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The Cochrane Database of Systematic... Feb 2020Induction of labour involves stimulating uterine contractions artificially to promote the onset of labour. There are several pharmacological, surgical and mechanical... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Induction of labour involves stimulating uterine contractions artificially to promote the onset of labour. There are several pharmacological, surgical and mechanical methods used to induce labour. Membrane sweeping is a mechanical technique whereby a clinician inserts one or two fingers into the cervix and using a continuous circular sweeping motion detaches the inferior pole of the membranes from the lower uterine segment. This produces hormones that encourage effacement and dilatation potentially promoting labour. This review is an update to a review first published in 2005.
OBJECTIVES
To assess the effects and safety of membrane sweeping for induction of labour in women at or near term (≥ 36 weeks' gestation).
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (25 February 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 February 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials comparing membrane sweeping used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed on a predefined list of labour induction methods. Cluster-randomised trials were eligible, but none were identified.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion, risk of bias and extracted data. Data were checked for accuracy. Disagreements were resolved by discussion, or by including a third review author. The certainty of the evidence was assessed using the GRADE approach.
MAIN RESULTS
We included 44 studies (20 new to this update), reporting data for 6940 women and their infants. We used random-effects throughout. Overall, the risk of bias was assessed as low or unclear risk in most domains across studies. Evidence certainty, assessed using GRADE, was found to be generally low, mainly due to study design, inconsistency and imprecision. Six studies (n = 1284) compared membrane sweeping with more than one intervention and were thus included in more than one comparison. No trials reported on the outcomes uterine hyperstimulation with/without fetal heart rate (FHR) change, uterine rupture or neonatal encephalopathy. Forty studies (6548 participants) compared membrane sweeping with no treatment/sham Women randomised to membrane sweeping may be more likely to experience: · spontaneous onset of labour (average risk ratio (aRR) 1.21, 95% confidence interval (CI) 1.08 to 1.34, 17 studies, 3170 participants, low-certainty evidence). but less likely to experience: · induction (aRR 0.73, 95% CI 0.56 to 0.94, 16 studies, 3224 participants, low-certainty evidence); There may be little to no difference between groups for: · caesareans (aRR 0.94, 95% CI 0.85 to 1.04, 32 studies, 5499 participants, moderate-certainty evidence); · spontaneous vaginal birth (aRR 1.03, 95% CI 0.99 to 1.07, 26 studies, 4538 participants, moderate-certainty evidence); · maternal death or serious morbidity (aRR 0.83, 95% CI 0.57 to 1.20, 17 studies, 2749 participants, low-certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.83, 95% CI 0.59 to 1.17, 18 studies, 3696 participants, low-certainty evidence). Four studies reported data for 480 women comparing membrane sweeping with vaginal/intracervical prostaglandins There may be little to no difference between groups for the outcomes: · spontaneous onset of labour (aRR, 1.24, 95% CI 0.98 to 1.57, 3 studies, 339 participants, low-certainty evidence); · induction (aRR 0.90, 95% CI 0.56 to 1.45, 2 studies, 157 participants, low-certainty evidence); · caesarean (aRR 0.69, 95% CI 0.44 to 1.09, 3 studies, 339 participants, low-certainty evidence); · spontaneous vaginal birth (aRR 1.12, 95% CI 0.95 to 1.32, 2 studies, 252 participants, low-certainty evidence); · maternal death or serious morbidity (aRR 0.93, 95% CI 0.27 to 3.21, 1 study, 87 participants, low-certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.40, 95% CI 0.12 to 1.33, 2 studies, 269 participants, low-certainty evidence). One study, reported data for 104 women, comparing membrane sweeping with intravenous oxytocin +/- amniotomy There may be little to no difference between groups for: · spontaneous onset of labour (aRR 1.32, 95% CI 88 to 1.96, 1 study, 69 participants, low-certainty evidence); · induction (aRR 0.51, 95% CI 0.05 to 5.42, 1 study, 69 participants, low-certainty evidence); · caesarean (aRR 0.69, 95% CI 0.12 to 3.85, 1 study, 69 participants, low-certainty evidence); · maternal death or serious morbidity was reported on, but there