Group B strep infection: preventable peril for newborns.

Group B Streptococcus (GBS) is a common strain of bacteria. In women it is sometimes found in the intestinal and urogenital tracts--that is, in the intestine, rectum, vagina, cervix, or uterus. In some parts of the country as many as 30 percent of women carry GBS. It usually does not give them noticeable symptoms of infection, but it can.

Babies who come in contact with GBS during the birth process may contract an infection resulting in meningitis, a localized inflammation of the lining of the brain or spinal cord that can cause brain damage; sepsis, a devastating generalized infection; or death. In the United States, between 12,000 and 15,000 infants per year are infected with GBS at birth.(1) A significant number of them die or sustain severe permanent brain damage as a result.

This disease is highly preventable. However, by the time signs of infection are clinically manifest, permanent damage may have occurred.(2)

Health care providers caring for pregnant women should make the effort to find expectant mothers who are actually carrying GBS or are otherwise at high risk to transmit it to their babies. Caregivers should administer prophylactic antibiotics to these women during labor. In some instances the neonates should be treated at birth to prevent infection. Treatment put off until symptoms of infection appear in the infant may not prevent the infection's devastating effects.

Detecting High-Risk Patients

Several screening methods--cultures, smears, rapid tests--can determine if a pregnant woman has GBS in the birth-canal area. To try to establish a GBS bacterial culture, the caregiver scrapes or swabs the suspected site and places the material obtained on a dish of bacterial growth medium, which is then incubated. If GBS is present, it will grow on the culture medium and can be identified by microscopic examination.

Another test involves smearing the scraped or swabbed material onto a microscope slide, treating it with a special dye called Gram's stain, and then evaluating it microscopically. If the slide shows bacteria that are spherical, linked together in chains, and stained ("Gram positive"), the presumptive diagnosis is GBS.

Both tests are inexpensive and simple and can be done in conjunction with any pelvic exam during routine prenatal care. Rapid detection techniques include the latex agglutination method and visual detection methods such as the enzymelinked immunosorbent assay (ELISA test). These tests are more specific for GBS but also more expensive. Not all medical facilities use them.

The American Academy of Pediatrics recently advocated the screening of all pregnant women for GBS at 28 weeks gestation.(3) The American College of Obstetricians and Gynecologists does not recommend routine prenatal screening cultures but states, "In populations in which the incidence of neonatal GBS infection is inordinately high, selective or routine screening cultures can be considered."(4) Patients who have had surgery to the cervix during pregnancy, threatened or arrested preterm labor, or prematurely ruptured amniotic membranes should be screened.

Standard of Care

Appropriate treatment for Group B Strep will depend on the circumstances under which it is discovered.

* Group B Strep is identified before or during labor. If GBS is detected during pregnancy, the nationally recognized standard of care requires that the mother be offered treatment with prophylactic antibiotics when she goes into labor. In certain instances, the baby should be treated with antibiotics immediately at birth. Studies have shown that this is very effective in preventing the newborn from developing a GBS infection.(5)

A pregnant woman may test positive for GBS at any point during her pregnancy. She may have a defined clinical infection such as a urinary tract infection in conjunction with a positive GBS culture. She may have a clinical infection in the birth canal area even though no positive identification of GBS is made.

In both these situations, she should be treated with appropriate antibiotics when the infection is found, and she should also be treated during labor. The earlier treatment may have relieved the symptoms but only temporarily sterilized the birth canal, leaving a reservoir of GBS in the gastrointestinal tract. If so, the bacteria may later have reinfected the birth canal.

Ampicillin is usually given unless the patient is allergic to penicillin. The dose for ampicillin is 2 grams intravenously every 6 hours when the mother is in labor. Erythromycin or clindamycin may be given if the woman is allergic to penicillin.

* Group B Strep is not identified, but the pregnant woman is at high risk for testing positive. Whether or not a pregnant woman is screened during the third trimester, health care providers must look for clinical signs of infection or colonization in the birth canal when labor begins. This is needed even when prior screening for GBS was negative.

