Use of the Arabin pessary in women at high risk for preterm birth: long-term experience at a single tertiary center in Malaysia.

BACKGROUND: Spontaneous preterm birth is a global issue that contributed to perinatal morbidities and mortalities worldwide. The study aimed to describe the experience at UKM Medical Center in managing women at high risk for spontaneous preterm birth using the Arabin pessary. METHODS: This is a retrospective observational study involving 58 pregnancies from 1st January 2013 to 31st December 2019. Inclusion criteria were previous mid-trimester miscarriage and/or preterm birth, previous cervical surgery or short cervical length on routine sonogram. The demographic data, characteristics of each pregnancy and details of outcomes and management were described. RESULTS: The majority of women were Malay with mean age and body mass index of 32.9 ± 4.2 years and 27.1 ± 6.3 kg/m2 respectively. The most frequent indications for Arabin pessary insertion were previous mid-trimester miscarriage (46.4%) and early preterm birth (17.2%). A total of 73.4% of these women had the pessary inserted electively at a mean cervical length of 31.6 ± 9.1 mm at median gestation of 15.0 weeks. They were managed as outpatient (56.9%), inpatient (24.1%) or mixed (19.0%) with combination of progestogen (81.0%) and 53.4% received antenatal corticosteroids. Spontaneous preterm birth at or more than 34 weeks gestation occurred in 74.1% with birthweight at or more than 2000 g (82.4%). Despite cervical funneling in 12 women (20.7%), 66.7% delivered at or later than 34 weeks gestation and 2 (16.7%) resulted in miscarriage. CONCLUSIONS: Insertion of the Arabin pessary is beneficial to prevent spontaneous preterm birth in pregnant women who are at high risk. In particular, early insertion and close monitoring allows the best possible outcomes. TRIAL REGISTRATION: This study was retrospectively registered with ClinicalTrials.gov ( NCT04638023 ) on 20/11/2020.

Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis.

BACKGROUND: Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix. METHODS AND FINDINGS: We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55-1.38], p = 0.54). The primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery-was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54-1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50-1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses. CONCLUSIONS: These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out. TRIAL REGISTRATION: ISRCTN Registry ISRCTN 02235181. ClinicalTrials.gov NCT02235181.

A prospective study of pessary use for severe pelvic organ prolapse: 3-year follow-up outcomes.

PURPOSE: To estimate the optimal definition of successful pessary use and the long-term success rate of the pessary as well as the complications and factors associated with continued pessary use. METHODS: Consecutive patients who had symptomatic stage III/IV POP were enrolled. The degrees of POP were assessed by POP-Q. All patients completed the PFIQ-7 questionnaire before pessary use. For the 1-week, 1-month, 3-month, 6-month, 1-year and 3-year follow-up assessments, patients visited the clinic for an examination and to complete the questionnaire. SPSS 18.0 was used for the data analysis. Wilcoxon's signed-rank test was performed to estimate the change in PFIQ-7 scores before and after pessary use. Logistic regression was performed to identify the factors associated with the duration of pessary use. RESULTS: A total of 60 subjects (average age 68.93 ± 8.98 years) were enrolled. The 3-year success rate of the pessary was 63.33%. The PFIQ-7 score in the 1-month follow-up was significantly decreased (16.22 ± 12.81 vs 1.39 ± 3.39, P = 0.000). During the follow-up, none of the patients experienced any severe complications, and the rate of vaginal erosion was 20% (12/60). The PFIQ-7 score in the 1-month follow-up decreased more than 50% and was associated with continuous pessary use [OR 20.75, P = 0.027, 95% CI (2.28, 189.27)]. CONCLUSIONS: Successful pessary use can be defined as fitting for longer than 3 months. The PFIQ-7 scores should be focused on during the follow-up. The treatment should be changed if the scores decrease less than 50% in the 1-month follow-up.

Long-term Outcomes of Self-Management Gellhorn Pessary for Symptomatic Pelvic Organ Prolapse.

