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American Journal of Obstetrics and... Jul 2020Randomized controlled trials that have assessed the efficacy of cervical pessary to prevent preterm birth in asymptomatic high-risk women have reported conflicting... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Randomized controlled trials that have assessed the efficacy of cervical pessary to prevent preterm birth in asymptomatic high-risk women have reported conflicting results.
OBJECTIVE
To evaluate the efficacy and safety of cervical pessary to prevent preterm birth and adverse perinatal outcomes in asymptomatic high-risk women.
DATA SOURCES
MEDLINE, EMBASE, POPLINE, CINAHL, and LILACS (from their inception to October 31, 2019), Cochrane databases, Google Scholar, bibliographies, and conference proceedings.
STUDY ELIGIBILITY CRITERIA
Randomized controlled trials that compared cervical pessary with standard care (no pessary) or alternative interventions in asymptomatic women at high risk for preterm birth.
STUDY APPRAISAL AND SYNTHESIS METHODS
The systematic review was conducted according to the Cochrane Handbook guidelines. The primary outcome was spontaneous preterm birth <34 weeks of gestation. Secondary outcomes included adverse pregnancy, maternal, and perinatal outcomes. Pooled relative risks with 95% confidence intervals were calculated. Quality of evidence was assessed using the GRADE methodology.
RESULTS
Twelve studies (4687 women and 7167 fetuses/infants) met the inclusion criteria: 8 evaluated pessary vs no pessary in women with a short cervix, 2 assessed pessary vs no pessary in unselected multiple gestations, and 2 compared pessary vs vaginal progesterone in women with a short cervix. There were no significant differences between the pessary and no pessary groups in the risk of spontaneous preterm birth <34 weeks of gestation among singleton gestations with a cervical length ≤25 mm (relative risk, 0.80; 95% confidence interval, 0.43-1.49; 6 trials, 1982 women; low-quality evidence), unselected twin gestations (relative risk, 1.05; 95% confidence interval, 0.79-1.41; 1 trial, 1177 women; moderate-quality evidence), twin gestations with a cervical length <38 mm (relative risk, 0.75; 95% confidence interval, 0.41-1.36; 3 trials, 1128 women; low-quality evidence), and twin gestations with a cervical length ≤25 mm (relative risk; 0.72, 95% confidence interval, 0.25-2.06; 2 trials, 348 women; low-quality evidence). Overall, no significant differences were observed between the pessary and no pessary groups in preterm birth <37, <32, and <28 weeks of gestation, and most adverse pregnancy, maternal, and perinatal outcomes (low- to moderate-quality evidence for most outcomes). There were no significant differences in the risk of spontaneous preterm birth <34 weeks of gestation between pessary and vaginal progesterone in singleton gestations with a cervical length ≤25 mm (relative risk, 0.99; 95% confidence interval, 0.54-1.83; 1 trial, 246 women; low-quality evidence) and twin gestations with a cervical length <38 mm (relative risk, 0.73; 95% confidence interval, 0.46-1.18; 1 trial, 297 women; very low-quality evidence). Vaginal discharge was significantly more frequent in the pessary group than in the no pessary and vaginal progesterone groups (relative risks, ∼2.20; high-quality evidence).
CONCLUSION
Current evidence does not support the use of cervical pessary to prevent preterm birth or to improve perinatal outcomes in singleton or twin gestations with a short cervix and in unselected twin gestations.
Topics: Asymptomatic Diseases; Cervix Uteri; Female; Humans; Pessaries; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Risk Assessment
PubMed: 32027880
DOI: 10.1016/j.ajog.2019.12.266 -
The Journal of Maternal-fetal &... Jan 2022To evaluate the effectiveness of cervical pessary in preventing preterm birth (PTB) and improving perinatal outcomes among singleton and twin pregnancies. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To evaluate the effectiveness of cervical pessary in preventing preterm birth (PTB) and improving perinatal outcomes among singleton and twin pregnancies.
METHODS
Electronic databases were systematically searched from their inception until 14 March 2019. Randomized clinical trials comparing the effectiveness of cervical pessary placement with expectant management were included. The primary outcome was the incidence of PTB <34 weeks.
