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Reproductive Biomedicine Online May 2024Is there a difference between the proportion of patients with serum progesterone <8.8 ng/ml on the day of embryo transfer when micronized vaginal progesterone (MVP) for...
RESEARCH QUESTION
Is there a difference between the proportion of patients with serum progesterone <8.8 ng/ml on the day of embryo transfer when micronized vaginal progesterone (MVP) for luteal phase support (LPS) is given as pessaries versus capsules?
DESIGN
This retrospective, matched-cohort, single-centre study compared pessaries (Cyclogest) versus capsules (Utrogestan, Progeffik) for LPS in hormone replacement treatment-embryo transfer (HRT-ET) cycles. Patients under 50 years old with a triple-layer endometrial thickness of ≥6.5 mm underwent transfer of one or two blastocysts. Serum progesterone concentrations were measured on the day of transfer; patients with concentrations <8.8 ng/ml received a single 'rescue' dose of additional progesterone by subcutaneous injection.
RESULTS
In total 2665 HRT-ET cycles were analysed; 663 (24.9%) used pessaries for LPS and 2002 (75.1%) used capsules. Mean serum progesterone concentrations with standard deviations on the day of embryo transfer were significantly higher in the group using MVP pessaries compared with those using capsules (14.5 ± 5.1 versus 13.0 ± 4.8 ng/ml; P = 0.000). The percentage of participants with suboptimal serum progesterone concentrations on the day of embryo transfer (<8.8 ng/ml) was significantly lower in the pessary group than the capsule group (10.3%, 95% confidence interval [CI] 7.9-12.6% versus 17.9%, 95% CI 16.2-19.6%; adjusted odds ratio 0.426, 95% CI 0.290-0.625; P = 0.000). No differences in pregnancy outcome were observed between the groups.
CONCLUSIONS
Using MVP pessaries rather than capsules for LPS resulted in significantly fewer patients having suboptimal serum progesterone concentrations on the day of embryo transfer. Consequently, almost 50% fewer patients in the pessary group needed rescue treatment.
Topics: Humans; Female; Progesterone; Retrospective Studies; Luteal Phase; Adult; Pregnancy; Administration, Intravaginal; Embryo Transfer; Pessaries; Pregnancy Rate; Capsules
PubMed: 38484430
DOI: 10.1016/j.rbmo.2023.103638 -
Urogynecology (Philadelphia, Pa.) Mar 2024This study identifies how neighborhood-level socioeconomic status (SES) may affect patients' treatment decisions for pelvic organ prolapse (POP).
IMPORTANCE
This study identifies how neighborhood-level socioeconomic status (SES) may affect patients' treatment decisions for pelvic organ prolapse (POP).
OBJECTIVE
This study aimed to evaluate the association of neighborhood-level SES with the decision of surgical versus conservative POP management.
STUDY DESIGN
This was a retrospective cohort study of patients newly diagnosed with POP at a tertiary medical center between 2015 and 2021. Patients lost to follow-up or poor surgical candidates were excluded. Patient characteristics, demographics, and treatment selection were abstracted from the electronic health record. Conservative management was defined as expectant, pessary, and/or pelvic floor physical therapy. Five-digit zip codes were linked to the Area Deprivation Index and used as a surrogate for neighborhood-level SES. Area Deprivation Indices were dichotomized at or below the sample median (less disadvantaged area) and above the sample median (more disadvantaged area). Logistic regression models estimated the odds of choosing surgical versus conservative management as a function of the Area Deprivation Index.
RESULTS
A total of 459 patients met the eligibility criteria (non-Hispanic White, 88.2%). The median age was 63 years (interquartile range, 52-70 years), and the majority had stage 2 POP (65.7%). Of all patients, 59.3% had Medicare/Medicaid, 39.9% were privately insured, and 0.9% were uninsured. Furthermore, 74.7% selected surgical management, and 25.3% chose conservative management. Increasing age and higher Pelvic Organ Prolapse Quantification System stage were significantly associated with selecting surgery (P = 0.01). Women residing in a more disadvantaged area had a 67% increased odds of choosing surgical over conservative management (adjusted odds ratio, 1.67; 95% confidence interval, 1.06-2.64) after adjusting for age, race/ethnicity, body mass index, and Pelvic Organ Prolapse Quantification System stage.
