Predisposing Factors For Bacterial Vaginosis, Treatment Efficacy And Pregnancy Outcome Among Term Deliveries; Results From A Preterm Delivery Study

Background
Bacterial vaginosis (BV) during pregnancy is associated with an increased risk of preterm delivery but little is known about factors that could predict BV. We have analysed if it is possible to identify a category of pregnant women that should be screened for BV, and if BV would alter the pregnancy outcome at term; we have also studied the treatment efficacy of clindamycin.

Methods
Prospective BV screening and treatment study of 9025 women in a geographically defined region in southeast Sweden. BV was defined as a modified Nugent score of 6 and above. Data was collected from the Swedish Medical Birth Register. Women allocated to treatment were supplied with vaginal clindamycin cream. The main outcome goals were to identify factors that could predict BV.

Results
Vaginal smears were consistent with BV criteria in 9.3%. Logistic regression indicates a significant correlation between smoking and BV (p < 0.001) and a greater prevalence of BV in the lower age groups (p < 0.001). We found no correlation between BV and history of preterm deliveries, previous miscarriages, extra-uterine pregnancies, infertility problems or reported history of urinary tract infections-factors that earlier have been associated with BV. Treatment with clindamycin cream showed a cure rate of 77%. Less than 1% of women with a normal vaginal smear in early pregnancy will develop BV during the pregnancy. There was no association between BV and the obstetric outcome among women who delivered at term. Women with BV, both treated patients and nontreated, had the same obstetric outcome at term as women with normal vaginal flora.

Conclusion
BV is more than twice as common among smokers, and there is a higher prevalence in the younger age group. However these two markers for BV do not suffice as a tool for screening, and considering the lack of other risk factors associated with BV, screening of all pregnant women might be a strategy to follow in a program intended to reduce the number of preterm births.

Background
Bacterial vaginosis (BV) is one of the most common vaginal infections with prevalence among pregnant women between 10 and 20%1-3. There is an association between BV and preterm delivery^1,2,4-6 and also between BV and early spontaneous miscarriage prior to 16 weeks gestation⁷. Associations between BV and urinary tract infections (UTI)^8,9 as well as between BV and history of infertility caused by tubal factors¹⁰ have been reported in other studies. There is also an association between smoking and BV^11-14.

The primary outcome is to determine the presence of predisposing factors which might be identified at the first antenatal visit and thus reduce the number of women potentially at risk for BV requiring treatment. The secondary outcome were the efficacy of clindamycin treatment during pregnancy and if there are any other associations on the obstetric outcome among term deliveries and BV.

Methods
All gravida who were booked for antenatal care at clinics in southeast Sweden between February 1999 and May 2001 were invited to take part in an intervention study to investigate whether treatment of BV with clindamycin cream could reduce the frequency of preterm delivery and the morbidity of preterm infants. The result from the latter study has been published¹⁵ and showed that treatment of BV with clindamycin was associated with significant prolongation of gestation with 32 days among women with late miscarriage or preterm delivery. The study at hand is an analysis of the same patient population. A vaginal smear was taken at the first antenatal visit and graded for BV according to Nugent with the exception that a Nugent score of 6 was defined as BV as discussed earlier^15-17.

We used modified Nugent scoring for the diagnosis of BV as we earlier encountered limitations in the use of Nugent scoring. This particularly applies to treatment studies and is even more pronounced when clindamycin vaginal cream is the selected treatment.

At the first antenatal visit, all women were interviewed regarding occupation, civil status, medical history, earlier pregnancies, fertility problems, alcohol, medication, history of UTI, and smoking habits (nonsmokers, smoke 1-9 cigarettes per day or smoke 10 or more cigarettes per day); the latter responses defined smoking habits 3 months prior to conception and the prevailing situation at the first antenatal visit. This information was registered in the antenatal medical record. After delivery, all data collected during the pregnancy, delivery and early puerperal period was sent to the Medical Birth Register (MBR) at the Swedish National Board of Health and Welfare. The study compared MBR data with the status of the vaginal smears. However if a gravida had a termination of pregnancy or a spontaneous abortion prior to 22 weeks gestation, or a intrauterine death between 22-28 weeks gestation no such data is available from MBR.

The women participated in a randomised consent design treatment study according to Zelen¹⁸ which investigated the outcome of treatment with vaginal clindamycin, or alternatively no treatment, on early preterm birth. All women with BV were randomised to either an intervention group with a 7-day regimen of treatment with clindamycin vaginal cream or a control group to remain untreated and uninformed of their BV status as stipulated in the pre-randomised consent design for clinical trials. Only women who were diagnosed with BV and randomised to the intervention group were informed of the status of their vaginal smear. Data from the frequency of preterm delivery is published¹⁵. Evaluation of treatment efficacy was done with new Gram-stained smears both 12 and 20 weeks after treatment. The treatment results were classified cured, improved, or failure. Cured meant the smear had a Nugent score of < 4 or a Hay/Ison score of1^2,19, improved meant the Nugent score was 4-5 or Hay/Ison score was 2, and treatment failure indicated that the Nugent score was > 6 or Hay/Ison score was 3. The women from the randomised control study are included in the analysis.

The study has been approved by the Regional Ethics Committee in Link

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