Findings from a multicentre, observational study on reproductive outcomes in women with unexplained recurrent pregnancy loss: the OTTILIA registry.

STUDY QUESTION: What evaluation and care is offered to women after unexplained recurrent pregnancy loss (RPL) or intra-uterine foetal death (IUFD) and what are the reproductive outcomes? SUMMARY ANSWER: Women are assessed for thrombophilia and often treated with low-molecular weight heparin (LMWH) and/or low-dose aspirin (ASA). WHAT IS KNOWN ALREADY: Randomized controlled trials (RCTs) on possible efficacy of heparins and/or aspirin have been inconclusive due to limited power to detect a difference and patient heterogeneity. STUDY DESIGN, SIZE, DURATION: Prospective multicentre cohort study performed in 12 hospitals in three countries between 2012 and 2019. PARTICIPANTS/MATERIALS, SETTING, METHODS: All consecutive pregnant women with recurrent PL (≥3 losses or 2 losses in the presence of at least one euploid foetal karyotype) or at least one IUFD. Eligible women may have undergone thrombophilia testing before conception, at the discretion of local providers. The possible assignment of women to treatments (such as LMWH) was not decided a priori but was determined based on the responsible provider's current practice. Aims of the study were: (i) to evaluate factors associated with pregnancy outcome; (ii) to compare clinical management strategies in women with and without a subsequent successful pregnancy; and (iii) to evaluate characteristics of women who may benefit from antithrombotic therapy. A propensity score matching method was used to balance the differences in baseline characteristics. MAIN RESULTS AND THE ROLE OF CHANCE: A matched sample of 265 pregnant women was analysed, with all undergoing thrombophilia screening; 103 out of 119 (86.6%) with and 98/146 (67.1%) without thrombophilia were prescribed with LMWH and/or ASA. Overall, live-births were recorded in 204 cases (77%), PL or IUFD in 61 (23%) pregnancies. Logistic regression showed a significant interaction between thrombophilia and treatment with LMWH (P = 0.03). Findings from sensitivity analysis showed odds ratio (OR) for pregnancy loss in women with inherited or acquired thrombophilia in absence of any treatment was 2.9 (95% CI, 1.4-6.1); the administration of LMWH (with or without ASA) was associated with higher odds of live-birth (OR, 10.6; 95% CI, 5.0-22.3). Furthermore, in women without thrombophilia, the odds of live-birth was significantly and independently associated with LMWH prophylaxis (alone or in association with ASA) (OR, 3.6; 95% CI, 1.7-7.9). LIMITATIONS, REASONS FOR CAUTION: While the propensity score matching allows us to balance the differences in baseline characteristics, it does not eliminate all confounding. WIDER IMPLICATIONS OF THE FINDINGS: Antithrombotic prophylaxis during pregnancy may be effective in women with otherwise unexplained PL or IUFD, and even more useful in those with thrombophilia. STUDY FUNDING/COMPETING INTEREST(S): The study was funded by Italian Ministry of Health (Ricerca Corrente 2018-2020). Dr G.P. has received research grant support from Bristol Myers Squibb/Pfizer Alliance, Janssen, Boston Scientific Corporation, Bayer, and Portola and consultant fees from Amgen and Agile Therapeutics. Dr E.G. has received consultant fees from Italfarmaco and Sanofi. All other authors declare that they have no conflict of interest. TRIAL REGISTRATION NUMBER: NCT02385461.

Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries.

BACKGROUND: Spontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50-60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries. METHODS: OTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST. DISCUSSION: Although RCTs are the 'gold standard' for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions. TRIAL REGISTRATION: NCT02385461 , retrospectively registered 5 March 2015 (OTTILIA); NCT02685800 , registered 10 February 2016 (FIRST).

Influence of maternal reflective functioning on mothers' and children's weight: A follow-up study.

