Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol.

BACKGROUND: Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings. METHODS/DESIGN: This will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate). TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR). Identifier: ACTRN12613000141741.

Utilization of carbetocin for prevention of postpartum hemorrhage after cesarean section: a randomized clinical trial.

PURPOSE: A randomized study involving pregnant women was conducted to compare the effectiveness of a single intravenous (IV) injection of carbetocin with that of a standard 2-h oxytocin IV infusion with respect to intraoperative blood loss in the prevention of uterine atony after cesarean section (CS). The two treatments also were compared for safety and ability to maintain adequate uterine tone and to reduce the incidence and severity of postpartum hemorrhage (PPH) in women at risk for this condition. METHODS: Between 1 September 2007 and 5 January 2008, we enrolled 104 patients with at least one risk factor for PPH undergoing CS in a randomized, controlled clinical trial. We compared the effect of a single 100 microg IV dose of carbetocin with that of a standard 2-h ten international units (IU) IV infusion of oxytocin. The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony. Fiftytwo women received 100 microg carbetocin IV immediately after placental delivery, while 52 women received 10 IU oxytocin IV infusion. Complete blood count was collected at entry and 24 h postpartum. All outcome measures, including the need for additional uterotonic agents or uterine massage, and blood loss, were analyzed using chi-square, Fisher exact, and Student's t tests. RESULTS: A single 100 microg IV injection of carbetocin was as effective as a continuous 2-h infusion of oxytocin in controlling intraoperative blood loss after placental delivery. Mean blood loss after carbetocin administration was 30 ml less than after oxytocin administration (P = 0.5). The percentage of patients with blood loss < or =500 ml was greater with carbetocin (81 vs. 55%; P = 0.05). Carbetocin enhanced early postpartum uterine involution. The fundus was below the umbilicus in more patients who received carbetocin at 0, 2, 6, and 24 h on the ward (P < 0.05). The main additional uterotonic agent used was a further administration of oxytocin (20 IU in physiological solution 500 ml at an infusion rate of 200 ml/h). In the carbetocin group, 20 of the 52 women (38.4%) required at least one uterine massage compared to 30 of the 52 women (57.7%) in the oxytocin group (P < 0.01). Overall, uterotonic intervention was clinically indicated in two of the women (3.8%) receiving carbetocin compared to five of the women (9.6%) given an IV oxytocin infusion (P < 0.01). The odds ratio of treatment failure requiring oxytocic intervention was 1.83 (95% confidence interval, CI, 0.9-2.6) times higher in the oxytocin group compared with the carbetocin group. CONCLUSIONS: Carbetocin makes possible to obtain, with a single IV injection, results equivalent to those of oxytocin on the maintenance of uterine tonicity and the limitation of blood losses, in the peri- and in the post-operative period, during a delivery by CS. It has in addition a comparable tolerance. Even in our series adverse events are practically of the same type and similar frequency in both study groups. Thus, the effectiveness of carbetocin consists, thanks to its long half-life, on an unique injection, whereas oxytocin requires repeated injections or a perfusion of several hours, with a variability of the administered doses.

Laparoscopic findings and pelvic anatomy in Mayer-Rokitansky-Küster-Hauser syndrome.

OBJECTIVE: To describe analytically the anatomic variety and laparoscopic findings observed in patients with Rokitansky syndrome throughout an 11-year span. METHODS: We analyzed the laparoscopic and chart records of 106 consecutive patients who underwent surgery for the creation of a neovagina, according to the modified laparoscopic Vecchietti procedure. RESULTS: A hypoplastic vagina was observed in 61 women. Müllerian remnants, laterally displaced in the pelvis, were identified in 92 cases; 42 (25.9%, 95% confidence interval [CI] 19.2-33.3) of 162 müllerian remnants were cavitated and contained endometrial mucosa. Ovaries were extrapelvic in 17 (16.0%, 95% CI 9.6-24.4) cases. Anomalies of the urinary tract were identified in 32 (30.2%, 95% CI 21.7-39.9) patients; unilateral renal agenesis was the most frequent finding (18 cases; 18%, 95%CI 10.4-25.5). CONCLUSION: Rokitansky syndrome has a wide variability of anatomic presentations, and, as the do other congenital anomalies of the female genital tract, it represents a continuum of embryonic malformations, which occur at different stages of development.

