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Scientific Reports Oct 2023Pelvic organ prolapse (POP) is a benign gynecological disease in which the pelvic organ descends into the vagina and causes voiding, and defecatory dysfunction, mainly...
Pelvic organ prolapse (POP) is a benign gynecological disease in which the pelvic organ descends into the vagina and causes voiding, and defecatory dysfunction, mainly occurs in older women. This study aimed to investigate the vaginal microbiome of POP and associated changes after anatomical restorative pessary or reconstructive pelvic operation. We analyzed the vaginal microbiome using 16S ribosomal RNA gene sequencing and compared the results among patient groups with POP, pessary, and postoperation. We also measured 10 inflammation-related cytokines in vaginal swab samples using multiplex immunoassay. In pelvic organ prolapse, vaginal community status type IV was the most prevalent, which showed a low abundance of Lactobacillus with increased diversity and abundance of anaerobic species. The alpha diversity of species richness was highest in the POP group. The beta diversity distance differed significantly between the three groups (p = 0.001). While human intestinal taxa-associated bacteria were reduced after pessary or operation, vaginitis-associated bacterial composition was altered but vaginal microbiome homeostasis was not improved. IFN-γ, IL-10, IL-12p70, IL-1β, IL-4 and TNF-α levels increased in the pessary group. Therefore, in addition to anatomical restorative treatment, supplementary treatment focusing on the recovery of the vaginal microbiome may be needed to maintain the health of gynecological organs in old age.
Topics: Female; Humans; Aged; Pelvic Organ Prolapse; Vagina; Pelvic Floor; Pessaries; Microbiota
PubMed: 37845312
DOI: 10.1038/s41598-023-44988-6 -
International Journal of Gynaecology... Apr 2024Prediction of pregnancies at risk of preterm birth (PTB) may allow targeted prevention strategies. (Review)
Review
BACKGROUND
Prediction of pregnancies at risk of preterm birth (PTB) may allow targeted prevention strategies.
OBJECTIVES
To assess quality of clinical practice guidelines (CPGs) and identify areas of agreement and contention in prediction and prevention of spontaneous PTB.
SEARCH STRATEGY
We searched for CPGs regarding PTB prediction and prevention in asymptomatic singleton pregnancies without language restriction in January 2024.
SELECTION CRITERIA
CPGs included were published between July 2017 and December 2023 and contained statements intended to direct clinical practice.
DATA COLLECTION AND ANALYSIS
CPG quality was assessed using the AGREE-II tool. Recommendations were extracted and grouped under domains of prediction and prevention, in general populations and high-risk groups.
MAIN RESULTS
We included 37 CPGs from 20 organizations; all were of moderate or high quality overall. There was consensus in prediction of PTB by identification of risk factors and cervical length screening in high-risk pregnancies and prevention of PTB by universal screening and treatment for asymptomatic bacteriuria, screening and treatment for BV in high-risk pregnancies, and use of preventative progesterone and cerclage. Areas of contention or limited consensus were the role of PTB clinics, universal cervical length measurement, biomarkers and cervical pessaries.
CONCLUSIONS
This review identified strengths and limitations of current PTB CPGs, and areas for future research.
PubMed: 38619379
DOI: 10.1002/ijgo.15514 -
Zeitschrift Fur Geburtshilfe Und... Jun 2024To evaluate the use and effect of cervical stitch cerclage, pessary, and progesterone on pregnancy outcome in mothers of very low birth weight infants (VLBWI) born<32...
BACKGROUND
To evaluate the use and effect of cervical stitch cerclage, pessary, and progesterone on pregnancy outcome in mothers of very low birth weight infants (VLBWI) born<32 weeks of gestation in the German Neonatal Network (GNN).
METHODS
The GNN is a population-based cohort study enrolling VLBWI since 2009. We included 575 neonates from 424 mothers into our analysis, who were born between 2015 and 2019, after prenatal intervention with cerclage, pessary, progesterone or a combination between 20/0 to 25/0 weeks of gestation to prevent preterm birth. Median intervention-to-birth interval was the primary endpoint.