Based on cross-sectional research linking poor reflective functionining (RF) to eating disorders, the current follow-up study tested whether maternal RF would explain the variance of mothers' and children's weight beyond the effects of maternal emotional dysregulation. During pregnancy (Time 1 [T1]), 51 women were administered the Difficulties in Emotion Regulation Scale (DERS) and interviewed using the Adult Attachment Interview (AAI). Seven months after delivery (Time 2 [T2]), mother-baby dyads who remained in the study (n = 44) were videotaped (Feeding Scale) during their feeding interaction. Last (Time 3 [T3]), the weight of the 34 children who were still in the study was collected at 3 years of age. Maternal AAI-RF at T1 did not correlate with the DERS at T1 nor with the quality of the feeding interacions at T2. However, it correlated, significantly, with maternal body mass index (BMI) at T1, r = -.298, P = .034, and marginally significantly with baby's BMI at T3, r = -.296, P = .089. Moreover, multiple regression models showed a trend indicating that maternal AAI-RF might explain the variance of mothers' and children's weight beyond the effects of maternal emotional dysregulation. These findings suggest that working on maternal mentalization might contribute to helping prevent childhood obesity from pregnancy.

Objetivo: con base en la investigación de naturaleza transversal que conecta el pobre funcionamiento con reflexión (RF) con los trastornos de alimentación, el presente estudio de seguimiento examinó si el RF materno podría explicar la variación del peso de las madres y de los niños más allá de los efectos de la desregulación emocional materna. Método: durante el embarazo (T1), a 51 mujeres se les administró la Escala de Regulación de las Dificultades en la Emoción (DERS) y se les entrevistó usando la Entrevista de la Afectividad Adulta (AAI). Siete meses después del parto (T2), las díadas mamá-bebé que permanecían en el estudio (n = 44) fueron grabadas en video (Escala de Alimentación) durante su interacción de alimentación. Por último (T3), se determinó el peso de los 34 niños que aún estaban en el estudio a los tres años de edad. Resultados: la información materna de AAI-RF al T1 no se correlacionó con DERS al T1, ni tampoco con la calidad de las interacciones de alimentación al T2. Sin embargo, sí se correlacionó, significativamente, con BMI materno al T1 (r = −.298, p = .034), y marginalmente significativo, con el BMI del bebé al T3 (r = −.296, p = .089). Es más, los modelos de regresión múltiple mostraron una tendencia indicando que la AAI-RF materna pudiera explicar la variación del peso de las madres y de los niños más allá de los efectos de la desregulación emocional materna. Conclusiones: estos resultados sugieren que trabajar en la mentalización materna pudiera contribuir a ayudar a prevenir la obesidad en la niñez desde el embarazo.

Objectif: Se basant sur des recherches transversales liant un faible fonctionnement de réflexion (RF) aux troubles du comportement alimentaire, cette étude de suivi a testé si le RF maternel pouvait ou non expliquer la variance des poids des mères et des enfants au-delà des effets de la dysrégulation émotionnelle maternelle. Méthode: Durant la grossesse (T1), 51 femmes ont reçu l'Echelle de Difficultés de Régulation de l'Emotion (en anglais Difficulties in Emotion Regulation Scale, soit la DERS) et ont passé un entretien utilisant l'Entretien d'Attachement Adulte (Adult Attachment Interview, AAI). Sept mois après l'accouchement (T2), les dyades mère-bébé encore dans l'étude (n = 44) ont été filmées (Echelle d'Alimentation) durant leur interaction alimentaires. Enfin (T3), le poids des 34 enfants étant encore dans l'étude a été pris à l'âge de trois ans. Résultats: Le RF-AAI maternel au T1 n'était pas en corrélation avec la DERS au T1, ni avec la qualité des interactions alimentaires au T2. Cependant, il était corrélé, et de manière importante, avec l'IMC maternel au T1 (r = −,298, p = ,034), et de manière marginalement importante, avec l'IMC du bébé au T3 (r = −,296, p = ,089). De plus plusieurs modèles de régression ont montré une tendance indiquant le le RF-AAI maternel pourrait expliquer la variance des poids des mères et des enfants au delà des effets de la dysrégulation émotionnelle maternelle. Conclusions: Ces résultats suggèrent que le fait de travailler sur la mentalisation maternelle peut contribuer à aider à prévenir l'obésité de l'enfance dès la grossesse.

