Pregnancy
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPerelel Prenatal Vitamin
Daily Perelel prenatal vitamin supplement throughout pregnancy
DIETARY_SUPPLEMENTGeneric Prenatal Vitamin
Daily generic prenatal vitamin supplement throughout pregnancy.
Sponsors
University of Pittsburgh
Perelel Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant with only one baby 2. Identify as having food insecurity 3. Receiving care at a Magee-Womens Hospital associated prenatal practice 4. Less than 12 weeks' of pregnancy
Exclusion criteria
1. Currently using prenatal supplement(s) 2. Unborn baby (fetus) identified as having a chromosomal or structural defect 3. Have a condition that prevents absorption of nutrients from food 4. History of medically treated thyroid disorder 5. Ongoing steroid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marker of Maternal Vitamin D Nutritional Status | Through study completion, an average of 30 weeks | Assay of Serum 25-hydroxyvitamin D3 in Blood Samples |
| Marker of Maternal Total Folate (RBC) Nutritional Status | Through study completion, an average of 30 weeks | Assay of Total Folate (RBC) in Blood Samples |
| Marker of Maternal Total Folate (Serum) Nutritional Status | Through study completion, an average of 30 weeks | Assay of Total Folate (Serum) in Blood Samples |
| Marker of Maternal Serum Ferritin Nutritional Status | Through study completion, an average of 30 weeks | Assay of Serum Ferritin in Blood Samples |
| Marker of Maternal Serum Vitamin B12 Nutritional Status | Through study completion, an average of 30 weeks | Assay of Serum Vitamin B12 in Blood Samples |
| Marker of Maternal Homocysteine Nutritional Status | Through study completion, an average of 30 weeks | Assay of Homocysteine in Blood Samples |
| Marker of Maternal Folate Metabolites Nutritional Status | Through study completion, an average of 30 weeks | Assay of Folate Metabolites in Blood Samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Nausea and Vomiting in Pregnancy | Through study completion, an average of 30 weeks | 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. |
| Symptoms of Depression in Pregnancy | Through study completion, an average of 30 weeks | 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. |
| Symptoms of Anxiety in Pregnancy | Through study completion, an average of 30 weeks | 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. |
| Symptoms of Stress in Pregnancy | Through study completion, an average of 30 weeks | 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. |
| Sleep Quality in Pregnancy | Through study completion, an average of 30 weeks | 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. |
| General Maternal Wellness in Third Trimester | Through study completion, an average of 30 weeks | 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. |
| Result of Clinically Reported Lab Tests of Group B Strep Culture in Pregnancy | Through study completion, an average of 30 weeks | 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. |
| Muscle Cramping Symptoms - Severity | Through study completion, an average of 30 weeks | 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. |
| Muscle Cramping Symptoms - Frequency | Through study completion, an average of 30 weeks | 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) |
Countries
United States
Contacts
CONTACTJeanette Boyce, RNC, MSN
PRINCIPAL_INVESTIGATORHyagriv Simhan, MD
Magee-Women's Research Institute
Outcome results
None listed