Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study.

OBJECTIVES: To compare patient-reported pain, bleeding, and device safety between intrauterine contraceptive device (IUD) insertion procedures employing a suction cervical stabilizer or single-tooth tenaculum. STUDY DESIGN: This was a randomized, prospective, single-blinded study conducted at two centers, enrolling women aged 18 years or older, eligible for IUD insertion. The primary end point measure was patient-reported pain, measured on a 100-mm Visual Analogue Scale. Safety was assessed on the amount of bleeding, adverse events, and serious adverse events. RESULTS: One hundred women were randomized, 48 to the investigational device and 52 to control. There were no statistically significant differences between the groups in factors potentially associated with pain on IUD insertion. IUD insertion was successful in 94% of all subjects. Subjects in the investigational device group reported pain scores ≥14 points lower than in the control group at cervix grasping (14.9 vs 31.3; p < 0.001) and traction (17.0 vs 35.9; p < 0.001), and smaller differences in pain scores at the IUD insertion (31.5 vs 44.9; p = 0.021) and cervix-release (20.6 vs 30.9; p = 0.049) steps. Nulliparous women experienced the greatest pain differences to control. Mean blood loss was 0.336 (range 0.022-2.189) grams in the investigational device group and 1.336 (range 0.201-11.936) grams in the control group, respectively (p = 0.03 for the comparison). One adverse event (bruising and minor bleeding) in the investigational device group was considered causally related to the study device. CONCLUSIONS: The suction cervical stabilizer had a reassuring safety profile and its use was associated with significant reductions in pain during the IUD insertion procedure compared with standard single-tooth tenaculum use, particularly among nulliparous women. IMPLICATIONS: Pain can be an important barrier to greater use of IUD devices among prescribers and users, particularly nulliparous women. The suction cervical stabilizer may provide an appealing alternative to currently available tenacula, filling an important unmet need.

Telecytologic diagnosis of cervical smears for triage of self-sampled human papillomavirus-positive women in a resource-limited setting: concept development before implementation.

INTRODUCTION: Cytology is an option for triaging human papillomavirus (HPV)-positive women. The interpretation of cytologic slides requires expertise and financial resources that are not always available in resource-limited settings. A solution could be offered by manual preparation and digitization of slides on site for real-time remote cytologic diagnosis by specialists. In the present study, we evaluated the operational feasibility and cost of manual preparation and digitization of thin-layer slides and the diagnostic accuracy of screening with virtual microscopy. MATERIALS AND METHODS: Operational feasibility was evaluated on 30 cervical samples obtained during colposcopy. The simplicity of the process and cellularity and quality of digitized thin-layer slides were evaluated. The diagnostic accuracy of digital versus glass slides to detect cervical intraepithelial neoplasia grade 2 or worse was assessed using a cohort of 264 HPV-positive Cameroonian women aged 30 to 49 years. The histologic results served as the reference standard. RESULTS: Manual preparation was found to be feasible and economically viable. The quality characteristics of the digital slides were satisfactory, and the mean cellularity was 6078 squamous cells per slide. When using the atypical squamous cells of undetermined significance or worse threshold for positivity, the diagnostic performance of screening digital slides was not significantly different statistically compared with the same set of slides screened using a light microscope (P = 0.26). CONCLUSIONS: We have developed an innovative triage concept for HPV-positive women. A quality-ensured telecytologic diagnosis could be an effective solution in areas with a shortage of specialists, applying a same day "test-triage-treat" approach. Our results warrant further on-site clinical validation in a large prospective screening trial.

Use of Autologous Platelet Rich Plasma (A-PRP) for Postpartum Perineal Repair Failure: A Case Report.

Perineal wound dehiscence is an uncommon but important postpartum complication. In many cases, it leads to extreme pain and urinary and defecation problems. For up to several weeks, it can interfere with the mother's daily activity, affecting psychosexual health and body image. The best way to manage perineal wound breakdown (resuturing vs. spontaneous closure) after childbirth remains controversial. A-PRP is the autologous human plasma containing an increased platelet concentration, rich in growth factors, and mediators with hemostatic, anti-inflammatory, and antimicrobial properties. It accelerates the natural healing process. Even though A-PRP is widely used in orthopedics and dermatology, its use in gynecological injuries is limited. We describe here a case of a woman with postpartum perineal dehiscence treated with A-PRP with positive outcomes.

Protein S100ß in Late-Pregnancy Fetuses with Low Birth Weight and Abnormal Cerebroplacental Ratio.

