The goal of this clinical trial is to learn if using Perelel-brand prenatal supplements versus a generic prenatal supplement improves the health of the mother and fetus (unborn baby) during pregnancy. The main question it aims to answer is: • How does taking Perelel prenatal supplements versus generic prenatal supplements during pregnancy change the nutritional markers in blood samples? Participants will: * Take either Perelel or generic prenatal supplements daily throughout pregnancy * Visit UPMC Magee-Womens Hospital once every trimester of pregnancy for blood draws and answering questionnaires In an observational part of this study for different participants, researchers will use blood tests and questionnaires only once during the first trimester to compare pregnant women without food insecurity to those with food insecurity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
600
Daily Perelel prenatal vitamin supplement throughout pregnancy
Daily generic prenatal vitamin supplement throughout pregnancy.
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGMarker of Maternal Vitamin D Nutritional Status
Assay of Serum 25-hydroxyvitamin D3 in Blood Samples
Time frame: Through study completion, an average of 30 weeks
Marker of Maternal Total Folate (RBC) Nutritional Status
Assay of Total Folate (RBC) in Blood Samples
Time frame: Through study completion, an average of 30 weeks
Marker of Maternal Total Folate (Serum) Nutritional Status
Assay of Total Folate (Serum) in Blood Samples
Time frame: Through study completion, an average of 30 weeks
Marker of Maternal Serum Ferritin Nutritional Status
Assay of Serum Ferritin in Blood Samples
Time frame: Through study completion, an average of 30 weeks
Marker of Maternal Serum Vitamin B12 Nutritional Status
Assay of Serum Vitamin B12 in Blood Samples
Time frame: Through study completion, an average of 30 weeks
Marker of Maternal Homocysteine Nutritional Status
Assay of Homocysteine in Blood Samples
Time frame: Through study completion, an average of 30 weeks
Marker of Maternal Folate Metabolites Nutritional Status
Assay of Folate Metabolites in Blood Samples
Time frame: Through study completion, an average of 30 weeks
Symptoms of Nausea and Vomiting in Pregnancy
Symptoms of nausea and vomiting will be assessed using the Pregnancy Unique Quantification of Emesis (PUQ-E) questionnaire score. The PUQ-E has a minimum score of 3 and maximum score of 15, with a higher score meaning more severe symptoms.
Time frame: Through study completion, an average of 30 weeks
Symptoms of Depression in Pregnancy
Symptoms of depression will be assessed using the Edinburg Postnatal Depression Scale (EPDS) questionnaire. The EPDS has a minimum score of 0 and maximum score of 30, with a higher score meaning more severe symptoms.
Time frame: Through study completion, an average of 30 weeks
Symptoms of Anxiety in Pregnancy
Symptoms of anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire. The STAI has a minimum score of 20 and maximum score of 80, with a higher score meaning more severe symptoms.
Time frame: Through study completion, an average of 30 weeks
Symptoms of Stress in Pregnancy
Symptoms of stress will be assessed using the Perceived Stress Scale-10 (PSS) questionnaire. The PSS has a minimum score of 0 and maximum score of 40, with a higher score meaning more severe symptoms.
Time frame: Through study completion, an average of 30 weeks
Sleep Quality in Pregnancy
Sleep quality will be assessed using the Global Sleep Assessment Questionnaire (GSAQ). The GSAQ has a minimum score of 0 and a maximum score of 45, with a higher score meaning worse sleep quality.
Time frame: Through study completion, an average of 30 weeks
General Maternal Wellness in Third Trimester
General maternal wellness in the third trimester will be assessed using the 36-item short-form (SF36) survey questionnaire. The SF36 has a minimum score of 0 and maximum score of 3600, with a higher score meaning a more favorable state.
Time frame: Through study completion, an average of 30 weeks
Result of Clinically Reported Lab Tests of Group B Strep Culture in Pregnancy
Group B strep culture result will be abstracted from the medical record. The result will be positive, negative, or missing/not obtained. There are no unit of measurements involved.
Time frame: Through study completion, an average of 30 weeks
Muscle Cramping Symptoms - Severity
Severity of muscle cramping symptoms will be assessed by asking, "How severe were they?" (Visual Analog Scale \[VAS\] response). The VAS responses include the options: Not Severe at All, A Little Severe, Somewhat Severe, Moderately Severe, Very Severe, all of which will be scored on a gradient using a slider.
Time frame: Through study completion, an average of 30 weeks
Muscle Cramping Symptoms - Frequency
Frequency of muscle cramping symptoms will be assessed by asking, "In the past week how many days did you experience leg cramps?" (0-7 days)
Time frame: Through study completion, an average of 30 weeks
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