RESULTS
Thirteen studies were included, involving eight studies about singleton and six studies about twin pregnancies. For singleton pregnancies with short cervical length, cervical pessary, comparing with expectant treatment, seemed have no effectiveness in preventing PTB <34 weeks (relative risk, 95% confidence interval, 0.73, 0.42-1.28), <37 weeks (0.69, 0.43-1.09), and <28 weeks (0.79, 0.42-1.48); while for twin pregnancies with short cervical length, cervical pessary also did not reduce the risk of PTB <34 weeks (0.81, 0.49-1.35), <37 weeks (0.93, 0.83-1.05), and <28 weeks (0.72, 0.38-1.38). However, cervical pessary seemed have the effectiveness of reducing the risk of spontaneous PTB <28 weeks (0.50, 0.25-0.99) and low birth weight (<1500 g) (0.68, 0.50-0.94) among twin pregnancies with short cervical length. In addition, cervical pessary increased the rate of vaginal discharge and did not improve perinatal outcomes among both singleton and twin pregnancies.
CONCLUSIONS
Comparing with the expectant treatment, the effectiveness of cervical pessary for reducing the risk of PTB remains uncertain. Additional trials are warranted to further evaluate the effectiveness of cervical pessary.
Topics: Cervix Uteri; Female; Humans; Infant, Low Birth Weight; Infant, Newborn; Pessaries; Pregnancy; Pregnancy, Twin; Premature Birth
PubMed: 31948303
DOI: 10.1080/14767058.2020.1712705 -
Arab Journal of Urology Mar 2019: To review lower urinary tract symptoms (LUTS), which include a large variety of bladder complaints, in women with simultaneous pelvic organ prolapse (POP). : This... (Review)
Review
: To review lower urinary tract symptoms (LUTS), which include a large variety of bladder complaints, in women with simultaneous pelvic organ prolapse (POP). : This article is a systematic review of the current literature on LUTS occurring simultaneously with POP following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. : The prevalence of both conditions is high, but they occur more frequently together than can be explained by chance. It appears that POP is in some women causative of overactive bladder (OAB) symptoms, as in many women correction of the POP resolves the bladder symptoms and small studies of women with detrusor underactivity also demonstrate resolution of symptoms. The most plausible explanation for the relationship is that POP causes bladder outlet obstruction, which results in excess bladder irritability or poor contractility. However, not all women have resolution of their OAB symptoms and some women develop them after POP repair, so this explanation requires more in depth study. : Women with both LUTS and symptomatic POP should probably have their POP targeted, as its reduction either via surgery or pessary can correct the LUTS. However, no studies have addressed asymptomatic POP, so it is unclear if treating POP in these instances is of benefit. BOO: bladder outlet obstruction; DO: detrusor overactivity; DU: detrusor underactivity; OAB: overactive bladder; PQ: detrusor pressure at maximum urinary flow; POP: pelvic organ prolapse; PVR: post-void residual urine volume; RR: relative risk; SUFU: Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction; UDS: urodynamic studies; (S)(U)UI: (stress) (urgency) urinary incontinence.
PubMed: 33110659
DOI: 10.1080/2090598X.2019.1589929 -
Archives of Gynecology and Obstetrics May 2019To assess the efficacy of cervical pessary application for the prevention of spontaneous preterm birth (SPB) in singleton pregnancies with a sonographically measured... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the efficacy of cervical pessary application for the prevention of spontaneous preterm birth (SPB) in singleton pregnancies with a sonographically measured short cervix.
METHODS
Searches were conducted in PubMed-Medline, Embase, Scopus, Web of Science, and Cochrane Library, and clinical trial registries for randomized controlled trials (RCTs) published in all languages from inception through 28 July 2018. Inclusion criteria were registered RCTs of singleton pregnants with a short cervix (≤ 25 mm) measured at 22-24 weeks comparing the use of a cervical pessary versus controls over the risk of SPB. Risk of bias was evaluated with the Cochrane tool. Risk ratios (RRs) and mean differences and 95% confidence intervals (CIs) were calculated.
