Study Update: Maternal Fetal Medicine Unit

Dr. John Thorp, who was recently appointed Vice Chair of Research for UNC, is also the Principal Investigator for UNC’s Maternal Fetal Medicine Unit (MFMU) and oversees much of the research conducted by the MFMU.  The network is comprised of 14 clinical units that were established in 1986. MFMU is devoted to administering groundbreaking biomedical research to improve pregnancy outcomes for mothers and babies as well as families in general.  There are currently four studies in progress at UNC’s MFMU.

The MFMU team is currently finishing the clinic: “A Randomized Trial of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy,” which examined the correlation between treating women diagnosed in the first half of their pregnancy with subclinical hypothyroidism or hypothyroxinemia, and the intellectual improvement of their offspring.  The study has followed infants from the prenatal stages up to age five.  The study is presently in the follow-up stage, with the youngest subjects currently three years-old, and it is projected to end in spring or summer of 2014. Thorp said the study has the potential to change medical practices. If positive results are produced from the trial, then a screening process could be implemented for every woman’s pregnancy.

The next MFMU study underway is entitled “A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring.” This study examines fetal electrocardiography (ECG) and determines whether there are changes in ECG with low oxygen levels in order to improve accuracy for electronic fetal monitoring. Thorp said that the study was about three-fourths completed and should be finished within a year.

The third study, “Congenital Cytomegalovirus (CMV) Infection: Randomized Placebo-Controlled Trial,” examines whether hyperimmune globulin treatment given to women with primary CMV, prior to 24 weeks of pregnancy, reduces the rate of congenital CMV infection. CMV is a serious viral infection that can cause deafness, mental retardation and developmental disabilities but it can be a subtle infection that often goes undetected or ignored.  Because the prevalence of infection is lower than what Thorp and his team projected (one or two out of 1000 as opposed to three or four out of 1000) they have encountered recruitment challenges and progressed at a slower rate.

The last MFMU study currently being conducted by UNC’s MFMU is called “Antenatal Late Preterm Steroids: Randomized Placebo-Controlled Trial.” The study has been temporarily suspended due to the closing down of a compounding pharmacy in Rhode Island, where MFMU had been obtaining their resources. Once they find a new compounding pharmacy, the study will continue to determine if antenatal corticosteroids given to moms in later term pregnancies, (34-36 weeks), are as effective as steroids given to moms earlier in their term.  Before suspension, the trial was halfway completed.

Thorp feels that the studies at MFMU are going well. He cites positive recruitment and their partnerships with the Wake Medical Center, Rex Hospital and the Wake Health Department in Raleigh and Memorial Mission Hospital in Asheville as key contributors to their success. The MFMU will continue to generate innovative studies that contribute key findings for medical practice.

MFMU receives administrative support for all its studies from the Center of Women’s Health Research at UNC.

To learn more about the Maternal Fetal Medicine Unit Network visit their website.

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