Uptake of cervical cancer screening among the migrant population of Prato Province, Italy.

OBJECTIVE: To determine the level of participation in cervical cancer screening among the migrant population of Prato Province, Italy. METHODS: A retrospective cross-sectional study was conducted using data for women aged 25-64 years who were resident in one of the municipalities of Prato Province and had received at least one invitation to undergo a cervical cancer screening test. Data were extracted from both the Local Health Unit Serviceable Registry and cervical cancer screening archives for the period July 1, 2004, to June 30, 2007. RESULTS: Of the 69 459 residents eligible for cervical cancer screening, 7339 (10.6%) did not have Italian citizenship. Adherence with cervical cancer screening among the migrant population was lower than that of the Italian resident population: uptake increased from 52.4% in 2004 to 57.3% in 2007 among the Italian resident population, but decreased from 31.4% to 28.2% among migrants. CONCLUSION: The migrant population of Prato Province has decreased adherence with cervical cancer screening.

Cervical cancer screening: A never-ending developing program.

With the term "oncological screening", we define the overall performances made to detect early onset of tumors. These tests are conducted on a population that does not have any signs or symptoms related to a neoplasm. The whole population above a certain age, only one sex, only subjects with a high risk of developing cancer due to genetic, professional, discretionary reasons may be involved. Screening campaigns should be associated, when risk factors that can be avoided are known, with campaigns for the prevention of cancer by means of suitable behavior. The goal of cancer screening cannot however be limited to the diagnosis of a greater number of neoplasms. Screening will be useful only if it leads to a reduction in overall mortality or at least in mortality related to the tumor. Screening should then allow the diagnosis of the disease at a stage when there is a possibility of healing, possibility that is instead difficult when the disease is diagnosed at the appearance of signs or symptoms. This is the reason why not all campaigns of cancer screening have the same effectiveness. In Italy, every year there are about 150000 deaths due to cancer. Some of these tumors can be cured with a very high percentage of success if diagnosed in time. Cervical cancer can be diagnosed with non-invasive tests. The screening test used all over the world is Papanicolaou (Pap) test. This test may be carried out over the entire healthy population potentially exposed to the risk of contracting cancer. Public health has begun the screening campaigns in the hope of saving many of the approximately 270000 new cases of cancer reported each year. Screening is done following protocols that guarantee quality at the national level: these protocols are subject to change over time to reflect new realities or to correct any errors in the system. A simplified sketch of a possible route of cancer screening is as follows: (1) after selecting the target population, for example all women between 25 and 64 years (in the case of monitoring of cervical cancer), an invitation letter with the date and time of the appointment, planned according to the acceptance capacity of the hospital, is sent to all individuals; (2) an examination, which depending on the individual and the type of cancer to be monitored, for example, can be a Pap smear, is performed and the patient can go home; (3) once available the results of examinations, if negative, they shall be communicated to the person concerned that will be notified by mail and will be recalled for a second test at a few years of distance, in the case of non-negativity, instead, the patient is contacted by telephone and informed of the need to carry out further examinations: it is said that the patient is in the "phase two" of the screening pathway; (4) in phase two, reached by only a small portion of the interested parties (usually less than 3%-5%), more in-depth tests are carried out, which, depending on the individual and the type of cancer, can be: cytological and colposcopic examinations, the removal of a fragment of tissue (biopsy) and subsequent histological examination, additional tests such as ultrasound, radiography, or others such as computerized tomography, magnetic resonance imaging, positron emission tomography, etc., in case of negativity, the concerned person will be called for new control tests at a a few years of distance, in case of non-negativity, it will be proposed instead an oncologic therapeutic plan and/or surgery to treat the diagnosed tumor; and (5) once the treatment plan is completed, the individual enters the follow-up protocol, which is monitored over time to see if the tumor has been completely removed or if instead it is still developing. Cervical cancer is undoubtedly the most successful example of a cancer screening campaign. Paradoxically, its effectiveness is one of the strongest reasons to criticize the usefulness of vaccination against human papillomavirus (HPV) in countries where the screening service with Pap test is organized in an efficient manner. Cervical cancer screening protocols are directed to sexually active women aged 25-64 years: they provide the Pap test performed by examining under a microscope or by staining with a specific "thin prep" the material taken from the cervix with a small spatula and a brush. It is recommended to repeat the test every two or three years. It is important to emphasize that women vaccinated against HPV must continue the screening with Pap test. Although some screening programs (e.g., Pap smears) have had remarkable success in reducing mortality from a specific cancer, any kind of screening is free from inherent limitations. The screening methods are in fact applied to large parts of the apparently healthy population. In particular, the limits for certain cancers may be as obvious as to prohibit the introduction of an organized screening program. Potential limitations of organized screenings are basically of two types: organizational and medical. The limits of organizational type relate to the ability of a program to recruit the whole target population. Although well organized, a screening program will hardly be able to exceed a coverage of 70%-80% of the target population, and in fact the results of the current programs are often much smaller. The limits of medical type are represented by the possibility of reducing the overall mortality, or specific mortality, using a specific screening campaign.

