Even in those women who did develop preterm labor, some believe that HUAM can be judged to be a total success only if the treatment is successful, i.
Finally, what component of the HUAM system was responsible for an effect, if any--was it the daily nursing contact, or was it the objective evidence provided by the recorded uterine contractions?
is prescribed for a very small percentage of pregnancies at high risk for preterm delivery, it has introduced change in the standard of high risk care provided to these women.
This study provides further evidence to support that the use of HUAM
technology also can lead to significant improvements in pregnancy outcomes as measured by reduced prematurity, increased birthweights and a reduction in neonatal intensive care unit (NICU) days for the newborn.
Both these studies followed the guidelines approved by the Food and Drug Administration (FDA) for HUAM clinical trials.
Professor and Chief of Obstetrics at UCLA Harbor Medical Center and one of the authors of the Healthdyne study, "Our study was a multi-center prospective randomized clinical trial of the efficacy of the HUAM device alone (without daily nursing contact) versus standard high risk prenatal care in a population of women at risk for premature birth because of a history of preterm birth.
Furthermore, the aggregate group in the study contained women with risk factors that are not ordinarily associated with HUAM use, such as hypertension, diabetes, or abdominal surgery.
MPH, Professor and Chief of Obstetrics and Gynecology at UCLA Harbor Medical Center, who attended the SPO oral presentation observed, "The Caremark study examined only the incremental value of HUAM in the presence of daily intensive nursing contact in both study arms.
All patients used a Caremark First Activity(R) HUAM monitor which included a small, pressure sensitive device that is placed on a pregnant woman's abdomen to convert uterine contractions into electronic signals that can be transmitted over the telephone to a computer (base station) that generates a printout.
In one study group, HUAM data was transmitted to a base station and revealed to nurses.
Healthdyne believes that this is a clear statement of the effectiveness of its "system of care," which combines a HUAM
device with intensive nursing contact.
Fred Zuspan, editor in chief of the American Journal of Obstetrics and Gynecology and chairman emeritus of the Department of Obstetrics and Gynecology at Ohio State University, drew applause from the packed house at the hearing when he challenged the advisory panel to be "open-minded" and called the "investigational" status of HUAM