[Preeclampsia: Guidelines for clinical practice from the French College of Obstetricians and Gynecologists]. / La pré-éclampsie : recommandations pour la pratique clinique du Collège national des gynécologues obstétriciens français.

OBJECTIVE: To identify strategies to reduce maternal and neonatal morbidity related to preeclampsia. 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, EMBASE and Google Scholar databases. The quality of the evidence was assessed (high, moderate, low, very low) and recommendations were formulated as a (i) strong, (ii) weak or (iii) no recommendation. The recommendations were reviewed in two rounds with external reviewers (Delphi survey) to select the consensus recommendations. RESULTS: Preeclampsia is defined by the association of gestational hypertension (systolic blood pressure≥140mmHg and/or diastolic blood pressure≥90mmHg) and proteinuria≥0.3g/24h or a Proteinuria/Creatininuria ratio≥30mg/mmol occurring after 20 weeks of gestation. Data from the literature do not show any benefit in terms of maternal or perinatal health from implementing a broader definition of preeclampsia. Of the 31 questions, there was agreement between the working group and the external reviewers on 31 (100%). In general population, physical activity during pregnancy should be encouraged to reduce the risk of preeclampsia (Strong recommendation, Quality of the evidence low) but an early screening based on algorithms (Weak recommendation, Quality of the evidence low) or aspirin administration (Weak recommendation, Quality of the evidence very low) is not recommended to reduce maternal and neonatal morbidity related to preeclampsia. In women with preexisting diabetes or hypertension or renal disease, or multiple pregnancy, the level of evidence is insufficient to determine whether aspirin administration during pregnancy is useful to reduce maternal and perinatal morbidity (No recommendation, Quality of the evidence low). In women with a history of vasculo-placental disease, low dose of aspirin (Strong recommendation, Quality of the evidence moderate) at a dosage of 100-160mg per day (Weak recommendation, Quality of the evidence low), ideally before 16 weeks of gestation and not after 20 weeks of gestation (Strong recommendation, Quality of the evidence low) until 36 weeks of gestation (Weak recommendation, Quality of the evidence very low) is recommended. In a high-risk population, additional administration of low molecular weight heparin is not recommended (Weak recommendation, Quality of the evidence moderate). In case of preeclampsia (Weak recommendation, Quality of the evidence low) or suspicion of preeclampsia (Weak recommendation, Quality of the evidence moderate, the assessment of PlGF concentration or sFLT-1/PlGF ratio is not routinely recommended) in the only goal to reduce maternal or perinatal morbidity. In women with non-severe preeclampsia antihypertensive agent should be administered orally when the systolic blood pressure is measured between 140 and 159mmHg or diastolic blood pressure is measured between 90 and 109mmHg (Weak recommendation, Quality of the evidence low). In women with non-severe preeclampsia, delivery between 34 and 36+6 weeks of gestation reduces severe maternal hypertension but increases the incidence of moderate prematurity. Taking into account the benefit/risk balance for the mother and the child, it is recommended not to systematically induce birth in women with non-severe preeclampsia between 34 and 36+6 weeks of gestation (Strong recommendation, Quality of evidence high). In women with non-severe preeclampsia diagnosed between 37+0 and 41 weeks of gestation, it is recommended to induce birth to reduce maternal morbidity (Strong recommendation, Low quality of evidence), and to perform a trial of labor in the absence of contraindication (Strong recommendation, Very low quality of evidence). In women with a history of preeclampsia, screening maternal thrombophilia is not recommended (Strong recommendation, Quality of the evidence moderate). Because women with a history of a preeclampsia have an increased lifelong risk of chronic hypertension and cardiovascular complications, they should be informed of the need for medical follow-up to monitor blood pressure and to manage other possible cardiovascular risk factors (Strong recommendation, Quality of the evidence moderate). CONCLUSION: The purpose of these recommendations was to reassess the definition of preeclampsia, and to determine the strategies to reduce maternal and perinatal morbidity related to preeclampsia, during pregnancy but also after childbirth. They aim to help health professionals in their daily clinical practice to inform or care for patients who have had or have preeclampsia. Synthetic information documents are also offered for professionals and patients.

Low-dose aspirin to prevent preeclampsia and growth restriction in nulliparous women identified by uterine artery Doppler as at high risk of preeclampsia: A double blinded randomized placebo-controlled trial.