RESULTS
231 of 424 pregnant women had a cerclage only (54.5%), 76 women a pessary only (17.9%), and 27 were prescribed progesterone only (15.3%). The most common combination treatment (>1 intervention group) was cerclage plus progesterone (n=27), followed by cerclage plus pessary (n=13). The median intervention-to-birth interval for the whole cohort was 24 days (IQR 19.0 days). The earlier the intervention was started, the longer the intervention-to-birth interval lasted: When started at 20 weeks, the interval was 34 days in contrast to 11.5 days, when started at 25 weeks. The >1 group was born at a significantly higher median GA with 27.0 weeks (IQR 2.9 weeks) and a higher median birth weight of 980 g (IQR 394 g) accordingly.
CONCLUSION
We propose that the earliest possible start of intervention leads to the most efficient pregnancy prolongation.
Topics: Humans; Female; Pessaries; Cerclage, Cervical; Progesterone; Pregnancy; Premature Birth; Germany; Infant, Newborn; Adult; Infant, Very Low Birth Weight; Secondary Prevention; Cohort Studies; Pregnancy Outcome; Combined Modality Therapy
PubMed: 38228167
DOI: 10.1055/a-2217-9463 -
Ultraschall in Der Medizin (Stuttgart,... Oct 2023In the present study we sought to compare the efficacy of cervical pessary to that of cerclage in terms of reducing preterm birth rates among women with a short (<25 mm)...
PURPOSE
In the present study we sought to compare the efficacy of cervical pessary to that of cerclage in terms of reducing preterm birth rates among women with a short (<25 mm) or ultra-short (<15 and <10 mm) cervix during the ultrasonographic second-trimester assessment.
METHOD
We retrospectively searched the hospital records for singleton pregnancies diagnosed with cervical insufficiency during the second trimester of pregnancy. The McDonald cerclage using a 5mm Mersilene tape was used in all women. An Arabin pessary was used uniformly. In all cases 80 mg of vaginal progesterone gel were administered daily until 37 weeks of gestation.
RESULTS
Overall, 294 women (124 (42.2%) with a McDonald cerclage and 170 (57.8%) with placement of an Arabin pessary) were selected for analysis. Preterm birth rates <37 weeks were similar in both groups (C: 30/122 vs. P: 35:165, p=.581) as well as PTB <34 weeks (C: 16/122 vs. 15/150, p=.278). Admission to the NICU and need for CPAP were more prevalent in the cerclage group (p<.001). Analysis of cases with a cervix <15 mm and <10 mm indicated that preterm birth rates remained equal among the groups, while an increased risk of NICU admission was seen in cases with a cervical length <10 mm that were treated with cerclage.
DISCUSSION AND CONCLUSION
Cervical pessary may be an alternative to cervical cerclage for women with second-trimester cervical shortening and its effect may persist even among cases with an ultra-short cervix. Future randomized trials are needed to ascertain these findings.
PubMed: 36070802
DOI: 10.1055/a-1938-6042 -
Patient experience of pain during vaginal pessary removal and insertion: a service evaluation study.International Urogynecology Journal Feb 2024Pelvic organ prolapse is a common problem affecting women, but there is currently a lack of research focusing on patient experience of pessary changes. This study was...
INTRODUCTION AND HYPOTHESIS
Pelvic organ prolapse is a common problem affecting women, but there is currently a lack of research focusing on patient experience of pessary changes. This study was aimed at capturing the patient perspective of pessary changes and formally assessing pain during pessary removal and insertion.
METHODS
A service evaluation request was granted by South Tees Hospitals NHS Trust. Patients undergoing pessary change (ring, shelf, or Gellhorn) in gynaecology outpatient clinics over a 6-month period were asked to rate their pain scores on a ten-point numerical pain-rating scale. Other associated data were collected.
RESULTS
Out of 213 women, 58.2% reported that pessary removal was more painful than insertion, 30.5% reported equal pain, and 10.8% reported that insertion was more painful than removal. Pain scores were significantly higher for removal (mean 4.37, median 4, IQR 4-7) than for insertion (mean 2.66, median 2, IQR 2-4, p <0.001). Ring pessaries were significantly less painful to both remove and insert than shelf and Gellhorn pessaries. Smaller pessaries were more painful to both remove and insert. There was no significant difference in pain scores reported by those with or without diagnosed vulval conditions.