A longitudinal study on emotional dysregulation and obesity risk: From pregnancy to 3 years of age of the baby.

Some recent findings indicate that maternal sensitivity and emotional regulation may play a key role in predicting the risk for obesity of the child in early ages. The current article describes a longitudinal study encompassing more than 50 women, across a time-span that currently goes from pregnancy (n = 65) to three years of age of the baby (n = 53). In a previous report on our ongoing research project, we showed that emotional regulation during pregnancy and pre-pregnancy BMI significantly predicted the quality of the early, dyadic feeding interactions, at 7 months of age of the baby. The current study confirmed and extended those findings, by showing that maternal emotional dysregulation (r = .355, p = .009) and pre-pregnancy BMI (r = .389, p = .004) predicted the BMI of the child at three years of age too, with a medium to large effect size. However, neither maternal emotional regulation nor pre-pregnancy BMI significantly predicted infant attachment at one year of age.

Tranexamic acid versus oxytocin prophylaxis in reducing post-partum blood loss, in low-risk pregnant women: TRANOXY STUDY, a phase III randomized clinical trial.

Background: To assess the equivalence of tranexamic acid (TRAN) versus synthetic oxytocin (OXY) in reducing post-partum blood loss, in full-term patients (37-42 weeks), at low risk of post-partum hemorrhage, with vaginal childbirth. Methods: Phase III, randomized (1:1), open-label, longitudinal, multi-center, prospective clinical trial (Prot. n 63209, ClinicalTrials.gov Identifier: NCT02775773). From January 7, 2020, to June 30, 2023, a total of 256 women were enrolled at two general urban community hospitals in Italy, serving a multi-ethnic patient population with National Health Insurance. The primary outcome was to explore a potential equivalence between the two treatments (OXY and TRAN) in preventing total blood loss. Therefore, we randomized 231 women into two groups: Group A (OXY), 127 women who were administered 10UI intramuscularly within 5 min from childbirth; Group B (TRAN), 104 women to whom 1-g slow intravenous infusion was administered within 5 min from childbirth. Findings: At the time of delivery, mean blood loss for OXY group versus TRAN group was 269.12 mL versus 263.88 mL, respectively, with equivalence between the two groups. Similarly, there was equivalence in total blood loss between the OXY and the TRAN group (397.66 mL versus 405.64 mL, respectively. No statistical differences between Hb levels at admission and discharge in the two groups were reported. No difference was found in terms of additional uterotonic and surgical therapies between the two groups of patients. Neither group showed thrombotic complications at check-up performed after 7 days or after a questionnaire regarding adverse effects, subjected after 40 days. Interpretation: The study shows the equivalence of tranexamic acid versus synthetic oxytocin in post-partum blood loss prophylaxis in term patients at low risk of PPH with vaginal childbirth. The safety profiles of OXY and TRAN were similar. Funding: None.

Rebuilding the labor curve during neuraxial analgesia.