OBJECTIVE: To evaluate the umbilical cord venous S100ß levels in late-pregnancy fetuses with abnormal growth and cerebral redistribution. METHODS: The pulsatility index of the umbilical and middle cerebral arteries and the cerebroplacental ratio (CPR) were measured in 132 fetuses at ≥34 weeks, and the CPR was converted into multiples of the median (MoM). A blood sample from the umbilical vein was collected at birth, and the umbilical venous S100ß levels were evaluated in small and non-small for gestational age (SGA) fetuses, with and without abnormal Doppler indices. The levels of S100ß were correlated with birth weight (BW) centile, CPR MoM and cord venous pH. RESULTS: While CPR MoM correlated with BW centile, S100ß showed no correlation with any of the studied fetal parameters. In addition, no differences were observed in S100ß level according to BW centile or Doppler parameters, neither was there any difference between SGA with low CPR MoM and non-SGA with normal CPR MoM. CONCLUSION: Late-pregnancy fetuses with abnormal growth or cerebral redistribution have normal cord blood levels of S100ß at birth. In these fetuses, the potential consequences of chronic hypoxemia on the fetal brain might not be detectable using tissue necrosis markers.

Fetal cerebral and umbilical Doppler in pregnancies complicated by late-onset placental abruption.

OBJECTIVE: To evaluate whether changes in the cerebroplacental Doppler and birth weight (BW) suggestive of chronic fetal hypoxemia, precede the development of late-onset placental abruption (PA) after 32 weeks. METHODS: In a multicenter retrospective study, the Doppler examinations of the fetal umbilical artery (UA) and middle cerebral artery (MCA) recorded after 32 weeks were collected in pregnancies subsequently developing PA. The BW centiles were calculated and the MCA pulsatility indices (PI), and UA PI were converted into multiples of the median (MoM). Afterwards, a comparison was made with a group of fetuses, which did not develop PA. Logistic regression was used to adjust for potential confounders and evaluate the feasibility of the prediction model. RESULTS: Pregnancies complicated by late-onset PA (n = 31) presented lower MCA PI (p = 0.015) and were smaller (p < 0.001) than those who did not (n = 1294). Logistic regression analysis indicated that cerebral vasodilation was more important than umbilical flow in the explanation of PA (MCA PI OR = 0.106, p = 0.014 and UA PI OR 1.901, p = 0.32). In addition, the influence of BW exerted was residual (BW centile OR = 0.989, p = 0.15). CONCLUSIONS: Fetuses developing late-onset PA demonstrate significant cerebral vasodilation with scarce placental dysfunction, suggesting the existence of some kind of chronic hypoxemia that follows the late-onset pattern.

Endometriosis peritoneal masiva asociada a gran elevación de CA-125: discrepancia entre hallazgos y clínica / Massive peritoneal endometriosis associated with high elevation of CA-125: discrepancy between findings and symptoms

ANTECEDENTES: Frecuentemente, las pacientes con endometriosis presentan una elevación de marcadores tumorales Ca 125 y Ca 19.9. No obstante, no existe correlación clara con la expresión clínica ni con el grado de afectación. En algunos casos, es necesario un diagnóstico diferencial con patologías malignas. CASO CLÍNICO: Mujer de 29 años con clínica aislada de dismenorrea moderada y hallazgo de masas ováricas bilaterales con elevación intensa de marcadores tumorales: Ca-125: 7.716 U/mL y Ca-19.9: 995 U/mL. Se decide intervención quirúrgica laparoscópica evidenciándose endometriosis ovárica y extensión peritoneal masiva con afectación de peritoneo parietal abdominal, superficie uterina, fondo de Douglas, parametrios, vejiga, hemidiafragma derecho, hígado y serosa intestinal. Se realiza adhesiolisis cuidadosa, quistectomía y extirpación de múltiples implantes endometriósicos en cavidad abdominal. Se observó un descenso de los marcadores a las 48 horas: Ca-125 de 253 U/mL y Ca 19.9 de 4,9 U/mL, ambos negativos al mes de la cirugía. CONCLUSIÓN: Una elevación intensa de los marcadores tumorales precisa de diagnóstico diferencial en el contexto de la endometriosis. Existe una gran discrepancia entre los valores de los marcadores tumorales con la clínica y severidad de la endometriosis. Los hallazgos quirúrgicos son fundamentales, evidenciando una afectación masiva subdiagnosticada hasta la cirugía.

BACKGROUND: Frequently, patients with endometriosis present elevated tumor marker Ca 125 and Ca 19.9. However, there is no clear correlation with the clinical expression or the degree of involvement. In some cases, differential diagnosis is necessary with malignancies. CASE REPORT: A 29 year old woman with moderate dysmenorrhea and finding of bilateral ovarian masses with intense elevation of tumor markers, CA125: 7,716 U/mL and Ca-19.9: 995 U/mL. Laparoscopic surgery is decided evidenced massive ovarian endometriosis and peritoneal extension with involvement of abdominal peritoneum, uterine surface, Douglas, parametrium, bladder, right hemidiaphragm, liver and intestinal serosa. Careful liberation of adherences, ovarian cystectomy and removal of multiple endometriosic implants. A decrease of tumor markers was observed at 48 hours (Ca-125: 253 U/mL and Ca-19.9: 4.9 U/mL), and negative one month after surgery. CONCLUSION: An intense elevated tumor markers accurate differential diagnosis in the context of endometriosis. There is a large discrepancy between the values of tumor markers with clinical and severity of endometriosis.