The use of oral probiotics in pregnant women as a new paradigm for healthy motherhood: A prospective study

Increased vaginal discharge in pregnant women in many instances is not pathological. Vulvovaginal infections like bacterial vaginosis (BV), candidiasis or trichomoniasis can result in abnormal vaginal discharge. Bacterial Vaginosis is diagnosed more frequently in women with established preterm labor (PTL) or delivery and with preterm rupture of membranes. Adverse pregnancy outcomes such as spontaneous abortion, PTL, premature delivery, preterm premature rupture of the membranes (PPROM), amniotic fluid infection, postpartum endometritis, and post-cesarean wound infections have been reported. We conducted this study to determine the prevalence of bacterial vaginosis in 246 pregnant women and its association with adverse perinatal outcomes. Prevalence of bacterial vaginosis in pregnant women attending the antenatal clinic was studied using Nugent’s scoring system. Perinatal outcomes were also assessed.The prevalence of bacterial vaginosis was maximum in the age group 21-25 years (46.43%), followed by 26-30 years (25%). The association of perinatal outcome and bacterial vaginosis among patients showed that PROM, LBW and IUGR infant had more bacterial vaginosis with a statistically significant association with bacterial vaginosis (P<0.05). Bacterial vaginosis is a major public health problem prevalent in pregnant women and associated with adverse perinatal outcomes. Research should continue to evaluate the risks and benefits of medications to the mother and fetus. More focus needs to be placed on the prevention of preterm labor and premature rupture of membranes rather than the treatment of preterm labor once it occurs.

Aim: To evaluate the incidence rate of bacterial vaginosis in pregnant women and to ascertain its obstetric consequences. Study design: A prospective, cohort study Place & duration of study: From 3rd June 2020 to 3rd June 2021 in the gynecology department of Nishtar Medical Hospital. Methodology: A total of 250 pregnant women who have surpassed their 10 weeks of gestation were included in the study. Vaginal swab samples were collected and microbiological testing was performed. Nugent scores and Amsel's composite criteria were used for diagnosing bacterial vaginosis and classifying women into bacterial vaginosis, non-bacterial vaginosis, and intermediate bacterial vaginosis. A mid-sample urine sample was also cultured to diagnose urinary tract infection in analyzed women. All women were then followed-up during the remaining pregnancy course for adverse antenatal events and newborn conditions were also observed. Results: Out of the total of 250 women, 19.2% were diagnosed positive for bacterial vaginosis. Candidiasis was the second-largest reported infection among the analyzed women affecting 4.8% of women. Bacterial vaginosis was significantly higher in women aged between 18-25 years, in nulliparous women, and those in lower social class (p<0.05). Abortion (6.25%), preterm labor (43.7%), premature rupture of membranes (PROM) (27%), and puerperal pyrexia (4.1%) were the most considerable adverse outcomes and were significantly higher in the bacterial vaginosis group. Conclusion: Bacterial vaginosis is significantly higher in pregnant women and is associated with adverse pregnancy outcomes such as abortion, preterm labor, puerperal pyrexia, and premature rupture of membranes. Keywords: Bacterial vaginosis, vaginal infections, pregnant women, urinary tract infection, fetomaternal outcomes

Objective of the study: to study the clinical and laboratory efficacy of the Femivag® (contains Lactobacillus gasseri, Lactobacillus rhamnosus) drug in the complex treatment of bacterial vaginosis (BV) in pregnant women with high risk of preterm birth.Materials and methods. 42 pregnant women at the 16–18 weeks of gestation with cervical dysfunction and BV diagnosed before cervical pessary installation were examined and treated. All patients were assessed the dynamics of symptoms severity, performed PCR testі with a quantitative count of opportunistic pathogens and Lactobacillus spp. Perinatal and neonatal outcomes were also assessed. Femivag® vaginal capsules were prescribed to 24 women (main group) to restore the vaginal microbiota after BV treatment. 18 pregnant women used dietary supplements containing pro- and prebiotics (comparison group). The examination was performed before treatment, 4 and 15–16 days from the therapy start, 4 and 8 weeks after treatment.Results. Vaginal probiotic Femivag® as a component of complex therapy of BV before the installation of cerclage pessary was more effective than the oral food supplements with pro- and prebiotics in terms of reducing in vaginal discharge and vaginal discomfort, the disappearance of vaginal itching and burning sensation for 4 days of therapy. Gardnerella vaginalis / Prevotella bivia / Porphyromonas spp., Mobiluncus spp. / Corynebacterium spp. and Atopobium vaginae disappeared and vaginal normobiota significant recovered in the second trimester in women with cervical dysfunction at 4 and 8 weeks from the start of BV treatment with Femivag®. Frequency of premature rupture of membranes and chorioamnionitis significantly decreased in the main group. Femivag® was well tolerated and had no side effects.Conclusions. Femivag® vaginal capsules had a pronounced clinical and laboratory effect in the complex treatment of BV in pregnant women with incompetent cervix

