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American Journal of Obstetrics and... Aug 2020We performed a systematic review and meta-analysis to determine whether D-mannose reduces urinary tract infection recurrence (ie, cumulative incidence) in adult women... (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVE
We performed a systematic review and meta-analysis to determine whether D-mannose reduces urinary tract infection recurrence (ie, cumulative incidence) in adult women with recurrent urinary tract infection compared with other prevention agents. Secondary outcomes included side effects and compliance with D-mannose use.
DATA SOURCES
Ovid Medline 1946-, Embase 1947-, Scopus 1823-, Cochrane Library, Web of Science 1900-, and ClinicalTrials.gov were searched through 4/15/2020.
STUDY ELIGIBILITY CRITERIA
Systematic review inclusion: randomized controlled trials, prospective cohorts, and retrospective cohorts written in English of women ≥18 years old with recurrent urinary tract infection in which D-mannose was utilized as an outpatient prevention regimen. Systematic review exclusion: lab or animal-based research, study protocols only, and conference abstracts. Meta-analysis inclusion: stated D-mannose dose, follow-up time ≥6 months, a comparison arm to D-mannose, and data available from women ≥18 years of age.
STUDY APPRAISAL AND SYNTHESIS METHODS
Two independent reviewers made abstract, full text, and data extraction decisions. Study methodologic quality was assessed using the Cochrane Risk of Bias tool. Relative risks, confidence intervals, and heterogeneity were computed.
RESULTS
Searches identified 776 unique citations. Eight publications met eligibility: 2 using D-mannose only; 6 using D-mannose combined with another treatment. Seven studies were prospective: 2 randomized controlled trials, 1 randomized cross-over trial, and 4 prospective cohort studies. One retrospective cohort study was included. Three studies met meta-analysis eligibility (1 randomized controlled trial, 1 randomized cross-over trial, and 1 prospective cohort). Pooled relative risk of urinary tract infection recurrence comparing D-mannose to placebo was 0.23 (95% confidence interval, 0.14-0.37; heterogeneity=0%; D-mannose n=125, placebo n=123). Pooled relative risk of urinary tract infection recurrence comparing D-mannose to preventative antibiotics was 0.39 (95% confidence interval, 0.12-1.25; heterogeneity=88%; D-mannose n=163, antibiotics n=163). Adverse side effects were reported in 2 studies assessing D-mannose only (1 study (n=10) reported none; the other reported a low incidence (8/103 participants) of diarrhea). Two studies reported compliance, which was high.
CONCLUSION
D-mannose appears protective for recurrent urinary tract infection (vs placebo) with possibly similar effectiveness as antibiotics. Overall, D-mannose appears well tolerated with minimal side effects-only a small percentage experiencing diarrhea. Meta-analysis interpretation must consider the small number of studies with varied study design and quality and the overall small sample size.
Topics: Adult; Anti-Bacterial Agents; Chemoprevention; Diarrhea; Female; Humans; Mannose; Medication Adherence; Recurrence; Urinary Tract Infections
PubMed: 32497610
DOI: 10.1016/j.ajog.2020.05.048 -
American Journal of Obstetrics &... Jul 2022Pelvic inflammatory disease during pregnancy is a rare and an understudied occurrence with potential negative outcomes. (Review)
Review
BACKGROUND
Pelvic inflammatory disease during pregnancy is a rare and an understudied occurrence with potential negative outcomes.
OBJECTIVE
This study aimed to evaluate the outcomes of pregnant women with pelvic inflammatory disease with or without pelvic abscesses.
DATA SOURCES
We performed a systematic review of the literature using Ovid MEDLINE, Scopus, CINAHL, and PubMed (including Cochrane) with no time limitations.
STUDY ELIGIBILITY CRITERIA
Relevant studies on pelvic inflammatory disease during pregnancy were identified and considered eligible if they described at least 1 case of pelvic inflammatory disease after conception, defined as infection in one or more of the following: uterus, fallopian tubes, and ovaries; based on clinical findings, physical examination, and imaging with or without pelvic abscesses present. Only studies on pelvic inflammatory disease with or without tubo-ovarian abscesses during pregnancy that evaluated perinatal outcomes were included. Data on the risk factors, delivery methods, and maternal, fetal, and neonatal outcomes were collected.
METHODS
Reviewers screened all relevant titles using the inclusion/exclusion criteria and selected relevant articles for appraisal. A total of 49 cases with reported pelvic inflammatory disease, pelvic abscesses, or both were included.