CONCLUSIONS
Residing in a more disadvantaged zip code was associated with 67% increased odds of choosing surgical versus conservative POP management.
Topics: Female; Humans; Aged; United States; Middle Aged; Retrospective Studies; Medicare; Ethnicity; Social Class; Pelvic Organ Prolapse
PubMed: 38484252
DOI: 10.1097/SPV.0000000000001488 -
Journal of Family Medicine and Primary... Jan 2024Vaginal pH has been suggested to be one of the causative factors, responsible for variation in prostaglandin efficacy for induction of labour. The purpose of this study...
OBJECTIVE
Vaginal pH has been suggested to be one of the causative factors, responsible for variation in prostaglandin efficacy for induction of labour. The purpose of this study was to analyse the effect of vaginal douching with normal saline before insertion of dinoprostone vaginal insert for induction of labour.
METHODS
This randomised controlled study was done in the Department of Obstetrics and Gynaecology for a period of 1 year. Using a computer-generated random number table, subjects were allocated in two groups. In group A (study group), vaginal douching was done with 20 cc of sterile 0.9% NaCl and vaginal pH was again measured with pH paper strips just before inserting dinoprostone pessary. Dinoprostone pessary was inserted without douching in group B (control group).
RESULTS
There was a significant increase in the vaginal pH after douching with normal saline (4.91 vs 5.52, < 0.001). Mean intrinsic vaginal pH (pH before inserting dinoprostone insert) in women who delivered vaginally was significantly higher than that of the women who had a caesarean section (5.10 vs 4.63, < 0.001). Time interval between dinoprostone insertion to active phase of labour, duration of active phase of labour, time interval between dinoprostone insertion, and complete cervical dilatation and mode of delivery were not significantly different between the two groups.
CONCLUSION
Although douching with normal saline increases vaginal pH, douching does not help in increasing the chances of vaginal delivery because it gives a transient effect. Rather, it is intrinsic vaginal pH, which is a better decisive factor for successful vaginal delivery.
PubMed: 38482325
DOI: 10.4103/jfmpc.jfmpc_1108_23 -
BMJ (Clinical Research Ed.) Mar 2024To compare the effectiveness of cervical pessary and vaginal progesterone in the prevention of adverse perinatal outcomes and preterm birth in pregnant women of... (Comparative Study)
Comparative Study Randomized Controlled Trial
Cervical pessary versus vaginal progesterone in women with a singleton pregnancy, a short cervix, and no history of spontaneous preterm birth at less than 34 weeks' gestation: open label, multicentre, randomised, controlled trial.
OBJECTIVE
To compare the effectiveness of cervical pessary and vaginal progesterone in the prevention of adverse perinatal outcomes and preterm birth in pregnant women of singletons with no prior spontaneous preterm birth at less than 34 weeks' gestation and who have a short cervix of 35 mm or less.
DESIGN
Open label, multicentre, randomised, controlled trial.
SETTING
20 hospitals and five obstetric ultrasound practices in the Netherlands.
PARTICIPANTS
Women with a healthy singleton pregnancy and an asymptomatic short cervix of 35 mm or less between 18 and 22 weeks' gestation were eligible. Exclusion criteria were prior spontaneous preterm birth at less than 34 weeks, a cerclage in situ, maternal age of younger than 18 years, major congenital abnormalities, prior participation in this trial, vaginal blood loss, contractions, cervical length of less than 2 mm or cervical dilatation of 3 cm or more. Sample size was set at 628 participants.
INTERVENTIONS
1:1 randomisation to an Arabin cervical pessary or vaginal progesterone 200 mg daily up to 36 weeks' of gestation or earlier in case of ruptured membranes, signs of infection, or preterm labour besides routine obstetric care.
MAIN OUTCOME MEASURES
Primary outcome was a composite adverse perinatal outcome. Secondary outcomes were rates of (spontaneous) preterm birth at less than 28, 32, 34, and 37 weeks. A predefined subgroup analysis was planned for cervical length of 25 mm or less.