RESULTS
We identified three RCTs meeting defined inclusion criteria, including a total of 1612 pregnancies (805 used a cervical pessary). SPB risk at < 37 was lower for participants using the pessary (RR 0.46; 95% CI 0.28-0.77). Pessary application was associated with a higher risk of presenting vaginal discharge (RR 2.05; 95% CI 1.82-2.31). There were no significant differences between pessary users and controls in terms of SPB at < 28 and < 34 weeks, and for any type of preterm birth < 34 weeks; mean gestational age and infant weight at delivery; and the risks of chorioamnionitis, cesarean delivery, and perinatal or neonatal outcomes. Sub-analysis by risk of bias showed that there was a lower risk of SPB < 34 weeks (RR 0.33; 95% CI 0.16-0.66) in two RCTs with low risk of bias.
CONCLUSION
Cervical pessary application was associated with a reduced risk of SPB at < 37 weeks and a higher risk of vaginal discharge.
Topics: Cervix Uteri; Female; Humans; Infant, Newborn; Pessaries; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic
PubMed: 30778728
DOI: 10.1007/s00404-019-05096-x -
Journal of Obstetrics and Gynaecology... Jan 2019The most effective preterm birth (PTB) intervention is unknown for women who are at risk of PTB due to a history of conization. The objective of this systematic review... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The most effective preterm birth (PTB) intervention is unknown for women who are at risk of PTB due to a history of conization. The objective of this systematic review was to determine whether PTB interventions, progesterone, cerclage, and pessary decrease the risk of PTB compared to no treatment in singleton-and separately in twin-pregnancies of women with history of conization.
METHODS
We searched Cochrane Central, MEDLINE, EMBASE, CINAHL, and ClinicalTrials.gov from January 1994 until May 2017. In duplicate, we reviewed titles, abstracts, full texts, extracted data, and assessed quality. We included RCTs and observational studies. Our primary outcomes were PTB <34 weeks, PTB <37 weeks, and neonatal mortality. We performed random effects meta-analyses and generated ORs with 95% CIs.
RESULTS
We screened 762 nonduplicate titles and abstracts and assessed 91 full texts. After contacting authors, we included nine studies. Women in the cerclage group were more likely to have a short cervix or another risk factor for PTB, raising the possibility of confounding by indication. In women with a history of conization and a singleton who received a cerclage compared to those who did not, the ORs of PTB <34 weeks was 3.99 (95% CI 0.67-23.62, three studies, I = 65%); of PTB <37 weeks was 2.10 (95% CI 0.87-5.05, four studies, I = 0%); and of neonatal mortality was 8.33 (95% CI 0.22-320.38, two studies, I = N/A). We did not find any studies comparing either progesterone or pessary to no treatment. Data for twins were very scarce.
CONCLUSION
In women with a previous conization and a current singleton gestation, the existing evidence, which is likely limited due to confounding by indication, does not support cerclage or other interventions used to try to decrease PTB.
Topics: Administration, Intravaginal; Cerclage, Cervical; Cervical Length Measurement; Cervix Uteri; Conization; Female; Humans; Pessaries; Pregnancy; Pregnancy, Twin; Premature Birth; Progesterone; Progestins; Risk Factors
PubMed: 30585167
DOI: 10.1016/j.jogc.2018.04.026 -
BJOG : An International Journal of... Apr 2019Recent progesterone trials call for an update of previous syntheses of interventions to prevent preterm birth. (Meta-Analysis)
Meta-Analysis
Vaginal progesterone, oral progesterone, 17-OHPC, cerclage, and pessary for preventing preterm birth in at-risk singleton pregnancies: an updated systematic review and network meta-analysis.
BACKGROUND
Recent progesterone trials call for an update of previous syntheses of interventions to prevent preterm birth.
OBJECTIVES
To compare the relative effects of different types and routes of administration of progesterone, cerclage, and pessary at preventing preterm birth in at-risk women overall and in specific populations.
SEARCH STRATEGY
We searched Medline, EMBASE, CINAHL, Cochrane CENTRAL, and Web of Science up to 1 January 2018.
