Anne Ego

Mechanical properties of synthetic implants used in the repair of prolapse and urinary incontinence in women: which is the ideal material?

The authors review the literature concerning all types of synthetics implants used in prolapse repair or the treatment of stress urinary incontinence, and analyze the mechanical properties of and the tolerance to the various products used. Various synthetic implants are also studied, including their advantages and disadvantages, as well as outcome following implantation and tolerance by the host, with respect to the type of product and the type of intervention. A review of current implant products demonstrated that the perfect product does not exist at present. The most promising of theses products for applications in transvaginal surgery to restore pelvic function appears to be the synthetic prostheses made predominantly of polypropylene, which offer mechanical properties of durability and elasticity. Their properties of resistance are undisputed, but it remains to be shown whether they are well tolerated when inserted by the vaginal route. The technical modalities for their use are still under evaluation, which should enable a better identification of the respective indications for these products in prolapse repair and treatment of urinary incontinence by the vaginal route.

A biomechanical study of the strength of vaginal tissues. Results on 16 post-menopausal patients presenting with genital prolapse.

AIMS Measurements of the tensile and bending strength of samples of vaginal tissue collected during corrective surgery of prolapse. MATERIALS AND METHODS Our measurements were conducted on two samples of vaginal tissue 2 cm x 2 cm collected during surgical correction of prolapse by vaginal route in 16 post-menopausal patients. The samples were collected from posterior vaginal fundus, were orientated, and then fixed on a plate holding the edges and allowing the tissue to be stretched over an orifice of 1 cm. The tensile measurements were made using a suture passed over this distance of 1 cm in one of the two samples by recording the strength curve in order to evaluate the force at rupture of the collagen fibres. The second sample was prepared in the same way and a piston of 1 cm diameter was made to penetrate to determine the strength of breakage of the fibres. The pressure and tensile strength curves were recorded up to rupture of the sample, as was the value of the tissue elongation. RESULTS There was a great variability in the measurements of maximum strength at rupture of the vaginal samples and in the elongation before rupture of the samples. The mean rupture values in tensile tests were 44 and 59 N in bending with extremes of 12 and 130 N. The values of elongation before rupture of a 10 mm sample were 23 mm in tensile tests and 11 mm in bending tests. There was a great variability of results from one patient to another. There was no relation between the values observed and the patient age. There was a statistical relation between the elongation values of the samples and the maximum force before rupture in both the tensile and bending tests. There was also a relation between the measurement of the maximum force at rupture in bending and in tensile tests although there was no such relation in terms of the values of elongation before rupture. DISCUSSION There is no published reference concerning the strength at rupture or the tensile strength curves for human vaginal tissues. Vaginal tissues are however commonly used as a suspension component in the vast majority of operations for correcting prolapse or urinary incontinence. These suspensions are made by passing a suture through the thickness of the vaginal tissue. The results that we report do however show that these vaginal tissues are very variable in strength from one patient to another. The same finding was made in terms of the elongation values for the vaginal tissue before rupture. The values in bending tests showed that the highest rupture force values and the greatest mean elongation before rupture were lower than in tensile tests. CONCLUSIONS These findings could explain some failures of these surgical procedures, which are all based on the tensile strength properties. Finally these results could be included in modelling of the reaction of vaginal tissues to the pressure experienced within the vagina.