RESULTS
From 1 July 2014 to 31 March 2022, 635 participants were randomly assigned to pessary (n=315) or to progesterone (n=320). 612 were included in the intention to treat analysis. The composite adverse perinatal outcome occurred in 19 (6%) of 303 participants with a pessary versus 17 (6%) of 309 in the progesterone group (crude relative risk 1.1 (95% confidence interval (CI) 0.60 to 2.2)). The rates of spontaneous preterm birth were not significantly different between groups. In the subgroup of cervical length of 25 mm or less, spontaneous preterm birth at less than 28 weeks occurred more often after pessary than after progesterone (10/62 (16%) 3/69 (4%), relative risk 3.7 (95% CI 1.1 to 12.9)) and adverse perinatal outcomes seemed more frequent in the pessary group (15/62 (24%) 8/69 (12%), relative risk 2.1 (0.95 to 4.6)).
CONCLUSIONS
In women with a singleton pregnancy with no prior spontaneous preterm birth at less than 34 weeks' gestation and with a midtrimester short cervix of 35 mm or less, pessary is not better than vaginal progesterone. In the subgroup of a cervical length of 25 mm or less, a pessary seemed less effective in preventing adverse outcomes. Overall, for women with single baby pregnancies, a short cervix, and no prior spontaneous preterm birth less than 34 weeks' gestation, superiority of a cervical pessary compared with vaginal progesterone to prevent preterm birth and consecutive adverse outcomes could not be proven.
TRIAL REGISTRATION
International Clinical Trial Registry Platform (ICTRP, EUCTR2013-002884-24-NL).
Topics: Adult; Female; Humans; Infant, Newborn; Pregnancy; Administration, Intravaginal; Cervix Uteri; Pessaries; Premature Birth; Progesterone; Vagina
PubMed: 38471724
DOI: 10.1136/bmj-2023-077033 -
Geburtshilfe Und Frauenheilkunde Mar 2024To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that...
INTRODUCTION
To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort.
MATERIALS AND METHODS
A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V > 0.35) with a power of 80% and an alpha of 0.05 for a 3 × 3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P < 0.05 was considered statistically significant.
RESULTS
Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n = 17), pelvic floor muscle training (n = 17), or vaginal cube pessary (n = 18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n = 14/18), compared to the standard care group (41.2%, n = 7/17), and the PFMT (23.5%, n = 4/17; χ = 14.55; p = 0.006, Cramer-V = 0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI.
CONCLUSION
Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found.
PubMed: 38455997
DOI: 10.1055/a-2243-3784 -
Urology Case Reports Mar 2024We present the case of a patient with pyelonephritis secondary to urinary tract obstruction caused by uterine prolapse. An 80-year-old woman with uterine prolapse...
We present the case of a patient with pyelonephritis secondary to urinary tract obstruction caused by uterine prolapse. An 80-year-old woman with uterine prolapse (pelvic organ prolapse stage 4) was treated with a pessary at an outside hospital due to her high perioperative risk. However, the pessary prolapsed. The patient developed pyelonephritis with hydronephrosis. A pessary was inserted to resolve the blockage of the urinary tract, antibiotic treatment was initiated, and the patient's condition improved. A total vaginal hysterectomy was ultimately performed. Challenges remain in the treatment of pelvic organ prolapse stage 4 for which a pessary cannot be used.
PubMed: 38444617
DOI: 10.1016/j.eucr.2024.102692 -
American Journal of Obstetrics and... May 2024Hippocrates, an influential figure in ancient Greek medicine, is best known for his lasting contribution, the Hippocratic Oath, which includes a significant message...