OBJECTIVE: The aim of this study is to estimate the long-term survival and to identify adverse events associated with the use of Gellhorn pessaries over a 9-year period. METHODS: This was a retrospective case series study at a tertiary urogynecology unit in Taiwan. Between January 2009 and June 2017, 93 patients who opted for self-management Gellhorn pessaries to treat symptomatic pelvic organ prolapse (POP) and who were continuously followed-up were enrolled. Long-term use was defined as use for longer than 1 year. Length of use, factors that predicted discontinuation, and adverse events were analyzed and reviewed by chart or telephone inquiry. RESULTS: The cumulative probabilities of continued pessary use at 1 and 5 years were 62.4% and 47.2%, respectively. Of those who discontinued use, 34 (70.8%) participants discontinued use within 1 year, and the mean duration of use was 13.7 months (range, 0-75 months; median, 5 months). Most of the participants stopped using the pessary because of bothersome adverse events such as pessary expulsion, vaginal pain, de novo urinary incontinence, and erosion/infection. CONCLUSIONS: Self-management Gellhorn pessary was safe and relatively effective and increased patients' autonomy and ability to manage their POP. One third of the patients discontinued use by 1 year, and half of the patients discontinued use at 5 years.

Moving On: How Many Women Opt for Surgery After Pessary Use for Prolapse?

OBJECTIVE: Our primary objective was to evaluate the proportion of women who underwent surgery after successful pessary fitting for pelvic organ prolapse (POP). Our secondary objectives were to assess when surgery occurs and to evaluate factors associated with choosing surgery as compared to continuing with a pessary. METHODS: Our study population included women successfully fitted with a pessary for POP 1/1/12 and 12/31/16. We excluded non-English-speaking women and those who used pessary only as a bridge until surgery. We evaluated events occurring after a successful fitting, including whether women (1) continued pessary use, (2) underwent surgery, or (3) discontinued pessary without surgery. Our primary outcome was the proportion of women who opted for surgery after a successful pessary fitting for POP. We also assessed the median time to surgery and compared women who underwent surgery with those who continued with a pessary to assess variables associated with surgery. RESULTS: Of the 444 women with POP who were successfully fitted with a pessary and met inclusion criteria, 137 (31%) ultimately underwent surgery. The median time to surgery was 10 months (interquartile range, 4-18), with 59% having surgery within 1 year, and 89% within 2 years. In a logistic regression analysis controlling for age in decades, advanced POP stage, and Charlson Comorbidity Index, younger age remained significantly associated with surgery (odds ratio, 0.77, 95% confidence interval, 0.62-0.95; P = 0.02). CONCLUSIONS: Among women successfully fitted with a pessary for POP, one third ultimately underwent surgery, with approximately 60% of these women undergoing surgery within the first year and 90% within 2 years.

Cervical modifications after pessary placement in singleton pregnancies with maternal short cervical length: 2D and 3D ultrasound evaluation.

INTRODUCTION: The use of a pessary proved to prevent preterm birth in asymptomatic women with mid-trimester short cervical length (CL); however, the precise mechanisms by which the pessary confers its benefit remain unclear. The aim of this study was to evaluate multiple cervical characteristics assessed by 2-dimensional and 3-dimensional ultrasound before and after placement of a cervical pessary to ascertain its mechanism of action. MATERIAL AND METHODS: In this prospective cohort study, we assessed the cervical characteristics in singleton pregnancies with maternal short CL and compared them with matched reference women with normal CL. The variables evaluated were: CL, uterocervical angles, cervical consistency indices (cervical consistency index and CL consistency index), cervical volume and vascular indices. All variables were re-assessed immediately after pessary placement and 4-6 weeks later in all participants. Mann-Whitney U test was used to assess differences between groups and paired samples t test for comparisons in two different examinations in the same women. The aim of this study was to evaluate multiple cervical ultrasound variables before and after the placement of a cervical pessary and compare the evolution of these variables with a reference group with normal CL to better understand the device's mechanism of action. RESULTS: Thirty-three women with short CL and 24 reference women with normal CL were enrolled. At the time of enrollment, gestational age and maternal baseline characteristics did not differ between groups. Immediately after pessary placement, CL increased, uterocervical angles were narrower and cervical consistency increased significantly. When the magnitude of change in cervical variables was compared over time between the reference group and the study group, median CL had increased in the study group (1.47 mm) but it had shortened in the reference group (-2.56 mm). These inverse trends were statistically significant (P = 0.006). CONCLUSIONS: Cervical pessary reduces both uterocervical angles and corrects cervical angulation by pushing the cervix up toward the uterus. Maintaining the cervix aligned to the uterine axis leads to reduced cervical tissue stretch, so avoiding further cervical shortening. All these changes were present after pessary placement; however, the clinical implications of these findings remain unknown.

