Evidence on the Benefits and Harms of Screening and Treating Pregnant Women Who Are Asymptomatic for Bacterial Vaginosis: An Update Review. Appendix Table 6

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Appendix Table 6. Characteristics of Included Studies

Study & Year (Reference)	Preterm Delivery Risk Level^a	Total Screened, n	Inclusion/ Exclusion Criteria	Setting and Country	Demographics	Completed/ Enrolled, n/n	Screening Method/ Diagnosis Criteria
Kekki, 2001⁴⁸	Low	5432	Exclude multiple pregnancies or women with previous PTD	Multiple prenatal clinics in Finland	Mean age, 28.8 y; predominantly white	375 Tx: 187 Placebo: 188	Gram stain (Spiegel)/NR
Kurkinen-Räty, 2000⁴⁹	Low	1956	Exclude multiple pregnancies or women with previous PTD	Multicenter, Finland	Mean age 27.9 y; race, NR; previous PTD, 10%; manual labor, 33%; middle- or upper-level employee, 67%	101/123 Tx: 62 Placebo: 61	Gram stain (Spiegel)/Gram stain—negative or Gram-variable rods of Gardnerella-type. Gram-intermediate findings not included
Odendaal, 2002⁵⁰	Low, High	1005	Exclude multiple pregnancies and known cervical incompetence, include if antibiotic free for >14 days	South Africa	Mean age, 21.6 y; race, NR; average unmarried, 86.4%	Low-risk (primigravidae) 459/464 BV-positive Tx: 66/67 BV-positive Placebo: 82/83 BV-negative: 311/314 High-risk (multigravidae) 472/491 BV-positive Tx: 70/74 BV-positive Placebo: 51/53 BV-negative: 351/364	Exam and/or Gram stain (Spiegel)/Stain label: 3+ Any 3 of the following: Gray discharge, pH >4.7, positive amine test, >20% clue cells, lactobacilli <2+
Guaschino, 2003⁵¹	Average	1890	Exclude multiple pregnancies; include asymptomatic, antibiotic free for >15 days	Outpatient obstetric clinics, multicenter, Italy	Mean age, 29.1 y; race, NR; education, 12.5 y (Tx), 10.8 y (control)	100/112 Tx: 49/55 Control: 51/57	Gram Stain/Hillier 1992 (Nugent)/NR
Kiss, 2004⁵²	Average	4080	Exclude multiple pregnancies; include asymptomatic, no vaginal bleeding	Non-hospital obstetrics clinics in Vienna, Austria	Mean age, 28.9 y; race, 98% white	292/297 (BV only) Tx: 144/151 Control: 135/146	Gram stain (Nugent)/Nugent score >4
Lamont, 2003⁵³	Average	NR	Include ages 16-40 y, Gram stain consistent with BV, asymptomatic, 13-20 wk of gestation. Exclusions: history of antibiotic-related colitis, inflammatory bowel disease, or frequent periodic diarrhea; multiple pregnancies; and pregnancy complications.	Hospital-based antenatal care; 3 sites in United Kingdom	Mean age, 27 y; race, 70% white, 15% black; previous PTD, 7.3%	368/409 Tx: 178/208 Placebo: 190/201	Gram stain (Nugent)/Nugent score >4
Larsson, 2006⁵⁴	Average	8547	Include >18 y, asymptomatic, no antibiotic use in early pregnancy, Swedish speaking. Exclude multiple pregnancies and other pregnancy complications.	Southeast Health Care Region of Sweden	Mean age, 28.5 y; race, 98% white; previous PTD, 9.2% (Tx), 6% (control)	819 BV-positive Tx: 408/408 Control: 411/411	Gram stain (Nugent) Hay/Ison criteria to verify diagnosis/Nugent score >6

Abbreviations: BV, bacterial vaginosis; NA, not applicable; NICU, neonatal intensive care unit; NR, not reported; NS, not significant; PTD, preterm delivery; Tx, treatment.
^a. Risk level: risk for pre-term delivery; low (no risk factors); average (mixed group, general population); high (previous PTD or other risk factors)

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