A study of pelvic ligament strength

OBJECTIVES To measure the strength at tearing of pelvic ligaments used in the cure of prolapse and urinary incontinence. MATERIAL AND METHODS We performed our measurements on pelvis ligaments from cadaveric specimens. We dissected 29 human female pelvis cadavers of which storage conditions differed. Ten were frozen, 10 fresh and 9 were stored in formalin. In each cadaver we dissected pre-vertebral ligaments at promontory and right and left symmetrical ligaments. These were the iliopectineal, sacrospinous and arcus tendineus of pelvic fascia. A subjective clinical evaluation of the ligament properties was performed by visual observation as well as finger palpation. Ligaments were classified into three groups. Group A contained high quality ligaments, in terms of thickness and apparent strength following finger palpation. Ligaments of doubtful quality were classified in group B and low apparent quality ligaments in group C. Then the ligaments were stitched by a suture taking the entire ligament and a force was applied on the vagina axis until tearing. The device used for strength measurement during traction was a SAMSON type force gauge, model EASY, serial number SMS-R-ES 300N manufactured by Andilog that was developed for the purpose of our study. Measurements were given in Newton (N). RESULTS There was a great variability in the values obtained at tearing with minimal values at around 20N and maximal values at 200N. Individually measured, ligament strength varied between individuals, and for the same patient between the type of ligaments and the side. The pre-vertebral ligament was on average the strongest. There was no significant difference according to the storage condition except for the pre-vertebral ligament in formalin cadavers. For bilateral ligaments, there was no difference between the left and right side. The iliopectineal ligament was statistically significantly stronger than the sacrospinous and arcus tendineus of pelvic fascia. There was a correlation between subjective evaluation and objective strength measurements. DISCUSSION No papers have been published on the strength of pelvic ligaments at tearing. These are however routinely used in the cure of prolapse and urinary incontinence. Our results show that there is a great variability in strength between individuals, and for a same patient between the types of ligaments and side. These observations could explain some of the surgical intervention failures and demonstrate the importance of per-operative strength evaluation. Per-operative subjective evaluation of strength is related to objective measurements and could be used to determine the type of ligaments to be used for surgical suspension. Freezing does not damage pre-vertebral ligament strength and further studies are required to evaluate elasticity of pelvic ligaments.

Survival analysis of fertility after ectopic pregnancy

OBJECTIVE To evaluate the reproductive outcome after ectopic pregnancy and to assess the contribution of risk factors to future fertility. DESIGN Prospective follow-up in a population-based sample. SETTING Register of ectopic pregnancies established in an urban area around Lille, France. PATIENT(S) Three hundred and twenty-eight women treated between April 1994 and March 1997 who had not been using an IUCD at the time of the ectopic pregnancy and were trying to become pregnant. INTERVENTION(S) Interviews by telephone every 6 months for 2 years and once yearly thereafter. MAIN OUTCOME MEASURE(S) Cumulative pregnancy rate. RESULT(S) Two hundred fifteen (65.5%) women became pregnant after a mean of 5 months. One hundred eighty-two (84.7%) pregnancies were intrauterine; 22 (10.2%) were recurrent ectopic pregnancies; and in 11 women (5.1%), it was too early to define implantation. The cumulative intrauterine pregnancy rate was 56% at 1 year and 67% at 2 years. After applying Cox regression, three factors associated with fertility seemed to decrease reproductive performance: age > 35 years, history of infertility, and anterior tubal damage . CONCLUSION(S) More than half of the women treated for ectopic pregnancy spontaneously conceived and had a normally progressive pregnancy at 1 year. Fertility depends more on established patient characteristics than characteristics of ectopic pregnancy itself or treatment thereof.

Should parity be included in customised fetal weight standards for identifying small-for-gestational-age babies? Results from a French multicentre study

Objective  Parity is one of several parameters used to customise fetal growth norms. However, it is uncertain whether the lower birthweight of babies born to primiparous women reflects physiological or pathological variation. Our aim was to assess the impact of adjusting for parity in identification of small‐for‐gestational‐age (SGA) births.

Patient satisfaction with management of ectopic pregnancy

OBJECTIVES This study was designed (1) to identify characteristics of patients and their treatment and aspects of care that may be associated with satisfaction, and (2) to investigate the way these factors contribute to the degree of satisfaction expressed after treatment of ectopic pregnancy. Our ultimate goal in so doing was to determine how to improve ectopic pregnancy management. STUDY DESIGN We used data from a register of ectopic pregnancy established in an urban area (Communauté Urbaine de Lille) in northern France. Two months after ectopic pregnancy, a self-administered satisfaction questionnaire was completed by 192 women treated between January 1995 and July 1996. We searched which factors were associated with satisfaction by a logistic regression model. RESULTS Greater satisfaction was significantly associated with average education. Women were more satisfied when pregnancy was an expected event, and when fallopian tube was unruptured. Patients satisfied with the way they were received, the comfort, the willingness to listen and provide explanations, were more satisfied overall. Physical pain, anxiety for later fertility, and need of psychological support were associated with lesser degrees of satisfaction. When adjusted for these factors, the following factors remained significant: level of education; conditions of conception; pain; reception and willingness to listen. CONCLUSION This study should increase awareness amongst health care professionals of the importance of a compassionate approach when dealing with patients following an ectopic pregnancy, since patients value this aspect of care.