Background: Bacterial vaginosis (BV) in pregnant women remains a cause for clinical concern among clinicians and health care professionals. BV has been linked to prenatal, antenatal and postnatal challenges in pregnant women. Information on prevalence of BV across trimesters of pregnancy is expected to give better clinical insight into the pathophysiology of this polymicrobial disorder. This study was conducted to determine the prevalence of BV in pregnant women attending the Nnamdi Azikiwe University Teaching Hospital (NAUTH), Nnewi, Nigeria.
 Methodology: This was a cross-sectional study of 120 pregnant women (40 in each trimester of pregnancy) who had symptoms suggestive of BV, selected by systematic random sampling from among the women attending the Obstetrics and Gynaecology (O & G) clinic of NAUTH, Nnewi. Each subject participant was examined by the attending clinician, and high vaginal swab (HVS) sample was collected for diagnostic analysis of BV using with complete Amsel’s clinical criteria, which consists of three of the four criteria; (i) adherent and homogenous vaginal discharge, (ii) vaginal pH > 4.5, (iii) detection of clue cells on saline wet mount, and (iv) amine odor after the addition of potassium hydroxide (positive Whiff test).
 Results: The mean age of the 120 selected participants was 27.25±6.09 years. The age groups 25-29 (36.7%) and 20-24 years (33.3%) constituted the largest proportion, while age groups <20 (5.0%) and 40-45 years (5.0%) constituted the least. Of the 120 participants, 26 (21.7%) were positive for BV by the Amsel’s criteria. Pregnant women in age group <20 years had the highest prevalence of BV (100%, 6/6), followed by those in the age groups 20-24 (27.5%), 40-45 (16.7%), 25-29 (15.9%), 30-34 (9.1%) and 35-39 years (0%) (X2=28.063, p=0.0001). Prevalence of BV was significantly higher in single (unmarried) pregnant women (45.5%, X2=4.038, p=0.045), women with primary school education level (66.7%, X2=14.530, p=0.001), unemployed women (36.1%, X2=13.278, p=0.0013), and nulliparous women [36.4%, X2 (for trend) = 4.805, p=0.0274), while there was no significant difference in the prevalence of BV with relation to trimester of pregnancy (X2=2.750, p=0.253).
 Conclusion: This study reveals a relatively high prevalence of BV and significant association with factors such as age group, education and occupational status among pregnant women attending NAUTH Nnewi. Regular screening of women for BV prenatally may enable appropriate interventions to prevent adverse pregnancy outcomes.

Effects of the sampling time on the vaginal microbiota in healthy pregnant women: a prospective observational study

