Baylor

Premature birth is a major health problem in the United States and is approaching epidemic proportions despitean increased utilization of prenatal care. The reason for concern is that prematurity is associated with significant potential for pain, suffering, disability, and large financial costs related to the long term health care and the developmental needs of these patients and their families.The prevention of prematurity therefore has the potential for a significant improvement in health and reduction in financial burden.

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Preterm birth has been associated with multiple clinical conditions including infectious agents, anatomic abnormalities, enodcrine disorders, maternal medical conditions, etc. A large body of evidence suggests that infection may play a role in up to two-thirds of premature birth, and thus a significant proportion of premature birth may be preventable with the appropriate use of antibiotics.

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Ureaplasma has been associated with many clinical diseases including non-gonococcal urethritis in men and women, prostatitis and epididymitis, urinary stone formation, suppurative arthritis, pelvic inflammatory disease, infertility in men and women, recurrent abortion, chorioamnionitis, stillbirths, prematurity, low birth weight, postpartum endometritis, and in the newborn several diseases including pneumonia, sepsis, meningitis, and chronic lung disease. The major similarity for all these conditions has been the variable occurrence of these diseases in patients colonized with this organism.The development of disease in only a subset of individuals colonized with Ureaplasma has led to speculation that only certain serotypes, biovars, or strains are pathogenic.

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Colonization of the lower genital tract with Ureaplasma in pregnant women is common varying from 44 to 88%, and is increased in certain subpopulations, however, does not appear to have an impact on adverse perinatal events, in particular premature birth. This lack of an association between Ureaplasma vaginal colonization and adverse perinatal outcome in particular premature birth, is not entirely unexpected, given the high vaginal colonization rate in pregnancy and the presence of numerous confounders for preterm birth. However, colonization of the upper genital tract with Ureaplasma in pregnant women appears to be strongly associated with adverse pregnancy outcome including spontaneous miscarriage, pre-term labor, pre-labor rupture of membranes, and post-partum endometritis.

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As a result, it has been proposed that Ureaplasma be eradicated from the urogenital tracts of women. Ureaplasma, however, is not susceptible in-vitro to penicillins, sulfonamides, trimethoprim, aminoglycosides, and clindamycin, but are generally (about 90%) susceptible in-vitro to tetracyclines, and macrolides (e.g. erythromycin).

Although newer antibiotics such as glycylcyclines and quinolones may prove more effective in eradicating this organism, their safety and efficacy during pregnancy have not been proven. Erythromycin has not been effective in either eradicating Ureaplasma from the genital tract or decreasing adverse perinatal outcomes in two randomized controlled trials. There are several reasons why these trials could have failed: 1) they did not treat a high-risk subgroup, specifically infected patients, but treated everyone, 2) nothing is known about erythromicin's ability to reduce or eradicate organisms from the amniotic fluid or placenta, 3) treatment began at or after 29 weeks gestation and this may be too late to eliminate infection from the placenta or have an impact on premature birth, 4) failure to treat partners and the high sexual transmission rate of Ureaplasma could have masked any potential effectiveness, and 5) Ureaplasma has been observed to persist in the genital tract despite antibiotic treatment. Current evidence also suggests that lack of specific antibodymay be a critical determinant for Ureaplasma infection, and antibodies to antigens of Ureaplasma can inhibit growth of these organisms in-vitro.10-12

Although other clinical conditions including other infectious agents, anatomic abnormalities, enodcrine disorders, maternal medical conditions, etc., may contribute to preterm birth, Ureaplasma colonization or infection of the placenta appears a significant association. If early in pregnancy the subpopulation of preterm births that develop Ureaplasma placental colonization or infection can be identified, then intervention strategies including antibiotics or vaccines could be developed to provide protection from Ureaplasma placental colonization or infection and adverse pregnancy outcome, in particular premature birth. It seems logical that those women who have Ureaplasma vaginal colonization during their pregnancy would be at risk for Ureaplasma placental colonization or infection but no such investigation has been conducted.

The purpose of this protocol is to determine if maternal Ureaplasma vaginal colonization or infection during pregnancy predicts Ureaplasma placental colonization or infection at delivery and if Ureaplasma antibiotic sensitivity, serotype, biovar, or maternal Ureaplasma antibody concentration affects the relationship in a private practice setting.

Other

There is a potential risk of bruising and small discomfort associated with drawing blood from the vein of the pregnant woman. Vaginal swabs are not part of routine care at the times required and may be associated with minimal discomfort. There are no potential risks in obtaining a culture from the placenta and a cord blood sample.

The patient may receive no direct benefit from participation in the study, but participation may help investigators determine if infection with an organism called Ureaplasma can affect pregnancy adversely and consequently the newborn.