A randomised controlled trial of amnioexchange for fetal gastroschisis.

OBJECTIVE: Morbidity in fetuses affected by gastroschisis is mainly the result of bowel ischaemic and inflammatory processes. Experimental studies on animal models show that clearing amniotic fluid from the digestive secretions by amnioexchange procedures reduces the inflammatory process. We evaluated the benefit of the amnioexchange procedure for fetal gastroschisis in humans. DESIGN: Prospective, interventional, randomised study. SETTING: Eight referral centres for fetal medicine. POPULATION: Pregnant women carrying a fetus with gastroschisis. METHODS: We compared, in utero, amnioexchange with a sham procedure. The protocol included, in both arms, steroid injections at 30 weeks of gestation and the use of postnatal minimal enteral feeding. MAIN OUTCOME MEASURES: The primary outcome was a composite variable based on the duration of ventilation and parenteral nutrition. Secondary outcomes were the effectiveness and safety of the amnioexchange procedure, including the rate of perinatal death, time to full enteral feeding, primary closure, and late feeding disorders. RESULTS: Sixty-four patients were randomised. There was no difference in the composite criteria between the amnioexchange and control groups. Based on an intention-to-treat analysis, there were no significant between-group differences in pregnancy outcome or complications. When studying the relationship between digestive compounds and amniotic fluid inflammatory markers, a clear correlation was found between bile acid and both ferritin and interleukin 1ß (IL1ß). CONCLUSIONS: In humans, amnioexchange, as described in our protocol, is not an option for fetal care; however, we provide supplementary proof of the involvement of inflammation in the pathogenicity of gastroschisis and suggest that future research should aim at reducing inflammation. ClinicalTrials.gov: NCT00127946. TWEETABLE ABSTRACT: A prospective, interventional, randomised study shows no benefit of amnioexchange for fetal gastroschisis in humans.

Association between inadequate antenatal care utilisation and severe perinatal and maternal morbidity: an analysis in the PreCARE cohort.

OBJECTIVE: Because the effectiveness of antenatal care in reducing pregnancy complications is still discussed despite widespread recommendations of its use, we sought to assess the association between utilisation of recommended antenatal care and severe maternal (SMM) and perinatal morbidity (SPM). DESIGN: Prospective cohort study. SETTING: Four maternity units around Paris in 2010-2012. SAMPLE: 9117 women with singleton pregnancies. METHODS: Logistic regression models adjusted for maternal social, demographic and medical characteristics. MAIN OUTCOME MEASURES: Antenatal care utilisation was assessed by: (1) initiation of care after 14 weeks, (2) < 50% of recommended visits made, according to gestational age, (3) absence of the first, second or third trimester ultrasounds, (4) two modified Adequacy of Prenatal Care Utilisation indexes, combining these components. The two main outcomes were composite variables of SMM and SPM. RESULTS: According to the modified Adequacy of Prenatal Care Utilisation index, 34.6% of women had inadequate antenatal care utilisation; the incidence of severe maternal morbidity (SMM) was 2.9% and severe perinatal morbidity (SPM) 5.5%. A percentage of recommended visits below 50% (2.6% of women) was associated with SMM [adjusted odds ratio (OR) 2.40 (1.38-4.17)] and SPM [aOR 2.27 (1.43-3.59)]. Late initiation of care (17.0% of women) was not associated with SMM or SPM. Failure to undergo the recommended ultrasounds (16, 17 and 22% of women) was associated with SPM. Inadequate antenatal care utilisation according to the index was associated with SPM [aOR 1.37 (1.05-1.80)]. CONCLUSION: Inadequate antenatal care utilisation is associated with SMM and SPM, to degrees that vary with the component of care and the outcome considered. TWEETABLE ABSTRACT: Inadequate antenatal care utilisation is associated with severe maternal and perinatal morbidity.

Effectiveness of elective cervical cerclage according to obstetric history.

