Intrapartum Protocol for GBS Negative Mothers Who

Received Antibiotics within Three Months of delivery

CASE PRESENTATION

SEPTEMBER 21, 2017

PERINATAL QUALITY COLLABORATIVE OF NORTH CAROLINA

Corinne Cochran DNP, NNP-BC

Sharon J. McCormick MS, MT (ASCP)
Jane Clair Dawkins, BSN, RN
 GBS Quick Review
Group B beta-hemolytic streptococcus
Streptococcus agalactiae
Group B is a cell-wall carbohydrate (18 types)

During 1960s became most common cause of newborn sepsis

In women, colonization is 15 35%, colonization can be intermittent

or constant

Intrapartum antimicrobial prophylaxis has decreased incidence of

early-onset newborn by 80%
 GBS Quick Review
Important Risk Factors:
Confirmed or suspected invasive maternal infection during labor or 24
hours before or after delivery
GBS affected previous sibling
Maternal GBS colonization, bacteriuria, or infection in current pregnancy
Intrapartum fever > 38 degrees C (100.4 F)
Rupture of membranes > 18 hours in term and preterm

Neonatal GBS Sepsis

v Early onset (<7 days)
Systemic infection, respiratory distress, shock, apnea, pneumonia.
(CSF only 5-10%)

v Late onset (7-89 days)

Occult onset bacteremia or meningitis (CSF 30%)
 Cost Associated with Early-onset GBS Sepsis

Direct cost of early onset GBS sepsis per case term infant $17,723-
$21,824

Total direct and indirect costs of early onset GBS sepsis per case
term infant $67,764 - $95,433

(Turrentine & Mastrobattista, 2017)

 Case Presentation A
Maternal Newborn
19 y.o. GI Presentation:
Pregnancy: Well appearing after birth
31 weeks- Tx UTI no culture Presented at 5 hours of age with
35 weeks- Admission NST due to respiratory distress,
MVA, IM Rocephin, suspected hypoglycemia, hypothermia
UTI Culture grew gram positive cocci
36 weeks- GBS screen negative within 9 hours
Intrapartum Treatment Course
Induction 40.2 Transfer to UNC-
AROM 12 hours v Septic shock, profound
Afebrile before and after delivery hypotension
APGAR 8, 9 Survived & discharged home
 Case Presentation A:
Predictor variables: 40.2wk, ROM 12hrs, Afebrile, NO intrapartum antibiotic prophylaxis
*Incidence of Early Onset Sepsis 0.6/1000 live births

Negative GBS (presumed) Positive GBS (actual)

 Case Presentation B
Maternal Newborn
18 y.o. G1 Presentation:
Pregnancy:
Difficult transition after birth 02 in
31weeks urine w/ mixed flora no tx delivery room
34 weeks urine mixed flora,
Transfer to NICU at 1 hour of age
admitted flank pain, kidney stones,
mild respiratory distress and 02
suspected UTI, IV ceftriaxone
requirement
35 weeks GBS Screen negative
Culture grew gram positive cocci
38 weeks UTI mixed flora tx PO
within 11 hours
Macrobid
Intrapartum
CSF with elevated WBC culture
negative.
NSVD 40.6
Treatment Course
AROM 6 hours, meconium
Afebrile before and after delivery Tx for suspected meningitis and
bacteremia x 14 days and
APGAR 6,8
discharged home
Case Presentation B
Predictor variables: 40.6 wk, ROM 6hrs, Afebrile, NO intrapartum antibiotic prophylaxis
*Incidence of Early Onset Sepsis 0.6/1000 live births
Negative GBS (presumed) Positive GBS (actual)
 Case Presentation C
Maternal Newborn
23 y.o. G2P1001 Presentation:
Pregnancy: Well appearing after birth
Previous pregnancy GBS + Presented at 7 hours of age
Hx Hepatitis C grunting, would not PO feed
TX UTI at 29 weeks Culture grew gram positive cocci
Cholestasis within 8 hours
GBS negative @36 weeks Treatment Course
Intrapartum Transfer to UNC-
Induction 37.2 r/t Cholestasis v Septic shock, profound
AROM 12 hours hypotension
Afebrile before and after delivery Survived & discharged home
APGAR 8, 9
Case Presentation C
Predictor variables: 37.2wk, ROM 12hrs, Afebrile, NO intrapartum antibiotic prophylaxis
*Incidence of Early Onset Sepsis 0.6/1000 live births

