Pregnancy
Conditions
Brief summary
Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV) by taking vaginal smear. Treatment will be given according to the results.
Detailed description
Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect AVF/BV by taking vaginal smear. Diagnosis will be according to the Nugent score criteria. Treatment will be given according to the results: Patient with a positive smear for AVF- patients tested positive will be treated with either clindamycin or metronidazole. Following treatment another smear will be taken according to which the patients will be divided into 2 research groups: (1) Assessing the effectiveness of probiotic formula to prevent AVF re-infection (secondary infection) - this group includes patients with normal vaginal flora following antibiotic administration. (2) Assessing the effectiveness of probiotic formula to eradicate AVF - this group includes patients with persistent AVF following antibiotic administration (first and second line). In each group the patients will be divided into a research group which will receive the probiotic formula UREX PLUS (containing L. rhamnosus GR-1and L. reuteri RC-14) and a control group which will receive a placebo twice a day until 36.6 weeks of gestation. Patient with a negative smear for AVF - in those patients the effectiveness of probiotic formula will be tested for primary prevention. These patients will be divided into a research group which will receive the probiotic formula UREX PLUS and a control group which will receive a placebo twice a day until 36.6 weeks of gestation. Finally, the colonization of lactobacilli in the vaginal flora will be examined by dividing patients with normal vaginal flora into one group receiving a probiotic capsule containing L. rhamnosus GR-1 and L. reuteri RC-14 twice a day for 2 months and a second group without intervention. After two months the group receiving probiotic capsule will receive no treatment and the second group will receive probiotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 twice a day for 2 months.
Interventions
DIETARY_SUPPLEMENTUrex Plus
Probiotic
OTHERPlacebo
capsule without active ingredient
DIETARY_SUPPLEMENTProbotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pregnant women from at least 13 weeks of gestation with a risk factor for preterm labor
Exclusion criteria
* Women with preterm premature rupture of the membranes * Immunocompromised women * Planned elective preterm birth for reasons other than preterm premature rupture of membranes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The amount of lactobacilli in the vaginal | once a month until week 36.6 of labor | Lactobacilli culture will be made from a vaginal specimen. The pattern of bacterial growth will be used for a semi-quantitative interpretation in a scale of 0-no vaginal colonization to 4-substantial colonization. |
| The rate of women with normal vaginal flora at enrollment, who developed AVF/BV during the study period | From date of randomization until the date of first documented episode or until delivery (around 4 months) | — |
| The rate of women with AVF/BV at enrollment whose infection was eradicated following antibiotics, who developed AVF/BV during the study period | From date of randomization until the date of first documented episode or until delivery (around 4 months) | — |
| The rate of women with AVF/BV at enrollment whose infection was not eradicated following antibiotics, who restored the normal vaginal flora during the study period | Until delivery (around 4 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of time from the beginning of the study until an episode of AVF/BV | From date of randomization until the date of first documented episode or until delivery (around 4 months) |
| Number of urinary tract infections during the study period | Until delivery (around 4 months) |
| The number of episodes of BV/AVF during pregnancy | Until delivery (around 4 months) |
| The rate of women, who suffer from obstetrical outcomes(preterm labor, intrauterine growth restriction, preterm premature rupture of membranes, chorioamnionitis, post-partum fever, post-partum endometritis, neonatal sepsis and neonatal complications) | Until delivery (around 4 months) |
| The rate and type of adverse effects in the probiotic versus placebo groups | Until delivery (around 4 months) |
Countries
Israel
Outcome results
None listed