SELECTION CRITERIA
We included randomised trials of progesterone, cerclage or pessary for preventing preterm birth in at-risk singleton pregnancies.
DATA COLLECTION AND ANALYSIS
We used a piloted data extraction form and performed Bayesian random-effects network meta-analyses with 95% credibility intervals (CrI), as well as pairwise meta-analyses, rating the quality of the evidence using GRADE.
MAIN RESULTS
We included 40 trials (11 311 women). In at-risk women overall, vaginal progesterone reduced preterm birth <34 (OR 0.43, 95% CrI 0.20-0.81) and <37 weeks (OR 0.51, 95% CrI 0.34-0.74), and neonatal death (OR 0.41, 95% CrI 0.20-0.83). In women with a previous preterm birth, vaginal progesterone reduced preterm birth <34 (OR 0.29, 95% CI 0.12-0.68) and <37 weeks (OR 0.43, 95% CrI 0.23-0.74), and 17α-hydroxyprogesterone caproate reduced preterm birth <37 weeks (OR 0.53, 95% CrI 0.27-0.95) and neonatal death (OR 0.39, 95% CI 0.16-0.95). In women with a short cervix (≤25 mm), vaginal progesterone reduced preterm birth <34 weeks (OR 0.45, 95% CI 0.24-0.84).
CONCLUSIONS
Vaginal progesterone was the only intervention with consistent effectiveness for preventing preterm birth in singleton at-risk pregnancies overall and in those with a previous preterm birth.
TWEETABLE ABSTRACT
In updated NMA, vaginal progesterone consistently reduced PTB in overall at-risk pregnancies and in women with previous PTB.
Topics: 17 alpha-Hydroxyprogesterone Caproate; Administration, Intravaginal; Administration, Oral; Cerclage, Cervical; Cervical Length Measurement; Cervix Uteri; Female; Humans; Infant, Newborn; Network Meta-Analysis; Perinatal Death; Pessaries; Pregnancy; Pregnancy, High-Risk; Premature Birth; Progesterone; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30480871
DOI: 10.1111/1471-0528.15566 -
Interventions during pregnancy to prevent preterm birth: an overview of Cochrane systematic reviews.The Cochrane Database of Systematic... Nov 2018Preterm birth (PTB) is a major factor contributing to global rates of neonatal death and to longer-term health problems for surviving infants. Both the World Health... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Preterm birth (PTB) is a major factor contributing to global rates of neonatal death and to longer-term health problems for surviving infants. Both the World Health Organization and the United Nations consider prevention of PTB as central to improving health care for pregnant women and newborn babies. Current preventative clinical strategies show varied efficacy in different populations of pregnant women, frustrating women and health providers alike, while researchers call for better understanding of the underlying mechanisms that lead to PTB.
OBJECTIVES
We aimed to summarise all evidence for interventions relevant to the prevention of PTB as reported in Cochrane systematic reviews (SRs). We intended to highlight promising interventions and to identify SRs in need of an update.
METHODS
We searched the Cochrane Database of Systematic Reviews (2 November 2017) with key words to capture any Cochrane SR that prespecified or reported a PTB outcome. Inclusion criteria focused on pregnant women without signs of preterm labour or ruptured amniotic membranes. We included reviews of interventions for pregnant women irrespective of their risk status. We followed standard Cochrane methods.We applied GRADE criteria to evaluate the quality of SR evidence. We assigned graphic icons to classify the effectiveness of interventions as: clear evidence of benefit; clear evidence of harm; clear evidence of no effect or equivalence; possible benefit; possible harm; or unknown benefit or harm. We defined clear evidence of benefit and clear evidence of harm to be GRADE moderate- or high-quality evidence with a confidence interval (CI) that does not cross the line of no effect. Clear evidence of no effect or equivalence is GRADE moderate- or high-quality evidence with a narrow CI crossing the line of no effect. Possible benefit and possible harm refer to GRADE low-quality evidence with a clear effect (CI does not cross the line of no effect) or GRADE moderate- or high-quality evidence with a wide CI. Unknown harm or benefit refers to GRADE low- or very low-quality evidence with a wide CI.