What Are the Clinical Factors That Are Predictive of Persistent Pessary Use at 12 Months?

OBJECTIVE: Urinary incontinence and pelvic organ prolapse are highly prevalent in women and have a significant impact on quality of life. Pessaries are devices that are used as a conservative management option. Many women use pessaries, which avoid surgical intervention with its associated morbidity and cost. However, not all women are good candidates for pessary use. The objective of this study was to determine clinical factors leading to persistent pessary use for incontinence or pelvic organ prolapse in a tertiary care centre at 12 months. Studying patient characteristics for long-term pessary use will contribute to better patient counselling, management, and health resource distribution. METHODS: This study was a retrospective outpatient chart review of new pessary fittings in patients in a tertiary care urogynaecology clinic between January and June 2014. Any woman over 18 years of age fitted with a pessary at that time was included in the study. All statistical analyses were performed using IBM SPSS Statistics version. 24 (IBM Corp., Armonk, NY) (Canadian Task Force Classification II-3). RESULTS: A total of 152 women were fitted with pessaries. A multivariable logistic regression analysis found that a patient's diagnosis of prolapse or incontinence (P = 0.01) and a lack of complications (P < 0.0001) were statistically significant for persistent pessary use at 12 months. Patients with prolapse had 7.7 times higher odds (95% CI 1.51-39.35) of using a pessary at 12 months than did patients with incontinence. Patients without complications had 250 times higher odds (95% CI 18.52-2500) of pessary use. Patients who tried two to three pessaries had 16 times higher odds (95% CI 1.80-137.00) of persistent use than patients who trialed just one. CONCLUSION: This study has found that a lack of complications, the number of pessaries tried, and a primary diagnosis of prolapse are significant factors for continued pessary use at 12 months.

Documenting pessary offer prior to hysterectomy for management of pelvic organ prolapse.

OBJECTIVES: To (1) determine the proportion of hysterectomy cases with documentation of pessary counseling prior to prolapse surgery and (2) identify variables associated with women offered a pessary. STUDY DESIGN: The Michigan Surgical Quality Collaborative (MSQC) is a hysterectomy improvement initiative. Hysterectomies from 2013 to 2015 in which prolapse was the principal diagnosis were included. "Pessary offer" was defined as documentation showing the patient declined, could not tolerate, or failed a pessary trial. Bivariate analyses were used to compare demographics, medical history, surgical route, concomitant procedures (colpopexy or colporrhaphy), and intra- and postoperative complications between women with and without pessary offer. Hierarchical logistic regression was used to determine factors independently associated with pessary offer. Risk-adjusted pessary offer rates by hospital were calculated. RESULTS: The adjusted rate of pessary offer was 25.2%, ranging from 3 to 76% per hospital. Bivariate comparisons showed differences between women with and without pessary offer in age, tobacco use, prior pelvic surgery, insurance status, surgical approach, secondary indication for surgery, concomitant prolapse procedure, teaching hospital status and hospital bed size. In logistic regression, odds of pessary offer increased with age > 55 years (OR 1.45, 95% CI 1.12-1.88, p = 0.006), Medicare insurance (OR 1.65, 95% CI 1.30-2.10, p < 0.0001), and a concomitant procedure (OR 1.5, 95% CI 1.16-1.93, p = 0.002). Postoperative urinary tract infections were more common in patients offered a pessary (6.4% vs. 2.5%, p < 0.0001), but other complications were similar. CONCLUSIONS: Overall, only one-quarter of hysterectomies for prolapse in MSQC hospitals had documentation of pessary counseling-suggesting an opportunity to improve documentation, counseling regarding pessary use, or both.