were no events. Two studies providing data for 160 women compared membrane sweeping with vaginal/oral misoprostol There may be little to no difference between groups for: · caesareans (RR 0.82, 95% CI 0.31 to 2.17, 1 study, 96 participants, low-certainty evidence). One study providing data for 355 women which compared once weekly membrane sweep with twice-weekly membrane sweep and a sham procedure There may be little to no difference between groups for: · induction (RR 1.19, 95% CI 0.76 to 1.85, 1 study, 234 participants, low-certainty); · caesareans (RR 0.93, 95% CI 0.60 to 1.46, 1 study, 234 participants, low-certainty evidence); · spontaneous vaginal birth (RR 1.00, 95% CI 0.86 to 1.17, 1 study, 234 participants, moderate-certainty evidence); · maternal death or serious maternal morbidity (RR 0.78, 95% CI 0.30 to 2.02, 1 study, 234 participants, low-certainty evidence); · neonatal death or serious neonatal perinatal morbidity (RR 2.00, 95% CI 0.18 to 21.76, 1 study, 234 participants, low-certainty evidence); We found no studies that compared membrane sweeping with amniotomy only or mechanical methods. Three studies, providing data for 675 women, reported that women indicated favourably on their experience of membrane sweeping with one study reporting that 88% (n = 312) of women questioned in the postnatal period would choose membrane sweeping in the next pregnancy. Two studies reporting data for 290 women reported that membrane sweeping is more cost-effective than using prostaglandins, although more research should be undertaken in this area.
AUTHORS' CONCLUSIONS
Membrane sweeping may be effective in achieving a spontaneous onset of labour, but the evidence for this was of low certainty. When compared to expectant management, it potentially reduces the incidence of formal induction of labour. Questions remain as to whether there is an optimal number of membrane sweeps and timings and gestation of these to facilitate induction of labour.
Topics: Amnion; Cervical Ripening; Female; Humans; Labor, Induced; Mechanical Phenomena; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic; Risk Factors; Term Birth
PubMed: 32103497
DOI: 10.1002/14651858.CD000451.pub3 -
Journal of Obstetrics and Gynaecology... Dec 2020This systematic review and meta-analysis assessed the effectiveness and safety of camylofin compared with other antispasmodics (drotaverine, hyoscine, valethamate,... (Review)
Review
This systematic review and meta-analysis assessed the effectiveness and safety of camylofin compared with other antispasmodics (drotaverine, hyoscine, valethamate, phloroglucinol, and meperidine) in labor augmentation. A systematic literature search until March 27, 2018, was performed, and data on the cervical dilatation rate (CDR) and duration of stages of labor reported in 39 eligible articles were analyzed using a random-effects model. CDR was significantly higher (0.38 cm/h, 95% confidence interval (CI) 0.10 to 0.67, = 0.007), and the duration of the first stage of labor was significantly shorter (- 41.21 minutes, 95% CI, - 77.19 to - 5.22, = 0.02) in women receiving camylofin than those receiving other antispasmodics for labor augmentation. CDR was significantly higher with camylofin compared with valethamate (0.6 cm/h, 95% CI 0.4 to 0.9, < 0.0001) and hyoscine (20 mg) (0.5 cm/h, 95% CI 0.1 to 0.8, = 0.02). The duration of the first stage of labor was significantly shorter with camylofin compared with hyoscine (20 mg) (- 59.9 min, 95% CI, - 117.9 to - 1.8, = 0.04). However, CDR and the duration of first stage of labor were not statistically different between camylofin and drotaverine groups. The percentage of women having nausea and vomiting, cervical/vaginal tear, and postpartum hemorrhage were comparable with all antispasmodics, whereas tachycardia was least reported in women receiving camylofin (3, 2.07%) than those receiving other antispasmodics. This meta-analysis demonstrated the benefit of camylofin in labor augmentation with a faster CDR and reduction in the active first stage of labor in Indian women.
PubMed: 33417640
DOI: 10.1007/s13224-020-01343-3 -
Sexual Medicine Reviews Oct 2022Vaginal stenosis is a distressing side effect of radiation therapy that can impair quality of life. Dilator therapy is an option for patients undergoing pelvic... (Review)
Review
INTRODUCTION
Vaginal stenosis is a distressing side effect of radiation therapy that can impair quality of life. Dilator therapy is an option for patients undergoing pelvic radiotherapy to mitigate vaginal stenosis. Currently, the dilators given to patients by most hospitals are made of plastic, compared to silicone dilators which are available on the market for purchase.