AIM: The aim of this study was to examine the pattern of labor progression among nulliparous women under neuraxial analgesia to obtain a new, specific reference labor curve and to compare the different effects of epidural and combined spinal epidural (CSE) analgesia on the progression of labor. MATERIAL AND METHODS: This perspective cohort study was carried out in the Obstetrics and Gynecology tertiary care unit. Six hundred nulliparous parturients were enrolled. A total of 545 nulliparous women were assigned to receive either epidural (272) or CSE (273) analgesia during labor. RESULTS: The mean duration of the first stage was 4 h and 30 min (SD 1.52 h) and the mean duration of the second stage was 1 h and 10 min (SD 0.43). In the second stage, the CSE analgesia labors showed an overall faster progression compared to the epidural labors but both lasted longer than the duration reported by Zhang (53 min) and Friedman (39 min). Both the first and the second-stage duration were significantly lower if neuraxial analgesia was performed as a CSE procedure with respect to the simple epidural procedure (first stage 4 h and 1 min vs. 4 h and 60 min, P = 0.043; second stage 1 h and 5 min vs 1 h and 15 min, P = 0.0356). CONCLUSIONS: The pattern of labor progression in contemporary obstetrics differs significantly from the Friedman curve. Based on these observations, we can obtain a more comprehensive knowledge of the partogram's modifications due to the analgesia.

Double inherited thrombophilias and adverse pregnancy outcomes: fashion or science?

AIM: To determine to what extent double inherited thrombophilias are associated with adverse obstetric complications correlated with fetoplacental insufficiency, such as preeclampsia, hemolytic anemia elevated liver enzymes and low platelet count (HELLP) syndrome, gestational hypertension, fetal growth restriction (FGR), intrauterine death (ID), abruptio placentae and disseminated intravascular coagulopathy. METHODS: Pregnant women coming to delivery were retrospectively divided into two groups: group A (controls) and group B (cases). Patients belonging to group B had one of the following: severe preeclampsia, HELLP syndrome, gestational hypertension, FGR, intrauterine death, abruptio placentae of disseminated intravascular coagulopathy. We detected methylenetetrahydrofolate reductase (MTHFR) A1298C, MTHFR C677T, factor V Leiden, PAI-1, mutant prothrombin G20210A, plasma homocysteine, antithrombin III, protein S and activated protein C resistance. Normal pregnant women or pregnant women with double defects were enrolled in this study. RESULTS: The combination of MTHFR C677T mutation with PAI-1 (5G/5G) mutation was significantly linked with the occurrence of ID. HELLP syndrome was significantly related to the simultaneous presence of factor VIII and X mutations. The combination of MTHFR C677T with factor VIII mutation and the combination of factor II and V mutations were significantly related to the occurrence of abruptio placentae. We found an association between double isoforms MTHFR mutation and FGR. CONCLUSION: It seems that some thrombophilias and a combination of thrombophilic factors carry a greater risk than others for a given adverse outcome. Further studies are needed to check the link between thrombophilic gene mutations and adverse pregnancy outcomes, such as recurrent miscarriages and deep venous thrombosis.

Ultrasonographic evaluation of the second stage of labor. Predictive parameters for a successful vaginal delivery with or without neuraxial analgesia: a pilot study.

PURPOSE: The aim of the study was to evaluate the progression and rotation of the fetal head during the second stage of labor using translabial ultrasound and to compare ultrasonographic data obtained in nulliparous women both receiving and not receiving neuraxial analgesia. METHODS: The 49 patients enrolled in the study were divided into two groups according to receiving or not receiving neuraxial analgesia. Every half hour from full dilation to delivery, the ultrasonographic translabial parameters of Angle of Progression, Head Symphysis Distance, and Midline Angle were obtained and recorded by a single operator. Then, these records were compared between the two groups of patients. RESULTS: Patients that underwent neuraxial analgesia presented with increased duration of the second stage of labor, with mean values of Angle of Progression significantly higher and of Midline Angle significantly lower for each time interval studied compared to patients without analgesia. A borderline significant relationship was found between administration of neuraxial analgesia and Head Symphysis Distance. CONCLUSIONS: In this study, we demonstrated that combined spinal-epidural analgesia influences the duration of the second stage of labor and the initial progression and rotation of the fetal head through the birth canal, but not the kind of delivery. A correlation between Angle of Progression values and success in the application of a vacuum has been reported by other authors and confirmed in our study.

Pelvic lymphadenectomy for cervical cancer: extraperitoneal versus laparoscopic approach.