OBJECTIVE: To assess the effectiveness of elective history-indicated cervical cerclage according to obstetrical history. STUDY DESIGN: We analyzed pregnancy outcome of a retrospective cohort of women who have had history-indicated McDonald's cerclage. Principal outcome was gestational age (GA) at delivery. RESULT: Between January 2003 and December 2013, 205 women were included. We analyzed population in two risk groups: 1- Low-risk (≤2 prior preterm birth (PTB)/second trimester loss (STL), or prior success of cerclage), 2- High risk (≥3 prior PTB/STL, or prior failure of cerclage). In the high-risk group, there was a higher frequency of deliveries before 37 weeks (47.5% vs. 24.5%, P=0.001, OR=2.79, 95% CI [1.49-5.23]). Fifty percent of women (n=6/12) delivered before 37 weeks in case of three or more prior PTB/STL, and 51% (n=24/47) in case of prior failure of cervical cerclage. CONCLUSION: Elective cervical cerclage may be indicated for women with≤2 prior PTB/STL, or prior successful cerclage. For women with≥3 prior PTB/STL, trachelorraphy or cervico-isthmic cerclage could be possible alternatives to cervical cerclage.

Sequential fetal serum ß2-microglobulin to predict postnatal renal function in bilateral or low urinary tract obstruction.

OBJECTIVE: Fetal serum ß2-microglobulin has been shown to predict postnatal renal outcome in cases of fetal obstructive uropathy. We assessed the value of serial measurements of fetal serum ß2-microglobulin in the prediction of postnatal renal outcome. METHODS: We retrospectively studied renal outcome in 42 fetuses with bilateral or low urinary tract obstruction that had fetal blood sampling on at least two occasions to assay serum levels of ß2-microglobulin. Amniotic fluid volume at the time of each sampling was recorded. We classified renal outcome as either favorable (when postnatal renal function was normal) or adverse (when postnatal chronic renal failure occurred or when renal dysplasia at autopsy was noted). A ß2-microglobulin cut-off of 5 mg/L and amniotic fluid index of 5 cm were used to predict postnatal renal outcome. RESULTS: Renal outcome was adverse in 28 cases and favorable in 14. In 12 (28.6%) cases, fetal serum ß2-microglobulin concentration differed between the first and last measurement. Prediction of postnatal renal outcome was correct in 11 of these cases based on the last ß2-microglobulin measurement. The sensitivity of ß2-microglobulin in predicting renal outcome was significantly higher (P = 0.005) when using the last rather than the first measurement (96.4% vs 64.3%), with similar specificity for both measurements (85.7% vs 78.6%, non-significant). The sensitivity of amniotic fluid volume was also significantly higher (P = 0.005) when using the last rather than the first measurement (75.0% vs 35.7%), with similar specificity for both measurements (64.3% vs 71.4%, non-significant). CONCLUSION: Sequential measurement of serum ß2-microglobulin, performed for adverse ultrasound findings, such as renal parenchymal abnormality or decreasing amniotic fluid volume, predicts postnatal renal outcome more accurately than does a single assay. This may be due to possible worsening of renal injury with increasing duration of urinary tract obstruction. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

[Management of shoulder dystocia]. / Conduite à tenir en cas de dystocie des épaules.

OBJECTIVE: The objective of this review is to propose recommendations on the management of shoulder dystocia. MATERIALS AND METHODS: The PubMed database, the Cochrane Library and the recommendations from the foreign obstetrical societies or colleges have been consulted. RESULTS: In case of shoulder dystocia, if the obstetrician is not present at delivery, he should be systematically informed as quickly as possible (professional consensus). A third person should also be called for help in order to realize McRoberts maneuver (professional consensus). The patient has to be properly installed in gynecological position (professional consensus). It is recommended not to pull excessively on the fetal head (grade C), do not perform uterine expression (grade C) and do not realize inverse rotation of the fetal head (professional consensus). McRoberts maneuver, with or without a suprapubic pressure, is simple to perform, effective and associated with low morbidity, thus, it is recommended in the first line (grade C). Regarding the maneuvers of the second line, the available data do not suggest the superiority of one maneuver in relation to another (grade C). We proposed an algorithm; however, management should be adapted to the experience of the operator. If the posterior shoulder is engaged, Wood's maneuver should be performed preferentially; if the posterior shoulder is not engaged, delivery of the posterior arm should be performed preferentially (professional consensus). Routine episiotomy is not recommended in shoulder dystocia (professional consensus). Other second intention maneuvers are described. It seems necessary to know at least two maneuvers to perform in case of shoulder dystocia unresolved by the maneuver McRoberts (professional consensus). CONCLUSION: All physicians and midwives should know and perform obstetric maneuvers if needed quickly but without precipitation.