OBJECTIVES
We conducted a systematic literature review to find information to guide clinical recommendations to pelvic radiotherapy patients on potential differences regarding the use of plastic vs silicone dilators with regard to efficacy, cost, and patient preferences.
METHODS
A systematic literature review was conducted in Embase, MEDLINE, and PubMed using Emtree terms. To be included in the review, papers needed to: focus on female patients undergoing radiation therapy, assess a vaginal dilator, measure any dilator intervention outcome, and specifically compare plastic vs silicone dilators for any measured outcome (either qualitative or quantitative).
RESULTS
The initial search yielded 195 articles. Two area experts, with a third expert for arbitration, read each article and found that none met all review inclusion criteria. No studies were found that compared silicone to plastic dilators with regard to efficacy in treating vaginal stenosis due to radiation therapy, no studies were found that compared cost or cost-effectiveness of the 2 dilator types, and no studies were found comparing patient preferences or experiences (eg, comfort, adherence, ease of use) between the 2 dilator types.
CONCLUSION
The materials used to create dilators have never been rigorously compared in the context of radiotherapy-related vaginal stenosis. Institutions and patients have no data to guide their choice. Significantly more research at the patient and institutional level is needed to explore the potential long-term quality of life and cost benefits of improved adherence with silicone dilator use, and to guide shared decision-making regarding dilator choice. Morgan O, Lopez MD, Martinez AJC, et al. Systematic Review of Comparisons Between Plastic and Silicone Dilators: Revealing a Knowledge Gap. Sex Med Rev 2022;10:513-519.
Topics: Constriction, Pathologic; Female; Humans; Plastics; Quality of Life; Silicones; Vagina
PubMed: 36030181
DOI: 10.1016/j.sxmr.2022.06.008 -
The Cochrane Database of Systematic... Sep 2014Vaginal dilation therapy is advocated after pelvic radiotherapy to prevent stenosis (abnormal narrowing of the vagina), but can be uncomfortable and psychologically... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vaginal dilation therapy is advocated after pelvic radiotherapy to prevent stenosis (abnormal narrowing of the vagina), but can be uncomfortable and psychologically distressing.
OBJECTIVES
To assess the benefits and harms of different types of vaginal dilation methods offered to women treated by pelvic radiotherapy for cancer.
SEARCH METHODS
Searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2013, Issue 5), MEDLINE (1950 to June week 2, 2013), EMBASE (1980 to 2013 week 24) and CINAHL (1982 to 2013).
SELECTION CRITERIA
Comparative data of any type, which evaluated dilation or penetration of the vagina after pelvic radiotherapy treatment for cancer.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no trials and therefore analysed no data.
MAIN RESULTS
We identified no studies for inclusion in the original review or for this update. However, we felt that some studies that were excluded warranted discussion. These included one randomised trial (RCT), which showed no improvement in sexual scores associated with encouraging women to practise dilation therapy; a recent small RCT that did not show any advantage to dilation over vibration therapy during radiotherapy; two non-randomised comparative studies; and five correlation studies. One of these showed that objective measurements of vaginal elasticity and length were not linked to dilation during radiotherapy, but the study lacked power. One study showed that women who dilated tolerated a larger dilator, but the risk of objectivity and bias with historical controls was high. Another study showed that the vaginal measurements increased in length by a mean of 3 cm after dilation was introduced 6 to 10 weeks after radiotherapy, but there was no control group; another case series showed the opposite. Three recent studies showed less stenosis associated with prophylactic dilation after radiotherapy. One small case series suggested that dilation years after radiotherapy might restore the vagina to a functional length.
AUTHORS' CONCLUSIONS
There is no reliable evidence to show that routine, regular vaginal dilation during radiotherapy treatment prevents stenosis or improves quality of life. Several observational studies have examined the effect of dilation therapy after radiotherapy. They suggest that frequent dilation practice is associated with lower rates of self reported stenosis. This could be because dilation is effective or because women with a healthy vagina are more likely to comply with dilation therapy instructions compared to women with strictures. We would normally suggest that a RCT is needed to distinguish between a casual and causative link, but pilot studies highlight many reasons why RCT methodology is challenging in this area.