The prophylactic treatment protocols described above should be instituted if any signs of clinical infection, colonization, or the risk factors(6) listed below are present. Signs, symptoms, and risk factors that put a pregnant woman at high risk to transmit GBS to her baby include:

1. Invasive surgical procedure in the endocervical area.

2. Previous child affected by Group B Streptococcus.

3. Elevated white blood cell count.

4. Elevated temperature.

5. Pain in endocervical area.

6. Yellow or greenish discharge.

7. Foul-smelling discharge.

8. Microscopic exam of endocervical swabbing that shows Gram-positive round bacteria that are linked together in chains.

9. Clinical inflammation of amniotic sac.

10. Preterm labor (before 37 weeks gestation ) .

11. Preterm rupture of amniotic membranes (before 37 weeks gestation).

12. Membranes ruptured for more than 18 hours.

13. Foul-smelling amniotic fluid.

14. Rapid heartbeat of fetus (baseline rate greater than 160).

The standard of care requires that a woman who has any of these risk factors must be tested for GBS immediately at the onset of labor. The woman should be placed on intravenous antibiotics pending the results of cultures. The newborn infant may be given prophylactic antibiotics immediately after delivery, especially when culture results are not yet known and the mother was not treated earlier.

In evaluating a potential case, it is necessary to determine the time of onset of symptoms in the newborn. There are two types of GBS infection: early onset and late onset.(7) The infection is considered early onset if the infant's symptoms began within 72 hours of birth. The infection is considered late onset if the symptoms first appeared more than 72 hours after birth.

Fifty percent of late-onset infections are believed to have been contracted from the environment after the delivery; 50 percent, from the mother's birth canal during childbirth. An early-onset infection is presumed to have been acquired from the birth canal during childbirth.

In late-onset cases, liability will depend on the failure of the nursery personnel to use aseptic techniques. The focus in these cases is on whether an infant with no known risk factors would have been spared an infection if ordinary care had been used in delivering the baby and aseptic techniques had been used in the newborn nursery.

In early-onset cases, the focus of this article, the high-risk pregnant woman is identified by direct testing or by noting a variety of clinical signs such as premature rupture of membranes or fever that occurs during labor.

Handling the Case

As in other medical negligence cases, the lawyer should first obtain all the medical records documenting every aspect of the mother's prenatal care, the labor and delivery records, the newborn nursery records (including chest X-rays and all other imaging films), and all subsequent medical records pertaining to the baby. The initial review should ascertain that sepsis or meningitis was diagnosed, with Group B Streptococcus identified on the cultures.

Next the lawyer should find out whether clinical signs that would have put the mother at high risk to transmit GBS were present. The research should cover virtually every page of the prenatal and labor and delivery records.

The next question is whether either mother or baby was given prophylactic antibiotics. If so, the standard of care may have been satisfied. If not, the lawyer must ascertain whether the mother was screened for GBS during the third trimester. If she tested positive, the record may show that she was treated sometime during the third trimester.

This treatment may have been medically indicated to deal with an overt Clinical infection at that time. However, this does not satisfy the health care provider's duty to give mother and child prophylactic treatment during labor and the neonatal period. The baby comes in physical contact with the bacteria during the birth process--the key time to prevent the disease.

If the investigation shows an early-onset GBS sepsis with severe and permanent neurological injury, a mother who tested positive for GBS or during labor showed signs of being a GBS carrier, and no preventive treatment for mother or infant, the case is probably meritorious. If the septic baby had an early-onset infection that produced a positive GBS culture, the infection was probably contracted from the mother during the birth process. If the facility negligently failed to respond to the risk factors, the case is probably meritorious.

Possible defendants in these cases include physicians providing prenatal care or labor and delivery services, hospital nurses providing labor and delivery services or newborn care, physicians providing newborn care, and the hospital.

* Ordinarily, the physician providing the prenatal, labor, and delivery services will be the primary defendant. However, in many pregnancies, several physicians will have provided those services and may share responsibility.

* A group of obstetricians may have provided prenatal services, with several caring for this pregnancy The obstetrician who delivered the baby may never have seen the patient or her records until just before the delivery. In these cases, several obstetricians may be liable.

* The baby may have been delivered at a major hospital where an obstetrical resident took the medical history and wrote the labor and delivery orders. In some cases this resident may have been negligent and may have been the ostensible agent of the hospital. (Many jurisdictions recognize an agency relationship if the hospital's employees or agents represented by act, conduct, or statement that the resident was an employee or agent, and as a result the mother or someone acting on her behalf justifiably relied on the care and skill of the resident.) The resident could be a defendant, and the hospital could be liable for letting an inexperienced doctor make crucial decisions.

