Restrictive versus routine episiotomy among Southeast Asian term pregnancies: a multicentre randomised controlled trial.

OBJECTIVE: To determine whether restrictive or routine episiotomy in term pregnant Southeast Asian women results in fewer complications. DESIGN: A multicentre randomised controlled trial. SETTING: Two tertiary and two general hospitals in Thailand. POPULATION: 3006 singleton pregnant women 18 years or older, ≥37 weeks of gestation, cephalic presentation and planned vaginal delivery. METHODS: This randomised controlled trial compared routine versus restrictive episiotomies in Thai women giving birth vaginally. Participants were singleton, term pregnant women with cephalic presentation. Block randomisation was stratified by study site and parity. Risk ratios (RR) and 95% confidence intervals (CI) were calculated to indicate between-group differences. MAIN OUTCOME MEASURES: Primary outcome was severe perineal laceration. Secondary outcomes included vaginal laceration, cervical laceration, and pregnancy outcomes. RESULTS: 3006 women were randomly assigned to restrictive (1502) and routine (1504) episiotomy. There was no difference in severe perineal laceration between the groups (RR 0.72, 95% CI 0.46-1.12). Restrictive episiotomy resulted in more intact perineums in multiparous women (RR 3.09, 95% CI 2.10-4.56). Restrictive episiotomy increased the risk of vaginal laceration in primiparous (RR 1.96, 95% CI 1.62-2.37) and multiparous women (RR 2.21, 95% CI 1.77-2.75) but did not lead to more suturing. There were comparable risks of cervical laceration, postpartum haemorrhage, wound complication, birth asphyxia, and admission to neonatal intensive care unit. CONCLUSIONS: Restrictive episiotomy results in more intact perineum in multiparous women. Risks of maternal and neonatal outcomes were comparable between the two practices. These results strengthen the certainty of the existing Cochrane review findings in supporting restrictive episiotomy. TWEETABLE ABSTRACT: Restrictive episiotomy results in more intact perineums after vaginal birth in multiparous Southeast Asian women.

Rapid versus stepwise application of negative pressure in vacuum extraction-assisted vaginal delivery: a multicentre randomised controlled non-inferiority trial.

OBJECTIVE: To evaluate whether the application of rapid negative pressure for vacuum-assisted delivery is as effective and safe as the stepwise method. DESIGN: Randomised controlled trial. SETTING: Six centres, including university, secondary and tertiary hospitals, in Thailand. SAMPLE: In total, 662 women were randomised to rapid and stepwise groups, with 331 women in each group. METHODS: Vacuum extraction was performed by applying a metal cup (Malmstrom) connected to an electric pump to the fetal head. The stepwise method consisted of four incremental steps of 0.2 kg/cm² every 2 minutes to obtain a final negative pressure of 0.8 kg/cm². In the rapid method the negative pressure of 0.8 kg/cm² was applied in one step in < 2 minutes. MAIN OUTCOME MEASURES: Success rate of vacuum extraction, vacuum cup detachment rate, duration of vacuum extraction, and maternal and neonatal complications. RESULTS: There were no significant differences in detachment rates (RD 0.3%, 95% CI -3.1 to 2.4). The overall success rates were identical, at 98.2%. There were significant reductions in the time between applying the vacuum cup and attaining maximum negative pressure (MD -4.6 minutes; 95% CI -4.4 to -4.8 minutes), and in the time between applying the cup and delivery (MD -4.4 minutes; 95% CI -4.8 to -4.0 minutes). There was a significantly higher rate of perineal suture in the rapid method group (RD 4.5%; 95% CI 1.1-8.2). There were no significant differences in maternal and fetal morbidities. CONCLUSIONS: Rapid negative pressure vacuum extraction could be performed as effectively and safely as the stepwise method, in a shorter period of time.

Prophylactic antibiotics for transcervical intrauterine procedures.

