Study & Year
(Reference) |
Neonatal Death |
Perinatal Death |
Other Outcomes |
Delivery <37 Weeks
in Placebo Group (%) |
Prevalence of Bacterial
Vaginosis
(% in Sample) |
Adverse Effects—All |
Adverse Effects Data:
Outcomes for Bacterial Vaginosis-Negative Women Given Treatment |
Bacterial Vaginosis Group
Only?
(Details on Other Syndromes) |
Blind for Second Test:
Yes/No/NR
Second Round Treatment Blind: Yes/No/NR
Placebo Get Second Round Too: Yes/No/NR |
Timing of Randomization Related
to Gestational Dating (e.g, Sonogram, Ultrasound, Exam) |
| Kekki,
200148 |
NR |
NR |
Peripartum infections
Tx: 21/187
Placebo: 33/188 |
3.7 |
10.4 |
Vulvovaginal itching
Tx: 6/187
Placebo: 6/188 |
Not studied |
Yes
(Screened for Neisseria gonorrhea, Chlamydia trachomatis; not explicitly stated that they are excluded) |
NA |
Not clear when dating
ultrasonography was done relative to the randomization; ultrasound and last
period for gestation estimate |
| Kurkinen-Räty,
200049 |
NR |
NR |
Puerperal infectious
morbidity seen more in cases of persistent BV |
6 |
7.3 |
Occurrence or absence of
adverse effects NR |
Not studied |
Yes
(Screened for Neisseria gonorrhea, Chlamydia trachomatis, group B streptococci; not explicitly stated that they are
excluded) |
NA |
Not clear when dating
ultrasonography was done relative to the randomization; biparietal diameter
at week 16 for gestational age estimate |
| Odendaal,
200250
|
Low-risk (primigravidae)
BV-positive Tx: 1/66
BV-positive Placebo: 0/82
BV-negative: 2/311
High-risk (multigravidae)
BV-positive Tx: 3/70
BV-positive Placebo: 0/51
BV-negative: 6/351
|
Low-risk (primigravidae)
BV-positive Tx: 1/66
BV-positive Placebo: 2/82
BV-negative: 7/311
High-risk (multigravidae)
BV-positive Tx: 7/70
BV-positive Placebo: 1/51
BV-negative: 18/351 |
Apgar score |
L: 15.9
H: 23.5 |
L: 32
H: 26 |
Occurrence or absence of
adverse effects NR |
Not studied |
Yes (low % with
bacteriuria)
(Test for lactobacilli, clue cells, Candida albicans, Trichomonas vaginalis; not explicitly stated that they are excluded.
Asymptomatic bacteriuria included:
Low-risk: Tx 11%; Placebo 13% NS
High-risk: Tx 11%; Placebo 8% NS) |
NR/NR/NR |
Not clear when dating
ultrasonography was done relative to the randomization; Confirmation
ultrasound (biparietal diameter) if suspected gestation <24 wk; after 24
wk, last period or clinical exam of fungal height |
| Guaschino,
200351
|
NR |
NR |
Caesarean delivery: NS
NICU admission: NS
Mean gestational age: NS
Respiratory distress syndrome: NS
Apgar score: NS |
15.7 |
6 |
1 case of suspected fracture of
neonate clavicle, group assignment not specified. No details on adverse
effects for mothers |
Not studied |
No; high % with
bacteriuria)
(Other asymptomatic infections possible; tested for Gardnerella, Bacteroides, and Mobiluncus; states concomitant infections in both groups approximately
44%) |
NA |
NR |
| Kiss,
200452
|
NR for BV subgroup |
NR |
Births at term:
Tx: 144
Control: 135 |
5.7 |
7.1 |
None of the women reported
adverse effects during the treatment period |
Not studied |
Yes; data provided for PTD
<37 weeks for BV group only
(Entire study group had multiple infections: Candida species, 12.6%. Post-hoc analysis by the authors of this review showed the Candida group had a significant Tx
effect for PTD <37 weeks; BV group did not) |
NR/NR/NA
44 women had BV at 2nd test |
Not clear when dating
ultrasonography was done relative to the randomization; Date of women's last
period, confirmed by ultrasound prior to 19 weeks |
| Lamont,
200353 |
NR |
NR |
Gestational age at delivery
was statistically significantly lower in the placebo group, however it did
not have an effect on the pregnancy outcomes |
9.8 |
NR |
Occurrence or absence of
adverse effects NR |
Not studied |
Yes
(Screened for syphilis, Neisseria gonorrhea, Trichomonas vaginalis, Chlamydia trachomatis; not explicitly stated that they are excluded) |
Yes/Yes/Yes |
Not clear when dating
ultrasonography was done relative to the randomization; date of women's last
period, and early scan consistent with this date
97% of the groups were recruited at or before 20 wk of gestation |
| Larsson,
200654 |
NR |
NR |
Gestational length:
Tx: 247.6; Control: 215 (P = 0.024)
Mothers' days of care:
Tx: 18; Control: 45 NS (P = 0.14)
Cumulative days of NICU:
Tx: 70; Control: 223 (P = 0.14) |
2.4 |
9.3 |
Follow-up with 21 low-birthweight
infants showed "very few sequelae"; 3 women withdrew from treatment
because of persistent itching |
Not studied |
Yes |
NR/No/No |
No change stated after
randomization
Medical Birth Register records; based on ultrasound scanning at 16-18 wk of
gestation or date of last menstrual period |
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