Non-invasive prenatal testing for trisomy 21 based on analysis of cell-free fetal DNA circulating in the maternal plasma.

OBJECTIVE: By-the-book implementation of non-invasive prenatal test and clinical validation for trisomy 21. STUDY DESIGN: Publicly funded prospective study of 225 cases. Women at risk for trisomy 21 > 1/250 based on combined ultrasound and serum markers during first or second trimester were eligible following an informed consent. The technique was established from the available literature and performed on 10 mL of venous blood collected prior to chorionic villus sampling or amniocentesis. Investigators were blinded to the fetal karyotype. Results were expressed in Z-scores of the percentage of each chromosome. RESULTS: Among 976 eligible cases, 225 were processed: 8 were used for pretesting phase and 23 to build a reference set. One hundred thirty six euploid cases and 47 with trisomy 21 were then run randomly. Eleven cases yielded no result (4.8%). Z-scores were above 3 (7.58+/-2.41) for chromosome 21 in all 47 trisomies and in none of the euploid cases (0.11+/-1.0). Z-scores were within normal range for the other chromosomes in both groups. Using a cut-off of 3, sensitivity and specificity were of 100% 95% CI [94.1, 100] and 100% 95% CI [98, 100], respectively. CONCLUSION: Non-invasive prenatal test for trisomy 21 is a robust strategy that can be translated from seminal publications. Publicly funded studies should refine its indications and cost-effectiveness in prenatal screening and diagnosis. © 2015 John Wiley & Sons, Ltd.

Fetal urine biochemistry at 13-23 weeks of gestation in lower urinary tract obstruction: criteria for in-utero treatment.

OBJECTIVES: To assess the value of fetal urine biochemistry before 23 weeks of gestation in cases of lower urinary tract obstruction (LUTO) to refine prognosis and to select potential candidates for in-utero intervention. METHODS: This was a retrospective study including 72 cases of LUTO with fetal urine sampled before 23 weeks and assayed for total protein, ß-2-microglobulin, sodium, chloride, calcium, phosphorus, glucose and gamma-glutamyl transpeptidase (GGTP). Two groups were defined according to renal outcome: 1) bilateral renal dysplasia on histological examination or renal failure at birth; 2) normal postnatal renal function or histologically normal appearance of the kidneys. Correlations between fetal urinary biochemical markers and postnatal renal function were studied. RESULTS: LUTO was isolated in 56/72 (77.8%) cases and was associated with other malformations in 16/72 (22.2%) cases. High GGTP levels (236 IU/L vs 5 IU/L; P < 0.0001) were observed in fetal urine in the five cases of urodigestive fistula. A significant difference between outcome groups was observed for ß-2-microglobulin (P = 0.0017), sodium (P = 0.0008), chloride (P = 0.0028) and calcium (P = 0.0092) but not for protein, glucose or phosphorus. Sensitivity and specificity in defining a poor renal prognosis were 80.6% and 89% for ß-2-microglobulin, 61.3% and 100% for sodium and 64.5% and 100% for calcium, respectively. CONCLUSIONS: Fetal urinalysis before 23 weeks of gestation allowed distinction between three groups: 1) fetuses with normal urine biochemistry for which fetal therapy should be discussed; 2) fetuses with abnormal urine biochemistry for which prognosis for renal outcome is poor and for which the benefit of fetal therapy is likely to be compromised; 3) fetuses with urodigestive fistula.

Trachelorraphy in cases of recurrent second trimester loss and prior failed vaginal cerclage.