* Nurses may have been negligent for failing to notify an attending physician of clinical signs placing the patient at high risk or failing to inform the nursery of these signs following delivery.

* The mother may have shown no evidence of GBS in the prenatal period, but on admission to the hospital she was found to have a high white blood cell count, foul-smelling vaginal discharge, and pelvic pain. The nurses may have been negligent for failing to chart this condition and notify the physician promptly. The doctors may have been negligent for failing to respond properly and promptly.

* The hospital may have been negligent as an institution for failing to have any policy or protocol for dealing with GBS.

There is a broad array of possibilities, and the lawyer must consider them all.

Reported Cases

Three recent cases provide insight into the scope of liability in GBS cases.

* In Timmons v. Baylor Health Care System, the defendants were the primary obstetrician who provided prenatal services, his partner who was covering his shift when the baby was delivered, and an obstetrical resident (the ostensible agent of the hospital) who wrote the orders admitting the mother to the hospital and to labor and delivery.(8) The resident had a duty to screen the mother for GBS and start her on intravenous antibiotics during delivery. The obstetrician who came in to deliver the baby had a duty to advise the nursery of the risk factors so antibiotics could have been started when the baby was admitted.

At 22 weeks Timmons had undergone a cervical cerclage (a procedure in which a suture is placed around the mouth of the cervix to keep it closed) and had had continuous threatened premature labor. She had never been screened for GBS. She delivered at 37 weeks. During labor she had no fever, no overt signs of infection, and was not screened for GBS or treated with prophylactic antibiotics. Her risk factors were the cerclage and the threatened premature labor.

The newborn nursery was not given the maternal history The baby exhibited normal progress in the newborn nursery and was discharged at about 48 hours of age, but became lethargic and limp about 7 hours later. The baby was brought back to the hospital, where GBS sepsis was confirmed. He suffered severe permanent brain damage.

Experts for both plaintiffs and defendants agreed that the sepsis was early onset and would have been prevented by prophylactic antibiotics. The defense contended there were insufficient risk factors to justify screening or instituting prophylactic antibiotics.

Recovery was based on the failure of the primary obstetrician to screen for GBS during the third trimester or during labor and to give prophylactic antibiotics to the mother during labor and to the baby at birth.

* In Boyd v. Tan, the defendants were the family physician who provided prenatal care and labor and delivery services, the nursery nurses, the hospital (vicarious liability for nurses), and the pediatrician responsible for the newborn care.(9) Boyd had a urinary tract infection during the third trimester and was treated with antibiotics. However, no attempt was made to identify the bacteria, and

Boyd's condition persisted despite the treatment. Prophylactic antibiotics were not offered during labor, and the baby was not treated until after becoming lethargic and sick in the newborn nursery. The baby was diagnosed as having early-onset GBS sepsis. He suffered brain damage leading to cerebral palsy, seizures, and blindness; he never learned to walk or talk.

Recovery of damages was based on the family physician's failure to determine what was causing the mother's third-trimester infection and then provide prophylactic antibiotics to the mother during labor. The hospital's liability was based on the failure of nursing personnel to properly recognize and promptly report the baby's deteriorating condition so that the baby could be treated sooner. The pediatrician's liability was based on his two-hour delay in instituting antibiotic treatment to the infant.

In Benge v. United States, a Federal Tort Claims case against an army hospital and its physician and nurse employees, the defendants were the obstetrician, the pediatrician, and the nursery nurses.(10)

During labor, Benge had a fever and tested positive for GBS. The baby was delivered by cesarean section and Benge was treated during the postpartum period with antibiotics. The baby was not treated prophylactically and appeared to be normal while in the newborn nursery. However, she developed GBS sepsis after discharge from the nursery. Two weeks later she was admitted to a different hospital with meningitis. She suffers from seizures and motor and cognitive disabilities.

Liability was based on the failure of the obstetrical personnel to properly communicate to nursery personnel the facts of the mother's GBS infection. It was also based on the nurses, and pediatrician's failure to ask about maternal risk factors during labor and delivery that would have indicated risk factors for the baby.