Umbilical endometriosis: a radical excision with laparoscopic assistance.

BACKGROUND: Umbilical endometriosis represents the most common site of cutaneous endometriosis. Although its treatment is typically surgical, in literature the approach used is variable and extends from diathermocoagulation to omphalectomy. Such superficial treatments for umbilical endometriosis can predispose the patient to a relapse of the disease. We here present seven cases of umbilical endometriosis treated with radical surgery with a laparoscopically-assisted approach, with a complete and long-term disease-free follow-up. CASES: Seven cases of umbilical endometriosis, four of which relapsing from a prior superficial treatment, were treated radically with a laparoscopically-assisted approach, with a long-term disease-free follow-up. CONCLUSION: Although a medical treatment can be considered, the treatment of choice in these patients should be that of excisional surgery so as to avoid lesion relapse and the risk of oncogenic transformation. Despite umbilical endometriosis is a rare finding, this relatively small case series treated by laparoscopically-assisted omphalectomy shows a complete resolution of the lesion and symptoms along with good aesthetic results at a long-term follow-up.

The unicornuate uterus with an occult adenomyotic rudimentary horn.

We report 2 case of an atypical variant of unicornuate uterus in 2 adolescent patients with severe dysmenorrhea. Pelvic ultrasonography and magnetic resonance imaging identified a normal uterine contour. On the right side within the uterine fundus, a nodule was detected with a small hypoechogenic content. At laparoscopy the uterus and adnexae appeared to be normal. No endometriotic lesions were identified. Hysteroscopy identified a single regular cervical canal and a uterine cavity resembling that of a left unicornuate uterus, with a single regular left tubal ostium. Complete resection of the right uterine nodule along with an ipsilateral salpingectomy was performed. The nodule contained a small endometrial cavity and hematometra. Histologic study showed a cavitated adenomyotic uterine rudiment. The patients were discharged on the second postoperative day. No intraoperative or postoperative complications or recurrence of pelvic pain occurred.

Prevention of cerebral palsy during labour: role of foetal lactate.

