Research Study for Pregnant Women
What is the purpose of this study?
The University of Cincinnati and Cincinnati Children’s Hospital Medical Center is conducting a research study (sometimes referred to as a clinical trial or clinical study), to look at the possible benefits of a nutritional supplement for pregnant women. The study will help us learn if the supplement may benefit both the mother and the baby, by working to maintain healthy blood sugar levels.
Who will be included in this study?
Pregnant women 18 to 40 years old who are less than 26 weeks (6 ½ months) pregnant and are in overall good health may be eligible to participate.
What is involved?
You would enter the study during the middle of pregnancy (24-28 weeks) and will continue until the delivery of your baby (38-40 weeks), making the total time about 10-12 weeks. If you are eligible, you will:
- Be randomized (put into one of two groups by chance) to either receive the nutrient-DHA supplement capsules and or the placebo (capsules containing corn/soybean oil)
- Have three scheduled study visits
- Have your blood drawn and height and weight measurements taken
- Complete questionnaires
- Be asked about your diet
- Have your placenta tissue collected after the birth of your baby
What are the benefits?
There is no known direct benefit to you for participating in this study. Previous studies with this DHA supplement suggest a possible positive effect on infant brain development. The researchers believe that the information learned from this study will benefit other patients as this could be a new, safe, low-cost, readily-available treatment for pregnant women who are at risk for developing diabetes in pregnancy or later in life is developed.
Will I get all the facts about the study?
You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until you have signed this form.
What are the risks and discomforts of the study?
There are no known risks associated with the dose of the DHA supplement administered in this study. There may be some discomfort from having your blood drawn, and for some individuals, the possibility of pain or bruising at the site where the blood is taken.
What is the pay?
Participants will receive up to $150 for their time.
Who should I contact for more information?
Margaret 513-558-4042 or Anu 513-558-7041
The Research Lab for Women and Children
Department of Nutritional Sciences at the University of Cincinnati
Principal Investigators:
Debra Krummel, PhD, RD, LD
Associate Professor in Nutritional Services
University of Cincinnati
Theresa Powell, PhD
Associate Professor in Obstetrics and Gynecology
University of Cincinnati
