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New treatment option for Pregnancy
Official title Prenatal Study in Healthy Pregnant Women
ClinicalTrials.gov ID: NCT07226414
What this study is testing
- What it's testing
- Clinical Trial Summary The goal of this clinical trial is to address the impact of a gummy prenatal vs a capsule based prenatal in pregnant women. The main question it aims to answer is: Does 12-week daily administration of Prenatal Capsule affect serum iron levels in pregnant women in their second trimester compared to a comparator gummy prenatal?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 40, women only
You may be able to join if
- Be able to give written informed consent.
- Healthy pregnant women between 21- 40 years of age (inclusive).
- Pregnant women in the second trimester of pregnancy (gestational age of 14-19 weeks).
- Willing to consume the Study Product daily for the duration of the study.
You likely can't join if
- History of drug or alcohol abuse
- Is hypersensitive to any of the contents of the study product, that would preclude intake of the study products.
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant...
- Severe nausea and vomiting in the first trimester, including hyperemesis gravidarum (HG)
- Inability to tolerate oral supplement intake due to gastrointestinal symptoms during the first trimester of pregnancy
- Prior Pregnancy Complications (gestational diabetes (GD), HG, or pre-eclampsia, NTDs (Neural Tube Defects))
See the full eligibility criteria
- Be able to give written informed consent.
- Healthy pregnant women between 21- 40 years of age (inclusive).
- Pregnant women in the second trimester of pregnancy (gestational age of 14-19 weeks).
- Willing to consume the Study Product daily for the duration of the study.
- History of drug or alcohol abuse
- Is hypersensitive to any of the contents of the study product, that would preclude intake of the study products.
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk, or would confound the interpretation of the study results as...
- Severe nausea and vomiting in the first trimester, including hyperemesis gravidarum (HG)
- Inability to tolerate oral supplement intake due to gastrointestinal symptoms during the first trimester of pregnancy
- Prior Pregnancy Complications (gestational diabetes (GD), HG, or pre-eclampsia, NTDs (Neural Tube Defects))
- Current pregnancy complications (GD, Iron Deficiency Anemia)
- Hypertension
- Diabetes mellitus
- Cardiovascular disease
- Class II/III obesity (defined as BMI ≥35.0 Kg/m2)
- Malabsorption syndromes (e.g., celiac disease, inflammatory bowel disease)
- Severe anemia or iron overload disorders
- Thyroid disorders
- Current or recent (in the past 12 weeks prior to Visit 1) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the...
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, 21 years to 40 years. 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.
Explore other conditions
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.