INTRODUCTION: This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester uterine artery Dopplers as at high risk of preeclampsia. METHODS: This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death. RESULTS: The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 [-2.6; 5.9] p = 0.45). The two groups did not differ significantly for the secondary outcomes. CONCLUSION: Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia. TRIAL REGISTRATION: (NCT0172946).

Laparotomy-Assisted 2-Port Fetoscopic Repair of Spina Bifida Aperta: Report of a Single-Center Experience in Paris, France.

BACKGROUND: Given the maternal morbidity of open fetal surgery, the development of prenatal fetoscopic repair for spina bifida aperta (SBA) is encouraged. OBJECTIVE: We hereby report the early results from our center, using a laparotomy-assisted CO2-fetoscopic approach. METHODS: This study was conducted in patients with an SBA < T1 and >S1, <26 weeks of gestation, with Chiari II. Fetoscopic repair was performed using 2 operating trocars in the uterus exteriorized through a transverse laparotomy. Endoscopy was performed under humidified and heated CO2 insufflation. Following dissection of the lesion, a 1-layer approach was performed with a muscle/skin flap sutured over a patch of Duragen. Main outcomes were watertight repair at birth and the need for postnatal neurosurgical surgery including shunting within 6 months. RESULTS: Of 87 women assessed for prenatal therapy, 7 were included. Surgery was performed at 24 (23-26) weeks' gestation. There was no fetal demise. Conversion to hysterotomy was not performed, although surgery could not be performed in 1 case because of fetal position. Severe preeclampsia developed postoperatively in 1 case. In the other 6 cases, follow-up was uneventful except for premature rupture membranes which occurred in 3/6 cases at 30, 34, and 36+5 weeks' gestation. Gestational age at delivery was 32 + 5 (31-36 + 5) weeks' gestation. Repair was watertight at birth except in 2 cases which required complementary postnatal surgical repair. Reverse hindbrain herniation during pregnancy was observed in 4/6 cases. In 3/6 cases, shunting was necessary within 6 months after birth. At 12 months, a functional gain of ≥2 metameric levels was observed in 3 cases of the 6 survivors. CONCLUSION: Laparotomy-assisted fetoscopic repair is a reasonable option for women who choose and are eligible for antenatal surgery, both in terms of maternal and perinatal morbidity.

The experience of giving birth: a prospective cohort in a French perinatal network.

BACKGROUND: To assess women's positive and negative perceptions after giving birth. The secondary objectives were to identify the women who had a negative perception of their delivery, define the risk factors, and propose actions that maternity units can take to improve their management. METHODS/DESIGN: This study was a multicenter, prospective cohort, conducted in 23 French maternity units constituting one perinatal network, in 2019. All adult women who understood French and gave birth between February 1 and September 27, 2019, were eligible. The exclusion criterion was the woman's objection to participation. Validated self-administered questionnaire (QACE) was sent by email 6 weeks after the child's birth. The main outcome was the experience of childbirth, assessed on a scale of 0 to 10. A good experience was defined by a score ≥ 8/10, and a poor experience by a score < 5. A multinomial logistic regression model, expressed by cumulative proportional odds ratios, were used to determine the factors that might have affected women's experiences during childbirth. RESULTS: Two thousand one hundred and thirty-fifth women completed the questionnaire, for a participation rate of 49.6%. Overall, 70.7% (n = 1501/2121) of the women reported a good experience, including 38% (n = 807/2121) who graded their experience with the maximum score of 10. On the other hand, 7.3% (n = 156) of the women reported a poor experience. Vaginal delivery (aOR 3.93, 95%CI, 3.04-5.08) and satisfactory management (aOR 11.35 (7.69-16.75)) were the principal determining factors of a positive experience. Epidural analgesia increased the feeling of failure (aOR 5.64, 95%CI, 2.75-13.66). Receiving information and being asked for and agreeing to consent improved the global experience (P = 0.03). CONCLUSION: The Identikit picture of the woman associated with a poor experience of childbirth shows a nullipara who had a complication during her pregnancy, gave birth after induction of labor, or by cesarean or operative vaginal delivery, with the newborn transferred for pediatric care, and medical management considered unsatisfactory.