OBJECTIVE: To compare the extraperitoneal versus the laparoscopic technique in performing pelvic lymphadenectomy in a series of patients undergoing a radical vaginal hysterectomy for locally advanced cervical cancer. STUDY DESIGN: Retrospective study with 42 patients undergoing a radical vaginal hysterectomy for cervical cancer. Patients from group A (20 patients) had a laparoscopic lymph node dissection and patients belonging to group B (22 patients) had an extraperitoneal lymphadenectomy. Historical data, clinical and surgical characteristics, perioperative and post-operative complications were analyzed. Follow-up was conducted according to the oncologic requirements. RESULTS: No significant difference was observed between the two groups in terms of blood loss, post-operative pain, transfusions, hospital stay and post-operative hematomas. The extraperitoneal group (group B) significantly showed a reduced operating time, a greater number of nodes removed (p<0.05). The only lymphocyst occurred in group B. CONCLUSIONS: Extraperitoneal pelvic lymphadenectomy can be considered an adequate technique to complement radical vaginal operations for cervical cancer.

Are gestational and essential hypertension similar? Left ventricular geometry and diastolic function.

OBJECTIVE: To evaluate the differences and similarities in diastolic function and left ventricular geometry in gestational and essential hypertension. METHODS: Thirty-nine consecutive gestational hypertensive pregnant women in the third trimester of gestation (GH), 40 nonpregnant essential hypertensive women (EH), and 38 normotensive nonpregnant women (N) matched for age were enrolled into the study and underwent echocardiographic and Doppler evaluations. The GH and EH patients were evaluated prior to the administration of any drug treatment. RESULTS: Left atrial function was similar in GH and N subjects and lower than that in EH patients. Both GH and EH patients had early left ventricular diastolic filling pattern significantly different as compared to N subjects (longer isovolumetric relaxation time, deceleration time of the E wave, and lower E wave velocity in GH and EH vs. N), whereas the late filling properties were similar in GH and N subjects with a lower A velocity, and velocity-time integral vs. EH (p < 0.05). Systolic fraction of the pulmonary vein flow was similar in GH and EH patients and lower in N subjects. Altered left ventricular geometry was more common in GH than in EH, whereas normotensive subjects did not show any alteration of the geometric pattern. CONCLUSIONS: Gestational and essential hypertension induce similar early altered diastolic filling of the left ventricle. Essential hypertension is characterized by a compensatory late filling mechanism due to an enhancement of left atrial function. Gestational hypertension is characterized by altered left ventricular geometry, which is far less common during essential hypertension.

C-peptide and insulin levels at 24-30 weeks' gestation: an increased risk of adverse pregnancy outcomes?

OBJECTIVE: The hypothesis was that fasting C-peptide and insulin values, during an oral glucose tolerance test (OGTT), might allow an estimation of the increased risk for gestational hypertension (GH) and fetal macrosomia. STUDY DESIGN: Two-hundred and six consecutive patients were submitted to an OGTT. Thirty-five developed gestational hypertension and 29 delivered large-for-gestational-age (LGA) newborns. Plasma glucose levels (mg/dl) and insulin levels (microU/ml) were measured fasting and after 60, 120 and 180 min C-peptide fasting levels (ng/ml) were also measured. RESULTS: Twenty-five patients were excluded, 181 were enrolled. According to the OGTT, 143 patients were classified as normal, 26 were found affected by gestational diabetes (GD) mellitus, and 12 had impaired gestational glucose tolerance (IGGT). Hypertensive women exhibited higher 60 and 120 min insulin values than the normotensive group (128.3+/-69.9 microU/ml versus 86.2+/-58.3 microU/ml, P<0.05; 104.9+/-66.4 microU/ml versus 78.7+/-56.5 microU/ml, P<0.05).C-peptide cut-off at 2.9 ng/ml resulted predictive for patients delivering large-for-gestational-age newborns (OR=3.42, 95% CI=1.59-7.39). CONCLUSIONS: C-peptide and insulin may be used as indicators of risk for the development of complications in late pregnancy.