Topics: Anti-Inflammatory Agents; Benzydamine; Brachytherapy; Constriction, Pathologic; Dilatation; Estrogens; Female; Humans; Hyperbaric Oxygenation; Pelvis; Radiation Injuries; Radiotherapy; Rupture; Sexual Dysfunction, Physiological; Time Factors; Vagina
PubMed: 25198150
DOI: 10.1002/14651858.CD007291.pub3 -
Scientific Reports May 2023The prevalence of cesarean sections is rising rapidly and is becoming a global issue. Vaginal birth after a cesarean section is one of the safest strategies that can be... (Meta-Analysis)
Meta-Analysis
The prevalence of cesarean sections is rising rapidly and is becoming a global issue. Vaginal birth after a cesarean section is one of the safest strategies that can be used to decrease the cesarean section rate. Different fragmented primary studies were done on the success rate of vaginal birth after cesarean section and its associated factors in Ethiopia. However, the findings were controversial and inconclusive. Therefore, this meta-analysis was intended to estimate the pooled success rate of vaginal birth after cesarean section and its associated factors in Ethiopia. Pertinent studies were searched in PubMed, Google Scholar, ScienceDirect, direct open-access journals, and Ethiopian universities' institutional repositories. The data were analyzed using Stata 17. The Newcastle-Ottawa quality assessment tool was used to assess the quality of the studies. I squared statistics and Egger's regression tests were used to assess heterogeneity and publication bias, respectively. A random effects model was selected to estimate the pooled success rate of vaginal birth after cesarean section and its associated factors. The PROSPERO registration number for this review is CRD42023413715. A total of 10 studies were included. The pooled success rate of vaginal birth after a cesarean section was found to be 48.42%. Age less than 30 years (pooled odds ratio (OR) 3.75, 95% CI 1.92, 7.33), previous history of vaginal birth (OR 3.65, 95% CI 2.64, 504), ruptured amniotic membrane at admission (OR 2.87, 95% CI 1.94, 4.26), 4 cm or more cervical dilatation at admission (OR 4, 95% CI 2.33, 6.8), a low station at admission (OR 5.07, 95% CI 2.08, 12.34), and no history of stillbirth (OR 4.93, 95% CI 1.82, 13.36) were significantly associated with successful vaginal birth after cesarean section. In conclusion, the pooled success rate of vaginal birth after a cesarean section was low in Ethiopia. Therefore, the Ministry of Health should consider those identified factors and revise the management guidelines and eligibility criteria for a trial of labor after a cesarean section.
Topics: Pregnancy; Female; Humans; Adult; Cesarean Section; Vaginal Birth after Cesarean; Ethiopia; Parturition; Labor, Obstetric
PubMed: 37188702
DOI: 10.1038/s41598-023-34856-8 -
American Journal of Obstetrics and... Mar 2024This study aimed to quantify the association between mode of operative delivery in the second stage of labor (cesarean delivery vs operative vaginal delivery) and... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
This study aimed to quantify the association between mode of operative delivery in the second stage of labor (cesarean delivery vs operative vaginal delivery) and spontaneous preterm birth in a subsequent pregnancy.
DATA SOURCES
MEDLINE, Embase, EmCare, CINAHL, the Cochrane Library, Web of Science: Core Collection, and Scopus were searched from database inception to April 1, 2023.
STUDY ELIGIBILITY CRITERIA
All retrospective cohort studies with participants who had a second-stage cesarean delivery (defined as intrapartum cesarean delivery at full cervical dilation) or operative vaginal delivery (including forceps- and/or vacuum-assisted delivery) and that reported the rate of preterm birth (either spontaneous or not specified) in subsequent pregnancy were included.
METHODS
Both a descriptive analysis and a meta-analysis were performed. A meta-analysis was performed for dichotomous data using the Mantel-Haenszel random-effects model and used the odds ratio as an effect measure with 95% confidence intervals. The risk of bias was assessed using Cochrane's 2022 Risk Of Bias In Non-randomized Studies of Exposure tool.