BACKGROUND: The transcervical intrauterine route is commonly used for operative gynecological procedures in women. The vagina is an area of the body that is abundant with normal bacterial flora. An operative procedure through the vagina may, therefore, be considered to have added potential for resulting in post-procedure infection. Prophylactic antibiotics may play a role in the prevention of post-procedure transcervical intrauterine infections. OBJECTIVES: To assess the effectiveness and safety of antibiotic prophylaxis compared to placebo or no treatment in women undergoing transcervical intrauterine procedures. SEARCH STRATEGY: The search strategy was based on the Menstrual Disorders and Subfertility Group's search strategy. The following databases were searched:Menstrual Disorders and Subfertility Group Specialized Register;Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2006, Issue 4;MEDLINE (1966 to November 2006);EMBASE (1966 to November 2006);Biological Abstracts (1966 to October 2006);AMED (1966 to November 2006). Key words were prepared, in consultation with the Trials Search Coordinator, according to the terms related to our objective: antibiotic, antibiotics, prophylaxis, transvaginal, transcervical intrauterine, endometrial sample, endometrium sampling, endometrial biopsy, hysterosalpingography, hysteroscope, hysteroscopy, hysteroscopic surgery, endometrial ablation, and endometrial resection. SELECTION CRITERIA: The review authors planned to include only truly randomized controlled trials that compared antibiotic prophylaxis with placebo or no treatment in order to prevent infectious complications after transcervical intrauterine procedures. Controlled clinical trials without randomization and pseudo-randomized trial were excluded. DATA COLLECTION AND ANALYSIS: No data collection or analysis was done because no trials were eligible for inclusion in the review. MAIN RESULTS: The search did not identify any randomized controlled trials investigating the effect of antibiotic prophylaxis compared to placebo or no treatment in women undergoing transcervical intrauterine procedures. AUTHORS' CONCLUSIONS: At this time, there are no published randomized controlled trials that assess prophylactic antibiotics effects on infectious complications following transcervical intrauterine procedures. It is, therefore, not possible to draw any conclusions regarding the use of prophylactic antibiotics for the prevention of post-procedure transcervical intrauterine infections.

Antibiotic prophylaxis for fourth-degree perineal tear during vaginal birth.

BACKGROUND: One to eight per cent of women suffer third-degree perineal tears (anal sphincter injury) and fourth-degree perineal tear (rectal mucosa injury) during vaginal birth, and these tears are more common after forceps delivery (28%) and midline episiotomies. Fourth-degree tears can become contaminated with bacteria from the rectum and this significantly increases in the chance of perineal wound infection. Prophylactic antibiotics might have a role in preventing this infection. OBJECTIVES: To assess the effectiveness of antibiotic prophylaxis for reducing maternal morbidity and side-effects in fourth-degree perineal tear during vaginal birth. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 July 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2005), MEDLINE (1966 to 15 July 2005), and LILACS (1982 to 15 July 2005). SELECTION CRITERIA: Randomised controlled trials which reported data comparing outcomes of prophylactic antibiotics versus placebo or no antibiotics in fourth-degree perineal tear during vaginal birth. DATA COLLECTION AND ANALYSIS: No trials were found that met the selection criteria. MAIN RESULTS: No randomised controlled trials were identified. AUTHORS' CONCLUSIONS: There are insufficient data to support a policy of routine prophylactic antibiotics in fourth-degree perineal tear during vaginal birth. A well-designed randomised controlled trial is needed.

Placebo-controlled, double-blind, randomized study of prophylactic antibiotics in elective abdominal hysterectomy.