RESULTS
After exclusion of articles that did not meet the inclusion criteria, 34 manuscripts describing the occurrence of pelvic inflammatory disease in 49 pregnancies were analyzed, focusing primarily on cases reported after 1971. The mean age of patients was 25±6.3 years, the mean gestational age at diagnosis was 19.0±10.3 weeks, and 67.6% of patients were multiparous. Of all included patients, 27 (62.8%) underwent exploratory laparotomies, 14 (32.6%) underwent unilateral salpingo-oophorectomies, and 11 (25.6%) underwent appendectomies. Of all the deliveries, 13 (50%) pregnancies were full term, 14 (53.8%) were cesarean deliveries, 10 (38.5%) were spontaneous vaginal deliveries, and 2 (7.7%) were cesarean hysterectomies. There were 26 (60.5%) cases of viable births (mean gestational age at delivery, 33.8±5.1 weeks) and 17 (39.5%) cases of nonviable births. Sepsis was a complication in 3 (7.0%) cases and caused 3 neonatal deaths.
CONCLUSION
Although rare, pelvic inflammatory disease can have severe health consequences. Risk factors for pelvic inflammatory disease development include maternal pelvic structural anomalies, a history of sexually transmitted infections, recent pelvic surgery, and in vitro fertilization or oocyte retrieval. Pelvic inflammatory disease can coincide with pregnancy and can occur in the second trimester. Making a prompt diagnosis can help to improve the outcomes; therefore, if a high enough suspicion exists, treatment should not be delayed.
Topics: Abscess; Cesarean Section; Female; Gestational Age; Humans; Parturition; Pelvic Inflammatory Disease; Pregnancy
PubMed: 35405372
DOI: 10.1016/j.ajogmf.2022.100643 -
Sexually Transmitted Infections Aug 2020Genital chlamydia infection in women is often asymptomatic, but may result in adverse outcomes before and during pregnancy. The purpose of this study was to examine the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Genital chlamydia infection in women is often asymptomatic, but may result in adverse outcomes before and during pregnancy. The purpose of this study was to examine the strength of the relationships between chlamydia infection and different reproductive health outcomes and to assess the certainty of the evidence.
METHODS
This review was registered and followed the Cochrane guidelines. We searched three databases to quantitatively examine adverse outcomes associated with chlamydia infection. We included pregnancy and fertility-related outcomes. We performed meta-analyses on different study designs for various adverse outcomes using unadjusted and adjusted analyses.
RESULTS
We identified 4730 unique citations and included 107 studies reporting 12 pregnancy and fertility-related outcomes. Sixty-eight studies were conducted in high-income countries, 37 studies were conducted in low-income or middle-income countries, and 2 studies were conducted in both high-income and low-income countries. Chlamydia infection was positively associated with almost all of the 12 included pregnancy and fertility-related adverse outcomes in unadjusted analyses, including stillbirth (OR=5.05, 95% CI 2.95 to 8.65 for case-control studies and risk ratio=1.28, 95% CI 1.09 to 1.51 for cohort studies) and spontaneous abortion (OR=1.30, 95% CI 1.14 to 1.49 for case-control studies and risk ratio=1.47, 95% CI 1.16 to 1.85 for cohort studies). However, there were biases in the design and conduct of individual studies, affecting the certainty of the overall body of evidence. The risk of adverse outcomes associated with chlamydia is higher in low-income and middle-income countries compared with high-income countries.
CONCLUSION
Chlamydia is associated with an increased risk of several pregnancy and fertility-related adverse outcomes in unadjusted analyses, especially in low-income and middle-income countries. Further research on how to prevent the sequelae of chlamydia in pregnant women is needed.
TRIAL REGISTRATION NUMBER
CRD42017056818.
Topics: Abortion, Spontaneous; Chlamydia Infections; Chlamydia trachomatis; Endometritis; Female; Fetal Membranes, Premature Rupture; Humans; Infant, Low Birth Weight; Infant, Newborn; Infant, Small for Gestational Age; Infertility, Female; Obstetric Labor, Premature; Pre-Eclampsia; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Outcome; Pregnancy, Ectopic; Premature Birth; Puerperal Infection; Reproductive Tract Infections; Stillbirth
PubMed: 31836678
DOI: 10.1136/sextrans-2019-053999 -
Neurological Sciences : Official... Mar 2023Multiple sclerosis (MS) is the most common chronic inflammatory demyelinating disease of the central nervous system (CNS). The most common clinical manifestations of MS... (Review)
Review
OBJECTIVE
Multiple sclerosis (MS) is the most common chronic inflammatory demyelinating disease of the central nervous system (CNS). The most common clinical manifestations of MS are spasticity, pain, vesico-urethral disorders, cognitive impairments, chronic fatigue and sexual dysfunction. This review aims to explore the possible therapeutic options for managing sexual dysfunction in people with MS (PwMS).