CONCLUSIONS
Pessary removal causes most women moderate pain, which should be communicated to patients beforehand. Ring pessaries are significantly less painful to change than other pessary types. Clinicians should consider pain as a factor in their decision-making surrounding pessary choice and when counselling patients. Future research should focus on ways to reduce pain during pessary removal.
Topics: Humans; Female; Pregnancy; Pessaries; Ambulatory Care Facilities; Colpotomy; Pain; Patient Outcome Assessment
PubMed: 37659003
DOI: 10.1007/s00192-023-05643-w -
International Journal of Gynaecology... May 2024Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. (Review)
Review
Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta-analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation.
BACKGROUND
Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent.
OBJECTIVES
Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure.
SEARCH STRATEGY AND SELECTION CRITERIA
Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries.
DATA COLLECTION AND ANALYSIS
We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices.
MAIN RESULTS
Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre-registration, but mainly non-adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12-0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13-0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10-0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35-0.82) after a pessary as compared with controls.
CONCLUSION
Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Pessaries; Medical Device Legislation; Randomized Controlled Trials as Topic; Cervix Uteri; Pregnancy, Twin
PubMed: 37830250
DOI: 10.1002/ijgo.15169 -
Human Reproduction (Oxford, England) Nov 2023Can supplementation with rectal administration of progesterone secure high ongoing pregnancy rates (OPRs) in patients with low serum progesterone (P4) on the day of...
Rectal progesterone administration secures a high ongoing pregnancy rate in a personalized Hormone Replacement Therapy Frozen Embryo Transfer (HRT-FET) protocol: a prospective interventional study.
STUDY QUESTION
Can supplementation with rectal administration of progesterone secure high ongoing pregnancy rates (OPRs) in patients with low serum progesterone (P4) on the day of blastocyst transfer (ET)?
SUMMARY ANSWER
Rectally administered progesterone commencing on the ET day secures high OPRs in patients with serum P4 levels below 35 nmol/l (11 ng/ml).
WHAT IS KNOWN ALREADY
Low serum P4 levels at peri-implantation in Hormone Replacement Therapy Frozen Embryo Transfer (HRT-FET) cycles impact reproductive outcomes negatively. However, studies have shown that patients with low P4 after a standard vaginal progesterone treatment can obtain live birth rates (LBRs) comparable to patients with optimal P4 levels if they receive additionalsubcutaneous progesterone, starting around the day of blastocyst transfer. In contrast, increasing vaginal progesterone supplementation in low serum P4 patients does not increase LBR. Another route of administration rarely used in ART is the rectal route, despite the fact that progesterone is well absorbed and serum P4 levels reach a maximum level after ∼2 h.
STUDY DESIGN, SIZE, DURATION
This prospective interventional study included a cohort of 488 HRT-FET cycles, in which a total of 374 patients had serum P4 levels ≥35 nmol/l (11 ng/ml) at ET, and 114 patients had serum P4 levels <35 nmol/l (11 ng/ml). The study was conducted from January 2020 to November 2022.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Patients underwent HRT-FET in a public Fertility Clinic, and endometrial preparation included oral oestradiol (6 mg/24 h), followed by vaginal micronized progesterone, 400 mg/12 h. Blastocyst transfer and P4 measurements were performed on the sixth day of progesterone administration. In patients with serum P4 <35 nmol/l (11 ng/ml), 'rescue' was performed by rectal administration of progesterone (400 mg/12 h) starting that same day. In pregnant patients, rectal administration continued until Week 8 of gestation, and oestradiol and vaginal progesterone treatment continued until Week 10 of gestation.