Nifedipine-induced changes in body composition in hypertensive patients at term.

BACKGROUND: There are few studies on the effect of nifedipine on fluid homeostasis during pregnancy. OBJECTIVE: To assess the variation of body composition at term in patients with normal pregnancy and patients with gestational hypertension (GH) treated with nifedipine. METHODS: Seventeen healthy patients with singleton pregnancies and 12 non-proteinuric patients with gestational hypertension treated with nifedipine were enrolled consecutively from our University Hospital from January 2000 to January 2001. Two evaluations were performed (anthropometric measurements, bioelectric impedance analysis (BIA) at 5, 50 and 100kHz and hematocrit), the first at 36.4+/-3.2 weeks' gestation, the second at 2.1+/-1.6 days of puerperium. The BIA measurements included: fat mass (FM, kg), fat-free mass (FFM, kg), extra-cellular water (ECW, Lt), intra-cellular water (ICW, Lt), total body water (TBW, Lt). Values were analyzed as mean+/-S.D. and statistical analysis was performed by using the Student's t-test for unpaired data. RESULTS: Birthweights were significantly lower in the gestational hypertensive patients (3472.7+/-266.4g versus 2735.8+/-575.9g, P<0.001). At the first study time, systolic and diastolic blood pressure were significantly higher in the hypertensive patients than in control group, notwithstanding the therapy. Interestingly we found pre-delivery and post-delivery TBW higher in gestational hypertensive patients versus the control patients (44.48+/-9.12Lt versus 36.60+/-5.07Lt, P<0.001 and 40.69+/-4.31Lt versus 37.30+/-4.35Lt, P=0.016, respectively). TBW loss after delivery was greater among hypertensive patients (3.79+/-4.81Lt versus -0.70+/-0.72Lt, P<0.001). CONCLUSIONS: Bioelectrical impedance analysis is a practical tool in the follow-up of anti-hypertensive therapy at term gestation. Moreover, nifedipine increases TBW in gestational hypertensive patients, reverting the pathophisiological pattern, yet described elsewhere.

The impact of maternal overweight and emotion regulation on early eating behaviors.

Empirical data indicate that the risk for childhood obesity and overweight increases when one or both parents are overweight or obese. Such an association, however, cannot be entirely explained only by biological factors. Based on available literature, we hypothesized that maternal emotion regulation might play a role in explaining the intergenerational transfer of overweight and obesity. We conducted a quasi-experimental, longitudinal study: (step I) during the third trimester of pregnancy of 65 Italian women (33 overweight and 32 non-overweight), the Difficulties in Emotion Regulation Scale were administered to assess the quality of their emotion regulation strategies; and (step II) seven months after the delivery, the feeding interactions between the participants and their babies were evaluated in a 20-minute video-recording, by using the Italian version of the Observational Scale for Mother-Infant Interaction during Feeding. When compared to the non-overweight group, the overweight group had more difficulties in emotion regulation, was more psychologically distressed, and had poorer feeding interactions with their babies. Perhaps more importantly, the extent to which the participants were suffering difficulties in emotion regulation during pregnancy predicted, significantly, and beyond the effects of pre-pregnancy maternal weight, the quality of the mother-child feeding interactions 7months after the delivery.

Cervicoscopy and Microcolposcopy in the Evaluation of Squamo Columnar Junction and Cervical Canal in LSIL Patients with Inadequate or Negative Colposcopy.