Aim: to assess the efficacy and safety of Lactogynal® to normalize vaginal microflora after antimicrobial treatment for bacterial vaginosis (BV) and to prevent recurrences of vulvovaginal candidiasis (VVC) during pregnancy. Patients and Methods: this multicenter prospective non-interventional comparative study included 100 women in the 3rd trimester of pregnancy diagnosed with acute BV (n=50) or acute VVC (n=50). 25 women of each group received standard antimicrobial treatment only. 25 women of each group received Lactogynal® as the second step of antimicrobial treatment. Women were followed up until delivery and discharge. The rate of BV and VVC recurrences before delivery was considered the key indicator of treatment efficacy. In addition, obstetrical and perinatal outcomes, compliance, the type and duration of antimicrobial treatment for BV and VVC were evaluated. Results: in women with BV and VVC who received Lactogynal®, no recurrences during the follow-up were reported (p<0.05). In women who received standard antimicrobial treatment only, the rate of recurrences of BV and VVC was 40% and 28%, respectively. As to the complications of pregnancy, delivery, and the postpartum period, women with BV who received probiotic therapy were less often diagnosed with anemia (p<0.05) while women with VVC who received probiotic therapy were less often diagnosed with the premature rupture of membranes (p<0.05). Conclusions: Lactogynal® is an effective and safe tool to normalize vaginal microflora after antimicrobial treatment for BV and to prevent VVC recurrences during the 3rd trimester of pregnancy. This drug (as a part of complex treatment for BV and VVC) reduces the risk of recurrences and promotes a more favorable pregnancy course until delivery. KEYWORDS: lactobacilli, bacterial vaginosis, vulvovaginal candidiasis, pregnancy, vaginal microflora. FOR CITATION: Radzinskiy V.E., Manukhin I.B., Ordiyants I.M. et al. Efficacy of normalization of vaginal microbiota after antimicrobial treatment for bacterial vaginosis and bacterial vaginosis in pregnant women (results of the multicenter prospective non-interventional comparative study). Russian Journal of Woman and Child Health. 2021;4(3):192–200 (in Russ.). DOI: 10.32364/2618-8430-2021-4-3-192-200.

To study the prevalence of bacterial vaginosis (BV) in pregnant women and to evaluate the accuracy of clinical criteria for the diagnosis of BV. In this observational study 502 asymptomatic pregnant women were screened for bacterial vaginosis in a rural health care facility by Gram stain. Accuracy of clinical diagnosis using individual and two of Amsel's criteria was evaluated. The frequency of BV was 8.6% by Nugent's method. For Amsel's criteria, sensitivity and specificity was 51.2 and 98%, with 71% PPV and 95.5% NPV. The most sensitive individual criterion was vaginal pH, but with lowest specificity. The criterion with highest specificity was clue cells. The combination of the two criteria, vaginal pH and positive amine test, had best positive and negative predictive values 60.5 and 97.8%, respectively. The diagnosis of BV according to Amsel's criteria may be simplified using a combination of the two criteria, vaginal pH and amine test, in settings where microscopy or Gram staining is not available.

Objective: To determine the prevalence of Bacterial Vaginosis (BV) in pregnant women using a simple clinical diagnostic approach. Method: The clinical criteria developed by Amsel`s and colleagues were used as a reference standard for accurate diagnosis of Bacterial vaginosis (BV) infection. This is based on the presence of the following clinical signs 1) Homogeneous thin, white vaginal discharge 2) Presence of clue cells (greater than 20%). 3) Positive amine (whiff) test. 4) Vaginal pH > than 4.5. The presence of any three of the four clinical criteria was considered diagnostic for BV. Samples were collected from 75 pregnant females, irrespective of their gestational duration, presenting with vaginal discharge at the antenatal clinic of Jinnah Hospital, Lahore. Results: BV was diagnosed in 14 females giving an incidence of 18.7%. The, most common symptom was a thin white homogeneous vaginal discharge seen in 27(36%) women. The other diagnostic clinical signs observed were the presence of clue cells on wet mount 9(12%), positive `whiff` test 13(17.3%), and elevated pH>4.5 in 18(24%) women. Microscopic analysis of vaginal secretion revealed diminished polymorph epithelial ratio 19(25.3%) and loss of normal vaginal Lactobaclli 22(29.3%). The other associated findings were candidiasis seen in 16(21.3%) women, while Trichomonas infection in only one woman. These findings were confirmed on Gram staining. Gardnerella vaginalis 9(12%) and Gram variable organisms (Mobiluncus) 11(14.7%) were also identified by Gram smear of vaginal discharge. Conclusion: The clinical diagnosis of BV infection can be established by identifying three of Amsel`s four clinical criteria. In most cases it provides a rapid inexpensive and accurate diagnosis. Strategies should be planned to screen and treat women with BV so as to prevent adverse Obstetric outcome associated with it.