RESULTS
After screening 2671 articles from 7 databases, a total of 18 retrospective cohort studies encompassing 605,138 patients were included. The pooled rates of spontaneous preterm birth in a subsequent pregnancy were 6.9% (12 studies) after second-stage cesarean delivery and 2.6% (8 studies) after operative vaginal delivery. A total of 7 studies encompassing 75,460 patients compared the primary outcome of spontaneous preterm birth after second-stage cesarean delivery vs operative vaginal delivery in an index pregnancy with an odds ratio of 2.01 (95% confidence interval, 1.57-2.58) in favor of operative vaginal delivery. However, most studies did not include important confounding factors, did not address exposure misclassification because of failed operative vaginal delivery, and considered operative vaginal delivery as a homogeneous category with no distinction between forceps- and vacuum-assisted deliveries.
CONCLUSION
Although a synthesis of the existing literature suggests that the risk of spontaneous preterm birth is higher in those with a previous second-stage cesarean delivery than in those with operative vaginal delivery, the risk of bias in these studies is very high. Findings should be interpreted with caution.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Premature Birth; Retrospective Studies; Labor Stage, Second; Cohort Studies; Delivery, Obstetric
PubMed: 37673234
DOI: 10.1016/j.ajog.2023.08.033 -
Obstetrics and Gynecology Jun 2021To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening in the outpatient setting alone.
DATA SOURCES
Searches for articles in English included MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and reference lists (up to August 2020).
METHODS OF STUDY SELECTION
Using predefined criteria and DistillerSR software, 10,853 citations were dual-reviewed for randomized controlled trials (RCTs) and cohort studies of outpatient cervical ripening using prostaglandins and mechanical methods in pregnant women at or beyond 37 weeks of gestation.
TABULATION, INTEGRATION, AND RESULTS
Using prespecified criteria, study data abstraction and risk of bias assessment were conducted by two reviewers, random-effects meta-analyses were conducted and strength of evidence was assessed. We included 30 RCTs and 10 cohort studies (N=9,618) most generalizable to women aged 25-30 years with low-risk pregnancies. All findings were low or insufficient strength of evidence and not statistically significant. Incidence of cesarean delivery was not different for any comparison of inpatient and outpatient settings, or comparisons of different methods in the outpatient setting (most evidence available for single-balloon catheters and dinoprostone). Harms were inconsistently reported or inadequately defined. Differences were not found for neonatal infection (eg, sepsis) with outpatient compared with inpatient dinoprostone, birth trauma (eg, cephalohematoma) with outpatient compared with inpatient single-balloon catheter, shoulder dystocia with outpatient dinoprostone compared with placebo, maternal infection (eg, chorioamnionitis) with outpatient compared with inpatient single-balloon catheters or outpatient prostaglandins compared with placebo, and postpartum hemorrhage with outpatient catheter compared with inpatient dinoprostone. Evidence on misoprostol, hygroscopic dilators, and other outcomes (eg, perinatal mortality and time to vaginal birth) was insufficient.
CONCLUSION
In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42020167406.
Topics: Ambulatory Care; Catheters; Cervical Ripening; Cesarean Section; Dilatation; Dinoprostone; Female; Hospitalization; Humans; Labor, Induced; Obstetric Labor Complications; Oxytocics; Pregnancy
PubMed: 33752219
DOI: 10.1097/AOG.0000000000004382 -
Midwifery Sep 2023To conduct a systematic review exploring women's experiences, views and understanding of any vaginal examinations during intrapartum care, in any care setting and by any... (Review)
Review
OBJECTIVE
To conduct a systematic review exploring women's experiences, views and understanding of any vaginal examinations during intrapartum care, in any care setting and by any healthcare professional. Intrapartum vaginal examination is deemed both an essential assessment tool and routine intervention during labour. It is an intervention that can cause significant distress, embarrassment, and pain for women, as well as reinforce outdated gender roles. In view of its widespread and frequently reported excessive use, it is important to understand women's views on vaginal examination to inform further research and current practice.
DESIGN
A systematic search and meta-ethnography synthesis informed by Noblit and Hare (1988) and the eMERGe guidance (France et al. 2019) was undertaken. Nine electronic databases were searched systematically using predefined search terms in August 2021, and again in March 2023. Studies meeting the following criteria: English language, qualitative and mixed-method studies, published from 2000 onwards, and relevant to the topic, were eligible for quality appraisal and inclusion.
FINDINGS
Six studies met the inclusion criteria. Three from Turkey, one from Palestine, one from Hong Kong and one from New Zealand. One disconfirming study was identified. Following both a reciprocal and refutational synthesis, four 3rd order constructs were formed, titled: Suffering the examination, Challenging the power dynamic, Cervical-centric labour culture embedded in societal expectations, and Context of care. Finally, a line of argument was arrived at, which brought together and summarised the 3rd order constructs.
