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 AIDS.
"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 sepsis.
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-fold.
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 1997;315:216-20.