OBJECTIVE: To evaluate the obstetric results of trachelorraphy in the prevention of recurrent second trimester loss in cases of prior failed vaginal cerclage. STUDY DESIGN: Data were collected retrospectively and prospectively from medical records. The analysis examined data for 18 women who underwent trachelorraphy between 2004 and 2013 at a tertiary referral unit in France. All patients in this high-risk population had a history of two or more second trimester losses, or one second trimester loss and one preterm labour, and at least one prior failed transvaginal cerclage. The main outcome measures were: livebirth rate; rate of second trimester loss; and surgical complications. RESULTS: Twenty pregnancies were conceived in 16 patients following trachelorraphy. Three patients experienced two pregnancies. Among the 20 pregnancies, there was one case of fetal loss in the first trimester; this pregnancy was excluded from the analysis. Of the remaining 19 pregnancies, there were nine (47%) term deliveries (after 37 weeks of gestation), seven (32%) preterm deliveries and three (16%) second trimester losses. The overall fetal survival rate was 84%. Surgical outcomes were excellent, with no complications. CONCLUSION: Trachelorraphy is a safe, reproducible, easy-to-learn procedure for the prevention of recurrent second trimester loss in cases of prior failed vaginal cerclage. The procedure has encouraging and favourable perinatal outcomes in patients with a poor obstetric history.

Fetal airway management on placental support: limitations and ethical considerations in seven cases.

The aim of this study was to evaluate the paediatric and maternal outcome after ex utero intrapartum treatment (EXIT). A retrospective review was carried out of the medical charts (gestational age, circumstances of diagnosis, multidisciplinary prenatal decision, date of surgery, paediatric and maternal outcome) of all the fetuses eligible for/delivered via the EXIT procedure in our paediatrics and obstetrics tertiary care and teaching centre, between October 2004 and May 2011. Seven fetuses with cervical teratoma, epignathus tumour or congenital high airway obstruction syndrome (CHAOS) were included in our study. Two pregnancies were terminated and five fetuses were delivered alive. The airway was secured in all five cases (two endotracheal intubations and three tracheostomies). No maternal complications were observed. On average, babies were delivered at 32 gestational weeks, and spent 31 days in the intensive care unit. All but one baby were ventilated for 18 days. Long-term paediatric outcome was favourable. It is concluded that airway management by the EXIT procedure has become an efficient technique. A multidisciplinary prenatal assessment is essential in order to select appropriate cases.

[Terminations of pregnancy for maternal indications in the Paris area: a retrospective multicenter study in the period between the 2001 French law on termination of pregnancy and the new bioethics law]. / Interruptions médicales de grossesse pour motifs maternels : étude rétrospective multicentrique des indications dans la période entre la loi sur l'interruption de grossesse de 2001 et la nouvelle loi de bioéthique.

OBJECTIVE: To analyze the reasons for terminations of pregnancy (TOP) in cases of "severe jeopardy of the woman's health" beyond the limit of 14weeks, performed under the 2001 French law on abortion which extended these indications, until a new bioethics law was promulgated in 2011. METHODS: A retrospective observational study of all TOP performed for maternal indications (excluding premature membrane rupture), following a medical decision, from 2001 to 2010 in four academic maternity units in northern Paris. RESULTS: One hundred and three patients were included. The incidence was approximately 1 per 1000 births. The mean gestational age at the time of the TOP was 21.5weeks (range 7.7-34.7); 7% occurred before 14weeks and 35% after 24weeks. Indications were: (1) maternal diseases (22%), (2) psychosocial indications (21%) in majority multiple drug addictions, (3) psychiatric indications (21%), (4) obstetrical complications (mainly preeclampsia) before fetal viability (20%) and (5) rape (16%) mostly on minors. In 16% of cases, several indications were associated. CONCLUSION: TOP for maternal indications remains exceptional, including for psychosocial indications. Our findings suggest that the French law on TOP was not misused in these centers to permit abortion on demand beyond the limit of 14weeks.

[Epignathus teratoma: diagnostic and neonatal management; a case report]. / Tératome épignathe: diagnostic et prise en charge néonatale; à propos d'un cas.

