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Wednesday
Jun162010

Chlorhexidine/Hibiclens Vaginal Wash Info

This is the handout I give to clients regarding some of the research available for an alternative to antibiotics in labor... Hibiclens. I add to it when I find new information.

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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):

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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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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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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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:

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 support people 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. 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.

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 done 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.

References (15)

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Reader Comments (7)

I'm due with my third in the next week and I'm GBS+... and really don't want to subject myself or my baby to flora killing antibiotics. I'm very interested in the hibiclens treatment for GBS, but the box says not for use on genital area. Do you know anything about why, or why it is that it is so widely used even though it says this???

Thanks!

July 26, 2010 | Unregistered CommenterBabychaser

I don't, sorry. Good question, though. Maybe as a CYA because they know so many women *do* use it there? Like the makers of cytotec who specifically say, "not for induction of labor" yet it's used thousands of times a day? That's my guess.

July 26, 2010 | Registered CommenterNavelgazing Midwife

Hi there -- thank you for posting so much useful information about GBS and Chlorhexadine. I will probably be birthing my baby in the next week and I tested GBS+ 2 weeks ago. I purchased Hibiclense yesterday, and am wondering if you can explain your recommended protocol -- exactly HOW should I use it to get the best effect?

Some specific questions: Could it be helpful to use it a few times throughout the week, or only when labor starts? Do I "squeeze" it from the peri-bottle just around the outside, or actually try to wash inside the vagina?

Thank you!
-
betsy

October 7, 2010 | Unregistered CommenterBetsy

Hi,

I am interested to read this post. Could you offer some more specific directions as to the procedure of washing with Hibiclense?

Thank you

So when I buy the bottle, how many ounces do I use at a time, how frequently do I use it, and do I need to dilute it? I'm going to try this option. I appreciate all of the information published here. It has been incredible helpful. I was also going to try a homeopathic, and some very potent probiotics... any thoughts on this? and thoughts on colloidal silver??

June 14, 2011 | Unregistered CommenterKari Ann

This is an interesting dilemma, because while I feel it the Hibiclens is *an* option for women, I no longer believe it is the *safest* option for babies. I've decided to keep the posts about this up only because women are going to explore this option and I'd like to see some clear instructions out there.

This is what is on my Informed Consent:

Hibiclens wash… 4% Hibiclens to 10% water, put in a PeriBottle to gently wash the lower vagina and vaginal area.

Initially, I counseled women to not have the liquid enter deep into the vagina, explaining to let the wash cleanse the floor of the vagina and the opening, through the vulva. But, in a recent discussion, I learned I misunderstood the instructions and women *are* supposed to "wash" the vagina, so with the peri-bottle, the squeeze needs to be enough to get liquid in there, but not so much as to cause any issues with forcing liquid or air in the vagina. I'm more hesitant about recommending this since learning this information, but, again, since women are going to ask about it and do it, the information should be correct, according to the positive studies mentioned here.

Let me say again that I believe the antibiotics in labor are the best way to avoid having a baby infected with GBS. It isn't a guarantee; nothing is.

I hope this helps.

June 14, 2011 | Registered CommenterNavelgazing Midwife

I am interested in an alternative vaginal prep for gyn surgery when the patient is allergic to iodine. I was hoping to use hibiclens. But the manufacturer clearly states for external use only. These warnings come with hibiclens...

Application of Hibiclens should be limited only to wounds involving damage of superficial layers of skin. Pregnant women or lactating mothers, however, should always consult a doctor before using this medicine. Although there are no reports to prove the presence of chlorhexidine in lactating milk, it is still advisable to wash the breasts thoroughly before nursing, especially if the drug has been used on the breasts for cleansing the skin.
Hypersensitivity and Allergic Reactions
Hibiclens chlorhexidine gluconate can be quite harmful in higher concentrations as it can pose serious allergic reactions and skin irritation. It can be life threatening and should be avoided, or at least carefully administered by people who have a high sensitivity to this drug. An article published in Livestrong.com suggests that “It is for external use only, and should not be placed in the eyes, ears or mouth. It should only be used on wounds involving superficial layers of the skin.” Allergic symptoms can occur if the drug comes in contact with the mucous membrane of any part of the body (that is, membranes of the anus, genitals or mouth). Hibiclens can also cause blistering, burning, skin rashes, itchiness, peeling and other signs of irritation such as redness or swelling of the skin, mouth, tongue, face and lips, hives and tightness of chest.
Ocular Effects
Hibiclens should always be kept away from eyes (as it can cause corneal damage). Accidental exposure of the chlorhexidine cleanser to eyes during the pre-preparation of facial surgery can sometimes result in severe eye pain, inflammation of the conjunctiva and swelling of the epithelium, keratitis, corneal epithelial cell loss and chronic corneal ulcers.
Effects on Stomach and Nervous System
Gastrointestinal side effects have been associated with the use of Hibiclens chlorhexidine cleansers, including acute cases of gastritis (i.e. inflammation especially of the mucous membrane of the stomach) and colitis (i.e. inflammation of the colon). Hibiclens chlorhexidine should strictly be used externally in case of ear and can lead to deafness. Associated side effects of the drug may also include headache.

So, despite all the reassuring studies using hibiclens, can it still be recommended for use as a vaginal prep for GBS prevention?

Sounds a little like the rebukes woman use about cytotec use with induction. That's is, don't use it despite study after study showing safe use in pregnancy even though the manufacturer lists it as a contraindication.

May 18, 2012 | Unregistered CommenterCaptainObvious

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