[Intrahepatic cholestasis of pregnancy: French College of Obstetricians and Gynecologists guidelines for clinical practice]. / La cholestase gravidique : recommandations pour la pratique clinique du Collège national des gynécologues obstétriciens français.

OBJECTIVE: To identify strategies for reducing neonatal and maternal morbidity associated with intrahepatic cholestasis pregnancy (ICP). MATERIAL AND METHODS: The quality of evidence of the literature was assessed following the GRADE methodology with questions formulated in the PICO format (Patients, Intervention, Comparison, Outcome) and outcomes defined a priori and classified according to their importance. An extensive bibliographic search was performed on PubMed, Cochrane, EMBASE and Google Scholar databases. The quality of the evidence was assessed (high, moderate, low, very low) and a (i) strong or (ii) weak recommendations or (iii) no recommendation were formulated. The recommendations were reviewed in two rounds with external reviewers (Delphi survey) to select the consensus recommendations. RESULTS: Of the 14 questions (from 12 PICO questions and one definition question outside the PICO format), there was agreement between the working group and the external reviewers on 14 (100%). The level of evidence of the literature was insufficient to provide a recommendation on two questions. ICP is defined by the occurrence of suggestive pruritus (palmoplantar, nocturnal) associated with a total bile acid level>10µmol/L or an alanine transaminase level above 2N after ruling out differential diagnoses. In the absence of suggestive symptoms of a differential diagnosis, it is recommended not to carry out additional biological or ultrasound tests. In women with CIP, ursodeoxycholic acid is recommended to reduce the intensity of maternal pruritus (Strong recommendation. Quality of the evidence moderate) and to decrease the level of total bile acids and alanine transaminases. (Strong recommendation. Quality of the evidence moderate). S-adenosyl-methionine, dexamethasone, guar gum or activated charcoal should not be used to reduce the intensity of maternal pruritus (Strong recommendation. Quality of evidence low), and there is insufficient data to recommend the use of antihistamines (No recommendation. Quality of evidence low). Rifampicin (Weak recommendation. Very low quality of evidence) or plasma exchange (Strong recommendation. Very low quality of evidence) should not be used to reduce maternal pruritus and perinatal morbidity. Serum monitoring of bile acids is recommended to reduce perinatal morbidity and mortality (stillbirth, prematurity) (Low recommendation. Quality of the evidence low). The level of evidence is insufficient to determine whether fetal heart rate or fetal ultrasound monitoring are useful to reduce perinatal morbidity (No recommendation). Birth is recommended when bile acid level is above 99µmol/L from 36 weeks gestation to reduce perinatal morbidity, in particular stillbirth. When bile acid level is above 99µmol/L is below 100µmol/L, women should be informed that induction of labor could be considered 37 and 39 weeks gestation to reduce perinatal morbidity. (Strong recommendation. Quality of evidence low). In postpartum, total bile acids and alanine transaminases level should be checked and normalized before prescribing estrogen-progestin contraception, ideally with a low estrogen dose (risk of recurrence of pruritus and cytolysis) (Low recommendation. Quality of evidence very low). CONCLUSION: Although the quality of evidence regarding ICP gestational cholestasis remains low, there is a strong consensus in France, as shown by our Delphi study, on how to manage women with ICP. The reference first-line treatment is ursodeoxycholic acid.

[The cesarean procedure: Guidelines for clinical practice from the French College of Obstetricians and Gynecologists]. / La technique de la césarienne : recommandations pour la pratique clinique du Collège national des gynécologues obstétriciens français.