Stillbirth classification in population-based data and role of fetal growth restriction: the example of RECODE

BackgroundStillbirth classifications use various strategies to synthesise information associated with fetal demise with the aim of identifying key causes for the death. RECODE is a hierarchical classification of death-related conditions, which grants a major place to fetal growth restriction (FGR). Our objective was to explore how placement of FGR in the hierarchy affected results from the classification.MethodsIn the Rhône-Alpes region, all stillbirths were recorded in a local registry from 2000 to 2010 in three districts (N = 969). Small for gestational age (SGA) was defined as a birthweight below the 10th percentile. We applied RECODE and then modified the hierarchy, including FGR as the penultimate category (RECODE-R).Results49.0% of stillbirths were SGA. From RECODE to RECODE-R, stillbirths attributable to FGR decreased from 38% to 14%, in favour of other related conditions. Nearly half of SGA stillbirths (49%) were reclassified. There was a non-significant tendency toward moderate SGA, singletons and full-term stillbirths to older mothers being reclassified.ConclusionsThe position of FGR in hierarchical stillbirth classification has a major impact on the first condition associated with stillbirth. RECODE-R calls less attention to monitoring SGA fetuses but illustrates the diversity of death-related conditions for small fetuses.

Diagnosis Accuracy of Transcutaneous Bilirubinometry in Very Preterm Newborns

Background: Transcutaneous bilirubin (TcB) is a validated test for systematic screening of neonatal hyperbilirubinemia and monitoring term and near-term infants under phototherapy. Objectives: To evaluate TcB diagnostic accuracy for very preterm neonates. Methods: Total serum bilirubin (TSB) and TcB measurements were performed prospectively in a multicenter sample of newborns <30 weeks of gestational age (GA). TcB sensitivity, specificity, predictive values, and likelihood ratios for the detection of neonates requiring phototherapy were calculated over the first 15 days of life, with or without phototherapy, with the expectation of achieving a detection rate of hyperbilirubinemia of over 95%. The potential influence of neonatal characteristics on the discordance between TcB and TSB in very preterm newborns was analyzed using multivariate multilevel logistic regression analyses. Results: Altogether, 481 measurements were analyzed in 167 preterm patients. Mean GA was 27.6 ± 1.6 weeks. The rates of newborns requiring phototherapy were 52% in the first 3 days, 16% from the 4th to the 7th day, and 2% during the second week. Diagnostic performance was similar among babies with or without phototherapy. TcB sensitivity decreased over time from 100% (93.9-100.0) to 50% (1.3-98.7). Specificity showed an inverse evolution from 14.8% (7.0-26.2) to 80.7% (72.2-89.2). The best performance was that of negative predictive values which varied from 95.5 to 100.0. False negatives were rare throughout the study (0.8% of measurements). In a multivariate analysis, the only factor significantly influencing discordance between TcB and TSB was postnatal age. We did not find any impact of GA and skin color. Conclusion: Among very preterm babies, TcB measurements might be useful for screening for neonatal jaundice in the first 2 weeks of life. In case of a TcB value below the phototherapy threshold, invasive TSB quantification could be unnecessary, with potential avoidance of blood drawing.

Parity and growth restriction: on whom the burden of proof?

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Clinical practice guidelines for neonatal arterial ischaemic stroke

SIR–Guidelines about neonatal arterial ischaemic stroke (NAIS) have recently been published in a special issue of the French journal Archives de P ediatrie. Supported by both the French Neonatal Society and the French Centre for Paediatric Stroke, a comprehensive review of the literature (up to July 2015) was conducted by independent experts and reviewed by various professionals. Only papers in which the data were specific to NAIS were extracted (excluding other forms of perinatal stroke). Following the methodology of the French Health Authority, which defines level of evidence assessment (LE1–4) and grading of recommendations (Grade A–C), this letter summarizes the key points for the formation of guidelines (Table I).