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Medicina (Kaunas, Lithuania) Mar 2023Preterm birth is the leading cause of neonatal mortality worldwide and may be responsible for lifelong morbidities in the survivors. Cervical shortening is one of the...
Preterm birth is the leading cause of neonatal mortality worldwide and may be responsible for lifelong morbidities in the survivors. Cervical shortening is one of the common pathways to preterm birth associated with its own diagnostic and management challenges. The preventive modalities that have been tested include progesterone supplementation and cervical cerclage and pessaries. The study aimed to assess the management strategies and outcomes in a group of patients with a short cervix during pregnancy or cervical insufficiency. Seventy patients from the Riga Maternity Hospital in Riga, Latvia, were included in the prospective longitudinal cohort study between 2017 and 2021. Patients were treated with progesterone, cerclage, and/or pessaries. The signs of intra-amniotic infection/inflammation were assessed, and antibacterial therapy was given when the signs were positive. The rates of PTB were 43.6% ( = 17), 45.5% ( = 5), 61.1% ( = 11), and 50.0% ( = 1) in progesterone only, cerclage, pessary, and cerclage plus pesssary groups, respectively. The progesterone therapy was associated with a reduced preterm birth risk (x2(1) = 6.937, = 0.008)), whereas positive signs of intra-amniotic infection/inflammation significantly predicted the risk of preterm birth ( = 0.005, OR = 3.82, 95% [CI 1.31-11.11]). A short cervix and bulging membranes, both indicators of intra-amniotic infection/inflammation, are the key risk factors in preterm birth risk predictions. Progesterone supplementation should remain at the forefront of preterm birth prevention. Among patients with a short cervix and especially complex anamnesis, the preterm rates remain high. The successful management of patients with cervical shortening lies between the consensus-based approach for screening, follow-up, and treatment on the one side and personalising medical therapy on the other.
Topics: Pregnancy; Humans; Female; Infant, Newborn; Progesterone; Premature Birth; Prospective Studies; Longitudinal Studies; Inflammation
PubMed: 37109611
DOI: 10.3390/medicina59040653 -
American Journal of Obstetrics &... Aug 2023In the past, some pregnant women have been recommended to be in activity restriction because of the presumed increased risk of preterm birth due to the increased release... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In the past, some pregnant women have been recommended to be in activity restriction because of the presumed increased risk of preterm birth due to the increased release of catecholamines, which might stimulate myometrial activity, during exercise and aerobic activity.
OBJECTIVE
This study aimed to test the hypothesis that in women with singleton pregnancy and arrested preterm labor, activity restriction would reduce the rate of preterm birth at <37 weeks of gestation.
STUDY DESIGN
This was a parallel-group nonblinded randomized trial conducted at a single center in Italy. Eligible patients were those with a diagnosis of arrested preterm labor, defined as not delivering after 48 hours of hospitalization for threatened preterm labor, with transvaginal ultrasound cervical length ≤25 mm, no other symptoms of possible uterine contractions, and cervical dilatation <3 cm at pelvic examination. Inclusion criteria were singleton pregnancies between 24 0/7 and 33 6/7 weeks of gestation. Participants were randomized in a 1:1 ratio to either activity restriction at the time of discharge or no activity restriction. Women in the intervention group were recommended activity restriction, defined as the following: pelvic rest, prohibition of sexual activity, and reduction of work and/or nonwork activity. The primary endpoint was preterm birth at <37 weeks of gestation.
RESULTS
A total of 120 participants were included in the trial; 60 patients were enrolled in the activity restriction group and 60 in the control group. Preterm birth at <37 weeks of gestation occurred in 15 of 60 women (25.0%) in the activity restriction group and 23 of 60 women (38.3%) in the control group (relative risk, 0.65; 95% confidence interval, 0.38-1.12). There was no significant between-group difference in the incidence of preterm birth at <32 weeks and in neonatal outcomes, but the trial was not powered for these outcomes.
CONCLUSION
In singleton gestations with arrested preterm labor, activity restriction, including pelvic rest, prohibition of sexual activity, and reduction of work and/or nonwork activity, does not result in a lower rate of preterm birth at <37 weeks. Given the evidence on the lack of benefits, use of activity restriction in this population should be discouraged.
Topics: Female; Infant, Newborn; Humans; Pregnancy; Premature Birth; Obstetric Labor, Premature; Cervix Uteri; Hospitalization; Pessaries
PubMed: 37080296
DOI: 10.1016/j.ajogmf.2023.100954 -
The American Journal of Case Reports Apr 2023BACKGROUND Vaginal wall hemangiomas are extremely rare, benign, vascular tumors of the female genitalia. Most cases occur in childhood, but a few cases can be acquired;...