MAIN RESULTS
We included 83 SRs; 70 had outcome data. Below we highlight key results from a subset of 36 SRs of interventions intended to prevent PTB.
OUTCOME
preterm birthClear evidence of benefitFour SRs reported clear evidence of benefit to prevent specific populations of pregnant women from giving birth early, including midwife-led continuity models of care versus other models of care for all women; screening for lower genital tract infections for pregnant women less than 37 weeks' gestation and without signs of labour, bleeding or infection; and zinc supplementation for pregnant women without systemic illness. Cervical cerclage showed clear benefit for women with singleton pregnancy and high risk of PTB only.Clear evidence of harmNo included SR reported clear evidence of harm.No effect or equivalenceFor pregnant women at high risk of PTB, bedrest for women with singleton pregnancy and antibiotic prophylaxis during the second and third trimester were of no effect or equivalent to a comparator.Possible benefitFour SRs found possible benefit in: group antenatal care for all pregnant women; antibiotics for pregnant women with asymptomatic bacteriuria; pharmacological interventions for smoking cessation for pregnant women who smoke; and vitamin D supplements alone for women without pre-existing conditions such as diabetes.Possible harmOne SR reported possible harm (increased risk of PTB) with intramuscular progesterone, but this finding is only relevant to women with multiple pregnancy and high risk of PTB. Another review found possible harm with vitamin D, calcium and other minerals for pregnant women without pre-existing conditions.
OUTCOME
perinatal deathClear evidence of benefitTwo SRs reported clear evidence of benefit to reduce pregnant women's risk of perinatal death: midwife-led continuity models of care for all pregnant women; and fetal and umbilical Doppler for high-risk pregnant women.Clear evidence of harmNo included SR reported clear evidence of harm.No effect or equivalenceFor pregnant women at high risk of PTB, antibiotic prophylaxis during the second and third trimester was of no effect or equivalent to a comparator.Possible benefitOne SR reported possible benefit with cervical cerclage for women with singleton pregnancy and high risk of PTB.Possible harmOne SR reported possible harm associated with a reduced schedule of antenatal visits for pregnant women at low risk of pregnancy complications; importantly, these women already received antenatal care in settings with limited resources.
OUTCOMES
preterm birth and perinatal deathUnknown benefit or harmFor pregnant women at high risk of PTB for any reason including multiple pregnancy, home uterine monitoring was of unknown benefit or harm. For pregnant women at high risk due to multiple pregnancy: bedrest, prophylactic oral betamimetics, vaginal progesterone and cervical cerclage were all of unknown benefit or harm.
AUTHORS' CONCLUSIONS
Implications for practiceThe overview serves as a map and guide to all current evidence relevant to PTB prevention published in the Cochrane Library. Of 70 SRs with outcome data, we identified 36 reviews of interventions with the aim of preventing PTB. Just four of these SRs had evidence of clear benefit to women, with an additional four SRs reporting possible benefit. No SR reported clear harm, which is an important finding for women and health providers alike.The overview summarises no evidence for the clinically important interventions of cervical pessary, cervical length assessment and vaginal progesterone because these Cochrane Reviews were not current. These are active areas for PTB research.The graphic icons we assigned to SR effect estimates do not constitute clinical guidance or an endorsement of specific interventions for pregnant women. It remains critical for pregnant women and their healthcare providers to carefully consider whether specific strategies to prevent PTB will be of benefit for individual women, or for specific populations of women.Implications for researchFormal consensus work is needed to establish standard language for overviews of reviews and to define the limits of their interpretation.Clinicians, researchers and funders must address the lack of evidence for interventions relevant to women at high risk of PTB due to multiple pregnancy.
