Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02637986 |
| Other study ID # |
0173-13-EMC |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 7, 2022 |
| Est. completion date |
November 7, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
HaEmek Medical Center, Israel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are
associated with several maternal and fetal complications, including maternal septic shock,
preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the
prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that
alterations in the vaginal flora were associated with recurrent UTIs, and probiotic
administrations may have a role in preventing those infections. Nevertheless, this has never
been tested in pregnant women.
Description:
Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are
associated with several maternal and fetal complications, including maternal septic shock,
preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the
prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that
alterations in the vaginal flora were associated with recurrent UTIs, and probiotic
administrations may have a role in preventing those infections. Nevertheless, this has never
been tested in pregnant women.
Working hypothesis and aims:Administration of oral probiotic formula to pregnant women,which
suffered from at least one episode of UTI, will reduce the recurrence of future UTIs events.
Methods: A prospective randomized double blind placebo-control study. Pregnant women which
suffered from at least one event of UTI during pregnancy will be divided into 2 research
arms:
ARM A - women who suffered from one episode of UTI during pregnancy before recruitment: after
antibiotic treatment achieving a sterile bacterial urine culture, these patients will be
divided into a research group which will receive the probiotic formula Urex Plus containing
L. rhamnosus GR-1 and L. reuteri RC-14, and a control group, which will receive a placebo,
twice a day until delivery.
ARM B - women who suffered from more than one episode of UTI or one episode of pyelonephritis
during pregnancy before recruitment will receive a preventive antibiotic treatment until
delivery. Similarly to ARM A, after achieving a sterile bacterial urine culture, those women,
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 delivery.
Once a month and with symptoms, urine culture will be taken in all of the study arms. Vaginal
swab test will also be taken to detect the presence of abnormal vaginal flora and
semi-quantitative assessment of vaginal lactobacilli.
Data regarding the rate of recurrent UTIs, time until infection, average number of
infections, the rate of pyelonephritis infections and obstetrical and neonatal outcomes will
be collected.