OBJECTIVE: To identify procedures to reduce maternal morbidity during cesarean. MATERIAL AND METHODS: The quality of evidence of the literature was assessed following the GRADE® method with questions formulated in the PICO format (Patients, Intervention, Comparison, Outcome) and outcomes defined a priori and classified according to their importance. An extensive bibliographic search was performed on PubMed, Cochrane and EMBASE databases. The quality of the evidence was assessed (high, moderate, low, very low) and a (i) strong or (ii) weak recommendations or (iii) no recommendation were formulated. The recommendations were reviewed in two rounds with external reviewers (Delphi survey) to select the consensus recommendations. RESULTS: Of the 27 questions, there was agreement between the working group and the external reviewers on 26. The level of evidence of the literature was insufficient to provide a recommendation on 15 questions. Preventing hypothermia is recommended to increase maternal satisfaction and comfort (weak recommendation) and to reduce neonatal hypothermia (strong recommendation). The quality of the evidence of the literature did not allow to recommend the skin disinfectant to be used nor the relevance of a preoperative vaginal disinfection nor the choice between the use or nonuse of an indwelling bladder catheterization (if micturition takes place 1 hour before the cesarean section). The Misgav-Ladach technique or its analogues should be considered rather than the Pfannenstiel technique to reduce maternal morbidity (weak recommendation) bladder flap before uterine incision should not be performed routinely (weak recommendation), but a blunt (weak recommendation) and cephalad-caudad extension of uterine incision (weak recommendation) should be considered to reduce maternal morbidity. Antibiotic prophylaxis is recommended to reduce maternal infectious morbidity (strong recommendation) without recommendation on its type or the timing of administration (before incision or after cord clamping). The administration of carbetocin after cord clamping does not significantly decrease the incidence of blood loss>1000 ml, anemia, or blood transfusion compared with the administration of oxytocin. Thus, it is not recommended to use carbetocin rather than oxytocin in cesarean. It is recommended that systematic manual removal of the placenta not to be performed (weak recommendation). An antiemetic should be administered after cord clamping in women having a planned cesarean under locoregional anaesthesia to reduce intraoperative and postoperative nausea and vomiting (strong recommendation) with no recommendation regarding choice of use one or two antiemetics. The level of evidence of the literature was insufficient to provide any recommendation concerning single or double-layer closure of the uterine incision, or the uterine exteriorization. Closing the peritoneum (visceral or parietal) should not be considered (weak recommendation). The quality of the evidence of the literature was not sufficient to provide recommendation on systematic subcutaneous closure, including in obese or overweight patients, or the use of subcuticular suture in obese or overweight patients. The use of subcuticular suture in comparison with skin closure by staples was not considered as a recommendation due to the absence of a consensus in the external review rounds. CONCLUSION: In case of cesarean, preventing hypothermia, administering antiemetic and antibiotic prophylaxis after cord clamping are the only strong recommendations. The Misgav-Ladach technique, the way of performing uterine incision (no systematic bladder flap, blunt cephalad-caudad extension), not performing routine manual removal of the placenta nor closure of the peritoneum are weak recommendations and may reduce maternal morbidity.

[Expert consensus from the College of French Gynecologists and Obstetricians: Management of nausea and vomiting of pregnancy and hyperemesis gravidarum]. / Consensus formalisé d'experts du Collège national des gynécologues et obstétriciens français : prise en charge des nausées et vomissements gravidiques et de l'hyperémèse gravidique.

OBJECTIVE: To determine the management of patients with 1st trimester nausea and vomiting and hyperemesis gravidarum. METHODS: A panel of experts participated in a formal consensus process, including focus groups and two Delphi rounds. RESULTS: Hyperemesis gravidarum is distinguished from nausea and vomiting during pregnancy by weight loss≥5 % or signs of dehydration or a PUQE score≥7. Hospitalization is proposed when there is, at least, one of the following criteria: weight loss≥10%, one or more clinical signs of dehydration, PUQE (Pregnancy Unique Quantification of Emesis and nausea) score≥13, hypokalemia<3.0mmol/L, hyponatremia<120mmol/L, elevated serum creatinine>100µmol/L or resistance to treatment. Prenatal vitamins and iron supplementation should be stopped without stopping folic acid supplementation. Diet and lifestyle should be adjusted according to symptoms. Aromatherapy is not to be used. If the PUQE score is<6, even in the absence of proof of their benefit, ginger, pyridoxine (B6 vitamin), acupuncture or electrostimulation can be used, even in the absence of proof of benefit. It is proposed that drugs or combinations of drugs associated with the least severe and least frequent side effects should always be chosen for uses in 1st, 2nd or 3rd intention, taking into account the absence of superiority of a class over another to reduce the symptoms of nausea and vomiting of pregnancy and hypermesis gravidarum. To prevent Gayet Wernicke encephalopathy, Vitamin B1 must systematically be administered for hyperemesis gravidarum needing parenteral rehydration. Patients hospitalized for hyperemesis gravidarum should not be placed in isolation (put in the dark, confiscation of the mobile phone or ban on visits, etc.). Psychological support should be offered to all patients with hyperemesis gravidarum as well as information on patient' associations involved in supporting these women and their families. When returning home after hospitalization, care will be organized around a referring doctor. CONCLUSION: This work should contribute to improving the care of women with hyperemesis gravidarum. However, given the paucity in number and quality of the literature, researchers must invest in the field of nausea and vomiting in pregnancy, and HG to identify strategies to improve the quality of life of women with nausea and vomiting in pregnancy or hyperemesis gravidarum.