Topics: Anti-Bacterial Agents; Bed Rest; Female; Humans; Pregnancy; Premature Birth; Smoking Cessation; Systematic Reviews as Topic; Vitamin D; Vitamins
PubMed: 30480756
DOI: 10.1002/14651858.CD012505.pub2 -
The Cochrane Database of Systematic... Aug 2018Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP is common, limited supportive data can be found in the literature regarding the preoperative and postoperative interventions related to these procedures. The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse. A broad spectrum of perioperative interventions are available, and although the benefits of interventions such as prophylactic antibiotics before abdominal surgery are well established, others are unique to women undergoing POP surgeries and as such need to be investigated separately.
OBJECTIVES
The aim of this review is to compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for pelvic organ prolapse.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In Process, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings (searched 30 November 2017), and reference lists of relevant articles. We also contacted researchers in the field.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic pelvic organ prolapse that compared a perioperative intervention related to pelvic organ prolapse surgery versus no treatment or another intervention.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. Our primary outcomes were objective failure at any site and subjective postoperative prolapse symptoms. We also measured adverse effects, focusing on intraoperative blood loss and blood transfusion, intraoperative ureteral injury, and postoperative urinary tract infection.
MAIN RESULTS
We included 15 RCTs that compared eight different interventions versus no treatment for 1992 women in five countries. Most interventions were assessed by only one RCT with evidence quality ranging from very low to moderate. The main limitation was imprecision, associated with small sample sizes and low event rates.Pelvic floor muscle training (PFMT) compared with no treatment (three RCTs) - peri-operative intervention The simplest of the PFMT programmes required women to attend six perioperative consultations in the three months surrounding prolapse surgery. Trial results provided no clear evidence of a difference between groups in objective failure at any site at 12 to 24 months (odds ratio (OR) 0.93, 95% confidence interval (CI) 0.56 to 1.54; two RCTs, 327 women; moderate-quality evidence). With respect to awareness of prolapse, findings were inconsistent. One RCT found no evidence of a difference between groups at 24 months (OR 1.07, 95% CI 0.61 to 1.87; one RCT, 305 women; low-quality evidence), and a second small RCT reported symptom reduction from the Pelvic Organ Prolapse Symptom Questionnaire completed by the intervention group at 12 months (mean difference (MD) -3.90, 95% CI -6.11 to -1.69; one RCT, 27 women; low-quality evidence). Researchers found no clear differences between groups at 24-month follow-up in rates of repeat surgery (or pessary) for prolapse (OR 1.92, 95% CI 0.74 to 5.02; one RCT, 316 women; low-quality evidence).Other interventionsSingle RCTs evaluated the following interventions: preoperative guided imagery (N = 44); injection of vasoconstrictor agent at commencement of vaginal prolapse surgery (N = 76); ureteral stent placement during uterosacral ligament suspension (N = 91); vaginal pack (N = 116); prophylactic antibiotics for women requiring postoperative urinary catheterisation (N = 159); and postoperative vaginal dilators (N = 60).Two RCTs evaluated bowel preparation (N = 298), and four RCTs assessed the method and timing of postoperative catheterisation (N = 514) - all in different comparisons.None of these studies reported our primary review outcomes. One study reported intraoperative blood loss and suggested that vaginal injection of vasoconstrictors at commencement of surgery may reduce blood loss by a mean of about 30 mL. Another study reported intraoperative ureteral injury and found no clear evidence that ureteral stent placement reduces ureteral injury. Three RCTs reported postoperative urinary tract infection and found no conclusive evidence that rates of urinary tract infection were influenced by use of a vaginal pack, prophylactic antibiotics, or vaginal dilators. Other studies did not report these outcomes.
AUTHORS' CONCLUSIONS
There was a paucity of data about perioperative interventions in pelvic organ prolapse surgery. A structured programme of pelvic floor muscle training before and after prolapse surgery did not consistently demonstrate any benefit for the intervention; however, this finding is based on the results of two small studies. With regard to other interventions (preoperative bowel preparation and injection of vasoconstrictor agent, ureteral stent placement during uterosacral ligament suspension, postoperative vaginal pack insertion, use of vaginal dilators, prophylactic antibiotics for postoperative catheter care), we found no evidence regarding rates of recurrent prolapse and no clear evidence that these interventions were associated with clinically meaningful reductions in adverse effects, such as intraoperative or postoperative blood transfusion, intraoperative ureteral injury, or postoperative urinary tract infection.