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.

Treatment of vaginal vault prolapse in The Netherlands: a clinical practice survey.

INTRODUCTION AND HYPOTHESIS: A great variety of conservative and surgical procedures to correct vaginal vault prolapse have been reported. The aim of this study was to describe practice pattern variation-the difference in care that cannot be explained by the underlying medical condition-among Dutch gynecologists regarding treatment of vaginal vault prolapse. METHODS: A clinical practice survey was conducted from March to April 2017. The questionnaire was developed to evaluate treatment of vaginal vault prolapse. All members of the Dutch Society for Urogynaecology were invited to participate in a web-based survey. RESULTS: One hundred four Dutch gynecologists with special interest in urogynecology responded to the survey (response rate, 44%). As first-choice therapy for vaginal vault prolapse, 78% of the respondents chose pessary treatment, whereas sacrospinous fixation was the second most common therapy choice according to 64% of the respondents. Preferences on how to approach vaginal vault prolapse surgically are conflicting. Overall, the most performed surgery for vaginal vault prolapse is sacrospinous fixation, followed by laparoscopic and robotic sacrocolpopexy. CONCLUSIONS: Gynecologists in The Netherlands manage vaginal vault prolapse very differently. No standardized method could be determined for the treatment of vaginal vault prolapse in The Netherlands, and we observed practice pattern variations.

Perioperative interventions in pelvic organ prolapse surgery.

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.

Cervical Pessary After Arrested Preterm Labor: A Randomized Controlled Trial.

OBJECTIVE: To assess the effectiveness of cervical pessary in reducing the rate of preterm birth in women at high risk for preterm birth who did not deliver after an episode of threatened preterm labor. METHODS: In a multicenter open-label randomized controlled trial, a cervical pessary was compared with no intervention (control group) (one-to-one ratio). Women between 24 and 34 weeks of gestation at high risk for preterm birth based on a short cervical length (less than 15 mm) or an intermediate cervical length (between 15 and 30 mm) with a positive fetal fibronectin test who did not deliver after an episode of threatened preterm labor were eligible. The primary outcome was birth before 37 weeks of gestation. Secondary outcomes were a composite adverse neonatal outcome, preterm birth before 34 and 32 weeks of gestation, and side effects. A total sample size of 200 women carrying singletons was planned so as to have adequate statistical power to detect a reduction in the rate of preterm birth from 40% to 20%. Women with twin gestations were also enrolled but were considered only in secondary analyses. After a planned interim analysis, the trial was stopped for futility. RESULTS: From November 2013 through September 2016, 130 women with a singleton pregnancy (65 pessary, 65 no treatment) were recruited. The groups had comparable baseline characteristics. In the cervical pessary group, 31 (48%) women delivered before 37 weeks of gestation compared with 25 (39%) in the no-treatment group (relative risk 1.2, 95% CI 0.83-1.8). Nine (15%) children in the cervical pessary group had the composite adverse perinatal outcome compared with eight (13%) in the control group (relative risk 1.2, 95% CI 0.49-2.9). CONCLUSION: In women at high risk for preterm birth who did not deliver after an episode of threatened preterm labor, treatment with a cervical pessary is not effective. CLINICAL TRIAL REGISTRATION: Netherlands Trial Register, NTR4210.

[PREVENTION OF PRETERM BIRTH IN TWINS WITH SHORT MID-TRIMESTER CERVICAL LENGTH LESS THAN 25MM -COMBINED TREATMENT WITH ARABIN'S CERCLAGE PESSARY AND INTRAVAGINAL MICRONIZED PROGESTERONE COMPARED WITH CONSERVATIVE TREATMENT].