BACKGROUND Vaginal wall hemangiomas are extremely rare, benign, vascular tumors of the female genitalia. Most cases occur in childhood, but a few cases can be acquired; however, the mechanism of hemangioma formation remains unknown. Most hemangiomas involving female genital organs are small and asymptomatic. However, huge hemangiomas can cause irregular genital bleeding, infertility, and miscarriage. Surgical excision and embolization are the most common treatment options. We reveal that sclerotherapy achieved good outcomes in a patient with an intractable huge vaginal wall hemangioma. CASE REPORT A 71-year-old woman visited a local doctor with concerns of frequent urination. A ring pessary was inserted after a diagnosis of pelvic organ prolapse. However, symptoms did not improve, and the patient consulted another hospital. The previous physician diagnosed vaginal wall tumors and prolapse and performed a colporrhaphy. However, she was referred to our hospital with heavy intraoperative bleeding. Imaging examination revealed a huge hemangioma on the vaginal wall, which was histologically diagnosed as a cavernous hemangioma. Angiography revealed hemorrhage in the right peripheral vaginal artery. Owing to concerns regarding extensive vaginal wall necrosis caused by arterial embolization, sclerotherapy using monoethanolamine oleate was selected. Hemostasis was achieved 1 month after sclerotherapy, and postoperative imaging showed the lesion had shrunk in size. No recurrence of hemangioma was observed 19 months after surgery. CONCLUSIONS We report a case of a large vaginal wall intractable bleeding hemangioma. Sclerotherapy can be a suitable treatment option for large vaginal hemangiomas that are too extensive to be treated using surgery or arterial embolization.
Topics: Female; Humans; Aged; Sclerotherapy; Hemangioma, Cavernous; Hemangioma; Vagina; Uterine Hemorrhage
PubMed: 37074991
DOI: 10.12659/AJCR.939474 -
PloS One 2023The therapeutic significance of the cervical pessary has been confirmed by several studies. However, the underlying mechanism by which pessaries reduce the risk of a...
A novel aspiration technique to assess cervical remodelling in patients with or without cervical shortening: Sequence of first changes, definition of cut-off values and impact of cervical pessary, stratified for cervical length.
BACKGROUND
The therapeutic significance of the cervical pessary has been confirmed by several studies. However, the underlying mechanism by which pessaries reduce the risk of a preterm birth remains elusive. The aim of this study is to investigate the hypothesis whether the application of a cervical pessary may stabilize the ectocervical stiffness in order to achieve a cervical arrest.
METHODS
This is a prospective, controlled, non-interventional, post-market, monocentric, longitudinal, cohort study in a tertiary maternity hospital to determine ectocervical stiffness and its changes measured before and after placement of a pessary in singleton pregnancies with cervical shortening in the mid trimester. In order to assess reference values for cervical stiffness, we measured also singleton pregnancies with normal cervical length in the same gestational week spectrum. The cervical stiffness measured with the Pregnolia System as the Cervical Stiffness Index (CSI, in mbar) shall be the primary endpoint, whilst patient delivery data (gestational age, mode of delivery and complications) will be the secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) to complete the study; pessary cohort: 60 (up to 71 recruited), control group: 60 (up to 71 recruited).
DISCUSSION
Our hypothesis is that patients with cervical shortening will present with lower CSI values and that pessary placement will be able to stabilize the CSI values through further prevention of cervical remodelling. The measurement of controls with normal cervical length shall serve as a reference.
Topics: Pregnancy; Humans; Female; Infant, Newborn; Pessaries; Premature Birth; Cohort Studies; Prospective Studies; Pilot Projects; Cervix Uteri; Uterine Cervical Incompetence
PubMed: 37023066
DOI: 10.1371/journal.pone.0283944 -
Urogynecology (Philadelphia, Pa.) Sep 2023Vaginal pessaries are an effective nonsurgical treatment for pelvic organ prolapse (POP) when properly fitted. However, pessary fitting and use are often unsuccessful or...
IMPORTANCE
Vaginal pessaries are an effective nonsurgical treatment for pelvic organ prolapse (POP) when properly fitted. However, pessary fitting and use are often unsuccessful or imperfect.
OBJECTIVE
The objective of this study was to assess the feasibility of using patient-specific pessaries fabricated from three-dimensional (3D)-printed molds to improve POP symptoms and increase overall satisfaction of pessary treatment in patients using standard vaginal pessaries.