METHOD
A thorough search of the PubMed Medline database was performed. Records were limited to clinical studies published between 01/01/2010 up to 01/01/2022. The results were screened by the authors in pairs.
RESULTS
The search identified 36 records. After screening, 9 records met the inclusion-exclusion criteria and were assessed. The pharmacological approaches investigated the effectiveness of sildenafil, tadalafil and onabotulinumtoxinA. Of the interventional studies the non-pharmacological investigated, the effectiveness of aquatic exercises, the application of pelvic floor exercises,the combination of pelvic floor exercises and mindfulness technique, the combination of pelvic floor exercises and electro muscular stimulation with electromyograph biofeedback, the application of yoga techniques and the efficacy of assistive devices like the clitoral vacuum suction device and the vibration device.
CONCLUSION
The management of sexual dysfunction in PwMS needs to be further investigated. A team of healthcare professionals should be involved in the management of SD in order to address not only the primary (MS-related) SD symptoms but the secondary and tertiary as well. The main limitations that were identified in the existing literature were related to MS disease features, sample characteristics and evaluation tools and batteries.
Topics: Humans; Multiple Sclerosis; Sexual Dysfunction, Physiological; Sildenafil Citrate; Pain; Exercise Therapy
PubMed: 36585597
DOI: 10.1007/s10072-022-06572-0 -
The Cochrane Database of Systematic... Aug 2023Currently, there are five major approaches to hysterectomy for benign gynaecological disease: abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic... (Review)
Review
BACKGROUND
Currently, there are five major approaches to hysterectomy for benign gynaecological disease: abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), robotic-assisted hysterectomy (RH) and vaginal natural orifice hysterectomy (V-NOTES). Within the LH category we further differentiate the laparoscopic-assisted vaginal hysterectomy (LAVH) from the total laparoscopic hysterectomy (TLH) and single-port laparoscopic hysterectomy (SP-LH).
OBJECTIVES
To assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions.
SEARCH METHODS
We searched the following databases (from their inception to December 2022): the Cochrane Gynaecology and Fertility Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO. We also searched the trial registries and relevant reference lists, and communicated with experts in the field for any additional trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) in which clinical outcomes were compared between one surgical approach to hysterectomy and another.
DATA COLLECTION AND ANALYSIS
At least two review authors independently selected trials, assessed risk of bias and performed data extraction. Our primary outcomes were return to normal activities, satisfaction and quality of life, intraoperative visceral injury and major long-term complications (i.e. fistula, pelvic-abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition and sexual dysfunction).
MAIN RESULTS
We included 63 studies with 6811 women. The evidence for most comparisons was of low or moderate certainty. The main limitations were poor reporting and imprecision. Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (12 RCTs, 1046 women) Return to normal activities was probably faster in the VH group (mean difference (MD) -10.91 days, 95% confidence interval (CI) -17.95 to -3.87; 4 RCTs, 274 women; I = 67%; moderate-certainty evidence). This suggests that if the return to normal activities after AH is assumed to be 42 days, then after VH it would be between 24 and 38 days. We are uncertain whether there is a difference between the groups for the other primary outcomes. Laparoscopic hysterectomy (LH) versus AH (28 RCTs, 3431 women) Return to normal activities may be sooner in the LH group (MD -13.01 days, 95% CI -16.47 to -9.56; 7 RCTs, 618 women; I = 68%, low-certainty evidence), but there may be more urinary tract injuries in the LH group (odds ratio (OR) 2.16, 95% CI 1.19 to 3.93; 18 RCTs, 2594 women; I = 0%; moderate-certainty evidence). This suggests that if the return to normal activities after abdominal hysterectomy is assumed to be 37 days, then after laparoscopic hysterectomy it would be between 22 and 25 days. It also suggests that if the rate of ureter injury during abdominal hysterectomy is assumed to be 0.2%, then during laparoscopic hysterectomy it would be between 0.2% and 2%. We are uncertain whether there is a difference between the groups for the other primary outcomes. LH versus VH (22 RCTs, 2135 women) We are uncertain whether there is a difference between the groups for any of our primary outcomes. Both short- and long-term complications were rare in both groups. Robotic-assisted hysterectomy (RH) versus LH (three RCTs, 296 women) None of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for our other primary outcomes. Single-port laparoscopic hysterectomy (SP-LH) versus LH (seven RCTs, 621 women) None of the studies reported satisfaction rates, quality of life or major long-term complications. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury. Total laparoscopic hysterectomy (TLH) versus laparoscopic-assisted vaginal hysterectomy (LAVH) (three RCTs, 233 women) None of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury or major long-term complications. Transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) versus LH (two RCTs, 96 women) We are uncertain whether there is a difference between the groups for rates of bladder injury. Our other primary outcomes were not reported. Overall, adverse events were rare in the included studies.