Topics: Antibiotic Prophylaxis; Exercise; Female; Humans; Imagery, Psychotherapy; Pelvic Floor; Pelvic Organ Prolapse; Perioperative Care; Pessaries; Randomized Controlled Trials as Topic; Recurrence; Reoperation; Stents; Vasoconstrictor Agents
PubMed: 30121957
DOI: 10.1002/14651858.CD013105 -
The Cochrane Database of Systematic... Mar 2018Posterior vaginal wall prolapse (also known as 'posterior compartment prolapse') can cause a sensation of bulge in the vagina along with symptoms of obstructed... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Posterior vaginal wall prolapse (also known as 'posterior compartment prolapse') can cause a sensation of bulge in the vagina along with symptoms of obstructed defecation and sexual dysfunction. Interventions for prevention and conservative management include lifestyle measures, pelvic floor muscle training, and pessary use. We conducted this review to assess the surgical management of posterior vaginal wall prolapse.
OBJECTIVES
To evaluate the safety and effectiveness of any surgical intervention compared with another surgical intervention for management of posterior vaginal wall prolapse.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register of controlled trials, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (searched April 2017). We also searched the reference lists of relevant articles, and we contacted researchers in the field.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing different types of surgery for posterior vaginal wall prolapse.
DATA COLLECTION AND ANALYSIS
We used Cochrane methods. Our primary outcomes were subjective awareness of prolapse, repeat surgery for any prolapse, and objectively determined recurrent posterior wall prolapse.
MAIN RESULTS
We identified 10 RCTs evaluating 1099 women. Evidence quality ranged from very low to moderate. The main limitations of evidence quality were risk of bias (associated mainly with performance, detection, and attrition biases) and imprecision (associated with small overall sample sizes and low event rates).Transanal repair versus transvaginal repair (four RCTs; n = 191; six months' to four years' follow-up)Awareness of prolapse is probably more common after the transanal approach (risk ratio (RR) 2.78, 95% confidence interval (CI) 1.00 to 7.70; 2 RCTs; n = 87; I = 0%; low-quality evidence). If 10% of women are aware of prolapse after transvaginal repair, between 10% and 79% are likely to be aware after transanal repair.Repeat surgery for any prolapse: Evidence is insufficient to show whether there were any differences between groups (RR 2.42, 95% CI 0.75 to 7.88; 1 RCT; n = 57; low-quality evidence).Recurrent posterior vaginal wall prolapse is probably more likely after transanal repair (RR 4.12, 95% CI 1.56 to 10.88; 2 RCTs; n = 87; I = 35%; moderate-quality evidence). If 10% of women have recurrent prolapse on examination after transvaginal repair, between 16% and 100% are likely to have recurrent prolapse after transanal repair.Postoperative obstructed defecation is probably more likely with transanal repair (RR 1.67, 95% CI 1.00 to 2.79; 3 RCTs; n = 113; I = 10%; low-quality evidence).Postoperative dyspareunia: Evidence is insufficient to show whether there were any differences between groups (RR 0.32, 95% CI 0.09 to 1.15; 2 RCTs; n = 80; I = 5%; moderate-quality evidence).Postoperative complications: Trials have provided no conclusive evidence of any differences between groups (RR 3.57, 95% CI 0.94 to 13.54; 3 RCTs; n = 135; I = 37%; low-quality evidence). If 2% of women have complications after transvaginal repair, then between 2% and 21% are likely to have complications after transanal repair.Evidence shows no clear differences between groups in operating time (in minutes) (mean difference (MD) 1.49, 95% CI -11.83 to 8.84; 3 RCTs; n = 137; I = 90%; very low-quality evidence).Biological graft versus native tissue repairEvidence is insufficient to show whether there were any differences between groups in rates of awareness of prolapse (RR 1.09, 95% CI 0.45 to 2.62; 2 RCTs; n = 181; I = 13%; moderate-quality evidence) or repeat surgery for any prolapse (RR 0.60, 95% CI 0.18 to 1.97; 2 RCTs; n = 