Strep Throat Incidence in Pregnant Women Study
What is the purpose of this study?
Cincinnati Children's is conducting a research study to investigate the effects of strep throat infection before and during pregnancy. The research will try to determine if there is any association between a mother's exposure to bacteria that normally causes "strep throat" and her baby developing certain types of heart disease.
Who will be included in this study?
Generally-healthy women less than 18 weeks pregnant (4 ½ months) to be part of a healthy control group.
What is involved?
The study includes 3 visits. The following is a list of procedures that will take place during the study visits:
- An initial screening prior to 18 weeks gestation (4 ½ months) with completion of a short questionnaire, a blood draw and 2 throat swabs
- A second visit prior to 30 weeks gestation with a blood draw and throat sample
- A final visit prior to 38 weeks gestation with a blood draw and throat sample
What are the benefits?
There is no direct medical benefit for you. The greatest benefit is that the information learned from this study may benefit other babies with heart defects in the future. Research studies are essential in finding new and improved treatments and diagnostic tools.
Will I get all the facts about the study?
Upon your decision to participate in this 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?
The risks of study participation include possible discomfort from having your blood drawn, and for some individuals, a potential for the throat swab to cause gagging.
What is the compensation?
Participants will receive $25 for completion of the initial visit, $25 for completion of the 2nd visit and $50 for the final visit (for completion of all three visits).
Who should I contact for more information?
Mary Fisher, R.N.
Cincinnati Children's Hospital Medical Center
Phone: 513-803-0127
mary.fisher@cchmc.org