AUTHORS' CONCLUSIONS
Among women undergoing hysterectomy for benign disease, VH appears to be superior to AH. When technically feasible, VH should be performed in preference to AH because it is associated with faster return to normal activities, fewer wound/abdominal wall infections and shorter hospital stay. Where VH is not possible, LH has advantages over AH including faster return to normal activities, shorter hospital stay, and decreased risk of wound/abdominal wall infection, febrile episodes or unspecified infection, and transfusion. These advantages must be balanced against the increased risk of ureteric injury and longer operative time. When compared to LH, VH was associated with no difference in time to return to normal activities but shorter operative time and shorter hospital stay. RH and V-NOTES require further evaluation since there is a lack of evidence of any patient benefit over conventional LH. Overall, the evidence in this review has to be interpreted with caution as adverse event rates were low, resulting in low power for these comparisons. The surgical approach to hysterectomy should be discussed with the patient and decided in the light of the relative benefits and hazards. Surgical expertise is difficult to quantify and poorly reported in the available studies and this may influence outcomes in ways that cannot be accounted for in this review. In conclusion, when VH is not feasible, LH has multiple advantages over AH, but at the cost of more ureteric injuries. Evidence is limited for RH and V-NOTES.
Topics: Female; Humans; Hysterectomy; Abdominal Injuries; Fever; Hospitals
PubMed: 37642285
DOI: 10.1002/14651858.CD003677.pub6 -
The Cochrane Database of Systematic... Apr 2020Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. This is an update of a Cochrane Review first published in 2010 and subsequently updated in 2012, twice in 2014, in 2017 and 2018.
OBJECTIVES
To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We also assessed the side effects of vaginal cleansing solutions to determine adverse events associated with the intervention.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (7 July 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity. Cluster-RCTs were eligible for inclusion, but we did not identify any. We excluded trials that utilized vaginal preparation during labor or that did not use antibiotic surgical prophylaxis. We also excluded any trials using a cross-over design. We included trials published in abstract form only if sufficient information was present in the abstract on methods and outcomes to analyze.
DATA COLLECTION AND ANALYSIS
At least three of the review authors independently assessed eligibility of the studies. Two review authors were assigned to extract study characteristics, quality assessments, and data from eligible studies.
MAIN RESULTS
We included 21 trials, reporting results for 7038 women evaluating the effects of vaginal cleansing (17 using povidone-iodine, 3 chlorhexidine, 1 benzalkonium chloride) on post-cesarean infectious morbidity. Trials used vaginal preparations administered by sponge sticks, douches, or soaked gauze wipes. The control groups were typically no vaginal preparation (17 trials) or the use of a saline vaginal preparation (4 trials). One trial did not report on any outcomes of interest. Trials were performed in 10 different countries (Saudi Arabia, Pakistan, Iran, Thailand, Turkey, USA, Egypt, UK, Kenya and India). The overall risk of bias was low for areas of attrition, reporting, and other bias. About half of the trials had low risk of selection bias, with most of the remainder rated as unclear. Due to lack of blinding, we rated performance bias as high risk in nearly one-third of the trials, low risk in one-third, and unclear in one-third. Vaginal preparation with antiseptic solution immediately before cesarean delivery probably reduces the incidence of post-cesarean endometritis from 7.1% in control groups to 3.1% in vaginal cleansing groups (average risk ratio (aRR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; 20 trials, 6918 women; moderate-certainty evidence). This reduction in endometritis was seen for both iodine-based solutions and chlorhexidine-based solutions. Risks of postoperative fever and postoperative wound infection are also probably reduced by vaginal antiseptic preparation (fever: aRR 0.64, 0.50 to 0.82; 16 trials, 6163 women; and wound infection: RR 0.62, 95% CI 0.50 to 0.77; 18 trials, 6385 women; both moderate-certainty evidence). Two trials found that there may be a lower risk of a composite outcome of wound complication or endometritis in women receiving preoperative vaginal preparation (RR 0.46, 95% CI 0.26 to 0.82; 2 trials, 499 women; low-certainty evidence). No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing. Subgroup analysis suggested a greater effect with vaginal preparations for those women in labour versus those not in labour for four out of five outcomes examined (post-cesarean endometritis; postoperative fever; postoperative wound infection; composite wound complication or endometritis). This apparent difference needs to be investigated further in future trials. We did not observe any subgroup differences between women with ruptured membranes and women with intact membranes.