KEY CONCLUSIONS AND IMPLICATIONS OF PRACTICE
The dominant biomedical discourse of vaginal examination and cervical dilatation as central to the birthing process does not align with midwifery philosophy or women's embodied experience. Women experience examinations as painful and distressing but tolerate them as they view them as necessary and unavoidable. Factors such as context of care setting, environment, privacy, midwifery care, particularly in a continuity of carer model, have considerable positive affect on women's experience of examinations. Further research into women's experiences of vaginal examination in different care models as well as research into less invasive intrapartum assessment tools that promote physiological processes is urgently required.
Topics: Pregnancy; Female; Humans; Gynecological Examination; Anthropology, Cultural; Parturition; Labor, Obstetric; Midwifery; Qualitative Research
PubMed: 37315454
DOI: 10.1016/j.midw.2023.103746 -
The Cochrane Database of Systematic... Apr 2015Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix. Almost 50% of hysteroscopic complications are related to difficulty with cervical entry. Potential complications include cervical tears, creation of a false passage, perforation, bleeding, or simply difficulty in entering the internal os (between the cervix and the uterus) with the hysteroscope. These complications may possibly be reduced with adequate preparation of the cervix (cervical ripening) prior to hysteroscopy. Cervical ripening agents include oral or vaginal prostaglandin, which can be synthetic (e.g misoprostol) or natural (e.g. dinoprostone) and vaginal osmotic dilators, which can be naturally occurring (e.g. laminaria) or synthetic.
OBJECTIVES
To determine whether preoperative cervical preparation facilitates cervical dilatation and reduces the complications of operative hysteroscopy in women undergoing the procedure for any condition.
SEARCH METHODS
In August 2014 we searched sources including the Menstrual Disorders and Subfertility Group (MDSG) Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and reference lists of relevant articles. We searched for published and unpublished studies in any language.
SELECTION CRITERIA
Two review authors independently selected randomised controlled trials (RCTs) of cervical ripening agents used before operative hysteroscopy in pre- and postmenopausal women. Cervical ripening agents could be compared to each other, placebo or no treatment.
DATA COLLECTION AND ANALYSIS
Data extraction and quality assessment were conducted independently by two review authors. The primary review outcomes were effectiveness of cervical dilatation (defined as the proportion of women requiring mechanical cervical dilatation) and intraoperative complications. Secondary outcomes were mean time required to dilate the cervix, preoperative pain, cervical width, abandonment of the procedure, side effects of dilating agents and duration of surgery. We calculated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, with 95% confidence intervals ( CIs). Data were statistically pooled where appropriate. Heterogeneity was assessed using the I(2) statistic. The overall quality of the evidence was assessed using GRADE methods.
MAIN RESULTS
Nineteen RCTs with a total of 1870 participants were included. They compared misoprostol with no treatment or placebo, dinoprostone or osmotic dilators.Misoprostol was more effective for cervical dilatation than placebo or no intervention, with fewer women requiring mechanical dilatation (OR 0.08, 95% CI 0.04 to 0.16, five RCTs, 441 participants, I(2)=0%, moderate quality evidence). This suggests that in a population in which 80% of women undergoing hysteroscopy require mechanical dilatation without use of preoperative ripening agents, use of misoprostol will reduce the need for mechanical dilatation to between 14% and 39%. Misoprostol was associated with fewer intraoperative complications (OR 0.37, 95% CI 0.18 to 0.77, 12 RCTs, 901 participants, I(2)=0%, moderate quality evidence). This suggests that in a population in which 3% of women undergoing hysteroscopy experience intraoperative complications without use of preoperative ripening agents, use of misoprostol will reduce the risk of complications to 2% or less.When specific complications were considered, the misoprostol group had a lower rate of cervical laceration or tearing (OR 0.25, 95% CI 0.11 to 0.57, nine RCTS, 669 women, I(2)=0%, moderate quality evidence) or false track formation (OR 0.34, 95% CI 0.12 to 0.97, seven RCTs, 560 participants, I(2)=0%, moderate quality evidence). There was no evidence of a difference between the groups in rates of uterine perforation (0.42, 95% CI 0.13 to 1.38, seven RCTs, 455 participants, I(2)=0%, low quality evidence) or uterine