Clinical trial NCT05156333: Probiotics and GBS Colonization in Pregnancy
Official title: Probiotics in Pregnancy and Rectovaginal Group B Streptococcus (GBS) Colonization
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: GBS Rectovaginal Colonization
Neonatal Sepsis
Keywords: Probiotics
Pregnancy
GBS colonization
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
Collaborators: name: Daniela Menichini
name: Maria Longo
First posted: 2021-12-14
Enrollment: 402
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group study aimed at underestimating the feasibility and effect of the use of probiotic starting from week 30 on vaginal / rectal colonization of GBS in women at low obstetric risk.
Primary purpose: PREVENTION

Brief summary: Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.

Detailed description: Multicenter, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.

The study includes low obstetric risk pregnant women within the 33rd week of gestation, with vaginal delivery expected. It excludes women who during pregnancy had a positive urine culture for GBS, women with a previous newborn suffering from early sepsis, use of antibiotics in the month prior to enrollment, women unable to understand the study and sign informed consent.

Intervention Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.

Eligibility criteria: Inclusion Criteria:

* low obstetric risk pregnant women by the 33rd week of gestation,
* vaginal delivery expected.

Exclusion Criteria:

* positive urine culture for GBS,
* previous newborn suffering from early sepsis,
* use of antibiotics in the month prior to enrollment,
* women unable to understand the study and sign informed consent.

Primary outcomes:
measure: GBS Rectovaginal colonization
timeFrame: at 35-37 weeks
Secondary outcomes:
measure: Intrapartum antibiotics profilaxisi
timeFrame: during labor
Other outcomes:
measure: PROM
timeFrame: pre-labor
measure: Pathologic APGAR score
timeFrame: at delivery
measure: Need for neonatal antibiotics
timeFrame: within the first 48 hours after birth
measure: Neonatal sepsis
timeFrame: within the first week after birth
Locations:
city: Milan
country: Italy
facility: Ospedale dei Bambini "Vittore Buzzi"
state: MI
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova Reggio Emilia
state: RE
city: Modena
country: Italy
facility: University Hospital of Modena
Study officials:
References: