Randomized study of vaginal and neonatal cleansing with 1% chlorhexidine (original) (raw)
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Chlorhexidine vaginal and neonatal wipes in home births in Pakistan: a randomized controlled trial
Obstetrics & …, 2007
To assess tolerance and safety of 0.6% chlorhexidine vaginal and neonatal wipes to improve perinatal outcomes in home deliveries in Pakistan and the ability of traditional birth attendants and project staff to perform a randomized trial of this intervention. METHODS: Focus groups of pregnant and nonpregnant women and in-depth interviews of traditional birth attendants explored barriers to the use of chlorhexidine wipes. Then, a study was performed of women delivering at home attended by traditional birth attendants. Consenting women were randomly assigned to receive either 0.6% chlorhexidine or saline vaginal and neonatal wipes. Women and their infants were followed up on postpartum days 7, 14, and 28. Acceptability and tolerance of vaginal and neonatal wipes, as well as maternal and neonatal outcomes, were assessed. RESULTS: The focus groups and interviews indicated that the chlorhexidine intervention would be acceptable to women and their providers. Of the 213 eligible pregnant women approached, 203 (95%) gave informed consent and were enrolled and allocated to groups. Traditional birth attendants had no difficulty administering chlorhexidine vaginal and neonatal wipes in a home setting. Of the 203 births, 103 (51%) of whom received 0.6% chlorhexidine, there were no allergic reactions, vaginal itching, burning, or requests for study termination. Follow-up at 28 days postpartum was more than 95%. Although this study was not powered to show significant differences in neonatal outcomes between treatment groups, the lower rates of some neonatal adverse clinical outcomes in the chlorhexidine group were encouraging. CONCLUSION: Use of 0.6% chlorhexidine vaginal and neonatal wipes for the prevention of neonatal infection is well-tolerated and seems safe. A trial of this intervention by traditional birth attendants in a home-delivery setting is feasible.
Chlorhexidine Vaginal and Neonatal Wipes in Home Births in Pakistan
Obstetrics & Gynecology, 2007
To assess tolerance and safety of 0.6% chlorhexidine vaginal and neonatal wipes to improve perinatal outcomes in home deliveries in Pakistan and the ability of traditional birth attendants and project staff to perform a randomized trial of this intervention. METHODS: Focus groups of pregnant and nonpregnant women and in-depth interviews of traditional birth attendants explored barriers to the use of chlorhexidine wipes. Then, a study was performed of women delivering at home attended by traditional birth attendants. Consenting women were randomly assigned to receive either 0.6% chlorhexidine or saline vaginal and neonatal wipes. Women and their infants were followed up on postpartum days 7, 14, and 28. Acceptability and tolerance of vaginal and neonatal wipes, as well as maternal and neonatal outcomes, were assessed. RESULTS: The focus groups and interviews indicated that the chlorhexidine intervention would be acceptable to women and their providers. Of the 213 eligible pregnant women approached, 203 (95%) gave informed consent and were enrolled and allocated to groups. Traditional birth attendants had no difficulty administering chlorhexidine vaginal and neonatal wipes in a home setting. Of the 203 births, 103 (51%) of whom received 0.6% chlorhexidine, there were no allergic reactions, vaginal itching, burning, or requests for study termination. Follow-up at 28 days postpartum was more than 95%. Although this study was not powered to show significant differences in neonatal outcomes between treatment groups, the lower rates of some neonatal adverse clinical outcomes in the chlorhexidine group were encouraging. CONCLUSION: Use of 0.6% chlorhexidine vaginal and neonatal wipes for the prevention of neonatal infection is well-tolerated and seems safe. A trial of this intervention by traditional birth attendants in a home-delivery setting is feasible.
Acta Obstetricia et Gynecologica Scandinavica
Introduction: Infection is one of the most common causes of maternal morbidities and mortality and has been reported to be responsible for about 15% of maternal deaths. Any woman is at risk of infection during childbirth, but women undergoing cesarean section are at higher risk. Improvement in surgical procedures with asepsis and the use of antibiotics have helped reduce postoperative infectious morbidities. However, ascending infection from the lower to the upper genital tract is a common but often neglected source of infection. Cleaning the vagina with chlorhexidine antiseptic solution before cesarean section can be a cheap and affordable source of infection control. This study is aimed at evaluating the efficacy of preoperative vaginal cleansing using 1.0% chlorhexidine in the reduction of post-cesarean section infectious morbidities. Material and methods: This prospective randomized control trial was conducted among 322 pregnant women who underwent an emergency cesarean section at Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AE-FUTHA). The women were randomized into two groups. The interventional group received vaginal cleansing with three standard gauzes soaked in 30 mL 1.0% chlorhexidine gluconate solution preoperatively in addition to surgical skin cleaning with chlorhexidine-alcohol. The women in the control group only had surgical skin cleaning with chlorhexidinealcohol. All the women received pre-and postoperative antibiotics. The primary outcomes were endometritis and wound infections. Results: Infectious morbidity was significantly reduced from 36.8% in the control group to 12.0% in the intervention group (P = .001). Endometritis occurred significantly less frequently in the intervention group than the control group (respectively 6.6% compared with 27.6%: relative risk [RR] 0.29, 95% confidence interval [CI] 0.16-0.53; P < .05). Foul-smelling vaginal discharge was significantly more common in the control group than in the intervention group (11.8% vs 1.3%, respectively) but the | 695 OGAH et Al.
