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JAMA Jul 2023A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting.
OBJECTIVE
To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix.
DESIGN, SETTING, AND PARTICIPANTS
We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded.
INTERVENTIONS
Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians.
MAIN OUTCOME AND MEASURES
The primary outcome was delivery or fetal death prior to 37 weeks.
RESULTS
A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32).
CONCLUSIONS AND RELEVANCE
Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02901626.
Topics: Adult; Female; Humans; Infant; Infant, Newborn; Pregnancy; Cervix Uteri; Fetal Death; Infant Death; Perinatal Death; Pessaries; Premature Birth; Progesterone; Ultrasonography; Young Adult; Uterine Cervical Diseases
PubMed: 37490086
DOI: 10.1001/jama.2023.10812 -
JAMA Aug 2023In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse.... (Comparative Study)
Comparative Study Randomized Controlled Trial
IMPORTANCE
In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure.
OBJECTIVE
To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent.
DESIGN, SETTING, AND PARTICIPANTS
Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen.
INTERVENTIONS
Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).
MAIN OUTCOMES AND MEASURES
The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications.
RESULTS
Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups.
CONCLUSIONS
Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure.
TRIAL REGISTRATION
TrialRegister.nl Identifier: NTR 6978.
Topics: Female; Humans; Middle Aged; Gynecologic Surgical Procedures; Pelvic Organ Prolapse; Treatment Outcome; Uterine Prolapse; Uterus; Aged
PubMed: 37581670
DOI: 10.1001/jama.2023.13140 -
Revista Brasileira de Ginecologia E... Dec 2023The aim of the present study is to compare the effectiveness of Arabin pessary and McDonald cervical cerclage on preterm delivery.
OBJECTIVE
The aim of the present study is to compare the effectiveness of Arabin pessary and McDonald cervical cerclage on preterm delivery.
METHODS
We conducted a retrospective analysis of data from patients who underwent either Arabin pessary or McDonald cerclage between January 1, 2019, and January 1, 2023. A total of 174 patients were included in the study, with 31 undergoing Arabin pessary and 143 receiving cervical cerclage using the McDonald technique in singleton pregnant women with cervical insufficiency, which applied between 14 and 22 gestational weeks. We included singleton pregnant women with normal morphology, and with normal combined test. The primary outcome was the impact of each method on preterm delivery (< 34 gestational weeks).
RESULTS
The weeks of cervical cerclage or pessary application were compatible with each other ( < 0.680). The pessary group had a statistically significant longer time to delivery compared with the Cerclage group (cerclage group mean 30.8 c 7.1 standard deviation [SD] versus pessary group mean 35.1 ± 4.4 SD; < 0.002). A statistically significant difference was found between the pessary and cerclage groups in terms of delivery at < 34 weeks ( = 0.002). In patients with cervical length between 25 and 15mm and < 15mm, no significant difference was found between the pessary and cerclage groups in terms of delivery week ( < 0.212; < 0.149). Regardless of the technique applied, no statistically significant difference was observed between cervical length and birth < 34 weeks.
CONCLUSION
Our study found that pessary use for cervical insufficiency is statistically more effective than cervical cerclage surgery in preventing preterm births < 34 weeks in singleton pregnancy.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Premature Birth; Pessaries; Retrospective Studies; Uterine Cervical Incompetence; Cervix Uteri
PubMed: 38141596
DOI: 10.1055/s-0043-1776033 -
Archives of Gynecology and Obstetrics Aug 2023Pelvic floor disorders are common and associated with pregnancy and childbirth. For restitution of pelvic floor connective tissue and thereby therapy of postpartum...
PURPOSE
Pelvic floor disorders are common and associated with pregnancy and childbirth. For restitution of pelvic floor connective tissue and thereby therapy of postpartum pelvic organ prolapse and stress urinary incontinence, the Restifem pessary is approved. It supports the anterior vaginal wall behind the symphysis, the lateral sulci and the sacro-uterine ligaments and stabilises the connective tissue. We evaluated the compliance and applicability of Restifem use in women postpartum in a preventive and therapeutic approach.
METHODS
Restifem pessary was handed out to 857 women. Six weeks after birth, they started the pessary use. After 8 weeks, 3 and 6 months postpartum, women received a questionnaire via online survey for evaluation of pessary applicability and efficacy.
RESULTS
After 8 weeks, 209 women answered the questionnaire. 119 women used the pessary. Common problems were discomfort, pain and the pessary use was to circuitous. Vaginal infections were rare. After 3 months, 85 women and after 6 months, 38 women still used the pessary. 3 months postpartum, 94% of women with POP, 72% of women with UI and 66% of women with OAB stated to have an improvement of their symptoms using the pessary. 88% women without any disorder felt an improvement of stability.
CONCLUSIONS
Use of the Restifem pessary in the postpartum period is feasible and accompanied with less complications. It reduces POP and UI and leads to an increased sense of stability. So, Restifem pessary can be offered to women postpartum to improve pelvic floor dysfunction.
