Participants are pregnant women found to carry group G or C Streptococcus as part of their vaginal-rectal flora in the late pregnancy vaginal-rectal culture routinely taken as GBS screening MedDRA version: 20.1 Level: LLT Classification code 10004038 Term: Bacterial infection due to streptococcus, group C System Organ Class: 100000004862 MedDRA version: 20.1 Level: LLT Classification code 10004040 Term: Bacterial infection due to streptococcus, group G System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Benzylpenicillin Panpharma 3 g (5 milj. KY) inj/inf kuiva-aine liuosta varten
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: BENZYLPENICILLIN
Sponsors
University of Oulu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All pregnant women who are shown by late pregnancy culture (taken at 35+0-38+0 gestational weeks) to carry group G or C Streptococcus in their vaginal-rectal flora are asked to participate. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 696 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are as follows: - The expectant mother carries both group B Streptococcus (GBS) and group G/C Streptoccoccus - The expectant mother has had a urinary infection caused by Group B Streptococcus at any time during her pregnancy or a previous child with GBS infection, as these women will routinely recieve antibiotic profylaxis during labour regardless of group G/C status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of intrapartum antibiotic profylaxis for the prevention of Group G/C infetions of the mother and the newborn. ;Secondary Objective: To clarify the role of group G/C streptococcus as a causative pathogen in the infections of the mother and the newborn both during labour and postpartum/neonatal period.;Primary end point(s): A postpartum infection of the mother requiring antibiotic treatment (primary end point). ;Timepoint(s) of evaluation of this end point: Up to 3 months after delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points: Positive blood culture of the mother, mode of delivery, need for blood culture from the newborn, antibiotic treatment of the newborn, transfer to NICU, days in the hospital for the mother and the newborn.;Timepoint(s) of evaluation of this end point: Up to 3 months after delivery for the mother and up to 18 months after birth for the newborn. | — |
Countries
Finland
Contacts
Public ContactDepartment of OB&GYN
Oulu University Hospital
Outcome results
None listed