AUTHORS' CONCLUSIONS
Vaginal preparation with povidone-iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post-cesarean endometritis, postoperative fever, and postoperative wound infection. Subgroup analysis found that these benefits were typically present whether iodine-based or chlorhexidine-based solutions were used and when women were in labor before the cesarean. The suggested benefit in women in labor needs further investigation in future trials. There was moderate-certainty evidence using GRADE for all reported outcomes, with downgrading decisions based on limitations in study design or imprecision. As a simple intervention, providers may consider implementing preoperative vaginal cleansing with povidone-iodine or chlorhexidine before performing cesarean deliveries. Future research on this intervention being incorporated into bundles of care plans for women receiving cesarean delivery will be needed.
Topics: Administration, Intravaginal; Anti-Infective Agents, Local; Benzalkonium Compounds; Cesarean Section; Chlorhexidine; Disinfection; Endometritis; Female; Fever; Humans; Povidone-Iodine; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Wound Infection
PubMed: 32335895
DOI: 10.1002/14651858.CD007892.pub7 -
American Journal of Obstetrics and... May 2023This study aimed to reassess the effect of prophylactic transcervical amnioinfusion for intrapartum meconium-stained amniotic fluid on meconium aspiration syndrome and... (Meta-Analysis)
Meta-Analysis Review
Intrapartum amnioinfusion reduces meconium aspiration syndrome and improves neonatal outcomes in patients with meconium-stained fluid: a systematic review and meta-analysis.
OBJECTIVE
This study aimed to reassess the effect of prophylactic transcervical amnioinfusion for intrapartum meconium-stained amniotic fluid on meconium aspiration syndrome and other adverse neonatal and maternal outcomes.
DATA SOURCES
From inception to November 2021, a systematic search of the literature was performed in PubMed, Embase, Web of Science, and Scopus databases and gray literature sources.
STUDY ELIGIBILITY CRITERIA
We identified randomized controlled trials of patients with intrapartum moderate to thick meconium-stained amniotic fluid that evaluated the effect of amnioinfusion on adverse neonatal and maternal outcomes.
METHODS
Of note, 2 reviewers independently abstracted data and gauged study quality by assigning a modified Jadad score. Meconium aspiration syndrome constituted the primary outcome. The secondary outcomes were meconium below the cords, Apgar scores of <7 at 5 minutes, neonatal acidosis, cesarean delivery, cesarean delivery for fetal heart rate abnormalities, neonatal intensive care unit admission, and postpartum endometritis. This study calculated the odds ratios with 95% confidence intervals for categorical outcomes and weighted mean differences with 95% confidence intervals for continuous outcomes.
RESULTS
A total of 24 randomized studies with 5994 participants met the inclusion criteria. The overall odds of meconium aspiration syndrome was reduced by 67% in the amnioinfusion group (pooled odds ratio, 0.33; 95% confidence interval, 0.21-0.51). Except for postpartum endometritis, amnioinfusion was associated with a significant reduction in all secondary outcomes.
CONCLUSION
Our study found that the use of intrapartum amnioinfusion in the setting of meconium-stained amniotic fluid significantly reduces the odds of meconium aspiration syndrome and other adverse neonatal outcomes.
Topics: Pregnancy; Female; Humans; Infant, Newborn; Meconium Aspiration Syndrome; Meconium; Amnion; Endometritis; Obstetric Labor Complications; Sodium Chloride; Amniotic Fluid
PubMed: 37164492
DOI: 10.1016/j.ajog.2022.07.047 -
The Cochrane Database of Systematic... Jun 2020The risk of maternal mortality and morbidity is higher after caesarean section than for vaginal birth. With increasing rates of caesarean section, it is important to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The risk of maternal mortality and morbidity is higher after caesarean section than for vaginal birth. With increasing rates of caesarean section, it is important to minimise risks to the mother as much as possible. This review focused on different skin preparations to prevent infection. This is an update of a review last published in 2018.