Antibiotics for adverse outcomes of pregnancy

Bacterial vaginosis is the most common disease of the genitals and affects 20–70% of women. This non-inflammatory syndrome is characterized by dysbiosis of the vaginal microbiota and is accompanied by a decrease in the number of lactobacilli. Bacterial vaginosis in 60% of pregnant women is asymptomatic, but can lead to obstetric complications such as late miscarriage, premature birth, fetal growth restriction, premature rupture of membranes, choriominionitis, postpartum endometritis, and sepsis. The clinical picture of bacterial vaginosis in pregnant women is the same as in non-pregnant women, namely homogeneous whitish-gray discharge from the genital tract, often with an unpleasant “fishy” smell, rarely itching and/or burning in the genital area and urethra, as well as soreness during urination (dysuria), with no signs of an inflammation detected in the genitals. Diagnosis of bacterial vaginosis in pregnant women, as well as in non-pregnant women, is based on the use of clinical and laboratory methods. Multiplex tests based on the nucleic acid amplification method, such as real-time polymerase chain reaction, are very popular for the diagnosis of bacterial vaginosis in this country. The Femoflor-16 Reagent Kit (DNA Technology CJSC, Moscow, Russia) is designed to detect the DNA of opportunistic microorganisms, lactobacilli DNA and human genomic DNA (as a control for taking biological material). Examination of pregnant women, especially in case of complaints of vaginal discharge, should be carried out when registering for pregnancy in order to start treatment early and prevent adverse pregnancy outcomes for the mother and fetus. Biofilms formed by microorganisms in bacterial vaginosis, especially G. vaginalis, limit the penetration of antibacterial agents to bacteria, their concentration being lower than therapeutic one, which leads to ineffective treatment. There remain many unexplored issues related to changes in the epidemiology of bacterial vaginosis, an increase in the frequency of relapses against the background of increasing resistance of microorganisms associated with bacterial vaginosis to antibiotics, and the development of agents that affect bacterial films.

Bacterial vaginosis has been associated with preterm birth. In clinical trials, the treatment of bacterial vaginosis in pregnant women who previously had a preterm delivery reduced the risk of recurrence. To determine whether treating women in a general obstetrical population who have asymptomatic bacterial vaginosis (as diagnosed on the basis of vaginal Gram's staining and pH) prevents preterm delivery, we randomly assigned 1953 women who were 16 to less than 24 weeks pregnant to receive two 2-g doses of metronidazole or placebo. The diagnostic studies were repeated and a second treatment was administered to all the women at 24 to less than 30 weeks' gestation. The primary outcome was the rate of delivery before 37 weeks' gestation. Bacterial vaginosis resolved in 657 of 845 women who had follow-up Gram's staining in the metronidazole group (77.8 percent) and 321 of 859 women in the placebo group (37.4 percent). Data on the time and characteristics of delivery were available for 953 women in the metronidazole group and 966 in the placebo group. Preterm delivery occurred in 116 women in the metronidazole group (12.2 percent) and 121 women in the placebo group (12.5 percent) (relative risk, 1.0; 95 percent confidence interval, 0.8 to 1.2). Treatment did not prevent preterm deliveries that resulted from spontaneous labor (5.1 percent in the metronidazole group vs. 5.7 percent in the placebo group) or spontaneous rupture of the membranes (4.2 percent vs. 3.7 percent), nor did it prevent delivery before 32 weeks (2.3 percent vs. 2.7 percent). Treatment with metronidazole did not reduce the occurrence of preterm labor, intraamniotic or postpartum infections, neonatal sepsis, or admission of the infant to the neonatal intensive care unit. The treatment of asymptomatic bacterial vaginosis in pregnant women does not reduce the occurrence of preterm delivery or other adverse perinatal outcomes.

Background Bacterial vaginosis has been associated with preterm birth. In clinical trials, the treatment of bacterial vaginosis in pregnant women who previously had a preterm delivery reduced the risk of recurrence. Methods To determine whether treating women in a general obstetrical population who have asympto- matic bacterial vaginosis (as diagnosed on the basis of vaginal Gram’s staining and pH) prevents preterm delivery, we randomly assigned 1953 women who were 16 to less than 24 weeks pregnant to receive two 2-g doses of metronidazole or placebo. The diagnostic studies were repeated and a second treatment was administered to all the women at 24 to less than 30 weeks’ gestation. The primary outcome was the rate of delivery before 37 weeks’ gestation. Results Bacterial vaginosis resolved in 657 of 845 women who had follow-up Gram’s staining in the metronidazole group (77.8 percent) and 321 of 859 women in the placebo group (37.4 percent). Data on the time and characteristics of delivery were available for 953 women in the metronidazole group and 966 in the placebo group. Preterm delivery occurred in 116 women in the metronidazole group (12.2 percent) and 121 women in the placebo group (12.5 percent) (relative risk, 1.0; 95 percent confidence interval, 0.8 to 1.2). Treatment did not prevent preterm deliveries that resulted from spontaneous labor (5.1 percent in the metronidazole group vs. 5.7 percent in the placebo group) or spontaneous rupture of the membranes (4.2 percent vs. 3.7 percent), nor did it prevent delivery before 32 weeks (2.3 percent vs. 2.7 percent). Treatment with metronidazole did not reduce the occurrence of preterm labor, intraamniotic or postpartum infections, neonatal sepsis, or admission of the infant to the neonatal intensive care unit. Conclusions The treatment of asymptomatic bacterial vaginosis in pregnant women does not reduce the occurrence of preterm delivery or other adverse perinatal outcomes