MAIN RESULTS AND THE ROLE OF CHANCE
Among 488 HRT-FET single blastocyst transfers, the mean age of the patients at oocyte retrieval (OR) was 30.9 ± 4.6 years and the mean BMI at ET 25.1 ± 3.5 kg/m2. The mean serum P4 level after vaginal progesterone administration on the day of ET was 48.9 ± 21.0 nmol/l (15.4 ± 6.6 ng/ml), and a total of 23% (114/488) of the patients had a serum P4 level lower than 35 nmol/l (11 ng/ml). The overall, positive hCG rate, clinical pregnancy rate, OPR week 12, and total pregnancy loss rate were 66% (320/488), 54% (265/488), 45% (221/488), and 31% (99/320), respectively. There was no significant difference in either OPR week 12 or total pregnancy loss rate between patients with P4 ≥35 nmol/l (11 ng/ml) and patients with P4 <35 nmol/l, who received rescue in terms of rectally administered progesterone, 45% versus 46%, P = 0.77 and 30% versus 34%, P = 0.53, respectively. OPR did not differ whether patients had initially low P4 and rectal rescue or were above the P4 cut-off. Logistic regression analysis showed that only age at OR and blastocyst scoring correlated with OPR week 12, independently of other factors like BMI and vitrification day of blastocysts (Day 5 or 6).
LIMITATIONS, REASONS FOR CAUTION
In this study, vaginal micronized progesterone pessaries, a solid pessary with progesterone suspended in vegetable hard fat, were used vaginally as well as rectally. It is unknown whether other vaginal progesterone products, such as capsules, gel, or tablet, could be used rectally with the same rescue effect.
WIDER IMPLICATIONS OF THE FINDINGS
A substantial part of HRT-FET patients receiving vaginal progesterone treatment has lowserum P4. Adding rectally administered progesterone in these patients increases the reproductive outcome. Importantly, rectal progesterone administration is considered convenient, and progesterone pessaries are easy to administer rectally and of low cost.
STUDY FUNDING/COMPETING INTEREST(S)
Gedeon Richter Nordic supported the study with an unrestricted grant as well as study medication. B.A. has received unrestricted grant from Gedeon Richter Nordic and Merck and honoraria for lectures from Gedeon Richter, Merck, IBSA and Marckyrl Pharma. P.H. has received honoraria for lectures from Gedeon Richter, Merck, IBSA and U.S.K. has received grant from Gedeon Richter Nordic, IBSA and Merck for studies outside this work and honoraria for teaching from Merck and Thillotts Pharma AB and conference expenses covered by Merck. The other co-authors have no conflict of interest to declare.
TRIAL REGISTRATION NUMBER (25)
EudraCT no.: 2019-001539-29.
Topics: Female; Pregnancy; Humans; Adult; Progesterone; Pregnancy Rate; Prospective Studies; Administration, Rectal; Embryo Transfer; Estradiol; Abortion, Spontaneous; Hormone Replacement Therapy; Retrospective Studies
PubMed: 37759346
DOI: 10.1093/humrep/dead185 -
International Urogynecology Journal Jan 2024The objective was to investigate the adherence to pessary treatment in women with pelvic organ prolapse (POP) who were found eligible for this treatment by the...
INTRODUCTION AND HYPOTHESIS
The objective was to investigate the adherence to pessary treatment in women with pelvic organ prolapse (POP) who were found eligible for this treatment by the urogynecologist, at the first visit at the Department of Gynecology and Obstetrics, Odense University Hospital.
METHODS
Data were extracted from the women's medical records. Frequency tabulations were performed to describe the women's reasons for pessary discontinuation by age group. Binominal logistic regression analysis was conducted to investigate how women's age, POP characteristics, urogynecological history, and their pessary experience and management were associated with continued pessary use.
RESULTS
This study included 1,371 women treated with support pessary. Of these, 850 women continued pessary treatment and 521 women underwent surgical treatment. A history of hysterectomy (OR: 0.68, 95% CI: 0.51-0.90, p = 0.008), urinary incontinence (OR: 0.71, 95% CI: 0.56-0.89, p = 0.003), and previous pessary use (OR: 0.75, 95% CI: 0.56-0.99, p = 0.047) were significant factors associated with discontinuation. Further, women aged 81-99 years were significantly more likely to continue pessary treatment (OR: 1.77, 95% CI: 1.15-2.74, p = 0.009). "POP surgery," "prolapse stage," and "prolapse predominant compartment" were not associated with discontinuation. Approximately 38% of women aged 26-54 years discontinued owing to personal preference.
