testing
- Maternal iron deficiency (ID) and iron deficiency anemia (IDA) is associated with maternal and infant mortality, spontaneous preterm birth, maternal postpartum hemorrhage, and neurocognitive defects in the neonate. Therefore, preventing maternal IDA in at-risk women is critical.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- singleton naturally conceived pregnancy;
- at risk of IDA [Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC)...
- 18 - 45 years old;
- 10-16 weeks GA;
- fluency in English to provide consent and complete study procedures;
You likely can't join if
- IDA or other nutritional anemia (i.e., diagnosed or suspected B12 or folate deficiency) based on new OB blood work that includes MCV and MCH to...
- recent blood transfusion;
- autoimmune disorder (e.g., rheumatoid arthritis);
- inflammatory bowel disease;
- oral or IV antibiotic use within 2 months;
- previous spontaneous preterm birth;
See the full eligibility criteria
- singleton naturally conceived pregnancy;
- at risk of IDA [Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR;
- 18 - 45 years old;
- 10-16 weeks GA;
- fluency in English to provide consent and complete study procedures;
- ability to provide consent;
- and ownership of a smartphone (currently more than 90% of our patient population at the CWH).
- IDA or other nutritional anemia (i.e., diagnosed or suspected B12 or folate deficiency) based on new OB blood work that includes MCV and MCH to characterize the anemia;
- recent blood transfusion;
- autoimmune disorder (e.g., rheumatoid arthritis);
- inflammatory bowel disease;
- oral or IV antibiotic use within 2 months;
- previous spontaneous preterm birth;
- history of bariatric surgery;
- malabsorptive disease;
- current hyperemesis;
- current eating disorder;
- hematologic disorder or trait carrier (e.g., hemochromatosis, β-thalassemia);
- current tobacco, alcohol or illicit drug use (Excluding marijuana).
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.