OBJECTIVE: The present study evaluated indications' validity of cervicoscopic and microcolposcopic examination in LSIL patients with unsatisfactory or negative colposcopy. MATERIAL AND METHODS: [corrected] In the cervico-vaginal pathology unit of the "San Giovanni Calibita Fatebenefratelli" University of Rome "Tor Vergata", 119 patients with a positive cervical cytology (LSIL), were submitted to the exam for the following two indications: 1) unsatisfactory colposcopy 37 (31.1%); 2) negative colposcopy 82 (68.9%). RESULTS: Cervicoscopy allowed the SCJ visualization in 115 (9.6%) patients. In 4 patients 3.4%, the SCJ visualization was not possible due to cervical stenosis. Cervicoscopy without staining, revealed endocervical squamous columnar junction in 33 (28.7%) patients. The blue dye in panoramic view detected endocervical SCJ in 41 (35.7%), out of 115 patients (>5 mm in 34 (29.6%) patients and >10 mm in 7 (6.1%)). CONCLUSIONS: Cervicoscopic examination revealed 7.8% of CIN2-3 in LSIL patients with inadequate or negative colposcopy. In patients with negative colposcopy the percentage of undiagnosed lesions inside the cervical canal was very low. The blue dye added sensitivity to the exam.

Carbetocin versus oxytocin in caesarean section with high risk of post-partum haemorrhage.

OBJECTIVES: the aims of the present study were to compare the haemodynamic effects of oxytocin and carbetocin and to assess the efficacy of these two drugs in terms of blood loss and the additional uterotonic needed in caesarean section at high risk of primary post-partum haemorrhage. METHODS: women in the carbetocin group (group A) received a bolus of 100 µg IV; women in the control group (group B) received 20 IU of oxytocin in 1000 ml of 0,9% Na-Cl solution IV (150 mL/hour). The main parameter evaluated was the haemodynamic effects of drugs and the need for additional uterotonic agents. In addition we compared the drop in haemoglobin level, the uterine tone, the uterine fundal state and the diuresis. RESULTS: regarding the haemodynamic effects, both drugs have a hypotensive effect, but we found a greater reduction in blood pressure within the oxytocin group. Significantly more women needed additional uterotonic agents in the oxytocin group (23,5% vs 0%, p<0.01), though there was no significant difference in estimated blood loss and in the drop haemoglobin level (p>0.05). There was a significant difference in the diuresis, higher in carbetocin group (1300 ml ± 450 ml vs 1100 ml ± 250 ml, p=0.01). CONCLUSIONS: a single injection of carbetocin appears to be more effective than a continuous infusion of oxytocin to prevent the PPH, with a similar haemodynamic profile and minor antidiuretic effect.

Schauta-Amreich Operation vs Piver II Procedure with Pelvic Lymphadenectomy for Cervical Cancer.

INTRODUCTION: The aim of this study was to compare two groups of patients with early stage cervical cancer who underwent either abdominal or vaginal surgery, in terms of post-operative findings and survival. MATERIALS AND METHODOLOGY: 55 patients with diagnosed cervical cancer were retrospectively selected for this study. They were preoperatively staged according to FIGO criteria. Forty four patients had disease between stages Ib and IIa with no evidence of extra-pelvic lymph node involvement and 10 patients had stage ≥ IIb. RESULTS: Of the 55 patients, 17 had been operated by Schauta-Amreich radical vaginal hysterectomy and 38 by Piver type II abdominal hysterectomy. No significant statistical differences have been found between two groups about age (median age was 49 for Schauta and 54 for Piver p=0.494) and parity of the patients (Median parity was 2 (range: 0-5) for Piver II group and 1 (range: 0-4) for Schauta group (p=0.607)) and about histotype and stage of the cervical cancer (34 patients with squamous cell carcinoma among Piver II Group vs 16 patients from Schauta Group; 4 women with adenocarcinoma from Piver II Group vs 1 subject from the Schauta Group; p value 1.000). Among the two groups there were significant statistical differences regarding the mean operative time (86 ± 28 minutes for Vaginal surgery and 115 ± 31 minutes for Abdominal surgery, p=0.038) and the average hospital stay (8.65 ± 4.42 days for abdominal surgery and 5.65 ± 2.3 days for vaginal surgery, p=0.020). Significant statistical difference was reported as regarding adjuvant RT, increased in the Piver II group with respect to the Schauta group (22 vs 4 pts; p=0.028). The survival rate at 5-years was without significant difference between the two groups (23 patients frof Piver II Group vs 11 patients from Schauta Group, p=0.510). DISCUSSION: This study confirms the benefits of the Schauta-Amreich vaginal radical hysterectomy in terms of hospital stay, mean operative time and early complications. CONCLUSION: We believe that this surgery is a plausible alternative to radical abdominal hysterectomy and could be considered to be a valid approach for the treatment of patients with cervical neoplasms, but still randomized trials are needed on this topic with respect to the ethical issues involved.