Topics: Pregnancy; Female; Humans; Male; Pessaries; Pelvic Floor; Prospective Studies; Postpartum Period; Parturition; Pelvic Organ Prolapse
PubMed: 37210701
DOI: 10.1007/s00404-023-07075-9 -
Cureus Jan 2024Preterm births are a significant concern, as they can have serious consequences for both infants and mothers. It is crucial to identify risk factors associated with... (Review)
Review
Preterm births are a significant concern, as they can have serious consequences for both infants and mothers. It is crucial to identify risk factors associated with preterm birth and to implement effective interventions, such as progesterone, cervical pessary, and cervical cerclage, to prevent it. This systematic review aims to evaluate the efficacy of cervical pessary in reducing spontaneous preterm delivery. However, cervical pessaries have limited research and conflicting findings when compared to other interventions for preventing preterm labor. Therefore, this review seeks to analyze various studies to evaluate their overall effectiveness and better understand their role in treating this vulnerable population. The literature search was conducted using PubMed between January and September 2023, and the systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The results of this review highlight the importance of continued research into mitigation strategies for preterm birth. There is some evidence that indicates that using cervical pessaries before 34 weeks can be effective. While some studies have reported positive outcomes when cervical pessaries are combined with other treatments like progesterone, there is no solid statistical evidence to support this claim. Furthermore, additional research is needed to comprehend the impact of singleton pregnancies and long-term outcomes for both mothers and infants.
PubMed: 38187016
DOI: 10.7759/cureus.51775 -
International Urogynecology Journal Aug 2023Patients with vaginal pessaries can learn to care for their pessary by themselves or they can have provider-led care, which requires more frequent follow-up visits. We...
INTRODUCTION AND HYPOTHESIS
Patients with vaginal pessaries can learn to care for their pessary by themselves or they can have provider-led care, which requires more frequent follow-up visits. We aimed to understand motivations for and barriers to learning self-care of a pessary to inform strategies to promote pessary self-care.
METHODS
In this qualitative study, we recruited patients recently fitted with a pessary for stress incontinence or pelvic organ prolapse, and providers who perform pessary fittings. Semi-structured, one-on-one interviews were completed to data saturation. A constructivist approach to thematic analysis using the constant comparison method was used to analyze interviews. A coding frame was created following independent review of a subset of interviews by three members of the research team and this frame was used to code interviews and develop themes through interpretive engagement with the data.
RESULTS
Ten pessary users and four health care providers (physicians and nurses) participated. Three major themes were identified: motivators, benefits, and barriers. There were several motivators for learning self-care, including care provider advice, personal hygiene, and ease of care. Benefits of learning self-care included autonomy, convenience, facilitation of sexual relations, avoidance of complications, and decreased burden on the health care system. Barriers to self-care included physical, structural, mental, and emotional barriers; lack of knowledge; lack of time; and social taboo.
CONCLUSIONS
Promotion of pessary self-care should focus on patient education about benefits and ways of mitigating common barriers while focusing on normalizing patient engagement in pessary self-care.
Topics: Humans; Female; Pessaries; Self Care; Pelvic Organ Prolapse; Urinary Incontinence, Stress; Attitude
PubMed: 36795110
DOI: 10.1007/s00192-023-05472-x -
Journal of Personalized Medicine Jun 2023Forty percent of women will experience prolapse in their lifetime. Vaginal pessaries are considered the first line of treatment in selected patients. Major complications... (Review)
Review
BACKGROUND
Forty percent of women will experience prolapse in their lifetime. Vaginal pessaries are considered the first line of treatment in selected patients. Major complications of vaginal pessaries rarely occur.
METHODS
PubMed and Embase were searched from 1961 to 2022 for major complications of vaginal pessaries using Medical Subject Headings (MeSH) and free-text terms. The keywords were pessary or pessaries and: vaginal discharge, incontinence, entrapment, urinary infections, fistula, complications, and vaginal infection. The exclusion criteria were other languages than English, pregnancy, complications without a prior history of pessary placement, pessaries unregistered for clinical practice (herbal pessaries), or male patients. The extracted data included symptoms, findings upon examination, infection, type of complication, extragenital symptoms, and treatment.
RESULTS
We identified 1874 abstracts and full text articles; 54 were assessed for eligibility and 49 met the inclusion criteria. These 49 studies included data from 66 patients with pessary complications amenable to surgical correction. Clavien-Dindo classification was used to grade the complications. Most patients presented with vaginal symptoms such as bleeding, discharge, or ulceration. The most frequent complications were pessary incarceration and fistulas. Surgical treatment included removal of the pessary under local or general anesthesia, fistula repair, hysterectomy and vaginal repair, and the management of bleeding.
CONCLUSIONS
Pessaries are a reasonable and durable treatment for pelvic organ prolapse. Complications are rare. Routine follow-ups are necessary. The ideal patient candidate must be able to remove and reintroduce their pessary on a regular basis; if not, this must be performed by a healthcare worker at regular intervals.
PubMed: 37511669
DOI: 10.3390/jpm13071056