Management of external cephalic version in France: A national practice survey.

INTRODUCTION: The breech presentation represents 4,7% of deliveries at term. There is a method of external cephalic version (ECV) performed from 36 weeks of gestation. French guidelines for the clinical practice of ECV were published in 2020. OBJECTIVE: To evaluate the national practices of ECV in French maternity units, especially on the use of tocolysis, 1 year after publication of the French clinical recommendations guidelines by the French national college of obstetricians and gynecologists (CNGOF). METHODS: Data self-reported for this national descriptive study were collected from March to May 2021 by an online questionnaire distributed to all French maternities. The 25 items of the questionnaire collected information of maternity units, the general practice of ECV, use or not of tocolysis for ECV attempt and the relevance of a prospective study. RESULTS: Of the 517 French maternity units, 150 (29%) responded to the online survey.  95,3% systematically performed ECV. A Kleihauer test was routinely performed in 71 units (49.7%). A tocolysis was associated with ECV attempt in 52.4% of cases. The drugs used were intravenous atosiban (30,7%), mainly in levels 2b and 3 maternity units, intravenous salbutamol (24%), other mode of administration of salbutamol (14,7%) and oral nifedipine (22,6%) mainly in levels 1 and 2a maternity units. Adverse effects were described in 20%, mainly with the use of salbutamol (73,3%). CONCLUSIONS: 52.4% of the French maternity units surveyed used tocolysis for the ECV attempt, although it is systematically recommended. The choice of tocolytic drug differed according to the maternity units.

Guidelines for the management of women with severe pre-eclampsia.

OBJECTIVE: To provide national guidelines for the management of women with severe pre-eclampsia. 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 emphasised. METHODS: The last SFAR and CNGOF guidelines on the management of women with severe pre-eclampsia were 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 analysed 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 pre-eclampsia.

Human placental perfusion measured using dynamic contrast enhancement MRI.

OBJECTIVES: To evaluate the feasibility of dynamic contrast enhanced magnetic resonance imaging (DCE MRI) and measure values of in vivo placental perfusion in women. METHODS: This study was part of the Placentimage trial (NCT01092949). Gadolinium-chelate (Gd) enhanced dynamic MRI was performed two days before termination of pregnancies at 16 to 34 weeks gestational age (GA). Quantitative analysis was performed using one-compartment intravascular modeling. DCE perfusion parameters were analyzed across GA and were compared in IUGR and AGA fetuses. RESULTS: 134 patients were enrolled. After quality control check, 62 DCE MRI were analyzed including 48 and 14 pregnancies with normal and abnormal karyotypes, respectively. Mean placental blood flow was 129±61 mL/min/100ml in cases with normal karyotypes. Fetuses affected by IUGR (n = 13) showed significantly lower total placental blood flow values than AGA fetuses (n = 35) (F total = 122±88 mL/min versus 259±34 mL/min, p = 0.002). DCE perfusion parameters showed a linear correlation with GA. CONCLUSIONS: Measuring placental perfusion in vivo is possible using DCE MRI. Although this study has many limitations it gives us the first DCE MRI values that provide a potential standard for future research into placental perfusion methods and suggests that placental functional parameters are altered in IUGR pregnancies.

MRI based morphological examination of the placenta.

Ultrasound is widely used as the initial diagnostic imaging modality during pregnancy with both high spatial and temporal resolution. Although MRI in pregnancy has long focused on the fetus, its use in placental imaging has greatly increased over recent years. In addition to the possibilities of evaluating function, MRI with a wide field of view and high contrast resolution allows characterization of placental anatomy, particularly in situations that are difficult to specify with ultrasound, especially for suspected placenta accreta. MRI also appears to be a particularly useful examination for the anatomical evaluation of the placenta independent of maternal body habitus or fetal position. Indeed, surprisingly little attention is paid to the placenta in MRI when the indication for the examination is fetal. Thus, some aspects of the placenta seem to us to be important to be recognized by the radiologist and to be described on the MRI report. In this review, we will describe MRI sequences used for, and common features seen in, imaging of i) the normal placenta, ii) abnormal aspects of the placenta that should be identified on MRI performed for fetal reason, and iii) placental anomalies for which placental MRI may be indicated.

