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Maternal-Fetal Medicine Clinical Trials

Maternal Fetal Medicine clinical trials are conducted through Kosair Children's Maternal Fetal Medicine. If you are interested in participating, please contact Christy Waldon at (502) 899-6931 or email MFMresearch@nortonhealthcare.org


PreTerm Labor

Title: Clinical Evaluation of the Actim Partus test for cervical secretions of women between 21+6 and 36+6 gestation.

Sponsor: Alere Scarborough, Inc.

Prinicipal Investigator: Helen How, M.D.

Purpose of the Study: The purpose of this study is to evaluate the ability of an investigational test to predict the risk of preterm or imminent.


Title: 17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy In Women with Preterm Rupture of the Membranes (PROM), Double-Blind Randomized Clinical Tria

Sponsor: OBSTETRIX

Prinicipal Investigator: Helen How, M.D.

Purpose of the Study: The purpose of this study is to determine if a weekly injection (shot) of a study medication called 17-a-hydroxyprogesterone caproate (17P, Makena®) will extend pregnancy and, therefore, will improve the health outcome of the baby.


Genetic Disorder Detection

Title: Prenatal Blood Test for Fetal Aneuploidy Detection (Protocol TDx-002)

Sponsor: Tandem Diagnostics

Prinicipal Investigator: Helen How, M.D.

Purpose of the Study: The purpose of this research is to find out whether analyzing DNA in a mother’s blood can be used to identify pregnancies with normal chromosomes and pregnancies with chromosome abnormalities such as Down syndrome.  This study will provide information that may eventually help determine if invasive procedures such as chorionic villus sampling and amniocentesis can be replaced by a blood test.


Title: A clinical field study to evaluate the clinical performance of the SEQure DX Trisomy 21 test in the detection of relative quantity of Chromosome 21 in circulating cell free DNA.

Sponsor: Sequenom

Prinicipal Investigator: Helen How, M.D.

Purpose of the Study: The purpose of this study is to collect whole blood samples from pregnant women who are at increased risk for fetal chromosomal aneuploidy, such as Down syndrome, for validation of a noninvasive fetal aneuploidy test.

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