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Sunday
Sep062009

Hibiclens Discussion (for GBS+ women)

This is a letter I share with moms considering the Hibiclens vaginal douche in lieu of antibiotics in labor when they are positive for Group B type of  beta-hemolytic streptococci (not Group Beta Strep as it is often mis-named):
This is the research information I have found regarding using chlorhexidine wash (Hibiclens) in lieu of antibiotics. I'll share some quotes along with where they came from (more from me at the end):

http://www.medscape.com/viewarticle/542430_4

Vaginal Cleansing

GBS Colonization and Infection. GBS is the major cause of early- and late-onset neonatal sepsis in full-term infants in developed countries. Intrapartum chemoprophylaxis and multivalent conjugate vaccines reduce neonatal colonization and the risk of early-onset sepsis. Costs, shifting serotypes, and lack of skilled personnel, however, have impeded widespread implementation of these strategies, particularly in low-resource settings.

Vaginal cleansing with chlorhexidine before or during delivery prevents vertical transfer of GBS to the neonate. The Swedish Chlorhexidine Study Group explored the minimum inhibitory and bactericidal concentrations of chlorhexidine, described postcleansing vaginal concentrations of chlorhexidine and its residual effect on GBS carriage, and demonstrated that trace levels of chlorhexidine could be absorbed through the vaginal mucosa. Pilot studies showed that vaginal washing with chlorhexidine reduced newborn colonization with GBS compared with those born to nonwashed controls. These studies prompted a series of large randomized controlled trials with varying vaginal cleansing protocols for further exploration of the potential of this intervention to reduce GBS-related neonatal morbidity ( Table 2 ).

Two trials demonstrated reductions in vertical transfer of GBS, admissions to the neonatal intensive care unit, and neonatal infections. A third study confirmed that vaginal disinfection reduced GBS colonization of the newborn, but hospital admissions, cases of probable infection, and mortality were equal between the groups. Conducting vaginal examinations during labor using surgical gloves lubricated with 1.0% chlorhexidine digluconate cream did not provide protection against vertical transfer of GBS compared with the use of nonlubricated gloves.

Although these data indicate that vaginal disinfection may reduce neonatal colonization with GBS, the low overall rates of early-onset GBS sepsis has precluded estimation of the impact on newborn infection. None of these studies was conducted in developing countries, and the validity of extrapolating the potential benefit to such settings is problematic. GBS generally has not been identified as a major neonatal pathogen in developing countries, especially in South Asia. In some settings, however, vaginal colonization rates among women are similar to those in industrialized countries. Because the majority of births occur outside of health facilities, the impact of maternal GBS colonization and vertical transfer may be underappreciated, yet further research is required.

Vaginal cleansing with chlorhexidine reduces vertical transmission of GBS to the same degree as intrapartum antibiotics and may be significantly cheaper and easier to implement in settings where skilled providers are lacking. Additionally, the antibacterial action of chlorhexidine extends beyond GBS to a broad spectrum of potentially invasive pathogens. In developing countries where sepsis rates in general are significantly higher, vaginal cleansing interventions have the potential to affect a wider range of neonatal infections.

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http://209.85.173.132/search?q=cache:_oI3xt55LPcJ:www.collegeofmidwives.org/GBS_2006/GBSprophylactic-VaginalFlush_07.pdf+chlorhexidine+in+labor+for+GBS+newborn&cd=8&hl=en&ct=clnk&gl=us

Chlorhexidine instead of Antibiotics in Treating Group B Strep at Birth
Submitted by Gretchen Humphries, who notes that this alternative treatment in GBS+ labor is easily
done at home.

J Matern Fetal Med 2002 Feb;l l(2):84-8 Chlorhexidine vaginal flushings versus systemic
ampicillin in the prevention of vertical transmission of neonatal group B streptococcus, at term.
Facchinetti F, Piccinini F, Mordini B, Volpe A. Department of Gynecology, Obstetrics and
Pediatric Sciences, University of Modena and Reggio Emilia, Modena, Italy.

OBJECTIVE: To investigate the efficacy of intrapartum vaginal flushings with Chlorhexidine
compared with ampicillin in preventing group B streptococcus transmission to neonates.

