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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 -
Obstetrical & Gynecological Survey Sep 2023Although not a common occurrence, uterine prolapse during pregnancy can have significant effects for pregnancy outcomes and quality of life of maternal patients. Most... (Review)
Review
IMPORTANCE
Although not a common occurrence, uterine prolapse during pregnancy can have significant effects for pregnancy outcomes and quality of life of maternal patients. Most data about management exist as case reports; a review of these cases provides some guidance about treatment options.
OBJECTIVES
This review examines current literature about uterine prolapse during pregnancy to assess current information about this condition, prevalence, diagnosis, management, and outcomes.
EVIDENCE ACQUISITION
Electronic databases (PubMed and Embase) were searched using terms "uterine prolapse" AND "pregnancy" AND "etiology" OR "risk factors" OR "diagnosis" OR "therapy" OR "management" limited to the English language and between the years 1980 and October 31, 2022.
RESULTS
Upon review of 475 articles, 48 relevant articles were included as well as 6 relevant articles found on additional literature review for a total of 54 articles. Of those articles, 62 individual cases of uterine prolapse in pregnancy were reviewed including pregnancy complications, mode of delivery, and outcomes. Prevalence was noted to be rare, but much more common in second and subsequent pregnancies. Most diagnoses were made based on symptomatic prolapse on examination. Management strategies included bed rest, pessary use, and surgery (typically during the early second trimester). Complications included preterm delivery, patient discomfort, urinary retention, and urinary tract infection. Delivery methods included both cesarean and vaginal deliveries.
CONCLUSIONS
Although a rare condition, uterine prolapse in pregnancy is readily diagnosed on examination. Reasonable conservative management strategies include observation, attempted reduction of prolapse, and pessary use; if these measures fail, surgical treatment is an option.
RELEVANCE
Our review compiles literature and known cases of uterine prolapse during pregnancy and current evidence about prevalence, diagnosis, management, outcomes, and complications of uterine prolapse during pregnancy in order to inform our target audience in their clinical practice.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Uterine Prolapse; Quality of Life; Pregnancy Complications; Pregnancy Outcome; Risk Factors
PubMed: 37976302
DOI: 10.1097/OGX.0000000000001192 -
Climacteric : the Journal of the... Aug 2023Local estrogen therapy (LET) is the mainstay of treatment for vaginal dryness, dyspareunia and other urogenital symptoms because it may reverse some pathophysiological... (Review)
Review
Local estrogen therapy (LET) is the mainstay of treatment for vaginal dryness, dyspareunia and other urogenital symptoms because it may reverse some pathophysiological mechanisms associated with decreasing endocrine function and increasing aging. Over the years, several vaginal products including different formulations (tablets, rings, capsules, pessaries, creams, gels and ovules) and molecules (estradiol [E2], estriol [E3], promestriene, conjugated equine estrogens and estrone) have been used with superimposable therapeutic results. Low-dose and ultra-low-dose LET is the gold standard due to its minimal systemic absorption, with circulating E2 levels persistently remaining in the postmenopausal range. In healthy postmenopausal women, preference among the various products is presently the main driver and dissatisfaction with LET seems high, namely because of the delayed use in those with severe symptoms of genitourinary syndrome of menopause (GSM). Specific concerns remain in high-risk populations such as breast cancer survivors (BCS), especially those under treatment with aromatase inhibitors. Based on the multitude of symptoms under the umbrella of GSM definition, which includes vulvovaginal atrophy (VVA), it is mandatory to investigate specific effects of LET on quality of life, sexual function and genitourinary conditions by conducting studies with a patient-tailored focus.
Topics: Humans; Female; Quality of Life; Estrogens; Vaginal Diseases; Dyspareunia; Hormone Replacement Therapy; Vagina; Atrophy; Menopause
PubMed: 37318030
DOI: 10.1080/13697137.2023.2218998 -
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 -
Obstetrics and Gynecology Sep 2023The U.S. Food and Drug Administration has recently withdrawn approval for 17-α hydroxyprogesterone caproate for prevention of recurrent preterm birth, and recent... (Review)
Review
The U.S. Food and Drug Administration has recently withdrawn approval for 17-α hydroxyprogesterone caproate for prevention of recurrent preterm birth, and recent studies have called into question benefits of the pessary in the setting of a short cervix. Obstetric health care professionals are once again left with limited remaining options for preterm birth prevention. This narrative review summarizes the best current evidence on the use of vaginal progesterone, low-dose aspirin, and cerclage for the prevention of preterm birth; attempts to distill possible lessons learned from studies of progesterone and pessary, as well as their implementation into practice; and highlights areas where inroads into preterm birth prevention may be possible outside of the progesterone-aspirin-cerclage paradigm.
Topics: Pregnancy; Female; Infant, Newborn; Humans; 17 alpha-Hydroxyprogesterone Caproate; Progesterone; Premature Birth; Administration, Intravaginal
PubMed: 37441790
DOI: 10.1097/AOG.0000000000005290 -
International Urogynecology Journal May 2024Continuation of using a pessary for the treatment of pelvic organ prolapse (POP) is important for improving symptoms but the data on long-term compliance is very...
INTRODUCTION AND HYPOTHESIS
Continuation of using a pessary for the treatment of pelvic organ prolapse (POP) is important for improving symptoms but the data on long-term compliance is very limited. Therefore, we conducted this study aimed at evaluating the compliance of patients in the long-term use of a pessary.
METHODS
The medical records of women with symptomatic POP were retrospectively reviewed to recruit cases opting for pessary use. The inclusion criteria were women who had a successful pessary fitting and completed at least 5 years of follow-up. Exclusion criteria were pregnancy, death during the follow-up period, and loss to follow-up. Demographic data, pelvic organ prolapse stage, associated symptoms, type and size of pessary, and reason for discontinuation were reviewed.
RESULTS
A total of 261 patients opted for pessary use. Of them, 88.9% (231 out of 261) were successful in initial pessary fitting and 54 were excluded for various reasons. The remaining 178 patients were available for analysis. The continuation rate of self-care pessary at the 5-year follow-up was 53.93% (96). The discontinuation rate was 46.07% (82). The main reasons for discontinuation were desire for surgery (39.1%) and discomfort (31.7%). The highest rate of discontinuation (46.63%) was found in the 1st year of follow-up. The significant risk factors of discontinuation included digitation symptoms on univariate analysis and prior hysterectomy on multivariate analysis, with an odds ratio (95% CI) of 5.98 (1.56-22.88).
CONCLUSIONS
Among Thai women, the adherence to self-care pessary in symptomatic pelvic organ prolapse at the 5-year follow-up was 53.93%. The main reason for discontinuation was a prior hysterectomy.
PubMed: 38748222
DOI: 10.1007/s00192-024-05806-3