[Ante- and postnatal growth charts in France - guidelines for clinical practice from the Collège national des gynécologues et obstétriciens français (CNGOF) and from the Société française de néonatologie (SFN)]. / Les courbes de croissance anté- et postnatales en France ­ recommandations pour la pratique clinique du Collège national des gynécologues et obstétriciens français (CNGOF) et de la Société française de néonatologie (SFN).

OBJECTIVE: To recommend the most appropriate biometric charts for the detection of antenatal growth abnormalities and postnatal growth surveillance. METHODS: Elaboration of specific questions and selection of experts by the organizing committee to answer these questions; analysis of the literature by experts and drafting conclusions by assigning a recommendation (strong or weak) and a quality of evidence (high, moderate, low, very low) and for each question; all these recommendations have been subject to multidisciplinary external review (obstetrician gynecologists, pediatricians). The objective for the reviewers was to verify the completeness of the literature review, to verify the levels of evidence established and the consistency and applicability of the resulting recommendations. The overall review of the literature, quality of evidence and recommendations were revised to take into consideration comments from external reviewers. RESULTS: Antenatally, it is recommended to use all WHO fetal growth charts for EFW and common ultrasound biometric measurements (strong recommendation; low quality of evidence). Indeed, in comparison with other prescriptive curves and descriptive curves, the WHO prescriptive charts show better performance for the screening of SGA (Small for Gestational Age) and LGA (Large for Gestational Age) with adequate proportions of fetuses screened at extreme percentiles in the French population. It also has the advantages of having EFW charts by sex and biometric parameters obtained from the same perspective cohort of women screened by qualified sonographers who measured the biometric parameters according to international standards. Postnatally, it is recommended to use the updated Fenton charts for the assessment of birth measurements and for growth monitoring in preterm infants (strong recommendation; moderate quality of evidence) and for the assessment of birth measurements in term newborn (expert opinion). CONCLUSION: It is recommended to use WHO fetal growth charts for antenatal growth monitoring and Fenton charts for the newborn.

[Reprint of: Severe pre-eclampsia: guidelines for clinical practice from the French Society of anesthesiology and intensive care (SFAR) and the French College of gynaecologists and obstetricians (CNGOF)]. / Republication de : recommandations formalisées d'experts. Prise en charge de la patiente avec une pré-éclampsie sévère­RFE communes Société française d'anesthésie-réanimation (SFAR)­Collège national des gynécologues et obstétriciens français (CGNOF).

OBJECTIVE: To provide national guidelines for the management of women with severe preeclampsia. DESIGN: A consensus committee of 26 experts was formed. A formal conflict of interest (COI) policy was developed at the onset of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding. The authors were advised to follow the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The last SFAR and CNGOF guidelines on the management of women with severe preeclampsia was published in 2009. The literature is now sufficient for an update. The aim of this expert panel guidelines is to evaluate the impact of different aspects of the management of women with severe preeclampsia on maternal and neonatal morbidities separately. The experts studied questions within 7 domains. Each question was formulated according to the PICO (Patients Intervention Comparison Outcome) model and the evidence profiles were produced. An extensive literature review and recommendations were carried out and analyzed according to the GRADE® methodology. RESULTS: The SFAR/CNGOF experts panel provided 25 recommendations: 8 have a high level of evidence (GRADE 1±), 9 have a moderate level of evidence (GRADE 2±), and for 7 recommendations, the GRADE method could not be applied, resulting in expert opinions. No recommendation was provided for 3 questions. After one scoring round, strong agreement was reached between the experts for all the recommendations. CONCLUSIONS: There was strong agreement among experts who made 25 recommendations to improve practices for the management of women with severe preeclampsia.