271; I = 0%; moderate-quality evidence). Trials have provided no conclusive evidence of a difference in rates of recurrent posterior vaginal wall prolapse (RR 0.55, 95% CI 0.30 to 1.01; 3 RCTs; n = 377; I = 6%; moderate-quality evidence); if 13% of women have recurrent prolapse on examination after native tissue repair, between 4% and 13% are likely to have recurrent prolapse after biological graft. Evidence is insufficient to show whether there were any differences between groups in rates of postoperative obstructed defecation (RR 0.96, 95% CI 0.50 to 1.86; 2 RCTs; n = 172; I = 42%; moderate-quality evidence) or postoperative dyspareunia (RR 1.27, 95% CI 0.26 to 6.25; 2 RCTs; n = 152; I = 74%; low-quality evidence). Postoperative complications were more common with biological repair (RR 1.82, 95% CI 1.22 to 2.72; 3 RCTs; n = 448; I = 0%; low-quality evidence).Other comparisonsSingle RCTs compared site-specific vaginal repair versus midline fascial plication (n = 74), absorbable graft versus native tissue repair (n = 132), synthetic graft versus native tissue repair (n = 191), and levator ani plication versus midline fascial plication (n = 52). Data were scanty, and evidence was insufficient to show any conclusions about the relative effectiveness or safety of any of these interventions. The mesh exposure rate in the synthetic group compared with the native tissue group was 7%.
AUTHORS' CONCLUSIONS
Transvaginal repair may be more effective than transanal repair for posterior wall prolapse in preventing recurrence of prolapse, in the light of both objective and subjective measures. However, data on adverse effects were scanty. Evidence was insufficient to permit any conclusions about the relative effectiveness or safety of other types of surgery. Evidence does not support the utilisation of any mesh or graft materials at the time of posterior vaginal repair. Withdrawal of some commercial transvaginal mesh kits from the market may limit the generalisability of our findings.
Topics: Awareness; Dyspareunia; Female; Gynecologic Surgical Procedures; Humans; Pelvic Organ Prolapse; Postoperative Complications; Randomized Controlled Trials as Topic; Recurrence; Reoperation; Surgical Mesh; Urinary Incontinence, Stress; Uterine Prolapse
PubMed: 29502352
DOI: 10.1002/14651858.CD012975 -
The Journal of Maternal-fetal &... May 2019The objective of this study is to evaluate the effectiveness and safety of cervical pessaries for the prevention of preterm birth. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The objective of this study is to evaluate the effectiveness and safety of cervical pessaries for the prevention of preterm birth.
METHODS
We searched PubMed, Embase, Web of Science, and other sources from inception to July 2016. This analysis referred to pregnant women with singleton/multiple viable fetus/fetuses, with or without cervical pessary placement.
RESULTS
Six randomized control trials and five cohort studies involving 3911 participants were included. Overall, cervical pessary placement was slightly associated with the decrease of spontaneous delivery less than 34 weeks (relative risk 0.65 [95% CI: 0.44-0.96]) and increased gestational age at delivery (weighted mean difference 1.03 weeks [95% CI: 0.37-1.70]) in multiple pregnancies, but not with poor perinatal outcomes. Pessary placement in singleton pregnancies did not show any difference. A planned subgroup analysis showed multiple pregnancies with shorter cervical length (≤25 mm) had a longer prolongation of pregnancy (weighted mean difference 2.08 weeks [95% CI: 1.35-2.82]).
CONCLUSION
This meta-analysis suggested pessary placement could slightly reduce the rate of spontaneous preterm delivery before 34 weeks, and increase gestational age at delivery in multiple pregnancies, but not in singleton pregnancies. More studies of high quality with detailed records are urgent to confirm the efficacy of this procedure.
Topics: Adult; Cervical Length Measurement; Cohort Studies; Female; Gestational Age; Humans; Infant, Newborn; Pessaries; Pregnancy; Pregnancy Outcome; Premature Birth; Randomized Controlled Trials as Topic
PubMed: 29212400
DOI: 10.1080/14767058.2017.1414795