In a study of nearly 7,000 pregnant women, cleansing the birth
canal with an inexpensive antiseptic solution dramatically reduced
post-birth infections, hospitalizations and deaths, according to a study
supported by the National Institutes of Health (NIH).
The research report was published in the July 26, 1997 issue of the
British Medical Journal. The study was funded by the National
Cancer Institute (NCI) and the National Institute of Allergy and
Infectious Diseases (NIAID).
"We found that washing the birth canal with a very safe
solution -- 0.25 percent chlorhexidine in sterile water -- at each
vaginal examination before delivery, and then wiping the babies with
the solution after delivery, significantly reduced postpartum infectious
problems in both mothers and babies," says co-author Paolo Miotti,
M.D., M.P.H., a pediatrician and medical officer in NIAID's Division of
"Perhaps most significant was our finding that infant deaths
related to sepsis, or bacteria in the bloodstream, were reduced
three-fold among babies in the intervention phase of the trial."
Chlorhexidine has a long track record of safety, and the
investigators noted no adverse reactions to the solution among
mothers or babies.
"The low-cost, simplicity and safety of this approach suggests
that it may have a role in reducing illness and death associated with
perinatal bacterial infections, which exact a considerable toll among
women and neonates, especially in the developing world," comments
the study's field director, Taha E. Taha, M.D., Ph.D., of Johns
Hopkins University. "Significantly, the cost of the antiseptic solution
used in this study, and the cotton to apply it, was less than 10 cents
per patient, making this a feasible approach for the most resource-poor
settings," adds co-author and senior investigator, Robert J. Biggar,
M.D., of NCI.
Although encouraged by these findings, the investigators
stress that further research is needed in a randomized study to
confirm the results.
In the study, the investigators enrolled a total of 6,965 women
at a busy hospital in Blantyre, Malawi. The study was divided
into control and intervention phases. During the first two months
of the trial -- a control phase -- women received the usual prenatal
care provided at the hospital, and underwent the typical delivery
procedures. In the subsequent three months -- the intervention
phase -- women received standard care plus birth canal washes with
the chlorhexidine solution administered by a nurse midwife. Babies
born in the intervention phase were wiped with pads soaked with
the solution immediately after delivery. The final month of the
study was a control month and no chlorhexidine solution was used.
In all, 3,635 women giving birth to 3,743 babies were enrolled
in the intervention phase of the trial, and 3,330 women giving birth to
3,417 babies were enrolled in the control months.
Benefits to Babies and Mothers
Compared to control infants, infants born in the intervention
phase of the study were 22 percent less likely to die; three times less
likely to die from sepsis; 12 percent less likely to be admitted to the
hospital for any reason; and 2.3 times less likely to be admitted for
Among mothers receiving the chlorhexidine intervention,
hospital admissions related to delivery were reduced by 27 percent
and admissions related to post-partum infections were reduced three-
Dr. Miotti notes that additional studies of vaginal cleansing to
prevent perinatal infections will be needed before the approach can
be considered standard care. Although the investigators speculate
that the benefits seen in the intervention arm of the trial were due to
reduction in pathogens in the birth canal, they did not have the
facilities in this study to document infections before and after
treatment with the chlorhexidine solution. Future studies may involve taking
vaginal swabs before and after cleansing with chlorhexidine and testing
them for pathogens such as Group B streptococcus, which are
recognized causes of neonatal sepsis.
The current report is the second from a study in Malawi that
evaluated the effects of birth canal cleansing. Previously, the
researchers reported that the 0.25 percent chlorhexidine solution did
not reduce the overall rate of HIV transmission from mother to infant.
It did, however, reduce HIV transmission when a woman's
membranes were ruptured for more than four hours prior to delivery
(See Biggar RJ, et al. Lancet 1996;347:1647-50).
"This study, designed in the context of HIV prevention,
demonstrates that HIV-related research often has positive spin-offs
relevant to other diseases as well," comments Anthony S. Fauci,
M.D., NIAID director.
NCI and NIAID are components of the National Institutes of
Health (NIH). NCI is the principal federal agency working to prevent
cancer and help patients live longer and healthier lives. NIAID
supports research on AIDS, malaria and other infectious diseases, as
well as allergies and asthma. In addition to the current study, NIAID
supports numerous other research to prevent perinatal infections,
including efforts toward understanding the mechanisms by which
bacteria infect newborns, and developing and testing maternal
vaccines to protect newborns against infections acquired in utero or
during delivery. NIH is an agency of the U.S. Department of Health
and Human Services.
Taha TE, Biggar RJ, Broadhead RL, Mtimavalye LAR, Justesen AB,
Liomba GN, Chiphangwi JD and Miotti PG. Effect of cleansing the
birth canal with antiseptic solution on maternal and newborn morbidity
and mortality in Malawi: clinical trial. British Medical Journal
Press releases, fact sheets and other materials are available on the
Internet via the NIAID home page at http://www.niaid.nih.gov, and
on the NCI home page at http://www.nci.nih.gov.