Outcome of the vaginal infections and prematurity study: Results of a clinical trial of erythromycin among pregnant women colonized with group B streptococci

Klebanoff, Mark A.; Regan, Joan A.; Rao, Adupa P.; Nugent, Robert P.; Blackwelder, William C.; Eschenbach, David A.; Pastorek, Joseph G.; Williams, Sharifa Z.; Gibbs, Ronald S.; Carey, John C.

doi:10.1016/0002-9378(95)90493-x

Cited by 87 publications

(33 citation statements)

References 19 publications

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“…The clinical trial results for women positive for U. urealyticum but negative for group B streptococci and C. trachomatis have been published, 13 as have the results for women with group B streptococci. 12 …”

Section: Subjects and Methods Study Designmentioning

confidence: 97%

“…Details of inclusion and exclusion criteria have been published previously. 12,13 Research personnel obtained demographic, obstetric, sexual, contraceptive, and drug use history on standardized coded forms; performed a standardized physical and pelvic examination; and collected urogenital cultures in a standard manner. At delivery the medical records of the mother and infants were reviewed and information on intervening therapy, including non-trial antibiotic use, was abstracted.…”

Section: Subjects and Methods Study Designmentioning

confidence: 99%

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Double-blind placebo-controlled treatment trial ofChlamydia trachomatis endocervical infections in pregnant women

Martín

Eschenbach

Cotch

et al. 1997

Infect. Dis. Obstet. Gynecol.

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Objective: The purpose of this study was to determine if treatment of pregnant women with Chlamydia trachomatis infection would lower the incidence of preterm delivery and/or low birth weight.Methods: Pregnant women between the 23rd and 29th weeks of gestation were randomized in double-blind fashion to receive either erythromycin 333 mg three times daily or an identical placebo.The trial continued until the end of the 35th week of gestation.Results: When the results were examined without regard to study site, erythromycin had little impact on reducing low birth weight (8% vs. 11%, P 0.4) or preterm delivery (13% vs. 15%, P 0.7). At the sites with high persistence of C. trachomatis in the placebo-treated women, low birth weight infants occurred in 9 (8%) of 114 erythromycin-treated and 18 (17%) of 105 placebo-treated women (P 0.04) and delivery <37 weeks occurred in 15 (13%) of 115 erythromycin-treated and 18 (17%) of 105 placebo-treated women (P 0.4).Conclusions: The results of this trial suggest that the risk of low birth weight can be decreased by giving erythromycin to some women with C. trachomatis. Due to the high clearance rate of C.

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Section: Subjects and Methods Study Designmentioning

confidence: 97%

Section: Subjects and Methods Study Designmentioning

confidence: 99%

Double-blind placebo-controlled treatment trial ofChlamydia trachomatis endocervical infections in pregnant women

Martín

Eschenbach

Cotch

et al. 1997

Infect. Dis. Obstet. Gynecol.

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“…It is possible that only the sub-group with evidence of inflammation would benefit from treatment and that the potential beneficial effects of such therapy are diluted in clinical trials which included all patients with the laboratory diagnosis of bacterial vaginosis. Similarly, antibiotic therapy of patients with asymptomatic Trichomonas vaginalis , Streptococcus agalactia [Klebanoff et al, 1995], and Ureaplasma urealyticum [Eschenbach et al, 1991] did not reduce the rate of preterm birth.…”

Section: Do We Know Enough To Guide Management?mentioning

confidence: 94%

Intrauterine infection and prematurity

Gonçalves

Chaiworapongsa

Romero

2002

Ment. Retard. Dev. Disabil. Res. Rev.

529

377

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Intrauterine infection is a major cause of premature labor with and without intact membranes. Intrauterine infection is present in approximately 25% of all preterm births and the earlier the gestational age at delivery, the higher the frequency of intra-amniotic infection. Microorganisms may also gain access to the fetus before delivery. A fetal inflammatory response syndrome elicited in response to microbial products is associated with the impending onset of preterm labor and also with multi-systemic organ involvement in the human fetus and a higher rate of perinatal morbidity. The most common microorganisms involved in intrauterine infections are Ureaplasma urealyticum, Fusobacterium species and Mycoplasma hominis. The role of Chlamydia trachomatis and viruses in preterm labor remain to be determined. Use of molecular microbiology techniques to diagnose intrauterine infection may uncover the role of fastidious microorganisms that have not yet been discovered. Antibiotic administration to patients with asymptomatic bacteriuria is associated with a significant reduction in the rate of preterm birth. However, such benefit has not been demonstrated for patients with bacterial vaginosis, or women who carry Streptococcus agalactia, Ureaplasma urealyticum or Trichomonas vaginalis. Antibiotic administration to patients with preterm premature rupture of membranes is associated with prolongation of pregnancy and a reduction in the rate of clinical chorioamnionitis and neonatal sepsis. The benefit has not been demonstrated in patients with preterm labor and intact membranes. Major efforts are required to determine why some women develop an ascending intrauterine infection and others do not and also what interventions may reduce the deleterious effect of systemic fetal inflammation.

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“…In contrast, antibiotic treatment of GBS carriers early in pregnancy failed to reduce preterm low birthweight or neonatal sepsis [Klebanoff et al, 1995]. Whether more effective approaches to reducing GBS colonization antenatally would actually reduce adverse outcomes of pregnancy is not known.…”

Section: Public Health Intervention Model For Intrauterine Infection mentioning

confidence: 80%

Public health issues related to infection in pregnancy and cerebral palsy

Schendel

Schuchat

Thorsen

2002

Ment. Retard. Dev. Disabil. Res. Rev.

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Cerebral palsy is the most common neuromotor developmental disability of childhood, affecting as many as 8,000 to 12,000 children born in the U.S. each year (corresponding to a prevalence rate of between 2 and 3 per 1000 children). Recent improvements in neonatal care have not resulted in a decline in the overall prevalence of cerebral palsy and, in fact, greater numbers of very preterm/very low birth weight infants are surviving with cerebral palsy and other developmental problems. Infection in pregnancy may be an important cause of the disorder. In preterm infants, there appears to be about a 2-fold increased risk for cerebral palsy from chorioamnionitis, and in term infants the estimated increased risk is about 4-fold. Provisionally, chorioamnionitis might account for 12% of spastic cerebral palsy in term infants and 28% of cerebral palsy in preterm infants. Studies of biochemical markers of fetal inflammation typically associated with infection also suggest that an inflammatory response may be an important independent etiologic factor. If a substantial proportion of cerebral palsy is attributable to acute amnionitis infection and/or neonatal sepsis, cerebral palsy should have decreased in the United States after administration of intrapartum antibiotics became widespread in response to publication of public health consensus guidelines for Group B streptococcus in 1996. However, failure to detect declines could have a number of explanations and these explanations illustrate the many public health challenges related to intrauterine infection and cerebral palsy. Given the gaps in our current knowledge about intrauterine infection and cerebral palsy, public health recommendations for timely and specific prevention activities are limited at this time.

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Outcome of the vaginal infections and prematurity study: Results of a clinical trial of erythromycin among pregnant women colonized with group B streptococci

Cited by 87 publications

References 19 publications

Double-blind placebo-controlled treatment trial ofChlamydia trachomatis endocervical infections in pregnant women

Double-blind placebo-controlled treatment trial ofChlamydia trachomatis endocervical infections in pregnant women

Intrauterine infection and prematurity

Public health issues related to infection in pregnancy and cerebral palsy

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