OBJECTIVES: Intrapartum foetal monitoring goal is to prevent foetal asphyxia and its most severe consequence: cerebral palsy (CP). In this paper we describe the detection methods and the criteria needed to assess asphyxia during labour for preventing CP. Foetal cerebral damage assessment is considered from the medical-legal point of view. CP represents the most frequent pathology of childhood related to pregnancy and childbirth with an incidence of 0.2% in children born alive. It is clinically regarded as the result of a spectrum of diseases due to damage or to faded development of the nervous system which generally appears at the time of the first stage of intra-uterine growth or depends on problems arising at birth. The goal of our analysis is to recall the various moments in which this event can take place and, if possible, the moment and the degree of the event of asphyxia and its effect on foetal conditions, in order to control and treat it. STUDY DESIGN: One hundred and eighty-eight fetuses were evaluated by means of Apgar score, intrapartum cardiotocography, observation of the presence of meconium stained amniotic fluid, and clinical features of distress at birth. Lactate concentrations were measured during labour and at delivery in blood samples obtained from the foetal presenting part (foetal scalp) and from the umbilical cord with the use of a rapid electrochemical technique. RESULTS: Evidence of clinical foetal distress was not related to the severity of asphyxia. An increased lactate level was found in asphyctic infants and a clear correlation between lactic acidosis and foetal distress was documented. Low Apgar scores were observed in infants with moderate or severe asphyxia at delivery. Scalp lactate correlated significantly with umbilical artery lactate (P = 0.49, 0.01), but with neither Apgar score at 1 min (R = -0.21, ns) nor at 5 min (R = -0.11, ns). Lactate concentration was higher in case of instrumental delivery compared to spontaneous delivery (P = 0.0001). No perfect correlation was found between lactate level and neonatal outcome, but there were not a significant number of neonates with immediate complications. The rate of instrumental delivery in the distress group was significantly higher than in that of the healthy fetuses (P < 0.01), so spontaneous labour was less frequently associated with foetal distress than instrumental delivery (P < 0.01). In the distress group, severe variable decelerations were generally recorded in the second stage of labour. The incidence of neonatal Apgar score /=45 min, compared with a shorter active second stage, and acidaemia at birth implied larger arterial-venous lactate differences (P < 0.001). The presence of foetal lactate at crowning was also significantly associated with the level of umbilical arterial-venous lactate difference (P = 0.03). CONCLUSIONS: Analysis of the fetus should start with the assessment of lactates and acid-base balance. The method which revolutionized the techniques of foetal monitoring is undoubtedly represented by cardiotocography. However, likely most of neurological outcomes are not correlated with a perinatal event or with peripartum asphyxia. Approximately 10% of cases of CP would actually be due to perinatal asphyxia, and this percentage approaches approximately to 15% if we consider only newborns at term. This again confirms the weak association of a causal relationship between asphyxia and CP. In addition, available foetal suffering markers are vague and allow to identify only less than half of the effective cases of newborns which will develop CP.

Foetal and neonatal ovarian cysts: a 5-year experience.

BACKGROUND: Abdominal cystic formations in newborns are relatively common and often diagnostic suspicion arises in this regard even before birth as a result of ultrasound scans carried out during pregnancy. The aim of this study is to highlight the problems posed by the prenatal diagnosis of abdominal cysts in order to outline the most appropriate therapeutic approach in case of suspected ovarian cysts. MATERIALS AND METHODS: Between January 2003 and January 2007, 57 women were enrolled in this study for a prenatal ultrasound (US) that revealed the presence of an echo-rare or echo-free area in the foetal abdomen. After birth all babies underwent blood tests and abdominal US scans in order to confirm or identify the nature of the cyst. If abdominal US could not show the nature of the cystic formation, magnetic resonance imaging with sedation was performed. When the radiological tests were not useful to identify the nature of the cysts and surgery was then necessary, surgical procedures were performed with laparoscopy. RESULTS: Ultrasounds were useful to identify the diameter of the cysts but not all their origins; also MRI confirmed the morphology and volume of the cysts, but could not give further details about their origin. DISCUSSION: Abdominal ultrasound and finally laparoscopy used to treat and remove the cysts were useful to monitor all simple abdominal cysts. MRI seemed not to be useful for the treatment of this condition, especially in the pediatric age when mild sedation is required.