Severe fetal distress and umbilical cord strangulation.

We describe an extreme case of amniotic band syndrome, presented with fetal stress during labor and associated with strangulation of umbilical cord.

Ultrasound detection of the "sliding viscera" sign promotes safer laparoscopy.

STUDY OBJECTIVE: To estimate the feasibility of preoperative ultrasound evaluation of the umbilical region in patients undergoing laparoscopy with a previous history of abdominal surgery. DESIGN: Prospective study (Canadian Task Force Classification II-1). SETTING: Department of Obstetrics and Gynecology Fatebenefratelli Isola Tiberina Hospital. PATIENTS: Twenty-five women with a previous history of open abdominal surgery (group A) and a group of 22 women with no previous history of surgery (group B) underwent dynamic ultrasound evaluation of the umbilical field. INTERVENTION: Ultrasound Slide-By test. RESULTS: Patients were asked to take a deep inspiratory breath, which accentuated respiratory excursion. The movement of the intraabdominal contents in a vertical fashion in relation to the abdominal wall, referred to as the "viscera slide," between the bowel and peritoneum was evaluated. Abdominal wall tissue thickness, Uracus to peritoneum thickness (UTP, mm) were also evaluated. Non parametric Mann-Whitney testing was used. No major demographic differences between the 2 study groups was noted. The abdominal wall tissue thickness was not significantly different between the 2 groups. The UTP was shorter in A group than in B group (1.5 +/- 0.3 mm vs 3.5 +/- 0.9 mm, p = .002). Absence of the "sliding viscera" sign was observed in 16 patients in group A and in 1 patient in group B. Patients with an absence of the sliding viscera sign were found to have subumbilical fibrous adhesions during laparoscopy. CONCLUSIONS: Evaluation of trocar insertion sites may be difficult and remains a challenge for peritoneal endosurgical access. We have shown that absence of the "sliding viscera" sign is more likely to be linked to subumbilical adhesions and represents a quick method for preoperative assessment. The UTP may also be a useful measurement, which requires further validation.

Could birthweight prediction models be improved by adding fetal subcutaneous tissue thickness?

AIM: The aims of the study were to: (i) compare the accuracy of standard ultrasonic algorithms in the estimation of fetal weight and; (ii) test two new algorithms in order to improve the global performance of birthweight prediction by adding fetal subcutaneous tissue thickness. METHODS: We enrolled 398 patients who were between 34 and 42 weeks' gestation. Routine ultrasonographic biometric parameters as well as subcutaneous tissue thickness ultrasound parameters were measured. Correlation matrices between ultrasound parameters, in order to evaluate the degree of multicollinearity between these parameters, were assessed to develop a stepwise multiple regression birthweight predictive model. RESULTS: Contributions of single ultrasound measurements in predicting birthweight were examined, by fitting Log-transformed birthweight versus single ultrasound measurements. We found that the mid-thigh tissue area was able to significantly improve the performance of the birthweight prediction process when added to the other standard ultrasound measurements. We derived two new algorithms which appeared to be better at predicting birthweight. Furthermore there was a lower minimum absolute estimation error noted when compared to other reported formulae. CONCLUSIONS: Our algorithms showed that the addition of the mid-thigh tissue evaluation in birthweight prediction was valuable in comparison to birthweight prediction models which are based on routine ultrasound parameters.