METHODS: This was a randomized controlled study, including singleton pregnancies delivering
vaginally. Rupture of membranes, when present, must not have occurred more than 6 h previously..
Women with any gestational complication, with a newborn previously affected by group B
streptococcus sepsis or whose cervical dilatation was greater than 5 cm were excluded. A total of
244 group B streptococcus-colonized mothers at term (screened at 36-38 weeks) were randomized
to receive either 140 ml Chlorhexidine 0.2% by vaginal flushings every 6 h or ampicillin 2 g
intravenously every 6 h until delivery. Neonatal swabs were taken at birth, at three different sites
(nose, ear and gastric juice).

RESULTS: A total of 108 women were treated with ampicillin and 109 with Chlorhexidine. Their
ages and gestational weeks at delivery were similar in the two groups. Nulliparous women were
equally distributed between the two groups (ampicillin, 87%; Chlorhexidine, 89%). Clinical data
such as birth weight (ampicillin, 3,365 +/- 390 g; Chlorhexidine, 3,440 +/- 452 g), Apgar scores at 1
min (ampicillin, 8.4 +/- 0.9; Chlorhexidine, 8.2 +/- 1.4) and at 5 min (ampicillin, 9.7 +/- 0.6;
Chlorhexidine, 9.6 +/- 1.1) were similar for the two groups, as was the rate of neonatal group B
streptococcus colonization (Chlorhexidine, 15.6%; ampicillin, 12%). Escherichia coli, on the other
hand, was significantly more prevalent in the ampicillin (7.4%) than in the Chlorhexidine group
(1.8%, p < 0.05). Six neonates were transferred to the neonatal intensive care unit, including two
cases of early-onset sepsis (one in each group).

CONCLUSIONS: In this carefully screened target population, intrapartum vaginal flushings with
Chlorhexidine in colonized mothers display the same efficacy as ampicillin in preventing vertical
transmission of group B streptococcus. Moreover, the rate of neonatal E. coli colonization was
reduced by Chlorhexidine.


PMID: 11995801 [PubMed - in process]
1: Int J Antimicrob Agents 1999 Aug;12(3):245-51 Vaginal disinfection with Chlorhexidine during
childbirth.

Stray-Pedersen B, Bergan T, Hafstad A, Normarm E, Grogaard J, Vangdal M. Department of
Gynecology and Obstetrics, Aker Hospital, University of Oslo, Norway.

The purpose of this study was to determine whether Chlorhexidine vaginal douching, applied by a
squeeze bottle intra partum, reduced mother-to-child transmission of vaginal microorganisms
including Streptococcus agalactiae (streptococcus serogroup B = GBS) and hence infectious
morbidity in both mother and child. A prospective controlled study was conducted on pairs of
mothers and their offspring.

Page 2
During the first 4 months (reference phase), the vaginal flora of women in labour was recorded and
the newborns monitored. During the next 5 months (intervention phase), a trial of randomized,
blinded placebo controlled douching with either 0.2% Chlorhexidine or sterile saline was performed
on 1130 women in vaginal labour.

During childbirth, bacteria were isolated from 78% of the women. Vertical transmission of
microbes occurred in 43% of the reference deliveries. In the double blind study, vaginal douching
with Chlorhexidine significantly reduced the vertical transmission rate from 35% (saline) to 18%
(Chlorhexidine), (P < 0.000 1, 95% confidence interval 0.12-0.22). The lower rate of bacteria
isolated from the latter group was accompanied by a significantly reduced early infectious
morbidity in the neonates (P < 0.05, 95% confidence interval 0.00-0.06).
This finding was
particularly pronounced in Str. agalactiae infections (P < 0.0 1).