Epignathus teratoma is a rare tumor whose prognosis essentially depends on its resectability and on neonatal care. When it is undiagnosed prenatally, mortality is close to 100 % at birth, because of obstruction of the upper airways. We present a case of epignathus teratoma detected during obstetrical ultrasound screening. Diagnosis enabled planning for a safe delivery in a suitable multidisciplinary unit and use of the EXIT procedure.

[Analysis of fetal heart rate abnormalities occurring within one hour after laying of epidural analgesia]. / Analyse des anomalies du rythme cardiaque fœtal survenant dans l'heure suivant la pose d'une analgésie péridurale.

OBJECTIVES: The objective of this study is to classify abnormalities of fetal heart rate (FHR) occurring in the first hour after performing the epidural analgesia, and to assess the impact of these abnormalities on delivery and on after-birth neonatal state. PATIENTS AND METHODS: Retrospective study of 6676 patients continuously from 1 January 2007 to 31 December 2010 who benefited, during the labor, of epidural analgesia. Seven hundred and sixty (14,1%) presented anomalies of FHR in the hour following the laying of epidural (group 1), and 5916 showed no abnormalities of the RCF (group 2). RESULTS: Among the 760 anomalies of the FHR in the hour following the laying of epidural, 319 (42%) showed prolonged decelerations, 169 (22.2%) variable decelerations, 122 (16.1%) early decelerations, 110 (14.5%) late decelerations and 40 bradycardia (5.3%). In the group 1, incidence of caesarean delivery was 21.4% (163 patients); in group 2, it was 9.63% (P<0.002). In group 1, the umbilical artery pH was less than 7.20 in 13,6% of patients, whereas in group 2, the prevalence was only 6,5% (P<0.002). There is no statistically significant differences on Apgar score between the two groups. CONCLUSION: This study helped to characterize anomalies in the FHR following epidural. There is an increase of obstetric interventions. There is no impact on neonatal clinical state. The administration of systematic ephedrine shall be investigated to reduce these interventions.

An individual scoring system for the prediction of postpartum anaemia.

BACKGROUND: Postpartum anaemia (PPA) is a common postpartum complication. The goal of this study was to prospectively construct a predictive score for individual risk of PPA. PATIENTS ET METHOD: We prospectively analyzed factors associated with PPA (<10gdL(-1) at 48hours postpartum). Parameters analyzed were demographic data, pregnancy characteristics, delivery and postpartum characteristics. Univariate analysis was performed using Anova or X(2); the Cox model was used for multivariate analysis. The scoring system was validated using ROC curve. RESULTS: Analysis was performed in 475 patients and validation was carried using an additional 95 patients. Multivariate analysis found four factors independently associated with PPA: anaemia during the third trimester of the pregnancy, Southeast Asian ethnic origin, episiotomy and severe postpartum haemorrhage (PPH) identified by the use of sulprostone. According to the score derived from the Cox model, patients were classified as low (22%, score=0), medium (55%, score=2 or 3) and high (86%, score>3) probability of PPA. Using the AUC of the ROC curve for both the first and the validation cohorts (performed on 95 further patients), we recorded AUCs of 72% and 70% respectively. CONCLUSIONS: This study allowed the derivation and validation of a predictive score of PPA. This score might be useful in targeting prophylactic strategies for PPA. Such strategies could include a more active treatment of iron deficiency (increasing oral iron treatment observance or intravenous iron therapy) especially in exposed population, improvement in the prevention and treatment of postpartum haemorrhage and decreasing the use of episiotomy. Future studies must focus on the external validation and generalisation of this scoring system.

Fetal obstructive uropathy complicated by urinary ascites: outcome and prognostic value of fetal serum ß-2-microglobulin.