BACKGROUND: Twin pregnancies with short mid-trimester cervical length have a high rate of preterm births. OBJECTIVES: To compare combined treatment of Arabin cerclage pessary, and intravaginal micronized progesterone to conservative treatment for the prevention of preterm births in twins pregnancies with short cervical length in second trimester of pregnancy. METHODS: A retrospective study that compared twin pregnancies with short ≤25mm cervix in second trimester 16-28 gestational weeks treated with combined treatment of Arabin cervical pessary and intravaginal micronized progesterone 200mg TID to a control group with conservative treatment for the prevention of preterm. RESULTS: The treatment group included 32 patients and the control group 26 patients. Average week at admission was 23 ± 2.2 vs 25 ±3.1 weeks, average cervical length at admission 14.1 ± 2.2 mm vs 13 ±2.1 mm respectively. Average week of delivery 34.4 ±3.9 vs. 33.4 ±4.1, p=0.6 and incidence of delivery ≤28weeks was 9.4% vs. 34% p=0.04. CONCLUSIONS: The treatment group had a lower incidence of preterm birth before 28 weeks. Further prospective studies are needed to assess preterm birth prevention treatments efficacy and the use of Arabin cervical pessary in twins.

What Interventions Are Being Used to Prevent Preterm Birth and When?

OBJECTIVE: This study sought to determine the proportions of women at risk of preterm birth who received progesterone, elective and rescue cerclage, or pessary to prevent preterm birth, by using medical records. The authors also sought to determine whether these proportions differed among primary-, secondary-, and tertiary-level centres. METHODS: The authors conducted a retrospective cohort study and extracted data from consecutive medical charts of women with an estimated date of confinement over 3 months in primary-, secondary-, and tertiary-level centres in Southern Ontario. The study identified women with a previous spontaneous preterm birth or a short cervix and determined whether they were offered and whether they received a preventive intervention for preterm birth. Descriptive statistics and Fisher exact tests were calculated. RESULTS: The authors reviewed 1024 consecutive charts at primary, secondary, and tertiary centres and identified 31 women with a previous spontaneous preterm birth or a short cervix. Of these women, less than one half (42%) received progesterone or cerclage for prevention of preterm birth, and none received pessary. One in four women (26%) were not referred to an obstetrician or maternal-fetal medicine specialist in time for an intervention, and among those referred before 24 weeks of gestation, an intervention was offered to 57% of the women. CONCLUSION: Less than half of women at risk of spontaneous preterm birth received progesterone, cerclage, or pessary, attesting to the importance of improving knowledge translation methods to encourage timely referral and use of progesterone for the prevention of preterm birth.

Predictors for dislodgment of vaginal pessary within one year in women with pelvic organ prolapse.

OBJECTIVES: To identify clinical risk factors for dislodgment of vaginal pessary within one year in women with symptomatic pelvic organ prolapse. STUDY DESIGN: This was a prospective observational study which recruited consecutive women with symptomatic pelvic organ prolapse in a tertiary urogynecology center. Basic demographics, clinical symptoms and staging of pelvic organ prolapse were assessed. A vaginal pessary was offered where appropriate. MAIN OUTCOME MEASURES: Demographics and clinical parameters were compared between women who were able to use a vaginal pessary for one year and those whose pessaries were dislodged within one year. RESULTS: A total of 779 women were recruited and had a vaginal pessary inserted. Of them, 528 women, with a mean age of 64.7 (SD 10.1) years, returned for one-year follow-up; 177 (33.5%) had their pessary dislodged within one year and 351 (66.5%) had been able to retain the pessary. Stage III or IV prolapse (OR 1.76), prolapse predominant at the apical compartment (OR 2.14) and larger genital hiatus (OR 1.63) were factors associated with dislodgment of the vaginal pessary. Age, body mass index, previous hysterectomy and short vagina were not associated with dislodgment. Nevertheless, 47.6% of women with stage III/IV prolapse could still keep the pessary for one year. CONCLUSION: Higher staging of prolapse, larger genital hiatus and apical compartment prolapse are clinical predictors for dislodgment of a vaginal pessary. Despite this, nearly half of women with stage III/IV prolapse were able to use a vaginal pessary for one year. Therefore, a vaginal pessary should be offered despite their staging of prolapse.