Abstract Objective: To evaluate the efficacy of preoperative vaginal cleansing using chlorhexidine 0.25% antiseptic wipes on rates of postcesarean section (CS) infectious morbidities (endometritis, febrile morbidity and wound infection). Methods: This prospective randomized trial was conducted among 218 pregnant women scheduled for term elective CS. Patients were equally divided into two groups by simple randomization. After spinal anesthesia and catheterization under aseptic technique, the study group had preoperative vaginal cleansing using chlorhexidine 0.25% antiseptic wipes for about 1 min, while the control group did not. All cases received the prophylactic antibiotics and the usual abdominal scrub. All participants received the routine postoperative care without other interventions. Adverse postcesarean infectious morbidities such as endometritis, febrile morbidity and wound infection were observed at the time of hospital discharge and weekly for 6 weeks postpartum. Results: Both groups were matched regarding the baseline patients’ characteristics (age, gestational age, BMI, operative time and postoperative hospital stay). Overall, post-CS infectious morbidity were significantly reduced from 24.4% in the control group to 8.8% in the intervention group; p value50.05. Marked reduction was seen in the incidence of endometritis (13.2% in the control group versus 2.9% in the intervention group; p value50.05). However, fever and wound infection showed no significant difference between both groups. Conclusion: Cleansing the birth canal with chlorhexidine 0.25% wipes prior to elective CS appears to be effective in reducing rates of post
Clinical Infection and Immunity, 2019
Background: Cesarean delivery is the most common major surgical procedure done by obstetricians. The rate of post-cesarean infectious morbidities is still unacceptably high despite the preoperative skin preparation and antibiotic use. There is evidence that vaginal cleansing prior to cesarean delivery decreases the risk of maternal infectious morbidities. This evidence, however, does not guide to the choice of the optimal antiseptic agent. The objective of the study was to evaluate the efficacy of abdominal and vaginal preparation with chlorhexidine compared to povidone-iodine prior to cesarean delivery in the reduction of post-cesarean infectious morbidities. Methods: This was a single-center randomized controlled trial. Patients undergoing cesarean delivery were randomly assigned to preoperative vaginal and skin preparation with either chlorhexidine or povidone-iodine in addition to the standard preoperative antibiotic prophylaxis. The primary outcome was a composite of postoperative infectious morbidity (fever, endometritis and wound infection) occurring within 30 days of the cesarean delivery. Results: In the period from February 2018 through February 2019, a total of 333 patients were recruited; 159 patients were assigned to chlorhexidine group and 174 to povidone-iodine group. Clinically there was a higher reduction of composite infectious morbidity in the group receiving chlorhexidine preparation when compared to povidone-iodine group; however, this did not reach statistical significance (7 (4.4%) vs. 14 (8.0%) respectively, P = 0.17). Nonetheless, a significant difference could be elicited in less number of clinic follow-up visits with the use of chlorhexidine. Conclusion: The frequency of postpartum infectious morbidity in the entire cohort was lower than expected. This might be the effect of vaginal cleansing (irrespective of the antiseptic used). The use of chlorhexidine or povidone-iodine for combined abdominal and vagi-nal preparation was not different in reducing post-cesarean infectious morbidities.
Clinical Nursing Studies
Objective: This study aims to assess effect of preoperative vaginal cleansing using chlorhexidine antiseptic on post cesarean section infectious morbidity.Methods: A randomized controlled trial was conducted on a random sample of 178 singleton term pregnant woman assigned for elective cesarean section. A simple random sample was recruited from the operating room of Obstetrics and Gynecology department, Zagazig University Hospitals-Egypt. Participants were randomly assigned either to conventional care group or study group. The conventional care group was exposed to the usual abdominal scrub with Povidone-iodine solution; while the study group subjected to vaginal cleansing using chlorhexidine antiseptic solution in addition to conventional preoperative care. Data were collected using an assessment sheet for demographic and clinical data and checklist for study outcomes.Results: Post intervention, assessment of the incisional wound revealed lower overall post cesarean section infectio...
American Journal of Obstetrics & Gynecology MFM, 2019
BACKGROUND: Several randomized controlled trials have demonstrated that preoperative abdominal skin preparation with chlorhexidine gluconate is superior to povidone-iodine for the prevention of surgical site infections. Despite these results, povidone-iodine is still the most commonly used agent for vaginal preparation, even though it may not be ideal. OBJECTIVES: The objectives of the study were as follows: (1) to determine whether vaginal cleansing with a 4% chlorhexidine gluconate solution results in fewer wound infections as compared with povidoneiodine when used for vaginal antisepsis prior to cesarean delivery and (2) to compare rates of patient reported side-effects associated with vaginal application of 4% chlorhexidine gluconate solution and 10% povidone-iodine. STUDY DESIGN: This is a block randomized, comparator-controlled, open-label trial. Women undergoing nonemergent cesarean delivery were randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% povidone-iodine solution prior to skin incision. The primary outcome was wound site infection occurring within 14 days of cesarean delivery including superficial or deep surgical site infection. Secondary outcomes included rates of endometritis, postoperative fever, and side effects (vaginal dryness, irritation, and desquamitization) occurring within 14 days of cesarean delivery. Risks were reported as odds ratios with 95% confidence intervals, with P < .05 considered as significant.