Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/30/2018 |
| Start Date: | June 2016 |
| End Date: | May 2019 |
The aim of this project is to identify the duration of vancomycin administration at which
group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal
mucosa. This will aid in labor management and delivery planning to ensure that the mother
receives adequate GBS prophylaxis while also minimizing the duration of exposure to
vancomycin. In addition, this could prevent unnecessary prolonged hospitalization or septic
workup of neonates whose mothers received vancomycin intrapartum.
This study aims to identify the time after administration of IV vancomycin at which GBS
colonies are 100% eradicated.
group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal
mucosa. This will aid in labor management and delivery planning to ensure that the mother
receives adequate GBS prophylaxis while also minimizing the duration of exposure to
vancomycin. In addition, this could prevent unnecessary prolonged hospitalization or septic
workup of neonates whose mothers received vancomycin intrapartum.
This study aims to identify the time after administration of IV vancomycin at which GBS
colonies are 100% eradicated.
Prophylaxis of group B streptococcus has been a major component of prenatal care in
preventing early onset of neonatal sepsis. While penicillin remains the gold standard
medication for prophylaxis, this medication is not an option in women who have high risk
allergic reactions to this class of medications. Furthermore, with rising rates of antibiotic
resistance to erythromycin and clindamycin, more women are requiring vancomycin for GBS
prophylaxis. While the CDC and ACOG recommend vancomycin as an alternative to penicillin for
GBS prophylaxis, little research has been conducted investigating the transplacental passage
of vancomycin.
Because of the gap in knowledge regarding intrapartum effects of IV vancomycin on GBS
colonization, neonates of women who received vancomycin are considered as inadequately
treated for GBS prophylaxis, and subsequently undergo additional observation, prolonged
hospitalization, and possible septic workup in the immediate postpartum period. Because of
this gap in knowledge, this research study investigates how quickly vaginal and recto-vaginal
GBS colonization is eradicated to aid in timing of delivery in patients with GBS colonization
who require vancomycin intrapartum.
In addition, the studies that investigated the duration of time of IV penicillin and IV
clindamycin necessary for eradication of GBS colonization only investigated vaginal
colonization, not recto-vaginal colonization. Their rationale was based on the assumption
that most cases of neonatal GBS sepsis are caused by vaginal colonization. Given that the
standard of care for GBS screening includes screening for colonization of both vaginal and
rectal mucosa, investigators also plan to compare rates of eradication of GBS in vaginal
colonies compared to recto-vaginal colonies.
preventing early onset of neonatal sepsis. While penicillin remains the gold standard
medication for prophylaxis, this medication is not an option in women who have high risk
allergic reactions to this class of medications. Furthermore, with rising rates of antibiotic
resistance to erythromycin and clindamycin, more women are requiring vancomycin for GBS
prophylaxis. While the CDC and ACOG recommend vancomycin as an alternative to penicillin for
GBS prophylaxis, little research has been conducted investigating the transplacental passage
of vancomycin.
Because of the gap in knowledge regarding intrapartum effects of IV vancomycin on GBS
colonization, neonates of women who received vancomycin are considered as inadequately
treated for GBS prophylaxis, and subsequently undergo additional observation, prolonged
hospitalization, and possible septic workup in the immediate postpartum period. Because of
this gap in knowledge, this research study investigates how quickly vaginal and recto-vaginal
GBS colonization is eradicated to aid in timing of delivery in patients with GBS colonization
who require vancomycin intrapartum.
In addition, the studies that investigated the duration of time of IV penicillin and IV
clindamycin necessary for eradication of GBS colonization only investigated vaginal
colonization, not recto-vaginal colonization. Their rationale was based on the assumption
that most cases of neonatal GBS sepsis are caused by vaginal colonization. Given that the
standard of care for GBS screening includes screening for colonization of both vaginal and
rectal mucosa, investigators also plan to compare rates of eradication of GBS in vaginal
colonies compared to recto-vaginal colonies.
Vancomycin Arm
Inclusion Criteria
- Women aged 18 years or older
- Pregnancies of at least 37w0d gestation at delivery
- History of high-risk allergy to penicillin (including pruritic rash, urticaria,
swelling, anaphylaxis)
- Women who are GBS positive
- Culture proven resistance or
- Unknown resistance to clindamycin or erythromycin
Exclusion Criteria
- Women with low risk allergy to penicillin
- History of allergy to vancomycin
- History of Red Man Syndrome
- History of renal or hepatic disease
- Immunocompromised patients
- History of chronic steroid use in current pregnancy
- Patient with fever or signs of chorioamnionitis on admission
Penicillin Arm
Inclusion Criteria
- Women aged 18 years or older
- Women who are GBS positive
- Pregnancies of at least 37w0d gestation at delivery
Exclusion Criteria
- Immunocompromised patients
- History of chronic steroid use in current pregnancy
- Patient with fever or signs of chorioamnionitis on admission
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