In the early postpartum period, fever in the mothers was significantly lower in the patients offered
vaginal disinfection, a reduction from 7.2% in those douched using saline compared with 3.3% in
those disinfected using Chlorhexidine (P < 0.05, 95% confidence interval 0.01-0.06). A parallel
lower occurrence of urinary tract infections was also observed, 6.2% in the saline group as
compared with 3.4% in the Chlorhexidine group (P < 0.01, 95% confidence p interval 0.00-0.05).
This prospective controlled trial demonstrated that vaginal douching with 0.2% Chlorhexidine
during labour can significantly reduce both maternal and early neonatal infectious morbidity. The
squeeze bottle procedure was simple, quick, and well tolerated. The beneficial effect may be
ascribed both to mechanical cleansing by liquid flow and to the disinfective action of Chlorhexidine.

Lancet. 1992 Sep 26;340(8822):791; discussion 791-2. Prevention of excess neonatal morbidity
associated with group B streptococci by vaginal Chlorhexidine disinfection during labour.

The Swedish Chlorhexidine Study Group.Burman LG, Christensen P, Christensen K, Fryklund B,
Helgesson AM, Svenningsen NW, Tullus K. National Bacteriological Laboratory, Stockholm,
Sweden.

Streptococcus agalactiae transmitted to infants from the vagina during birth is an important cause of
invasive neonatal infection. We have done a prospective, randomised, double-blind, placebo-
controlled, multi-centre study of Chlorhexidine prophylaxis to prevent neonatal disease due to
vaginal transmission of S agalactiae.

On arrival in the delivery room, swabs were taken for culture from the vaginas of 4483 women who
were expecting a full-term single birth. Vaginal flushing was then done with either 60 ml
Chlorhexidine diacetate (2 g/1) (2238 women) or saline placebo (2245) and this procedure was
repeated every 6 h until delivery.

The rate of admission of babies to special-care neonatal units within 48 h of delivery was the
primary end point. For babies born to placebo-treated women, maternal carriage of S agalactiae was
associated with a significant increase in the rate of admission compared with non-colonised mothers
(5.4 vs 2.4%; RR 2.31, 95% CI 1.39-3.86; p = 0.002). Chlorhexidine reduced the admission rate for
infants born of carrier mothers to 2.8% (RR 1.95, 95% CI 0.94-4.03), and for infants born to all
mothers to 2.0% (RR 1.48, 95% CI 1.01-2.16; p = 0.04). Maternal S agalactiae colonisation is
associated with excess early neonatal morbidity, apparently related to aspiration of the organism,
that can be reduced with Chlorhexidine disinfection of the vagina during labour.

Page 3
1: Eur J Obstet Gynecol Reprod Biol 1989 Apr;31(l):47-51 Prevention of group B streptococci
transmission during delivery by vaginal application of Chlorhexidine gel.
Kollee LA, Speyer I, van Kuijck MA, Koopman R, Dony JM, Bakker JH, Wintermans RG.
Department of Paediatrics, University Hospital, Nijmegen, The Netherlands.

In a prospective study in 227 parturients, carriership of group B streptococci was established to be 25%. In carriers, transmission of streptococci to the newborn occurred in 50%. 10 ml of a Chlorhexidine gel
containing hydroxypropylmethylcellulose was introduced into the vagina during labor in 17
parturients, who were known to be carriers of group B streptococci from the first trimester of
pregnancy. In none of the newborns from these mothers colonization by group B streptococci did
occur. Vaginal application of Chlorhexidine may prevent transmission of group B streptococci, and
serve as an alternative to intrapartum prophylaxis using antibiotics.
A large multicenter randomized
controlled study should be performed to confirm this hypothesis.

Eur J Obstet Gynecol Reprod Biol 1985 Apr;19(4):231-6

Chlorhexidine for prevention of neonatal colonization with group B streptococci. III. Effect of vaginal washing with Chlorhexidine before rupture of the membranes.
Christensen KK, Christensen P, Dykes AK, Kahlmeter G.

A single vaginal washing with 2 g/1 of Chlorhexidine was performed before rupture of the
membranes in 19 parturients who were urogenital carriers of group B streptococci (GBS). Two
(11%) of the infants became colonized immediately after birth, in contrast to 16 of 41 (39%) infants
to controls (P = 0.02). A significant reduction of GBS colonization of the ear (P = 0.02) and
umbilicus (P = 0.01) was noted. Taken together, 2 of 57 (4%) cultures obtained at birth were
positive in the Chlorhexidine group, in contrast to 30 of 123 (24%) among the controls (P less than
0.01). These findings raise hope for the design of a simple washing procedure which might prevent
serious infections in the early neonatal period with GBS but also with other chlorhexidine-sensitive
organisms.