OBJECTIVES
To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 July 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised and quasi-randomised trials, evaluating any type of preoperative skin preparation (agents, methods or forms). We included studies presented only as abstracts, if there was enough information to assess risk of bias. Comparisons of interest in this review were between: different antiseptic agents (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different packages of skin preparation including a mix of agents and methods, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. We mainly focused on the comparison between different agents, with and without the use of drapes. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, extracted the data and checked data for accuracy. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included 13 individually-randomised controlled trials (RCTs), with a total of 6938 women who were undergoing caesarean section. Twelve trials (6916 women) contributed data to this review. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in India, Egypt, Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly at low risk of bias for most domains, although high risk of detection bias raised some specific concerns in a number of studies. Length of stay was only reported in one comparison. Antiseptic agents Parachlorometaxylenol with iodine versus iodine alone We are uncertain whether parachlorometaxylenol with iodine made any difference to the incidence of surgical site infection (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.04 to 2.99; 1 trial, 50 women), or endometritis (RR 0.88, 95% CI 0.56 to 1.38; 1 trial, 50 women) when compared with iodine alone, because the certainty of the evidence was very low. Adverse events (maternal or neonatal) were not reported. Chlorhexidine gluconate versus povidone iodine Moderate-certainty evidence suggested that chlorhexidine gluconate, when compared with povidone iodine, probably slightly reduces the incidence of surgical site infection (RR 0.72, 95% CI 0.58 to 0.91; 8 trials, 4323 women). This effect was still present in a sensitivity analysis after removing four trials at high risk of bias for outcome assessment (RR 0.87, 95% CI 0.62 to 1.23; 4 trials, 2037 women). Low-certainty evidence indicated that chlorhexidine gluconate, when compared with povidone iodine, may make little or no difference to the incidence of endometritis (RR 0.95, 95% CI 0.49 to 1.86; 3 trials, 2484 women). It is uncertain whether chlorhexidine gluconate reduces maternal skin irritation or allergic skin reaction (RR 0.64, 95% CI 0.28 to 1.46; 3 trials, 1926 women; very low certainty evidence). One small study (60 women) reported reduced bacterial growth at 18 hours after caesarean section for women who had chlorhexidine gluconate preparation compared with women who had povidone iodine preparation (RR 0.23, 95% CI 0.07 to 0.70). Methods Drape versus no drape This comparison investigated the use of drape versus no drape, following preparation of the skin with antiseptics. Low-certainty evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (RR 1.29, 95% confidence interval (CI) 0.97 to 1.71; 3 trials, 1373 women), and probably makes little or no difference to the length of stay in the hospital (mean difference (MD) 0.10 days, 95% CI -0.27 to 0.46; 1 trial, 603 women; moderate-certainty evidence). One trial compared an alcohol scrub and iodophor drape with a five-minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very-low certainty evidence). We were uncertain whether the combination of a one-minute alcohol scrub and a drape reduced the incidence of metritis when compared with a five-minute scrub, because the certainty of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The studies did not report on adverse events (maternal or neonatal).
AUTHORS' CONCLUSIONS
Moderate-certainty evidence suggests that preparing the skin with chlorhexidine gluconate before caesarean section is probably slightly more effective at reducing the incidence of surgical site infection in comparison to povidone iodine. For other outcomes examined there was insufficient evidence available from the included RCTs. Most of the evidence in this review was deemed to be very low or low certainty. This means that for most findings, our confidence in any evidence of an intervention effect is limited, and indicates the need for more high-quality research. Therefore, it is not yet clear what sort of skin preparation may be most effective for preventing postcaesarean surgical site infection, or for reducing other undesirable outcomes for mother and baby. Well-designed RCTs, with larger sample sizes are needed. High-priority questions include comparing types of antiseptic (especially iodine versus chlorhexidine), and application methods (scrubbing, swabbing, or draping). We found two studies that are ongoing; we will incorporate the results of these studies in future updates of this review.
Topics: Adult; Anti-Infective Agents, Local; Bandages; Cesarean Section; Chlorhexidine; Endometritis; Ethanol; Female; Humans; Iodine; Iodophors; Length of Stay; Povidone-Iodine; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Drapes; Surgical Wound Infection; Xylenes
PubMed: 32580252
DOI: 10.1002/14651858.CD007462.pub5 -
PloS One 2021To review the effect of different intramuscular injection (IMI) techniques on injection associated pain, in adults. (Meta-Analysis)
Meta-Analysis
AIM
To review the effect of different intramuscular injection (IMI) techniques on injection associated pain, in adults.