Laparoscopically assisted uterovestibular anastomosis in patients with uterine cervix atresia and vaginal aplasia.

OBJECTIVE: To describe the surgical technique and the long-term anatomic and functional results of laparoscopically assisted uterovestibular anastomosis. DESIGN: Descriptive study. SETTING: Tertiary referral center. PATIENT(S): Twelve consecutive patients with uterine cervix atresia and vaginal aplasia. INTERVENTION(S): Laparoscopically assisted uterovestibular anastomosis was performed in all patients. Follow-up assessments at 1, 6, and 12 months included pelvic examination, transvaginal ultrasonography, and, in selected cases, vaginoscopy and hysteroscopy. Subsequent follow up was done by referring physicians or by means of telephone interview. Mean follow-up was 6 years. MAIN OUTCOME MEASURE(S): Intra- and postoperative characteristics and anatomic and functional outcome. RESULT(S): The surgical procedure was successful in all cases and all of the women have experienced regular menstruation. At 6-month follow-up, mean vaginal length was 6 cm and at least 80% of neovaginal epithelium was iodine-positive in all patients. Six women were sexually active during follow-up without difficulty. None have yet attempted to seek a pregnancy. CONCLUSION(S): The study shows the safety and effectiveness of a laparoscopic approach to uterovestibular anastomosis in women with cervical atresia and vaginal aplasia. In these patients, we believe that conservative surgery should represent the first therapeutic option. A longer follow-up is needed to assess pregnancy rates and outcome.

Laparoscopic creation of a neovagina with the laparoscopic Vecchietti operation: comparison of two instrument sets.

OBJECTIVE: To compare safety and effectiveness of two different instrument sets for the laparoscopic Vecchietti operation for the creation of a neovagina. DESIGN: Descriptive study. SETTING: Tertiary referral center. PATIENT(S): Twenty-six women with Rokitansky syndrome. Twelve consecutive patients had surgery with the kit recently developed by Storz (group 1) and 14 consecutive patients had surgery with the original kit of Vecchietti (group 2). INTERVENTION(S): Laparoscopic Vecchietti operation and clinical and instrumental follow-up for all patients. MAIN OUTCOME MEASURE(S): All the parameters reflecting safety, effectiveness, and compliance that were systematically measured for all patients. RESULT(S): Patients in group 1 had a wider vagina at device removal and experienced less vaginal bleeding than patients in group 2, and the removal of the device was simpler. Patients in group 1 had a shorter vagina at device removal and retained the device and the Foley catheter for a longer period than patients in group 2. Diameter and length of neovagina at 1-month follow-up were comparable in the two groups. CONCLUSION(S): The availability of this new instrument set represents a small but significant improvement in the creation of a neovagina by the laparoscopic Vecchietti operation in women with Rokitansky syndrome.

Tailoring radicality in demolitive surgery for deeply infiltrating endometriosis.

OBJECTIVE: The purpose of this study was to compare the outcome of standard extrafascial hysterectomy and tailored radical hysterectomy as a definitive treatment of recurrent deep endometriosis. STUDY DESIGN: This was a descriptive study that comprised 38 patients who underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy between 1989 and 2002 for symptomatic recurrences of deep endometriosis, after>or=1 previous surgical procedures and ovarian suppressive medical treatments. After the operation, all of the patients were given transdermal estradiol. The minimum follow-up time was 24 months. RESULTS: Twenty-six patients underwent standard extra-fascial hysterectomy (group A), and 12 patients underwent modified radical hysterectomy that included the removal of all deeply infiltrating endometriotic lesions (group B). The recurrence of pain caused by endometriosis occurred in 8 women (31%) of group A and in no patients of group B. CONCLUSION: Definitive surgery for deep endometriosis should include the removal of the uterus, adnexa, and all surgically accessible deep lesions. As a consequence, the surgeon must be familiar with radical pelvic surgery.