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http://www.medscape.com/viewarticle/542430_6

A review of topical applications of antiseptics to the umbilical cord noted the strong evidence for reductions in bacterial colonization after chlorhexidine treatment of the cord and highlighted the need for further investigations with 4.0% chlorhexidine in developing-country settings.

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http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2386993

We conclude that maternal vaginal cleansing combined with newborn skin cleansing could reduce neonatal infections and mortality in hospitals of sub-Saharan Africa, but the individual impact of these interventions must be determined, particularly in community settings. There is evidence for a protective benefit of newborn skin and umbilical cord cleansing with chlorhexidine in the community in south Asia.

(Me again)

So, when we move to the Informed Consent aspects of GBS treatment during labor, it is important to know that the recommended protocol is IV antibiotics given every 4-6 hours (depending on the medication given), with at least two doses needing to have been given before delivery. The protocol can be found here:

http://www.cdc.gov/groupbstrep/guidelines/recommendations.htm

So, I am offering you the option of IV antibiotics, either with my giving them or your going into the hospital to receive them (and birthing there) OR the chlorhexidine wash (which includes a shallow douche as well as a wash).

Either way, there will be extremely minimal vaginal exams since that seems to assist in the transmission of GBS to the baby; with or without rupture of membranes.

I encourage you to look over the information I am sending here as well as exploring more on your own. You will also find information saying the wash doesn't work (or rather, more research is needed), but it is also important to know that having the IV antibiotics does not preclude the possibility of infection in the newborn either.

The majority of early-onset newborn GBS occurs in the first 24 hours, so no matter what protocol we decide to do (together), I will educate you and your partner on the signs and symptoms of GBS infection for after we leave your home after the birth. I will also return about 24 hours after the birth (or sooner) and will assess the baby as well. It will be vital to take the baby's temperature every 4 hours without fail. A baby cannot regulate his/her temperature very well with GBS infection; not just a fever, but also low temperatures. Please make sure you have a good working thermometer in the baby bag. The forehead ones cannot be used, nor can the ear ones. It has to be taken under the baby's armpit.
The other sign is respiratory distress. We will talk about that as well.

We will continue this discussion because I want you to be as informed about your decision as possible. I am here to offer what I know and my experience, but I also need your input before your decision is made during your labor.

Please ask any questions at all. I am here to answer what I can and what I cannot, we will explore together.
This is the consent I have them sign:

Barbara E. Herrera, LM, CPM has informed me of an herbal treatment that is done during pregnancy that has been shown to be effective in eliminating GBS. The protocol is a standard of care in the midwifery community, but I understand it is not in the medical community. After completing the herbal treatment, re-testing can confirm or deny if there is a continued GBS status. If I am negative, I have the option of continuing the treatment through until birth or I can stop the herbal treatments, accepting that I am GBS Negative. I understand that the medical community considers me GBS Positive after a positive result whether or not I subsequently test negative. 

Barbara E. Herrera, LM, CPM has informed me of the standard MEDICAL protocol for a GBS Positive woman. The CDC protocol requires a woman to receive IV antibiotics in labor, one dose every four hours after the initial loading dose. I understand that at least two doses must be given in order for it to be effective. I also understand that accepting the antibiotics does not guarantee my baby will not get GBS and that additional antibiotics would need to be given to the baby if s/he is GBS Positive. 

Barbara E. Herrera, LM, CPM has also informed me of an alternative to the routine antibiotics in labor: a Hibiclens wash… 4% Hibiclens to 10% water, put in a PeriBottle to gently wash the lower vagina and vaginal area. She has sent me information showing the effectiveness of the wash and I have also researched the research myself. I understand this protocol is an (alternative) standard of care in the midwifery community.

(in the present again)

So there you have it. I really do prefer this to IV antibiotics; it is easier for the mother and better on the mother's and baby's system.