bleeding (OR 0.51, 95% CI 0.10 to 2.49, four RCTs, 340 participants, I(2)=0%, low quality evidence). Some treatment side effects (mild abdominal pain, vaginal bleeding, and increased body temperature) were more common in the misoprostol group.Compared with dinoprostone, misoprostol was associated with more effective cervical dilatation, with fewer women requiring mechanical dilatation (OR 0.58; 95% CI 0.34 to 0.98; one RCT, 310 participants, low quality evidence) and with fewer intraoperative complications (OR 0.32; 95% CI 0.12 to 0.83, one RCT, 310 participants, low quality evidence). However treatment side effects were more common in the misoprostol arm.Compared to osmotic dilatation (laminaria), misoprostol was associated with less effective cervical dilatation, with more women in the misoprostol group requiring mechanical dilatation (OR 5.96, 95% CI 2.61 to 13.59, one RCT, 110 participants, low quality evidence). There was no evidence of a difference between misoprostol and osmotic dilators in intraoperative complication rates (OR 5.14, 95% CI 0.24 to 109.01, three RCTs, 354 participants, low quality evidence), with only two events reported altogether.The overall quality of the evidence ranged from low to moderate. The main limitations in the evidence were imprecision and poor reporting of study methods.
AUTHORS' CONCLUSIONS
There is moderate quality evidence that use of misoprostol for preoperative ripening of the cervix before operative hysteroscopy is more effective than placebo or no treatment and is associated with fewer intraoperative complications such as lacerations and false tracks. However misoprostol is associated with more side effects, including preoperative pain and vaginal bleeding. There is low quality evidence to suggest that misoprostol has fewer intraoperative complications and is more effective than dinoprostone.There is also low quality evidence to suggest that laminaria may be more effective than misoprostol, with uncertain effects for complication rates. However the possible benefits of laminaria need to be weighed against the inconvenience of its insertion and retention for one to two days.
Topics: Cervical Ripening; Cervix Uteri; Dilatation; Dinoprostone; Female; Humans; Hysteroscopy; Laminaria; Misoprostol; Oxytocics; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic
PubMed: 25906113
DOI: 10.1002/14651858.CD005998.pub2 -
Patient Preference and Adherence 2018Vaginal dilator (VD) therapy is often recommended for women receiving pelvic radiation therapy or experiencing pain and discomfort during intercourse, as well as for...
BACKGROUND
Vaginal dilator (VD) therapy is often recommended for women receiving pelvic radiation therapy or experiencing pain and discomfort during intercourse, as well as for women with a congenital malformation of the vagina. VD use has both physical and psychological benefits; however, it often causes pain, discomfort, and adverse emotions, including embarrassment and loss of modesty, which often result in low adherence to therapy.
OBJECTIVES
The aims of this study were to explore the use and adherence of VD therapy in women, identify barriers and facilitators of therapy adherence, and suggest improvement strategies from the theoretical perspective of symbolic interactionism.
METHODS
A systematic review of the literature was conducted using PubMed, CINAHL, and Scopus databases, with no year restrictions. Articles addressing the experience of women using VD therapy, as well as barriers and facilitators of therapy adherence were selected and analyzed. Then, the theoretical perspective of symbolic interactionism was introduced and applied to synthesize the results.
RESULTS
A total of 21 articles were selected for the review. Most of the reviewed studies explored VD therapy in women who had undergone pelvic radiation therapy for gynecological cancer. Women's adherence to the therapy ranged between 25% and 89.2%, with great variance in definitions and methods for assessing therapy adherence. Among the five categories of identified barriers to therapy adherence, "unhelpful circumstances" and "negative perceptions toward the VD" were the two most frequently mentioned. The two most frequently reported facilitators of adherence among the six identified categories were "supportive interactions with health care providers" and "risk perception and positive outcome expectancies". On the basis of the perspective of symbolic interactionism, strategies for strengthening interactions with others (eg, health care providers, significant others, and support groups) are discussed in detail.
CONCLUSION
Strategic intervention regarding the decisive factors identified in the review can benefit women by enhancing their experience and adherence to VD therapy.
PubMed: 29695897
DOI: 10.2147/PPA.S163273