STUDY DESIGN
Patients undergoing POP treatment with standard vaginal pessaries were enrolled in this pilot prospective study. Patient-specific pessaries were designed and fabricated for each patient using patient input, physician input, and anatomic measurements from clinical assessment. Pessary fabrication involved injection of biocompatible liquid silicone rubber into 3D-printed molds followed by a biocompatible silicone coating. Pelvic organ prolapse symptomatic distress and pessary treatment satisfaction were evaluated before and after a 3-week patient-specific pessary home trial using the validated Pelvic Organ Prolapse Distress Inventory-6 form and a visual analog scale, respectively.
RESULTS
Eight women were included in this study. Changing from standard pessary to patient-specific pessary treatment was associated with an improvement in prolapse symptoms on the Pelvic Organ Prolapse Distress Inventory-6 (median change, -3.5; interquartile range, -5 to -2.5; P = 0.02) and an increase in overall pessary satisfaction on a visual analog scale (median change, +2.0; interquartile range, +1.0 to +3.0; P = 0.02). All patients reported either an improvement or no change in pessary ease of use, comfort, and the feeling of support provided by the pessary.
CONCLUSION
Patient-specific vaginal pessaries are a promising alternative to standard pessaries for alleviating POP symptoms and improving patient satisfaction with pessary use.
Topics: Humans; Female; Pessaries; Pilot Projects; Prospective Studies; Pelvic Organ Prolapse; Printing, Three-Dimensional
PubMed: 36946908
DOI: 10.1097/SPV.0000000000001346 -
Frontiers in Medicine 2023To assess the impact of progesterone treatment on maternal and neonatal outcomes in women with a history of preterm birth and short cervical length diagnosed after 24...
The effectiveness of vaginal progesterone in reducing preterm birth in high-risk patients diagnosed with short cervical length after 24 weeks: A retrospective cohort study.
OBJECTIVE
To assess the impact of progesterone treatment on maternal and neonatal outcomes in women with a history of preterm birth and short cervical length diagnosed after 24 weeks of gestation.
METHODS
A retrospective cohort study included women with a history of preterm birth and a transvaginal sonographic cervical length measurement of ≤ 25 mm, diagnosed between 24 and 33 weeks of gestation. Exclusion criteria included prior progesterone treatment, cervical cerclage, or pessary. The study population was divided into the progesterone treatment group and the non-treatment group.
RESULTS
The study included 104 women, with 46.2% (48/104) receiving progesterone treatment and 53.8% (56/104) not receiving treatment. The rate of spontaneous preterm birth before 37 weeks of gestation was 43% (24/56) in the non-treatment group and 31% (15/48) in the progesterone treatment group ( = 0.14); the rate of spontaneous preterm birth before 34 weeks was 7% (4/56) in the non-treatment group and 0% (0/48) in the progesterone treatment group ( = 0.05). Progesterone treatment was associated with a significant decrease in neonatal intensive care unit admissions (OR 0.20, 95% CI 0.05-0.74) and in the neonatal hospitalization period (mean difference in days 2.43, 95% CI 0.44-4.42). The risk of recurrent spontaneous preterm birth was highest (71%) among women with two or more previous preterm deliveries who did not receive progesterone treatment, and lowest (24%) among women with one previous preterm delivery who received progesterone treatment.
CONCLUSION
Progesterone treatment was associated with a reduction in rates of spontaneous preterm birth before 34 weeks of gestation, neonatal intensive care unit admission, and neonatal length of stay in high-risk patients, even when initiated after 24 weeks of gestation.
PubMed: 36936220
DOI: 10.3389/fmed.2023.1130942 -
Frontiers in Medicine 2023Preterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on... (Review)
Review
BACKGROUND
Preterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on progesterone, cerclage, pessary, and acetylsalicylic acid (ASA) to prevent preterm birth in asymptomatic women with singleton pregnancies defined as risk of preterm birth and multifetal pregnancies.
METHODS
Six databases (including PubMed, Embase, Medline, the Cochrane Library) were searched up to February 2022. RCTs published in English or Scandinavian languages were included through a consensus process. Abstracts and duplicates were excluded. The trials were critically appraised by pairs of reviewers. The Cochrane risk-of-bias tool was used for risk of bias assessment. Predefined outcomes including preterm birth, perinatal/neonatal/maternal mortality and morbidity, were pooled in meta-analyses using RevMan 5.4, stratified for high and low risk of bias trials. The certainty of evidence was assessed using the GRADE approach. The systematic review followed the PRISMA guideline.