Discontinuation rate and adverse events after 1 year of vaginal pessary use in women with pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: To ascertain the rate of discontinuation after vaginal pessary use among pelvic organ prolapse patients. METHODS: We enrolled women suffering from pelvic organ prolapse who opted to use vaginal pessary as the first line of treatment and were fitted with a pessary at the urogynecological clinic in Khon Kaen University's Srinagarind Hospital (Thailand) during the period between 2010 and 2016. Patients' medical records were retrospectively reviewed. Patients were contacted by telephone if there were missing data or if more information was required. RESULTS: One hundred and forty women were included. The median age was 71.5 years (interquartile = 65.0, 77.0) and normal vaginal parity was 4.0 (interquartile =3.0, 6.0). The mean ± SD of BMI was 23.5± 3.6 kg/m2. Most of the women enrolled in the study (97.9%) were postmenopausal and many were at an advanced stage of prolapse (73.6%). Support pessaries were the most common treatment (95.0%). The discontinuation rate of pessary use after 1 year was 16.1%. The most common reason for discontinuing the vaginal pessary was frequent expulsion (26.3%). Abnormal vaginal discharge was the most common adverse effect after pessary insertion (17.1%). Lower BMI and history of hysterectomy were the significant risk factors for discontinuation of pessary use (0.76 [95%CI 0.62-0.93] and 15.89 [95%CI 1.67-151.02] respectively). CONCLUSIONS: The discontinuation rate of pessary use in the case of pelvic organ prolapse was low after 1 year. Abnormal vaginal discharge was the most common adverse side effect. Lower BMI and history of hysterectomy were factors significantly associated with the discontinuation.

Anesthetic Cream Use During Office Pessary Removal and Replacement: A Randomized Controlled Trial.

OBJECTIVE: To estimate the effect of lidocaine-prilocaine cream on patient pain at the time of office pessary removal and reinsertion. METHODS: In this double-blind, randomized placebo-controlled trial, participants undergoing routine pessary care in a urogynecology office at a tertiary referral center were randomized to application of 4 g of either lidocaine-prilocaine or placebo cream 5 minutes before pessary change. Visual analog scale pain scores were collected from the patient at baseline, after pessary removal, and after pessary reinsertion. Physicians also recorded their estimate of patient pain at pessary removal and reinsertion. The primary outcome was the participant-reported visual analog scale pain score at the time of pessary removal and reinsertion. A sample size of 26 per group (n=52) was planned to estimate an absolute mean difference in visual analog scale pain of 2.1 cm at the time of pessary removal. An analysis of covariance was used to evaluate pain at removal and reinsertion as a function of treatment assignment controlling for baseline pain. RESULTS: From July 2015 through February 2016, 116 women were screened and 54 were recruited: 28 in the lidocaine-prilocaine cream group and 26 in the placebo group. One patient in the lidocaine-prilocaine cream group was later withdrawn owing to vaginal erosion. The participants were all postmenopausal women, with an average age of 77.8 years. Most characteristics were similar between groups. After adjusting for baseline pain, participants randomized to the lidocaine-prilocaine group had lower pain at pessary removal when compared with those assigned to placebo (mean difference=-2.05, 95% confidence interval -3.69 to -0.41; P=.015). CONCLUSION: Lidocaine-prilocaine cream use at the time of office pessary removal reduces patient-reported pain. Clinicians may wish to include this simple intervention to optimize patient comfort and compliance. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02380742.

Pelvic organ prolapse surgery in elderly patients.

PURPOSE: Pelvic organ prolapse (POP) can cause incomplete bladder emptying or hydronephrosis and renal failure. These are serious conditions, especially in elderly women, requiring resolution of POP. Pessary use is an alternative, but there are specific problems or patients may not want it. We therefore conducted a retrospective study on surgical treatment of elderly women with respect to the type of surgery and intra- and postoperative complications. METHODS: From two urogynecologic centers, we reviewed treatment data between 2003 and 2013, including patients ≥80 years of age. From the hospital records, intra- and postoperative data were extracted. RESULTS: 91 cases met the inclusion criteria. Mean age was 84.38 years (±3.05, max 92 years). Two patients (2.2%) were diagnosed with hydronephrosis and two with urosepsis/renal failure. The mean length of surgery was 81 min (±45 min, range 10-270), 94.5% of patients were under general anesthesia. Two bowel lesions occurred. The mean length of hospital stay was 8 days (range 1-22, n = 90). There were no perioperative mortalities. Six patients (6.6%) were admitted to intensive care unit. CONCLUSIONS: In the future, we will be facing a growing number of elderly women seeking care for POP. In our retrospective analysis, we were able to show that POP surgery could be performed safely. We therefore consider surgical treatment as a valuable alternative if pessary use is not an option.

