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| Name | Class |
|---|---|
| Perelel Inc. | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perelel Prenatal Supplement Group | Active Comparator |
| |
| Generic Prenatal Supplement Group | Active Comparator |
| |
| Observational Arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perelel Prenatal Vitamin | Dietary Supplement | Daily Perelel prenatal vitamin supplement throughout pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Marker of Maternal Vitamin D Nutritional Status | Assay of Serum 25-hydroxyvitamin D3 in Blood Samples | Through study completion, an average of 30 weeks |
| Marker of Maternal Total Folate (RBC) Nutritional Status | Assay of Total Folate (RBC) in Blood Samples | Through study completion, an average of 30 weeks |
| Marker of Maternal Total Folate (Serum) Nutritional Status | Assay of Total Folate (Serum) in Blood Samples | Through study completion, an average of 30 weeks |
| Marker of Maternal Serum Ferritin Nutritional Status | Assay of Serum Ferritin in Blood Samples | Through study completion, an average of 30 weeks |
| Marker of Maternal Serum Vitamin B12 Nutritional Status | Assay of Serum Vitamin B12 in Blood Samples | Through study completion, an average of 30 weeks |
| Marker of Maternal Homocysteine Nutritional Status | Assay of Homocysteine in Blood Samples | Through study completion, an average of 30 weeks |
| Marker of Maternal Folate Metabolites Nutritional Status | Assay of Folate Metabolites in Blood Samples | Through study completion, an average of 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 30 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeanette Boyce, RNC, MSN | Contact | 412-641-4072 | tessje@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hyagriv Simhan, MD | Magee-Women's Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee-Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Generic Prenatal Vitamin | Dietary Supplement | Daily generic prenatal vitamin supplement throughout pregnancy. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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) | Through study completion, an average of 30 weeks |