Hippocrates, an influential figure in ancient Greek medicine, is best known for his lasting contribution, the Hippocratic Oath, which includes a significant message about obstetrics and gynecology. Given the Oath's status as a widely regarded ethical code for medical practice, it requires critical evaluation. The message of the Oath, as it related to obstetrics and gynecology, is expressed in ancient Greek by the phrase "οὐδὲ γυναικὶ πεσσὸν φθόριον δώσω" which translates directly to "I will not give to any woman a harming pessary." The words fetus and abortion were not present in the original Greek text of the Oath. Yet, this message of the Hippocratic Oath has been interpreted often as a prohibition against abortion. In this article, we present a critical linguistic and historical analysis and argue against the notion that the Hippocratic Oath was prohibiting abortion. We provide evidence that the words "foetum" (fetus) and "abortu" (abortion) were inserted in the Latin translations of the Oath, which then carried on in subsequent English versions. The addition of the words "fetus" and "abortion" in the Latin translations significantly altered the Oath's original meaning. Unfortunately, these alterations in the translation of the Hippocratic Oath have been accepted over the years because of cultural, religious, and social reasons. We assert that because the original Hippocratic Oath did not contain language related to abortion, it should not be construed as prohibiting it. The interpretation of the Oath should be based on precise and rigorous translation and speculative interpretations should be avoided.
Topics: Hippocratic Oath; Obstetrics; Humans; Gynecology; History, Ancient; Female; Pregnancy; Abortion, Induced
PubMed: 38413328
DOI: 10.1016/j.ajog.2024.01.027 -
Proceedings of the Institution of... Feb 2024A pessary is a medical device that is inserted into the vagina to provide structural support to one or more of the descending vaginal compartments in women with pelvic...
A pessary is a medical device that is inserted into the vagina to provide structural support to one or more of the descending vaginal compartments in women with pelvic organ prolapse. It is a common management option offered to women in the short and long term. This article will discuss the current use of vaginal pessaries for POP, the current challenges with their use and common complications seen in practise. It will also discuss the unmet needs in the current products available on the market and suggest ideas for product design, materials and considerations for future development.
PubMed: 38408886
DOI: 10.1177/09544119241231991 -
European Journal of Obstetrics,... Apr 2024Premature births are a health problem arising in triplet pregnancies, resulting in high levels of morbidity and mortality. The objective of this study is to evaluate the... (Observational Study)
Observational Study
OBJECTIVE
Premature births are a health problem arising in triplet pregnancies, resulting in high levels of morbidity and mortality. The objective of this study is to evaluate the utility of cervical pessaries in reducing prematurity (<34 weeks) in triplet pregnancies.
METHODS
This is a single-center, retrospective case-control study regarding triplet pregnancies with follow-up at the La Paz University Hospital between 2000 and 2023. Maternal characteristics, obstetric and perinatal outcomes, and the use of cervical pessaries were examined.
RESULTS
165 triplet pregnancies were analyzed: 87 (52.7 %) in the case group (premature triplet pregnancies) and 78 in the control group (non-premature triplet pregnancies). A cervical pessary was inserted in 15 (17.2 %) triplet pregnancies in the case group and in 12 (16.7 %) triplet pregnancies in the control group (p = 0.92; OR = 1.04 (0.46-2.35)). A pessary was later inserted in the non-premature group (p = 0.01). The risk of preterm labor and the use of tocolytics ± glucocorticoids were found to be significantly more frequent in the premature group, with p = 0.01; OR = 2.30 (1.21-4.36) and p < 0.01; OR = 2.36 (1.23-4.44), respectively. Protocol-based cesarean sections were more frequent in the non-premature group (p < 0.01), while cesarean sections due to maternal complications (p < 0.01) and premature membrane rupture (p < 0.01) were more frequent in the premature group.
CONCLUSION
The cervical pessary is not useful in preventing preterm births (< 34 weeks) in triplet pregnancies. It is likely that being pregnant with triplets is a powerful independent factor associated with prematurity, despite other pregnancy conditions. Women who are pregnant with triplets and at risk of preterm labor and those taking tocolytics ± glucocorticoids may benefit from pessary insertion.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Retrospective Studies; Pessaries; Pregnancy, Triplet; Tocolytic Agents; Case-Control Studies; Obstetric Labor, Premature; Cervix Uteri
PubMed: 38335584
DOI: 10.1016/j.ejogrb.2024.01.036 -
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