National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

A Comparison of Screening Methods of T. Vaginalis,
Bacterial Vaginosis and Candida Sp.

Objective

To compare the wet mount, culture and DNA probe test (Affirm assay) for diagnosing Trichomonas vaginalis in asymptomatic pregnant women in order to determine the specificity and sensitivity of the assay test.

Conclusion

The DNA probe test was found to have unacceptable sensitivity but acceptable specificity and was not recommended for use in a subsequent randomized clinical trial.

Clinical Centers

Magee Womens, Oklahoma, Bowman Gray, Wayne State

Major Eligibility Criteria

• Presenting for routine speculum exam at ≤ 36 weeks gestation
• Asymptomatic
• Informed consent

Sample Size

• Goal = 1,000

Scheduled Evaluations/Data Collection

• At Enrollment:
• Vaginal pH
• Wet Prep for Trichomonas
• Culture for Trichomonas
• Gram stain for bacterial vaginosis
• Affirm assay for Trichomonas, gardnerella, candida

Outcome Measures

• Primary:
• Result of Affirm assay for Trichomas classified as true +, false -, true -, or false + when compared with wet mount or culture
• Secondary:
• Results of Affirm assay for bacterial vaginosis when compared with wet mount or culture

Timetable

• Recruitment (n=1,018): 03/93-12/93
• Data Collection: 12/93-01/94
• Closeout/Final Analysis: 01/94-03/94