[CNGOF clinical practice guidelines: Evaluation one year after revision of the methodology]. / Recommandations pour la pratique clinique du CNGOF : évaluation un an après révision de la méthodologie.

OBJECTIVES: To evaluate the revision of methodology of the clinical practice guidelines (CPG) of the French National College of Gynecologists and Obstetricians (CNGOF). METHOD: Three CPGs were organized in 2020 on the topics of severe preeclampsia, menorrhagia, and prophylactic surgery according to AGREE II (Apraisal of Guidelines for Research & Evaluation). Questions were presented in PICO (Population, Intervention, Comparison, Outcome) format and the grading of scientific evidence was based on the GRADE (Grading of Recommendation Assessment, Development and Evaluation) method. RESULTS: All three CPGs groups adhered to this new methodology. However, the presentation of the arguments, the formulation of the recommendations and the development of the GRADE tables were heterogeneous from one group to another. A homogenization of the presentation is proposed, as well as a guide to the critical analysis of the literature to help the experts to rate the evidence. CONCLUSION: Adherence to these quality criteria should make it easier to apply the recommendations at the national level and improve international recognition of the work done by the CNGOF.

[Term Prelabor Rupture of Membranes: CNGOF Guidelines for Clinical Practice - Short Text]. / Rupture des membranes à terme avant travail. Recommandations pour la pratique clinique du CNGOF ­ Texte court.

OBJECTIVE: To determine the management of patients with term prelabor rupture of membranes. METHODS: Synthesis of the literature from the PubMed and Cochrane databases and the recommendations of French and foreign societies and colleges. RESULTS: Term prelabor rupture of membranes is considered a physiological process up to 12hours of rupture (Professional consensus). In case of expectant management and with a low rate of antibiotic prophylaxis, home care compared to hospitalization could be associated with an increase in neonatal infections (LE3), especially in case of group B streptococcus colonization (LE3). Home care is therefore not recommended (Grade C). In the absence of spontaneous labor within 12hours of rupture, antibiotic prophylaxis could reduce the risk of maternal intrauterine infection but not of neonatal infection (LE3). Its use after 12hours of rupture in term prelabor rupture of the membranes is therefore recommended (Grade C). When antibiotic prophylaxis is indicated, intravenous beta-lactams are recommended (Grade C). Induction of labor with oxytocin (LE1), prostaglandin E2 (LE1) or misoprostol (LE1), is associated with shorter rupture of membranes to delivery intervals when compared to expectant management. Compared with expectant management, immediate induction of labor is not associated with lower rates of neonatal infection (LE1), even among women with a positive streptococcus B vaginal swab (LE2). Thus, expectant management can be offered without increasing the risk of neonatal infection (Grade B). Induction of labor is not associated with an increase or decrease in the cesarean delivery rate (LE2), whatever parity (LE2) or Bishop score at admission (LE3). Induction can thus be proposed without increasing the risk of cesarean delivery (Grade B). No induction method (oxytocin, dinoprostone, misoprostol or Foley® catheter) has demonstrated superiority over another, whether to reduce rate of intrauterine or neonatal infection, rate of cesarean delivery or to shorten rupture of membranes to delivery intervals regardless of Bishop's score and parity. CONCLUSION: Term prelabor rupture of membranes is a frequent event. A 12-hour delay without onset of spontaneous labor was chosen to differentiate a physiological condition from a potentially unsafe situation justifying an antibiotic prophylaxis. Expectant management or induction of labor can both be proposed, even in case of positive screening for streptococcus B, depending on the patient's wishes and maternity units' organization (Professional consensus).

