Preventive antibiotic treatment during child birth for the prevention of group G and C streptococcal infekctions

Phase 1

• Conditions: 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: 20.1Level: LLTClassification code 10004038Term: Bacterial infection due to streptococcus, group CSystem Organ Class: 100000004862; MedDRA version: 20.1Level: LLTClassification code 10004040Term: Bacterial infection due to streptococcus, group GSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-002696-34-FI
• Lead Sponsor: niversity of Oulu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 696

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Main Objective: To evaluate the effect of intrapartum antibiotic profylaxis for the prevention of Group G/C infetions of the mother and the newborn. ;Primary end point(s): A postpartum infection of the mother requiring antibiotic treatment (primary end point).<br><br>;Timepoint(s) of evaluation of this end point: Up to 3 months after delivery.

Secondary Outcome Measures

Name	Time	Method
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.;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.