Dynamic contrast enhanced magnetic resonance imaging: A review of its application in the assessment of placental function.

It is important to develop a better understanding of placental insufficiency given its role in common maternofetal complications such as preeclampsia and fetal growth restriction. Functional magnetic resonance imaging offers unprecedented techniques for exploring the placenta under both normal and pathological physiological conditions. Dynamic contrast-enhanced magnetic resonance imaging (DCE MRI) is an established and very robust method to investigate the microcirculatory parameters of an organ and more specifically its perfusion. It is currently a gold standard in the physiological and circulatory evaluation of an organ. Its application to the human placenta could enable to access many microcirculatory parameters relevant to the placental function such as organ blood flow, fractional blood volume, and permeability surface area, by the acquisition of serial images, before, during, and after administration of an intravenous contrast agent. Widely used in animal models with gadolinium-based contrast agents, its application to the human placenta could be possible if the safety of contrast agents in pregnancy is established or they are confirmed to not cross the placenta.

Contribution of ultrasonography to the prediction of the induction-delivery interval: The ECOLDIA prospective multicenter cohort study.

INTRODUCTION: To evaluate the ability of preinduction ultrasonographic cervical length to predict the interval between induction and delivery in women at term with a Bishop score of 4 to 6 at induction. STUDY DESIGN: This multicenter prospective observational cohort recruited 334 women from April 2010 to March 2014. Inclusion criteria were women with singleton pregnancies at a gestational age ≥37 weeks, with no previous caesarean, a medical indication for induction of labor, and a Bishop score of 4, 5, or 6. All women underwent cervical assessment by both transvaginal ultrasound and digital examination (Bishop score). The induction protocol was standardized. The primary outcome measure was the induction-delivery interval. Hazard ratios (HR) and their 95% confidence intervals (95% CI) were used to assess potential predictors. RESULTS: Mean gestational age at induction was 40.1 weeks, 60.8% of the women were nulliparous, and the cesarean rate was 13.4%. The mean induction-delivery interval was 20.8 h (± 10.6). Delivery occurred within 24 h for 56.9% (n=190) of the women. An ultrasonographic cervical length measurement less than 25 mm (HR=1.50, 95% CI 1.18-1.91, P<0.01) and parity (HR=1.41, 95% CI 1.21-1.65, P<0.01) appeared to predict induction-delivery interval. The cervical length cutoff to reduce the induction-delivery interval was 25 mm. CONCLUSION: A cervical length cutoff of 25 mm was associated with shorter induction-delivery interval in women at term with a Bishop score of 4 to 6.

Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial.

BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.

Impact of antenatal corticosteroids on head circumference of full-term newborns: A French multicenter cohort study.

INTRODUCTION: Our main objective was to evaluate whether antenatal corticosteroids increase the risk of small head circumference in children born at term. Secondary objectives were to evaluate whether they increase the risk of small birthweight and birth length among those children. MATERIAL AND METHODS: A historical cohort included 275 270 live term born children between 2000 and 2013 in 175 French maternity units. The rate of head circumference below the 5th percentile among children born at term and exposed to antenatal corticosteroids was compared with that of two unexposed groups: those children born at term whose mothers had an episode of threatened preterm labor without corticosteroids and those whose mothers had neither threatened preterm labor nor corticosteroids. The association between this treatment and head circumference was evaluated by calculating adjusted risk ratios (aRRs) and their 95% confidence intervals (CIs). The main outcome measure was a head circumference below the 5th percentile at birth, adjusted for sex, and gestational age according to the Pediatric, Obstetrics, and Gynecology Electronic Records Users Association (AUDIPOG) curves. Secondary outcomes were birthweight and birth length below the 5th percentile. RESULTS: The rate of head circumference below the 5th percentile was 5.8% (n = 3388) among children exposed to antenatal corticosteroids and 4.3% (n = 7077) and 4.6% (n = 198 462), respectively, for the two unexposed groups. After adjustment, the risk of having a head circumference below the 5th percentile did not differ between the exposed group and the two control groups (aRR 1.28, 95% confidence interval [CI] 0.97-1.69] and aRR 0.91, 95% CI 0.74-1.13). We did not find an association between antenatal corticosteroids and the rate of birthweight below the 5th percentile. Children exposed to antenatal corticosteroids had a higher risk of a birth length below the 5th percentile when compared with those not exposed to threatened preterm labor or corticosteroids. CONCLUSIONS: We found no association between antenatal corticosteroids and increased risk of head circumference below the 5th percentile in children born at term.