Negative GBS (presumed) Positive GBS (actual)

Perfect Storm:

UTI, some Negative

symptomatically GBS Screen
@ 36 weeks
treated
Negative GBS
screening due to
exposure of UTI within
8-10 weeks
antibiotics weeks of delivery
earlier RX

Newborn GBS
Septicemia
 Common Cause Analysis

v Prior to June 2016 no cases of newborn GBS disease at MRH

v Between July 2016 and March 2017 three cases of newborn GBS
v All three cases: mothers screened GBS negative
v All three cases: mother received antibiotics between 7 and 41 days
prior to screening
 Feb 2017 Late March GBS
March 2017
3 Cases Early Infection 2017 Rapid
OB Section
GBS Control Multidisciplinary Screen
Notified Policy
Notified task force

Neonatology
9 Nursing
months Pharmacy
Lab
OB
 Admission to LD in Labor Full-term

LD Admission GBS LD Admission GBS LD Admission GBS

Negative Unknown Positive

GBS
Antibiotics
last 3 months? Rapid Screen
Policy

NO YES

GBS Rapid Screen

Rapid Screen Rapid Screen

Routine Care Routine IAP
GBS Negative GBS Positive
Laboratory Detection:
Group B Strep during
Pregnancy
Traditional Culture
taken 35-37 weeks

v Vaginal/rectal swab
collected

v Inoculated into LIM broth

overnight at 35C

v Sub onto SBA and CNA

media

v Check for large

translucent colonies with
beta hemolysis
The Cepheid Solution: Xpert GBS

FDA Cleared Kit

Highly sensitive and specific
Results in ~52 minutes
Reagents on board
On-demand results: 24/7
Random access
Minimal hands-on time
Closed system minimizing
contamination
Sample Type:
Vaginal/rectal double-
swab specimens
Xpert GBS Assay Testing Protocol
 Factors That Negatively Affect Results
v Incorrect swabbing technique
Always swab the vagina and then the rectum
Vaginal only swabbing can cause errors or invalid test results
v Use of unapproved swabs
Only use Cepheid Collection Device (P/N 900-0370)
Other swabs can cause errors or invalid results
v Length of swab inserted in the Xpert cartridge
Break the swab at the score mark
Make sure the swab is free to move within the sample chamber
v Incorrect storage of collected specimen
If specimen is to be run on a different day from collection, store the specimen at
a temperature of 2 to 8C
Avoid storage in other conditions because they can cause errors or invalid test
results
 Interfering Substances

Inhibition may occur if the following are present in excessive

amounts:
Mucus
Blood
Lubricant

Running tests in the presence of excessive amounts of these

substances can cause errors or invalid results
 Clinical Trials
Intrapartum Rapid GBS Testing in Patients Presenting with Threatened
Preterm Labor (Not yet published, available at ClinicalTrials.gov.)

Interventional study to evaluate the test characteristics of a rapid intrapartum

real- time polymerase chain reaction (RT-PCR) compared to the intrapartum
GBS culture as the standard in preterm patients presenting with threatened
preterm labor or with obstetric indications for preterm delivery.

The investigators seek to evaluate the utility of RT-PCR for screening of GBS in
women at risk of preterm labor with an unknown GBS status. The investigators
also aim to identify the ability of RT-PCR to identify GBS colonization in patients
who would have otherwise been missed by culture.

Intrapartum Rapid GBS Testing in Patients Presenting With Threatened Preterm Labor. [serial online]. 2017;Available
from: ClinicalTrials.gov, Ipswich, MA. Accessed September 13, 2017
 FirstHealth GBS Rapid Screen Protocol

Cost
Lab cost $24.00 per test (not including labor)
Began Screening April 2017
Total specimens = 21 ~$500
Total positive 11 (52%)
Direct cost of early onset GBS sepsis case term infant $17,723-
$21,824

Estimated cost savings?

Do the math..
Questions?
 References
Fong, A. (2017). Intrapartum Rapid GBS Testing in Patients Presenting With Threatened Preterm Labor. [serial online].
2017;Available from: ClinicalTrials.gov, Ipswich, MA. Accessed September 13, 2017

Turrentine M, Ramirez M, Mastrobattista J. (2009) Cost-Effectiveness of Universal Prophylaxis in Pregnancy with Prior
Group B Streptococci Colonization. Infectious Diseases In Obstetrics & Gynecology [serial online].
January, 2009:2. Available from: Complementary Index, Ipswich, MA. Accessed September 8, 2017.