[Breech Presentation: CNGOF Guidelines for Clinical Practice - Short Text]. / Présentation du siège. Recommandations pour la pratique clinique du CNGOF ­ Texte court.

OBJECTIVES: To determine the optimal management of singleton breech presentation. MATERIALS AND METHODS: The PubMed database, the Cochrane Library and the recommendations from the French and foreign obstetrical societies or colleges have been consulted. RESULTS: In France, 5% of women have breech deliveries (Level of Evidence [LE3]). One third of them have a planned vaginal delivery (LE3) of whom 70% deliver vaginally (LE3). External cephalic version (ECV) is associated with a reduced rate of breech presentation at birth (LE2), and with a lower rate of cesarean section (LE3) without increases in severe maternal (LE3) and perinatal morbidity (LE3). It is therefore recommended to inform women with a breech presentation at term that ECV could be attempted from 36 weeks of gestation (Professional consensus). In case of breech presentation, planned vaginal compared with planned cesarean delivery might be associated with an increased risk of composite perinatal mortality or serious neonatal morbidity (LE2). No difference has been found between planned vaginal and planned cesarean delivery for neurodevelopmental outcomes at two years (LE2), cognitive and psychomotor outcomes between 5 and 8 years (LE3), and adult intellectual performances (LE4). Short and long term maternal complications appear similar in case of planned vaginal compared with planned cesarean delivery in the absence of subsequent pregnancies. A previous cesarean delivery results for subsequent pregnancies in higher risks of uterine rupture, placenta accreta spectrum and hysterectomy (LE2). It is recommended to offer women who wish a planned vaginal delivery a pelvimetry at term (Grade C) and to check the absence of hyperextension of the fetal head by ultrasonography (Professional consensus) to plan their mode of delivery. Complete breech presentation, previous cesarean, nulliparity, term prelabor rupture of membranes do not contraindicate planned vaginal delivery (Professionnal consensus). Term breech presentation is not a contraindication to labor induction when the criteria for acceptance of vaginal delivery are met (Grade C). CONCLUSION: In case of breech presentation at term, the risks of severe morbidity for the child and the mother are low after both planned vaginal and planned cesarean delivery. For the French College of Obstetricians and Gynecologists (CNGOF), planned vaginal delivery is a reasonable option in most cases (Professional consensus). The choice of the planned route of delivery should be shared by the woman and her caregiver, respecting the right to woman's autonomy.

[CNGOF Guidelines for Clinical Practice: Revision of the Methodology]. / Recommandations pour la pratique clinique du CNGOF : révision méthodologique du processus d'élaboration.

OBJECTIVES: To revise the organization and the methodology of the Practice Clinical Guidelines (PCG) of the French College of Gynecologists and Obstetricians (CNGOF). METHODS: The different available methods of PCG organization and of scientific evidence grading have been consulted after searching in the Medline database. RESULTS: The PCG group of the CNGOF has decided to adopt the AGREE II (for Appraisal of Guidelines for REsearch and Evaluation) methology for PCG organization and the GRADE (for Grading of Recommendation Assessment, Development, and Evaluation) system for grading scientific evidence. CONCLUSION: By adopting the AGREE II consortium criteria and grading scientific evidence according to the GRADE system, the CNGOF will increase the quality of the overall process, will deliver more targeted and easy to assimilate recommendations, to facilitate professional decision making.

[Diagnostic and therapeutic recommendations for sexually transmitted diseases: Genital herpes]. / Recommandations diagnostiques et thérapeutiques pour les maladies sexuellement transmissibles : herpès génital au cours de la grossesse.