To assess the efficacy of a single dose of ampicillin or cefazolin in preventing fever and infection after elective abdominal hysterectomy, we conducted a multicentre, randomized, double-blind, controlled trial at Srinagarind Hospital, Faculty of Medicine, Khon Kaen University and Khon Kaen Regional Hospital. Three hundred and thirty patients scheduled for elective abdominal hysterectomy were randomly allocated into either placebo, ampicillin or cefazolin groups. Patients received sterile water (3 mL) or ampicillin (1 g) or cefazolin (1 g) intravenously according to random assignment 30 min before the operation. After the operation, all patients were assessed by blinded independent evaluators until discharged from the hospitals. Our main outcome measures were postoperative fever and infectious morbidity. We found that 321 patients (97.3% of recruited patients) were available for data analysis, 108 in placebo, 106 in ampicillin and 107 in cefazolin group. Febrile morbidity occurred in 13/108 (12.0%), 14/106 (13.2%) and 12/107 (11.2%) of patients in the placebo, ampicillin and cefazolin groups, respectively. There was no statistically significant difference in febrile morbidity between the three groups. Infectious morbidity was found in 29/108 (26.9%), 24/106 (22.6%) and 11/107 (10.3%) of patients in the placebo, ampicillin and cefazolin groups, respectively. There was a statistically significant difference between the placebo and cefazolin groups (P = 0.002). Between the placebo and ampicillin groups, the result was not significantly different (P = 0.476). There was a statistically significant difference between the cefazolin and ampicillin groups (P = 0.015). The common causes of infectious morbidity were urinary tract infection, vaginal cuff infection and surgical wound infection. We concluded that antibiotic prophylaxis by cefazolin should be recommended for elective total abdominal hysterectomy.

Prophylactic antibiotic administration in pregnancy to prevent infectious morbidity and mortality.

BACKGROUND: Some previous studies suggested that prophylactic antibiotics given during pregnancy improved maternal and perinatal outcomes, some did not show any benefit and some even reported adverse effects. OBJECTIVES: To determine the effect of prophylactic antibiotics during second and third trimester of pregnancy on maternal and perinatal outcomes. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register (April 2002), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002) and reference lists of articles were searched. SELECTION CRITERIA: Randomized controlled trials comparing prophylactic antibiotic treatment with placebo or no treatment for women in the second or third trimester of pregnancy before labour. DATA COLLECTION AND ANALYSIS: Trial quality assessment and data extraction were done by the reviewers. MAIN RESULTS: There were six randomized controlled trials which recruited 2184 women to detect the effect of prophylactic antibiotic administration in the second or third trimester on pregnancy outcomes. Antibiotic prophylaxis in unselected pregnant women reduced the risk of prelabour rupture of membranes (Peto odds ratio (OR) 0.32, 95% confidence interval (CI) 0.14 to 0.73). In women with a previous preterm birth there was a risk reduction in low birth weight (OR 0.48, 95% CI 0.27 to 0.84) and postpartum endometritis (OR 0.46, 95% CI 0.24 to 0.89). There was a risk reduction in preterm delivery (OR 0.48, 95% CI 0.28 to 0.81) in pregnant women with a previous preterm birth associated with bacterial vaginosis (BV) during the current pregnancy but there was no risk reduction in pregnant women with previous preterm birth without BV during pregnancy (OR 1.06, 95% CI 0.68 to 1.64). However, vaginal antibiotic prophylaxis during pregnancy did not prevent infectious pregnancy outcomes and there is a possibility of adverse effects such as neonatal sepsis (OR 8.07, 95% CI 1.36 to 47.77). REVIEWER'S CONCLUSIONS: Antibiotic prophylaxis given during the second or third trimester of pregnancy reduces the risk of prelabour rupture of the membranes when given routinely to pregnant women. Beneficial effects on birth weight and the risk of postpartum endometritis were seen for high risk women.

Vaginal chlorhexidine during labour for preventing maternal and neonatal infections (excluding Group B Streptococcal and HIV).