I hope this helps those curious about this option in midwifery care.

References (10)

References allow you to track sources for this article, as well as articles that were written in response to this article.
  • Response
    - Navelgazing Midwife Blog - Hibiclens Discussion (for GBS  women)
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    Great Site, Continue the good job. With thanks!
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    - Navelgazing Midwife Blog - Hibiclens Discussion (for GBS+ women)
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    - Navelgazing Midwife Blog - Hibiclens Discussion (for GBS+ women)
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    Response: unhealthy colon
    - Navelgazing Midwife Blog - Hibiclens Discussion (for GBS+ women)
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    - Navelgazing Midwife Blog - Hibiclens Discussion (for GBS+ women)
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    Response: coffee beans
    - Navelgazing Midwife Blog - Hibiclens Discussion (for GBS+ women)
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    - Navelgazing Midwife Blog - Hibiclens Discussion (for GBS+ women)
  • Response
    - Navelgazing Midwife Blog - Hibiclens Discussion (for GBS+ women)

Reader Comments (9)

My only comment as an OB RN (and homebirther!) is that parents need to understand that an infected baby generally does not run a "fever", they usually have trouble maintaining a normal temp.

I was GBS negative with my last, but probably would have done the hibiclens had I been +.

September 6, 2009 | Unregistered CommenterDenise

Thanks for this, I've been looking into it a bit recently as I have my GBS swab coming up soon, although I didn't test pos with Ray so I'm not too worried. Just good to be prepared. :)

September 6, 2009 | Unregistered CommenterStassja

What a wealth of information! Thank you for sharing this. I'm really glad to know about this option.

September 6, 2009 | Unregistered CommenterDou-la-la

Thank you, Denise. I will fix that right now.

September 6, 2009 | Registered CommenterNavelgazing Midwife

Very timely as I'm 34 weeks already and would like to be tested, but our midwives here don't do antibiotics at home, so I'd been waffling. Hibiclens seems like a great alternative.

September 6, 2009 | Unregistered Commentercileag

Another question Barb---how does this affect the incidence of yeast infections? What have you seen afterward with women who rinse with Hibiclens?

September 8, 2009 | Unregistered Commentercileag

I would love to know whether research has been done on the impact of intrapartum intravenous antibiotic use on the mothers' subsequent vaginal flora. This is because I was given FOUR half-hour-long penicillin drips during my first labor (every 3 hrs), and had a treatment-resistant yeast infection for SIX MONTHS following the resultant cesarean birth (my daughter also fought thrush for nearly three months). Although I understand the seriousness of GBS and would not risk my childs' health, it was NEVER presented to me at that time that there were other options or that we might suffer sequelae.

September 9, 2009 | Unregistered CommenterDanica

navelgazingmidwife.squarespace.com's done it once more! Amazing read!

May 27, 2010 | Unregistered CommenterMillie Dean

When patients are allergic to iodine, we cannot use betadine washes for pre operative cleansing. If we are doing a vaginal hysterectomy and need to perform an abdominal prep and a vaginal prep we cannot use hibiclens either because the package insert specifically states it is for external use only and to avoid mucous membranes, like the eyes, mouth, or vagina.

WARNINGS
For external use only. Keep out of eyes, ears and mouth. Hibiclens should not be used as a preoperative skin preparation of the face or head. Misuse of hibiclens has been reported to cause serious and permanent eye in- jury when it has been permitted to enter and remain in the eye during surgical procedures. If Hibiclens should contact these areas, rinse out promptly and thoroughly with water.
Avoid contact with meninges. HIBICLENS should not be used by persons who have a sensitivity to it or its com- ponents. Chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforated eardrums. Irritation, sensitization, and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas. If adverse reactions occur, discontinue use immediately and if severe, contact a physician. Keep this and all drugs out of the reach of children. In case of ac- cidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

I know there are studies using hibiclens for GBBS. But wouldn't this be off label prescribing? Similar to what MW argue about many of the medicines hospitals use in labor? Are there any reports off women reacting to hibiclens sensitivity wise or allergic wise?

February 12, 2012 | Unregistered CommenterOR RN

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