Clinical use of ring with support pessary for advanced pelvic organ prolapse and predictors of its short-term successful use.

OBJECTIVE: This study aimed to evaluate the success rate, patient satisfaction and adverse events with the use of the ring with support pessary in patients with advanced pelvic organ prolapse (POP), and to identify the factors associated with successful pessary use. METHODS: In this prospective study, 151 patients with symptomatic advanced POP (POP quantification stage III/IV) came to the Centre of Obstetrics and Gynaecology, Peking Union Medical College Hospital, for POP treatment between May 2015 and December 2015. In all, 97 patients who chose the ring with support pessaries were included in this study. Successful pessary use was defined as the continuous use of the pessary at a 3-month follow-up visit. Independent-samples t tests, nonparametric tests, chi-square tests, Fisher's exact test, and logistic regression were used for data analysis. RESULTS: In all, 82 patients continued to use the ring with support pessary for 3 months, whereas 15 patients discontinued, corresponding to a success rate of 84.5% (82/97). Most patients (80/82, 97.6%) who achieved success using the ring with support pessary felt satisfied. No severe complications were observed. Size 3 was the most commonly used size in our center (59.8% of the study patients). Predominant anterior wall prolapse was associated with the successful use of ring with support pessary (odds ratio 5.08, 95% confidence interval 1.33-19.43, P = 0.02). CONCLUSIONS: The ring with support pessary was successfully used for the treatment of advanced POP with high rates of success and satisfaction. A predominant prolapse in the anterior wall may be a potential influence factor for successful pessary use.

Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta-analysis.

BACKGROUND: Preterm birth (PTB) is the leading cause of infant death, but it is unclear which intervention is best to prevent it. OBJECTIVES: To compare progesterone, cerclage and pessary, determine their relative effects and rank them. SEARCH STRATEGY: We searched Medline, EMBASE, CINAHL, Cochrane CENTRAL and Web of Science (to April 2016), without restrictions, and screened references of previous reviews. SELECTION CRITERIA: We included randomised trials of progesterone, cerclage or pessary for preventing PTB in women with singleton pregnancies at risk as defined by each study. DATA COLLECTION AND ANALYSIS: We extracted data by duplicate using a piloted form and performed Bayesian random-effects network meta-analyses and pairwise meta-analyses. We rated evidence quality using GRADE, ranked interventions using SUCRA and calculated numbers needed to treat (NNT). MAIN RESULTS: We included 36 trials (9425 women; 25 low risk of bias trials). Progesterone ranked first or second for most outcomes, reducing PTB < 34 weeks [odds ratio (OR) 0.44; 95% credible interval (CrI) 0.22-0.79; NNT 9; low quality], <37 weeks (OR 0.58; 95% CrI 0.41-0.79; NNT 9; moderate quality), and neonatal death (OR 0.50; 95% CrI 0.28-0.85; NNT 35; high quality), compared with control, in women overall at risk. We found similar results in the subgroup with previous PTB, but only a reduction of PTB < 34 weeks in women with a short cervix. Pessary showed inconsistent benefit and cerclage did not reduce PTB < 37 or <34 weeks. CONCLUSIONS: Progesterone was the best intervention for preventing PTB in singleton pregnancies at risk, reducing PTB < 34 weeks, <37 weeks, neonatal demise and other sequelae. TWEETABLE ABSTRACT: Progesterone was better than cerclage and pessary to prevent preterm birth, neonatal death and more in network meta-analysis.