METHODS
The review protocol was registered on PROSPERO (CRD42019136097). MEDLINE, EMBASE, British Nursing Index and CINAHL were searched up to June 2020. Included studies were appraised and a meta-analysis, where appropriate, was conducted with a random effects model and test for heterogeneity. Standardised mean difference (SMD) with a 95% confidence interval in reported injection pain (intervention cf. control) was reported.
RESULTS
29 studies were included in the systematic review and 20 studies in the meta-analysis. 13 IMI techniques were identified. 10 studies applied local pressure to the injection site. Of these, applying manual pressure (4 studies, SMD = -0.85[-1.36,-0.33]) and Helfer (rhythmic) tapping (3 studies, SMD = -2.95[-5.51,-0.39]) to the injection site reduced injection pain, whereas the use of a plastic device to apply local pressure to the skin (ShotBlocker) did not significantly reduce pain (2 studies, SMD = -0.51[-1.58,0.56]). Acupressure techniques which mostly involved applying sustained pressure followed by intermittent pressure (tapping) to acupressure points local to the injection site reduced pain (4 studies: SMD = -1.62[-2.80,-0.44]), as did injections to the ventrogluteal site compared to the dorsogluteal site (2 studies, SMD = -0.43[-0.81,-0.06]). There was insufficient evidence on the benefits of the 'Z track technique' (2 studies, SMD = -0.20[-0.41,0.01]) and the cold needle technique (2 studies, SMD = -0.73[-1.83,0.37]) on injection pain. The effect of changing the needle after drawing up the injectate on injection pain was conflicting and warming the injectate did not reduce pain. Limitations included considerable heterogeneity, poor reporting of randomisation, and possible bias in outcome measures from unblinding of assessors or participants.
CONCLUSIONS
Manual pressure or rhythmic tapping over the injection site and applying local pressure around the injection site reduced IMI pain. However, there was very high unexplained heterogeneity between studies and risk of significant bias within small studies.
Topics: Humans; Injections, Intramuscular; Pain; Pain Measurement
PubMed: 33939726
DOI: 10.1371/journal.pone.0250883 -
The Cochrane Database of Systematic... Aug 2020Pelvic inflammatory disease (PID) affects 4% to 12% of women of reproductive age. The main intervention for acute PID is broad-spectrum antibiotics administered... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pelvic inflammatory disease (PID) affects 4% to 12% of women of reproductive age. The main intervention for acute PID is broad-spectrum antibiotics administered intravenously, intramuscularly or orally. We assessed the optimal treatment regimen for PID. OBJECTIVES: To assess the effectiveness and safety of antibiotic regimens to treat PID.
SEARCH METHODS
In January 2020, we searched the Cochrane Sexually Transmitted Infections Review Group's Specialized Register, which included randomized controlled trials (RCTs) from 1944 to 2020, located through hand and electronic searching; CENTRAL; MEDLINE; Embase; four other databases; and abstracts in selected publications.
SELECTION CRITERIA
We included RCTs comparing antibiotics with placebo or other antibiotics for the treatment of PID in women of reproductive age, either as inpatient or outpatient treatment. We limited our review to a comparison of drugs in current use that are recommended by the 2015 US Centers for Disease Control and Prevention guidelines for treatment of PID.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two authors independently extracted data, assessed risk of bias and conducted GRADE assessments of the quality of evidence.