Perinatal outcomes of intrahepatic cholestasis during pregnancy: An 8-year case-control study.

INTRODUCTION: Previous studies of fetal effects have suggested that intrahepatic cholestasis of pregnancy is associated with a higher rate of adverse neonatal outcomes including preterm birth, neonatal respiratory distress syndrome, meconium-stained amniotic fluid, neonatal intensive care unit admission, and stillbirth. The objective was to compare the neonatal and maternal consequences in pregnancies affected by intrahepatic cholestasis and normal pregnancies. MATERIAL AND METHODS: This case-control study compares pregnancies affected by intrahepatic cholestasis (pruritus and bile acid ≥ 10 µmol/L) with low-risk pregnancies managed between December 2006 and December 2014 at a French university hospital center. RESULTS: There were 83 (59.3%) cases of mild cholestasis (10≤ BA ≤39 µmol/L), 46 (32.8%) of moderate cholestasis (40≤ BA ≤99 µmol/L), and 11 (7.9%) of severe cholestasis (BA ≥100 µmol/L). No in utero fetal deaths occurred in the 140 women with cholestasis or the 560 controls analyzed. The rate of respiratory distress syndrome was higher in neonates of women with intrahepatic cholestasis (17.1% vs. 4.6%, P<0.001; crude OR 4.46 (CI95% 2.49-8.03)). This risk was also significant after adjustment for gestational age at birth and mode of delivery, adjusted OR 2.56 (CI95%1.26-5.18). The postpartum hemorrhage rate was twice as high among the case mothers (25% versus 14.1% for controls, P = 0.002). CONCLUSION: After adjustment on the confounding factors we found a higher rate of respiratory distress syndrome and neonatal morbidity among neonates of the cholestasis group.

Effectiveness of nitrous oxide in external cephalic version on success rate: A randomized controlled trial.

INTRODUCTION: Approximately 4% of singleton pregnancies at term are in breech presentation. External cephalic version (ECV) can reduce the risks of noncephalic birth and cesarean delivery, but this maneuver can be painful. Our aim was to analyze the effect of administering inhaled nitrous oxide for analgesia on the ECV success rate. MATERIAL AND METHODS: This prospective, randomized, single-blind, controlled trial included women with singleton pregnancies in breech presentation at term who were referred for ECV in a tertiary care center. Women were assigned according to a balanced (1:1) restricted randomization design to inhale either nitrous oxide (N2 O) in a 50:50 mix with oxygen or medical air during the procedure. The main outcomes reported are the ECV success rate, degree of pain, adverse event rate, and women's satisfaction. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01948115. RESULTS: The study included 150 women (nitrous oxide group: n = 74; medical air: n = 76). Inhaled nitrous oxide was not associated with a higher ECV success rate than medical air (24.3 vs 19.7%, P = 0.51). Among parous women (n = 34 in each group), the ECV success rate appeared higher in the nitrous oxide group, respectively 47.1% (n = 16) vs 23.5% (n = 8) (P = 0.042). Neither the median pain level nor adverse event rates differed significantly in women with inhaled nitrous oxide compared with medical air. CONCLUSIONS: Use of an equimolar mixture of oxygen and nitrous oxide during ECV appears safe. Although it does not seem to change the overall success rate, it may increase success in parous women.

Development of a Fluid Dynamic Model for Quantitative Contrast-Enhanced Ultrasound Imaging.

Contrast-enhanced ultrasound (CEUS) is a non-invasive imaging technique extensively used for blood perfusion imaging of various organs. This modality is based on the acoustic detection of gas-filled microbubble contrast agents used as intravascular flow tracers. Recent efforts aim at quantifying parameters related to the enhancement in the vascular compartment using time-intensity curve (TIC), and at using these latter as indicators for several pathological conditions. However, this quantification is mainly hampered by two reasons: first, the quantification intrinsically solely relies on temporal intensity variation, the explicit spatial transport of the contrast agent being left out. Second, the exact relationship between the acquired US-signal and the local microbubble concentration is hardly accessible. This paper introduces the use of a fluid dynamic model for the analysis of dynamic CEUS (DCEUS), in order to circumvent the two above-mentioned limitations. A new kinetic analysis is proposed in order to quantify the velocity amplitude of the bolus arrival. The efficiency of proposed methodology is evaluated both in-vitro, for the quantitative estimation of microbubble flow rates, and in-vivo, for the classification of placental insufficiency (control versus ligature) of pregnant rats from DCEUS. Besides, for the in-vivo experimental setup, we demonstrated that the proposed approach outperforms the performance of existing TIC-based methods.