RESULTS
The search identified 2,309 articles, of which 87 were included in the assessment: 71 original RCTs and 16 secondary publications with 23,886 women and 32,893 offspring. Conclusions were based solely on trials with low risk of bias ( = 50).Singleton pregnancies: Progesterone compared with placebo, reduced the risk of preterm birth <37 gestational weeks: 26.8% vs. 30.2% (Risk Ratio [RR] 0.82 [95% Confidence Interval [CI] 0.71 to 0.95]) (high certainty of evidence, 14 trials) thereby reducing neonatal mortality and respiratory distress syndrome. Cerclage probably reduced the risk of preterm birth <37 gestational weeks: 29.0% vs. 37.6% (RR 0.78 [95% CI 0.69 to 0.88]) (moderate certainty of evidence, four open trials). In addition, perinatal mortality may be reduced by cerclage. Pessary did not demonstrate any overall effect. ASA did not affect any outcome, but evidence was based on one underpowered study.Multifetal pregnancies: The effect of progesterone, cerclage, or pessary was minimal, if any. No study supported improved long-term outcome of the children.
CONCLUSION
Progesterone and probably also cerclage have a protective effect against preterm birth in asymptomatic women with a singleton pregnancy at risk of preterm birth. Further trials of ASA are needed. Prevention of preterm birth requires screening programs to identify women at risk of preterm birth.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.uk/prospero/], identifier [CRD42021234946].
PubMed: 36936217
DOI: 10.3389/fmed.2023.1111315 -
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 -
Acta Obstetricia Et Gynecologica... May 2023Preterm birth is the most common cause of neonatal morbidity and mortality. Women with twin pregnancies and a short cervical length are at high risk for preterm birth.... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Preterm birth is the most common cause of neonatal morbidity and mortality. Women with twin pregnancies and a short cervical length are at high risk for preterm birth. Vaginal progesterone and cervical pessary have been proposed as potential strategies to reduce preterm birth in this high-risk population. Therefore, we aimed to compare the effectiveness of cervical pessary and vaginal progesterone in improving developmental outcomes of children born to women with twin pregnancies and mid-trimester short cervical length.
MATERIAL AND METHODS
This was a follow-up study (NCT04295187) of all children at 24 months of age, born from women treated with cervical pessary or progesterone to prevent preterm birth in a randomized controlled trial (NCT02623881). We used a validated Vietnamese version of Ages & Stages Third Edition Questionnaires (ASQ-3) and a red flag questionnaire. In surviving children, we compared the mean ASQ-3 scores, abnormal ASQ-3 scores, the number of children with any abnormal ASQ-3 scores and red flag signs between the two groups. We reported the composite outcome of perinatal death or survival with any abnormal ASQ-3 score in offspring. These outcomes were also calculated in a subgroup of women with a cervical length ≤28 mm (<25th percentile).
RESULTS
In the original randomized controlled trial, we randomized 300 women to pessary or progesterone. After counting the number of perinatal deaths and lost to follow-up, 82.8% parents in the pessary group and 82.5% parents in progesterone group returned the questionnaire. The mean ASQ-3 scores of the five skills and red flag signs did not differ significantly between the two groups. However, the percentage of children having abnormal ASQ-3 scores in fine motor skills was significantly lower in the progesterone group (6.1% vs 1.3%, P = 0.01). There were no significant differences in the composite outcome of perinatal death or survival with any abnormal ASQ-3 score in unselected women and in those with cervical length ≤28 mm.
CONCLUSIONS
Cervical pessary and vaginal progesterone may have comparable effects on developmental outcomes in children at ≥24 months of age, born to women with twin pregnancies and short cervical length. However, this finding could be likely due to a lack of study power.
Topics: Pregnancy; Infant, Newborn; Female; Child; Humans; Progesterone; Pregnancy, Twin; Follow-Up Studies; Premature Birth; Pessaries; Perinatal Death; Cervix Uteri; Administration, Intravaginal
PubMed: 36905390
DOI: 10.1111/aogs.14545 -
Journal of Obstetrics and Gynaecology... Feb 2023Medical devices and materials commonly used in management of common gynecological conditions or during surgical procedures may present with acute or chronic...
Medical devices and materials commonly used in management of common gynecological conditions or during surgical procedures may present with acute or chronic complications due to incorrect application, improper use and lack of follow up. We present two interesting cases highlighting this problem. A strong index of suspicion is very crucial in early diagnosis and successful management.
PubMed: 36879934
DOI: 10.1007/s13224-021-01543-5