OBJECTIVES: To determine whether the prognostic value of fetal serum ß-2-microglobulin is altered and whether the occurrence of fetal urinary ascites prevents kidney damage in cases of fetal obstructive uropathy with urinary ascites. METHODS: This was a retrospective study of cases of fetal bilateral obstructive uropathy that occurred between 2006 and 2010, for which both fetal serum and ascites samples were sent to our laboratory for analysis. ß-2-microglobulin was assayed in both fetal serum and the corresponding ascites. Renal outcome was analyzed. Histological features of the kidney in cases of termination of pregnancy and renal function of liveborn infants were recorded. RESULTS: Fourteen cases with analysis of fetal serum and fetal ascites in a context of urinary obstruction were included. Renal outcome was unfavorable in eight cases (57%) and favorable in six (43%). When fetal serum ß-2-microglobulin was < 5 mg/L, renal outcome was favorable in all cases (4/4). When fetal serum ß-2-microglobulin was ≥ 5 mg/L, 8/10 cases (80%) had an unfavorable renal outcome (sensitivity, 100%; specificity, 66%). CONCLUSION: Fetal serum ß-2-microglobulin reliably predicts postnatal renal outcome in obstructive uropathy complicated by urinary ascites. Moreover, urine extravasation does not seem to protect fetal renal function.

[Induction of labour and breech presentation: experience of a French maternity ward]. / Induction du travail et présentation du siège : expérience de la maternité de l'hôpital Robert-Debré, Paris.

INTRODUCTION: For a few years, we can notice a progressive increase in the practice of systematic caesarean delivery as far as breech delivery is concerned. This is true notably since the publication of Hannah's "Term Breech Trial" in 2000 which recommends systematic caesarean delivery in the case of breech presentation. But the conclusions of this North-American study are questionable, knowing that French practice is often quite different from Hannah's study. OBJECTIVE: In the maternity ward of the French hospital Robert-Debré, Paris, vaginal delivery may be authorized as far as breech presentation is concerned if defined obstetrical criteria are met. Labour can be induced when a maternal or fetal indication exists. In the following study, we tried to assess our practice. STUDY DESIGN: Our retrospective study included 624 patients with a breech presentation, of which 501 within the group of spontaneous labour (group 1) and 123 within the group of cervical preparation and induced labour (group 2), for the period going from 1 January 2000 to 31 December 2008. RESULTS: The results do comfort our attitude since they show equivalent results in terms of delivery mode and neonatal issues between breech presentations with spontaneous labour on one hand, and with labour induced by cervical maturation on the other hand. CONCLUSION: The primary objective of this study was to evaluate an unusual operating practice in a well-trained level 3 obstetrical team. The results do comfort our attitude since they show equivalent results in terms of delivery mode and neonatal issues between breech presentations with spontaneous labour on one hand, and with labour induced by cervical maturation on the other hand. It seems however difficult to extrapolate our results and apply them to usual practice due to the lack of power of a retrospective and non-randomized study. Setting up a randomized and prospective study seems however difficult because of the medical and ethical problems it would raise.

[Cerebellar injury in premature infants less than 30 weeks of gestation]. / Lésions acquises du cervelet chez le grand prématuré : prévalence, facteurs de risque et conséquences fonctionnelles.

UNLABELLED: Traditionally, the cerebellum has been regarded as a central component of the motor system. Recent studies suggest an important role played by the cerebellum in the development of cognitive and social functions. The objective of this study was to evaluate the incidence of cerebellar injury and to define the obstetrical, neonatal, and radiologic characteristics, as well as the functional outcomes in a population of very preterm infants. METHODS: This retrospective study included neonates born before 30 weeks of gestational age between March 2004 and July 2007. Infants underwent MRI studies at a term-adjusted age; for each preterm infant with cerebellar injury, we identified two infants for the control group with normal MRI, matched on the basis of gestational age. We collected pertinent demographic, prenatal, and acute postnatal data for all infants. Follow-up assessment was performed at 2 years, using the Brunet-Lezine scale. RESULTS: A total of 148 ex-preterm infants were studied. Cerebellar injury was present in 14 (9 %) cases and associated with supratentorial parenchymal injury in 90 %. Duration of ventilation was longer in children with cerebellar injury, compared to controls (19.5 days vs 16.5 days; P=0.03). The other neonatal criteria analyzed were comparable between the two groups. Global developmental, functional, and social-behavioral deficits were more common and profound in preterm infants with cerebellar injury, with no significant difference. CONCLUSION: This study confirms the high incidence of cerebellar injury in very preterm infants and the importance of a specific neurobehavioral follow-up.