TREATMENT OF THE INITIAL INFECTION OR FIRST CLINICAL EPISODE OF GENITAL HERPES: An initial infection or first clinical episode of genital herpes is treated with oral aciclovir 200mg×5/d for 5 to 10 days depending on clinical status. The recommended dosage for valaciclovir is 1g×2/d and treatment duration is identical to that for aciclovir. TREATMENT OF HERPES RECURRING DURING PREGNANCY: There are no studies of the efficacy of antiviral therapy on the symptoms of genital recurring during pregnancy. However, initial anti-viral treatment using aciclovir or valaciclovir may be given where warranted by symptoms (i.e. duration and severity of symptoms). Valaciclovir may be used instead (equivalent efficacy but better safety data for aciclovir). Valaciclovir may be given at a dosage of 1×500mg b.i.d. p.o. for 5 days. PROPHYLACTIC ANTI-VIRAL TREATMENT DURING PREGNANCY: In female patients presenting an initial infection or infection recurring during pregnancy, although there is no demonstrated benefit for prophylactic treatment in reducing the risk of neonatal herpes, anti-viral prophylaxis is recommended after 36 WA (weeks' amenorrhoea) to limit the need for Caesarean section due to herpetic lesions. The recommended antivirals are aciclovir at a dosage of 400mg t.i.d p.o. or valaciclovir at a dosage of 500mg b.i.d. p.o. until delivery.

[Preterm premature rupture of membranes: CNGOF Guidelines for clinical practice - Short version]. / Rupture prématurée des membranes avant terme : recommandations pour la pratique clinique du CNGOF ­ Texte court.

OBJECTIVE: To determine management of women with preterm premature rupture of membranes (PPROM). METHODS: Bibliographic search from the Medline and Cochrane Library databases and review of international clinical practice guidelines. RESULTS: In France, PPROM rate is 2 to 3% before 37 weeks of gestation (level of evidence [LE] 2) and less than 1% before 34 weeks of gestation (LE2). Prematurity and intra-uterine infection are the two major complications of PPROM (LE2). Compared to other causes of prematurity, PPROM is not associated with an increased risk of neonatal mortality and morbidity, except in case of intra-uterine infection, which is associated with an augmentation of early-onset neonatal sepsis (LE2) and of necrotizing enterocolitis (LE2). PPROM diagnosis is mainly clinical (professional consensus). In doubtful cases, detection of IGFBP-1 or PAMG-1 is recommended (professional consensus). Hospitalization of women with PPROM is recommended (professional consensus). There is no sufficient evidence to recommend or not recommend tocolysis (grade C). If a tocolysis should be prescribed, it should not last more than 48hours (grade C). Antenatal corticosteroids before 34 weeks of gestation (grade A) and magnesium sulfate before 32 weeks of gestation (grade A) are recommended. Antibiotic prophylaxis is recommended (grade A) because it is associated with a reduction of neonatal mortality and morbidity (LE1). Amoxicillin, 3rd generation cephalosporins, and erythromycin in monotherapy or the association erythromycin-amoxicillin can be used (professional consensus), for 7 days (grade C). However, in case of negative vaginal culture, early cessation of antibiotic prophylaxis might be acceptable (professional consensus). Co-amoxiclav, aminosides, glycopetides, first and second generation cephalosporins, clindamycin, and metronidazole are not recommended for antibiotic prophylaxis (professional consensus). Outpatient management of women with clinically stable PPROM after 48hours of hospitalization is a possible (professional consensus). During monitoring, it is recommended to identify the clinical and biological elements suggesting intra-uterine infection (professional consensus). However, it not possible to make recommendation regarding the frequency of this monitoring. In case of isolated elevated C-reactive protein, leukocytosis, or positive vaginal culture in an asymptomatic patient, it is not recommended to systematically prescribe antibiotics (professional consensus). In case of intra-uterine infection, it is recommended to immediately administer an antibiotic therapy associating beta-lactamine and aminoside (grade B), intravenously (grade B), and to deliver the baby (grade A). Cesarean delivery should be performed according to the usual obstetrical indications (professional consensus). Expectative management is recommended before 37 weeks of gestation in case of uncomplicated PPROM (grade A), even in case of positive vaginal culture for B Streptococcus, provided that an antibiotic prophylaxis has been prescribed (professional consensus). Oxytocin and prostaglandins are two possible options to induce labor in case of PPROM (professional consensus). CONCLUSION: Expectative management is recommended before 37 weeks of gestation in case of uncomplicated PPROM (grade A).

[Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial]. / Prédiction échographique du risque de rupture utérine après césarienne : LUSTrial, un essai randomisé pragmatique.

BACKGROUND: The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. METHODS/DESIGN: This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be performed by expert sonographers after certification by the main investigator. Women aged 18 years or older are eligible for this trial if they have a singleton pregnancy in cephalic presentation at a gestational age from 36 to 38 weeks, a previous low transverse cesarean delivery and sign the informed consent sheet. Women will be asked to participate in this study when they reach a term of 36 to 38 weeks of gestation. After agreement, women will be randomized into two groups: in the study group, they will have the LUS measured by ultrasound and the patient will be informed that, based on a threshold value of 3.5mm for the ultrasound measurement of the LUS thickness, the patient with a higher measurement will be considered at low risk and will be encouraged to choose a trial of labor whereas the patient with a measurement is equal to or less than this threshold will be considered at risk and encouraged to choose an elective repeat cesarean; in the control group, ultrasound LUS measurement will not be performed. The mode of delivery will be decided according to standard practice at the center. The primary composite outcome will include: uterine rupture, uterine dehiscence, hysterectomy, thromboembolic complications, transfusion, endometritis, maternal mortality, fetal prenatal and intrapartum mortality, hypoxic-ischemic encephalopathy and neonatal mortality. DISCUSSION: This trial assesses the efficacy of ultrasound measurement of the lower uterine segment in women with a prior cesarean delivery in reducing fetal and maternal morbidity and mortality and it will provide evidence in order to establish clinical recommendations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01916044 (date of registration: 5 August 2013).

Prognosis of isolated congenital diaphragmatic hernia using lung-area-to-head-circumference ratio: variability across centers in a national perinatal network.

OBJECTIVE: Congenital diaphragmatic hernia (CDH) is a severe anomaly. The observed-to-expected lung-area-to-head-circumference ratio (o/e-LHR) has been shown to provide a useful prediction of subsequent survival of fetuses with CDH in referral centers with expertise and a large caseload. However, the accuracy of o/e-LHR measurements in general fetal medicine units with less expertise is not well known. The aim of this study was to evaluate the capacity of o/e-LHR to provide a useful prediction of mortality of fetuses with CDH when the measurement is performed in fetal medicine units with different levels of expertise. METHODS: Between January 2008 and November 2013, 305 live births with expectantly managed left-sided isolated CDH were recorded in the database of the French National Center for Rare Diseases (31 centers) and followed up after birth. Centers were grouped into two categories according to their mean annual CDH caseload over the study period: large centers with an average of ≥ 14 cases and smaller centers with < 14 cases per year. The relationship between o/e-LHR and 28-day and 6-month mortality was modeled using fractional polynomials and the predictive value of o/e-LHR was quantified using the area under the receiver-operating characteristics curve. Comparisons between the two center categories were carried out. Analyses were adjusted for potential confounders such as thoracic herniation of the liver and gestational age at birth and at diagnosis. RESULTS: During the study period, two large centers managed a total of 82 CDH cases and 29 smaller centers a total of 223 CDH cases. Overall, there was a significant inverse relationship between 28-day mortality rate and o/e-LHR, which decreased from 54% when o/e-LHR was 20% to 6% when o/e-LHR was 75% (P < 0.01). When the category of center was considered, adjusted associations between o/e-LHR and 28-day mortality were significantly different (P = 0.032) between large and smaller centers. The ability to predict survival at 28 days postpartum based on o/e-LHR was better in large centers; for a specificity of 0.30, the sensitivity was 0.71 in large centers and 0.55 in smaller ones. The results were similar for 6-month mortality. CONCLUSIONS: Our results show that o/e-LHR measured on two-dimensional ultrasound is a good indicator of neonatal prognosis in cases of CDH that may be used even in fetal medicine centers with a small caseload. However, our results also suggest that LHR measurement may be difficult to perform correctly. Therefore, appropriate training should be offered to professionals. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.