BACKGROUND: The incidence of chlorioamnionitis occurs in between 8 to 12 women for every 1000 live births and 96% of the cases of chlorioamnionitis are due to ascending infection. Following spontaneous vaginal delivery, 1% to 4% of women develop postpartum endometritis. The incidence of neonatal sepsis is 0.5% to 1% of all infants born. Maternal vaginal bacteria are the main agents for these infections. It is reasonable to speculate that prevention of maternal and neonatal infections might be possible by washing the vagina and cervix with an antibacterial agent for all women during labour. Chlorhexidine belongs to the class of compounds known as the bis-biguanides. Chlorhexidine has antibacterial action against a wide range of aerobic and anaerobic bacteria, including those implicated in peripartal infections. OBJECTIVES: To evaluate the effectiveness and side-effects of chlorhexidine vaginal douching during labour in reducing maternal and neonatal infections (excluding Group B Streptococcal and HIV). SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (July 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2002), MEDLINE (from 1966 to 2002), EMBASE (from 1980 to 2002), CINAHL (from 1982 to 2002) and LILACS (from 1982 to 2002). SELECTION CRITERIA: Randomized or quasi-randomized trials comparing chlorhexidine vaginal douching during labour with placebo or other vaginal disinfectant to prevent (reduce) maternal and neonatal infections (excluding Group B Streptococcal and HIV). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility and quality, extracted and entered the data into the RevMan software and interpreted the data. A third reviewer analysed and interpreted the data. The fourth reviewer also interpreted the data. MAIN RESULTS: Three studies (3012 participants) were included. There was no evidence of an effect of vaginal chlorhexidine during labour in preventing maternal and neonatal infections. Although the data suggest a trend in reducing postpartum endometritis, the difference was not statistically significant (relative risk 0.83; 95% confidence interval 0.61 to 1.13). REVIEWERS' CONCLUSIONS: There is no evidence to support the use of vaginal chlorhexidine during labour in preventing maternal and neonatal infections. There is a need for a well-designed randomized controlled trial using appropriate concentration and volume of vaginal chlorhexidine irrigation solution and with adequate sample size.

Vaginal fluid pH as a screening test for vaginitis.

OBJECTIVE: To assess how effective the pH test can detect infectious vaginitis. METHODS: Ambulatory gynecological patients attending the gynecological out-patient department of Srinagarind Hospital from May 1 to July 31, 1997 were assessed for vaginitis by history, overall physical examination and vaginal examination. Specimens were collected for microbiological examination and measurement of pH level. RESULTS: Among 422 women recruited, a vaginal fluid pH level greater than 4.5 was found in 149 (35.3%) cases. The vaginal fluid pH as a screening test for infectious vaginitis showed a sensitivity of 49.7% (95% C.I.: 42.6-56.9). When using vaginal fluid pH combined with clinical symptoms and signs to screen for vaginitis the sensitivity was 67.5% (95% C.I.: 60.4-73.9). If a pH test was used to screen for BV, its sensitivity was 73.4% (95% C.I.; 60.7-83.3). Using a pH test in combination with clinical symptoms and signs of vaginitis to screen for BV, its sensitivity was 81.3% (95% C.I.: 69.2-89.5). CONCLUSION: Vaginal fluid pH combined with clinical symptoms and signs had a considerably high sensitivity to screen for BV.

Loss to follow-up of patients with abnormal Pap smear: magnitude and reasons.

We studied the magnitude and reasons for loss to follow-up in cases of abnormal Pap smears. We studied 162 women whose Pap smear results were abnormal. The lost follow-up rate was 41.1 per cent (95% CI: 33.1 to 49.3). Reasons for not coming to receive treatment was mostly related to communication such as not receiving informed letters from the hospital (35.6%), not understanding the messages in the informed letters (10.2%), were informed from the hospital's letters that their results were normal (5.1%), and perceiving that the test result was not serious (13.6%). One third of them had traveling-related reasons. There were 25.4 per cent of patients who sought treatment at other hospitals and 8.5 per cent went to see a traditional healer for treatment. The results provide information to prevent such unnecessary loss after having a Pap smear screening test for cervical carcinoma.

Prevention of HIV transmission from mother-to-child in Srinagarind Hospital.

From January 1996 to December 1999, HIV infected pregnant women and their newborns were studied. Informed consent was obtained and HIV-tests were performed after counselling. ZDV for perinatal prophylaxis starting on week 14 to week 36 of gestation and continued throughout pregnancy was given following an ACTG 076 regimen except that during labour, intravenous ZDV was replaced by oral ZDV 300 mgs, given every 3-hours as a loading dose and ZDV syrup 2 mgs/kg every 6 hours for 7 days orally for the newborns. Newborn HIV-Ab and PCR were done at 6 weeks and 6 months after birth. Eighty-four HIV infected pregnant women were enrolled in the study, eighty-three of whom were delivered. The overall transmission rate was 5.2 per cent, with 3/58 children confirmed infected with HIV by at least two positive PCR test results.