GBS Rectovaginal Colonization, Neonatal Sepsis
Conditions
Keywords
Probiotics, Pregnancy, GBS colonization
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.
Interventions
DIETARY_SUPPLEMENTRespecta
Respecta® complex (mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171). 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.
Sponsors
Daniela Menichini
Maria Longo
University of Modena and Reggio Emilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The randomization (1: 1) will take place in each center, using the same allocation sequence, in blocks of 4, with the indication of the treatment code inserted in a white, closed envelope. The code will correspond to the number written on the packages to be administered and the list of codes containing the definition of the treatments, will be kept in a sealed envelope, by a collaborator of the PI (Head Nurse), and opened upon completion of the study or at the time of need, in case maternal-fetal or neonatal serious adverse event. No member of the research team knows which treatment the patients receive because both the active and the placebo are packaged identically and are contained in identical white boxes. Only the randomization numbers distinguish them.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GBS Rectovaginal colonization | at 35-37 weeks | Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 \^ week). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intrapartum antibiotics profilaxisi | during labor | Rata of women requiring antibiotic profilaxis intrapartum |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROM | pre-labor | Prelabor rupture of membranes evaluated according to clinical signs or fibronectin test |
| Pathologic APGAR score | at delivery | The Apgar score is a measure of a baby's condition after birth. It guides midwives, doctors and nurses as to whether a baby needs immediate treatment or monitoring. It is used to check a newborn baby born at 1 minute and 5 minutes after their birth. It is named after Dr Virginia Apgar who developed the score. The Apgar score goes from 0 to 10 and it is classified as pathologic when is \</= 7 |
| Need for neonatal antibiotics | within the first 48 hours after birth | Rate of neonates requiring antibiotics within the first 48h of life |
| Neonatal sepsis | within the first week after birth | Rate of neonates developing a sepsis |
Countries
Italy
Outcome results
None listed