Intraoperative Factors that Predict the Successful Placement of Essure Microinserts.

STUDY OBJECTIVE: To determine whether the number of coils visualized in the uterotubal junction at the end of hysteroscopic microinsert placement predicts successful tubal occlusion. DESIGN: Cohort retrospective study (Canadian Task Force classification II-2). SETTING: Department of obstetrics and gynecology in a teaching hospital. PATIENTS: One hundred fifty-three women underwent tubal microinsert placement for permanent birth control from 2010 through 2014. The local institutional review board approved this study. INTERVENTION: Three-dimensional transvaginal ultrasound (3D TVU) was routinely performed 3 months after hysteroscopic microinsert placement to check position in the fallopian tube. MEASUREMENTS AND MAIN RESULTS: The correlation between the number of coils visible at the uterotubal junction at the end of the hysteroscopic microinsert placement procedure and the device position on the 3-month follow-up 3D TVU in 141 patients was evaluated. The analysis included 276 microinserts placed during hysteroscopy. The median number of coils visible after the hysteroscopic procedure was 4 (interquartile range, 3-5). Devices for 30 patients (21.3%) were incorrectly positioned according to the 3-month follow-up 3D TVU, and hysterosalpingography was recommended. In those patients the median number of coils was in both the right (interquartile range, 2-4) and left (interquartile range, 1-3) uterotubal junctions. The number of coils visible at the uterotubal junction at the end of the placement procedure was the only factor that predicted whether the microinsert was well positioned at the 3-month 3D TVU confirmation (odds ratio, .44; 95% confidence interval, .28-.63). When 5 or more coils were visible, no incorrectly placed microinsert could be seen on the follow-up 3D TVU; the negative predictive value was 100%. No pregnancies were reported. CONCLUSION: The number of coils observed at the uterotubal junction at the time of microinsert placement should be considered a significant predictive factor of accurate and successful microinsert placement.

Real-Time Monitoring of Placental Oxygenation during Maternal Hypoxia and Hyperoxygenation Using Photoacoustic Imaging.

PURPOSE: This preclinical study aimed to evaluate placental oxygenation in pregnant rats by real-time photoacoustic (PA) imaging on different days of gestation and to specify variations in placental oxygen saturation under conditions of maternal hypoxia and hyperoxygenation. MATERIAL AND METHODS: Placentas of fifteen Sprague-Dawley rats were examined on days 14, 17, and 20 of pregnancy with a PA imaging system coupled to high-resolution ultrasound imaging. Pregnant rats were successively exposed to hyperoxygenated and hypoxic conditions by changing the oxygen concentration in inhaled gas. Tissue oxygen saturation was quantitatively analyzed by real-time PA imaging in the skin and 3 regions of the placenta. All procedures were performed in accordance with applicable ethical guidelines and approved by the animal care committee. RESULTS: Maternal hypoxia was associated with significantly greater decrease in blood oxygen saturation (ΔO2 Saturation) in the skin (70.74% ±7.65) than in the mesometrial triangle (32.66% ±5.75) or other placental areas (labyrinth: 18.58% ± 6.61; basal zone: 13.13% ±5.72) on different days of pregnancy (P<0.001). ΔO2 Saturation did not differ significantly between the labyrinth, the basal zone, and the decidua. After the period of hypoxia, maternal hyperoxygenation led to a significant rise in oxygen saturation, which returned to its initial values in the different placental regions (P<0.001). CONCLUSIONS: PA imaging enables the variation of blood oxygen saturation to be monitored in the placenta during maternal hypoxia or hyperoxygenation. This first preclinical study suggests that the placenta plays an important role in protecting the fetus against maternal hypoxia.