MAIN RESULTS
We included 39 RCTs (6894 women) in this review, adding two new RCTs at this update. The quality of the evidence ranged from very low to high, the main limitations being serious risk of bias (due to poor reporting of study methods and lack of blinding), serious inconsistency, and serious imprecision. None of the studies reported quinolones and cephalosporins, or the outcomes laparoscopic evidence of resolution of PID based on physician opinion or fertility outcomes. Length of stay results were insufficiently reported for analysis. Regimens containing azithromycin versus regimens containing doxycycline We are uncertain whether there was a clinically relevant difference between azithromycin and doxycycline in rates of cure for mild-moderate PID (RR 1.18, 95% CI 0.89 to 1.55; 2 RCTs, 243 women; I = 72%; very low-quality evidence). The analyses may result in little or no difference between azithromycin and doxycycline in rates of severe PID (RR 1.00, 95% CI 0.96 to 1.05; 1 RCT, 309 women; low-quality evidence), or adverse effects leading to discontinuation of treatment (RR 0.71, 95% CI 0.38 to 1.34; 3 RCTs, 552 women; I = 0%; low-quality evidence). In a sensitivity analysis limited to a single study at low risk of bias, azithromycin probably improves the rates of cure in mild-moderate PID (RR 1.35, 95% CI 1.10 to 1.67; 133 women; moderate-quality evidence), compared to doxycycline. Regimens containing quinolone versus regimens containing cephalosporin The analysis shows there may be little or no clinically relevant difference between quinolones and cephalosporins in rates of cure for mild-moderate PID (RR 1.05, 95% CI 0.98 to 1.14; 4 RCTs, 772 women; I = 15%; low-quality evidence), or severe PID (RR 1.06, 95% CI 0.91 to 1.23; 2 RCTs, 313 women; I = 7%; low-quality evidence). We are uncertain whether there was a difference between quinolones and cephalosporins in adverse effects leading to discontinuation of treatment (RR 2.24, 95% CI 0.52 to 9.72; 6 RCTs, 1085 women; I = 0%; very low-quality evidence). Regimens with nitroimidazole versus regimens without nitroimidazole There was probably little or no difference between regimens with or without nitroimidazoles (metronidazole) in rates of cure for mild-moderate PID (RR 1.02, 95% CI 0.95 to 1.09; 6 RCTs, 2660 women; I = 50%; moderate-quality evidence), or severe PID (RR 0.96, 95% CI 0.92 to 1.01; 11 RCTs, 1383 women; I = 0%; moderate-quality evidence). The evidence suggests that there was little to no difference in in adverse effects leading to discontinuation of treatment (RR 1.05, 95% CI 0.69 to 1.61; 17 studies, 4021 women; I = 0%; low-quality evidence). . In a sensitivity analysis limited to studies at low risk of bias, there was little or no difference for rates of cure in mild-moderate PID (RR 1.05, 95% CI 1.00 to 1.12; 3 RCTs, 1434 women; I = 0%; high-quality evidence). Regimens containing clindamycin plus aminoglycoside versus quinolone We are uncertain whether quinolone have little to no effect in rates of cure for mild-moderate PID compared to clindamycin plus aminoglycoside (RR 0.88, 95% CI 0.69 to 1.13; 1 RCT, 25 women; very low-quality evidence). The analysis may result in little or no difference between quinolone vs. clindamycin plus aminoglycoside in severe PID (RR 1.02, 95% CI 0.87 to 1.19; 2 studies, 151 women; I = 0%; low-quality evidence). We are uncertain whether quinolone reduces adverse effects leading to discontinuation of treatment (RR 0.21, 95% CI 0.02 to 1.72; 3 RCTs, 163 women; I = 0%; very low-quality evidence). Regimens containing clindamycin plus aminoglycoside versus regimens containing cephalosporin We are uncertain whether clindamycin plus aminoglycoside improves the rates of cure for mild-moderate PID compared to cephalosporin (RR 1.02, 95% CI 0.95 to 1.09; 2 RCTs, 150 women; I = 0%; low-quality evidence). There was probably little or no difference in rates of cure in severe PID with clindamycin plus aminoglycoside compared to cephalosporin (RR 1.00, 95% CI 0.95 to 1.06; 10 RCTs, 959 women; I= 21%; moderate-quality evidence). We are uncertain whether clindamycin plus aminoglycoside reduces adverse effects leading to discontinuation of treatment compared to cephalosporin (RR 0.78, 95% CI 0.18 to 3.42; 10 RCTs, 1172 women; I = 0%; very low-quality evidence).
AUTHORS' CONCLUSIONS
We are uncertain whether one treatment was safer or more effective than any other for the cure of mild-moderate or severe PID Based on a single study at a low risk of bias, a macrolide (azithromycin) probably improves the rates of cure of mild-moderate PID, compared to tetracycline (doxycycline).
Topics: Adolescent; Adult; Aminoglycosides; Anti-Bacterial Agents; Azithromycin; Cephalosporins; Clindamycin; Doxycycline; Drug Therapy, Combination; Female; Humans; Nitroimidazoles; Pelvic Inflammatory Disease; Publication Bias; Quinolones; Randomized Controlled Trials as Topic
PubMed: 32820536
DOI: 10.1002/14651858.CD010285.pub3