The common denominator in these cases is the failure to prophylactically treat the mother during labor and the baby at birth. If proper and timely prophylaxis is instituted, the baby will not develop GBS sepsis. Failure of obstetrical personnel to communicate the presence of risk factors to nursery personnel is a significant basis for liability.

Expert Witnesses

Plaintiffs will need an array of expert witnesses to prove liability in GBS cases. Depending on who the defendants are, the liability expert may be an obstetrician, a maternal-fetal medicine specialist, a family practitioner, a nurse practitioner, or an obstetrical nurse.

A pediatric infectious disease specialist can be important. This expert will prove to the jurors that the sepsis was early onset, that therefore the baby's infection was acquired during birth, and that if prophylactic antibiotics had been administered to the mother during labor and to the baby at birth, the infection and resulting sepsis would have been prevented. In all three of the cases described above, a pediatric infectious disease expert was used.

Ordinarily a pediatric neurologist will not be needed to prove causation, but may be needed to testify on prognosis and future damages.

The damages are usually substantial enough that in most cases a life-care planner and an economist will also be needed. The life-care planner will provide a list of what care the damaged baby is going to need each year and what it will cost. The economist will calculate the cost of future medical care needs in present dollars. This calculation is based on the life-care plan, the victim's life expectancy, and the present value of the victim's lost future earning capacity. Litigation over inadequate obstetrical and perinatal care leading to GBS sepsis in newborns is increasing. Familiarity with how the bacteria is transmitted and how the sepsis should be prevented will help lawyers serve families coping with the aftermath of this devastating disease.

Notes

(1) Vern L. Katz, Management of Group B Streptococcal Disease in Pregnancy, 36 CLINICAL OBSTETRICS & GYNECOLOGY 832 (1993). Group B Strep was the subject of an ATLA Alert in October 1992. ATLA joined advocates and families in urging expectant parents to educate themselves about Group B Strep and request screening in the 26th week of pregnancy See 7 Prof Negl. L. Rep. (ATLA) 195 (Dec. 1992). (2) Kenneth M. Boyer & Samuel P. Gotoff, Prevention of Early-Onset Neonatal Group B Streptococcal Disease with Selective Intrapartum Chemoprophylaxis, 314 NEW ENG. J. MED 1665 (1986). (3) American Acad. Pediatrics, Comm. on Infectious Diseases & Comm. on Fetus and Newborn, Guidelines for Prevention of Group B Streptococcal Infection by Chemoprophylaxis, 90 PEDIATRICS 775, 777 (1992). (4) American College of Obstetricians & Gynecologists, Group B Streptococcal Infections in Pregnancy: ACOG's Recommendations, ACOG NEWSL., Jam 1993, at 1. (5) Kenneth M. Boyer & Samuel P Gotoff, Antimicrobial Prophylaxis of Neonatal Group B Streptococcal Sepsis, 15 CLINICS PERINATOLOGY 831 (1988). (6) AMERICAN COLLEGE OF OBSTETRICIANS & GYNECOLOGlSTS TECHNICAL BULL., No. 170, GROUP B STREPTOCOCCAL INFECTIONS IN PREGNANCY (1992) . (7) Leonard E. Weisman et al., Early-Onset Group B Streptococcal .Sepsis: A Current Assessment, 90 PEDIATRICS 428-33 (1992) (8) Timmons v Baylor Health Care System, No. 89 043180 (Tex., Harris County 164th Jud. Dist. Ct. Feb. 15, 1992); 8 Prof Negl. L. Rep. (ATLA) 56 (Apr.1993),8 Prof Negl. L. Rep. (ATLA) 9 (Feb. 1993). (9) Boyd v. Tan, No. 87-517,353 (Tex., Lubbock County 137th Jud. Dist. Ct. Oct. 21, 1991); 7 Prof Negl. L. Rep. (ATLA) 109 (July 1992) (10) Benge v. United States, No. C92 5114-B (W.D. Wash. May 20, 1993); 8 Prof. Negl. L. Rep. (ATLA) 168 (Nov. 1993).

Rockne W. Onstad practices with Onstad, Kaiser & Fontaine in Houston. Michael Cardwell, M.D., is director of maternal-fetal medicine at St. Vincent Medical Center in Toledo, Ohio.