Bacterial vaginosis (BV) is a lower genital tract infection of reproductive women which can occur in pregnant and non-pregnant women. BV in pregnant women can increase the risk of complications, including increased incidence of abortion, premature rupture of membranes, preterm birth, and babies with low birth weight. BV can also increase the risk of acquired sexually transmitted infection (STI) and their further transmission, including human immuno-deficiency virus (HIV). Each country has a different prevalence of BV. The previous report of BV prevalence in pregnant women was submitted in Jakarta, Indonesia in 1990. Until now, there is no update data of BV in pregnant women, especially in West Java, Indonesia. Thus, we conducted a descriptive observational study using a cross-sectional design and a consecutive sampling method in June 2018. This study included 60 pregnant women in the Maternal and Child Hospital, Bandung, Indonesia. Out of 60 participants, seven (11.67%) participants had BV according to Amsel criteria. Asymptomatic BV was diagnosed in all participants. This study shows the prevalence of BV in pregnant women in the Maternal and Child Hospital in Bandung during June 2018. The assessment of screening BV should be recommended as a routine workup. To avoid complications in pregnant women and infants it should not be waited for the symptoms to reveal.

Objective: To study the incidence of bacterial vaginosis in pregnant women in preterm labor and in labor at term and the relation of bacterial vaginosis with preterm delivery, neonatal birth weight and puerperal sepsis. Material and Methods: This prospective case control study included 150 pregnant women. 100 pregnant women with singleton pregnancy between 28 to 36 weeks of pregnancy with preterm labor pains were selected randomly in study group and 50 pregnant women in labor at term ( >37 weeks) were enrolled in control group. Diagnosis of bacterial vaginosis was made by clinical criteria (Amsel’s criteria). The two groups were compared in regard to the presence of bacterial vaginosis. Pregnancy outcome variables assessed included gestational age at delivery, neonatal birth weight and puerperal sepsis. Results: In study group 38% women, while in the control group 16% women had bacterial vaginosis. This difference is statistically highly significant. ( p < .001). Out of 30 women with bacterial vaginosis in study group, 27 (90%) women delivered before 37 completed weeks, while only 10% delivered at term. Bacterial vaginosis was associated with low birth weight and was significantly associated with puerperal sepsis. Conclusion: Bacterial vaginosis in pregnancy is associated with adverse pregnancy outcomes including preterm labor, preterm delivery, low birth weight and puerperal sepsis. Thus screening for bacterial vaginosis in all pregnant women complaining of vaginal discharge and also in all patients with preterm labour is justifiable.

Bacterial vaginosis is a disease that is a public health problem, especially in women, both non-pregnant and pregnant women. Bacterial vaginosis is caused by an excess and overgrowth of anaerobic bacteria such as Gardnerella vaginalis, Ureaplasma urealyticum, Mycoplasma hominis, Mobiluncus sp., Prevotella sp., and other anaerobic bacteria. Bacterial vaginosis is characterized by the presence of an itchy greyish white discharge with a fishy odor, an increase in the pH of the vaginal fluid and is found clue cells on Whiff's test using KOH10%. Management of bacterial vaginosis is in the form of antibiotics with the drug of choice being metronidazole 500 mg orally twice a day for 7 days. In pregnant women, bacterial vaginosis has been reported to increase the incidence of abortion, premature rupture of membranes, preterm labour, low birth weight, and intrauterine infection. Therefore, early diagnosis and appropriate management of bacterial vaginosis can reduce maternal and infant morbidity and mortality.