CONCLUSIONS
Hysterectomy, incontinence, and previous pessary use are significant predictors of pessary discontinuation. Increasing age is significantly associated with pessary continuation.
Topics: Female; Humans; Retrospective Studies; Pessaries; Pelvic Organ Prolapse; Hysterectomy; Urinary Incontinence
PubMed: 37548745
DOI: 10.1007/s00192-023-05616-z -
International Urogynecology Journal Oct 2023Vaginal pessaries are a low-cost, effective treatment for pelvic organ prolapse (POP) and an alternative to surgery. Whilst traditionally pessary management (PM) has...
INTRODUCTION AND HYPOTHESIS
Vaginal pessaries are a low-cost, effective treatment for pelvic organ prolapse (POP) and an alternative to surgery. Whilst traditionally pessary management (PM) has been provided by medical professionals, particularly gynaecologists, recent international studies found other professionals, including physiotherapists and nurses, may be involved. It is unknown which health care practitioners (HCPs) provide PM for POP in Australia or the distribution of services.
METHODS
In a cross-sectional study design, a self-reported electronic survey investigated Australian HCPs providing PM for POP. Purposive and snowball sampling targeted HCPs, professional organisations and health care facilities. Descriptive statistics described PM in relation to HCP professional profile, PM provision and geographical location.
RESULTS
There were 536 respondents (324 physiotherapists, 148 specialists, 33 general practitioners (GPs) and 31 nurses providing PM. Most worked within metropolitan regions (n = 332, 64%), 140 (27%) in rural, 108 (21%) in regional and 10 (2%) in remote areas. Most worked privately (n = 418, 85%), 153 (46%) worked publicly and 85 (17%) in both. Ring pessaries were most commonly used, followed by cube and Gellhorn. HCPs reported variable training in PM, and 336 (69%) had no mandatory workplace competency standard; however, 324 (67%) wanted further training. Women travelled long distances to access services.
CONCLUSIONS
Doctors, nurses and physiotherapists provided PM in Australia. HCPs had variable training and experience in PM, with rural and remote HCPs particularly wanting further training. This study highlights the need for accessible PM services, standardised and competency-based training for HCPs, and governance structures ensuring safe care.
PubMed: 37222737
DOI: 10.1007/s00192-023-05540-2 -
Journal of the Formosan Medical... Aug 2023The rate of induction of labour has increased over the decades and numerous medications are available in the market. This study compares the efficacy and safety between... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The rate of induction of labour has increased over the decades and numerous medications are available in the market. This study compares the efficacy and safety between dinoprostone slow-release pessary (Propess) and dinoprostone tablet (Prostin) for labour induction at term in nulliparous women.
METHODS
This was a prospective single-blind randomized controlled trial conducted in a tertiary medical centre in Taiwan from September 1, 2020 to February 28, 2021. We recruited nulliparous women at term with a singleton pregnancy, fetus in cephalic presentation, an unfavourable cervix, and the cervical length had been measured by transvaginal sonography three times during labour induction. The main outcomes are duration from induction of labour to vaginal delivery, vaginal delivery rate, maternal and neonatal complication rates.
RESULTS
In both groups, Prostin and Propess, 30 pregnant women were enrolled. The Propess group had higher vaginal delivery rate but it did not meet statistically significant difference. The Prostin group had significantly higher rate of adding oxytocin for augmentation (p = 0.0002). No significant difference was observed in either labouring course, maternal or neonatal outcomes. The probability of vaginal delivery was independently related to the cervical length measured by transvaginal sonography 8 h after Prostin or Propess administration as well as neonatal birth weight.
CONCLUSION
Both Prostin and Propess can be used as cervical ripening agents with similar efficacy and without significant morbidity. Propess administration was associated with higher vaginal delivery rate and less need to add oxytocin. Intrapartum measurement of cervical length is helpful in predicting successful vaginal delivery.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Dinoprostone; Oxytocics; Oxytocin; Prospective Studies; Single-Blind Method; Labor, Induced
PubMed: 36907791
DOI: 10.1016/j.jfma.2023.02.006