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  1. Article ; Online: Perinatal outcomes of intrahepatic cholestasis during pregnancy

    Chloé Arthuis / Caroline Diguisto / Henri Lorphelin / Vincent Dochez / Emmanuel Simon / Franck Perrotin / Norbert Winer

    PLoS ONE, Vol 15, Iss 2, p e

    An 8-year case-control study.

    2020  Volume 0228213

    Abstract: 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 ... ...

    Abstract 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.
    Keywords Medicine ; R ; Science ; Q
    Subject code 610
    Language English
    Publishing date 2020-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC)

    Norbert Winer / Franck Perrotin / Solène Brunet-Houdard / Loïc Sentilhes / Denis Gallot / Thiphaine Barjat / Caroline Diguisto / Amélie Le Gouge / Guillaume Legendre / Raoul Desbriere / Marion De Berti / Fanny Monmousseau / Aude Girault / Jordan Pozzi / Bertrand Gachon

    BMJ Open, Vol 13, Iss

    protocol for an open multicentre randomised non-inferiority trial

    2023  Volume 4

    Abstract: Introduction It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered ...

    Abstract Introduction It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered trial has compared these strategies. We hypothesise that induction of labour with oxytocin among women who have just undergone an ineffective first ripening procedure is not associated with a higher risk of caesarean delivery than a repeated cervical ripening with prostaglandins.Methods and analysis We will conduct a multicentre, non-inferiority, open-label, randomised controlled trial aimed at comparing labour induction by oxytocin with a second cervical ripening that uses prostaglandins (slow-release vaginal dinoprostone; oral misoprostol 25 µg; dinoprostone vaginal gel 2 mg). Women (n=1494) randomised in a 1:1 ratio in 10 French maternity units must be ≥18 years with a singleton fetus in vertex presentation, at a term from ≥37+0 weeks of gestation, and have just completed a 24-hour cervical ripening procedure by any method (pharmacological or mechanical) with a Bishop score ≤6. Exclusion criteria comprise being in labour, having more than 3 contractions per 10 min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate. The primary endpoint will be the caesarean delivery rate, regardless of indication. Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations. The nature of the assessed procedures prevents masking the study investigators and patients to group assignment.Ethics and dissemination All participants will provide written informed consent. The ethics committee ‘Comité de Protection des Personnes Ile de France VII’ approved this study on 2 April 2021 (No 2021-000989-15). Study findings will be submitted for publication and presented at relevant conferences.Trial registration number ...
    Keywords Medicine ; R
    Subject code 610
    Language English
    Publishing date 2023-04-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Prenatal parental involvement in decision for delivery room management at 22-26 weeks of gestation in France - The EPIPAGE-2 Cohort Study.

    Cerise Levaillant / Laurence Caeymaex / Hélène Béhal / Monique Kaminski / Caroline Diguisto / Barthélémy Tosello / Elie Azria / Olivier Claris / Pierre Bétrémieux / Laurence Foix L'Hélias / Patrick Truffert / EPIPAGE 2 Extreme Prematurity Group

    PLoS ONE, Vol 14, Iss 8, p e

    2019  Volume 0221859

    Abstract: Objective Our main objective was to examine if parental prenatal preferences predict delivery-room management of extremely preterm periviable infants. The secondary objectives were to describe parental involvement and the content of prenatal counseling ... ...

    Abstract Objective Our main objective was to examine if parental prenatal preferences predict delivery-room management of extremely preterm periviable infants. The secondary objectives were to describe parental involvement and the content of prenatal counseling given to parents for this prenatal decision. Design Prospective study of neonates liveborn between 22 and 26 weeks of gestation in France in 2011 among the neonates included in the EPIPAGE-2 study. Setting 18 centers participating in the "Extreme Prematurity Group" substudy of the EPIPAGE-2 study. Patients 302 neonates liveborn between 22-26 weeks among which 113 with known parental preferences while parental preferences were unknown or unavailable for 186 and delivery room management was missing for 3. Results Data on prenatal counseling and parental preferences were collected by a questionnaire completed by professionals who cared for the baby at birth; delivery room (DR) management, classified as stabilization or initiation of resuscitation (SIR) vs comfort care (CC). The 113 neonates studied had a mean (SD) gestational age of 24 (0.1) weeks. Parents of neonates in the CC group preferred SIR less frequently than those with neonates in the SIR group (16% vs 88%, p < .001). After multivariate analysis, preference for SIR was an independent factor associated with this management. Professionals qualified decisions as shared (81%), exclusively medical (16%) or parental (3%). Information was described as medical with no personal opinion (71%), complete (75%) and generally pessimistic (54%). Conclusion Parental involvement in prenatal decision-making did not reach satisfying rates in the studied setting. When available, prenatal parental preference was a determining factor for DR management of extremely preterm neonates. Potential biases in the content of prenatal counselling given to parents need to be evaluated.
    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2019-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system

    Caroline Diguisto / Amélie Le Gouge / Chloé Arthuis / Norbert Winer / Olivier Parant / Christophe Poncelet / Celine Chauleur / Jacob Hannigsberg / Guillaume Ducarme / Denis Gallot / Rene Gabriel / Raoul Desbriere / Gael Beucher / Cyrille Faraguet / Helene Isly / Patrick Rozenberg / Bruno Giraudeau / Franck Perrotin / Groupe de Recherche en Obstétrique et Gynécologie (GROG)

    PLoS Medicine, Vol 18, Iss 2, p e

    The MAGPOP randomised controlled trial.

    2021  Volume 1003448

    Abstract: 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 ... ...

    Abstract 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 ...
    Keywords Medicine ; R
    Subject code 610
    Language English
    Publishing date 2021-02-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Intensity of perinatal care, extreme prematurity and sensorimotor outcome at 2 years corrected age

    Andrei S. Morgan / Laurence Foix L’Helias / Caroline Diguisto / Laetitia Marchand-Martin / Monique Kaminski / Babak Khoshnood / Jennifer Zeitlin / Gérard Bréart / Xavier Durrmeyer / François Goffinet / Pierre-Yves Ancel

    BMC Medicine, Vol 16, Iss 1, Pp 1-

    evidence from the EPIPAGE-2 cohort study

    2018  Volume 12

    Abstract: Abstract Background Emerging evidence suggests intensity of perinatal care influences survival for extremely preterm babies. We evaluated the effect of differences in perinatal care intensity between centres on sensorimotor morbidity at 2 years of age. ... ...

    Abstract Abstract Background Emerging evidence suggests intensity of perinatal care influences survival for extremely preterm babies. We evaluated the effect of differences in perinatal care intensity between centres on sensorimotor morbidity at 2 years of age. We hypothesised that hospitals with a higher intensity of perinatal care would have improved survival without increased disability. Methods Foetuses alive at maternal admission to a level 3 hospital in France in 2011, subsequently delivered between 22 and 26 weeks gestational age (GA) and included in the EPIPAGE-2 national prospective observational cohort study formed the baseline population. Level of intensity of perinatal care was assigned according to hospital of birth, categorised into three groups using ‘perinatal intensity’ ratios (ratio of 24–25 weeks GA babies admitted to neonatal intensive care to foetuses of the same GA alive at maternal admission to hospital). Multiple imputation was used to account for missing data; hierarchical logistic regression accounting for births nested within centres was then performed. Results One thousand one hundred twelve foetuses were included; 473 survived to 2 years of age (126 of 358 in low-intensity, 140 of 380 in medium-intensity and 207 of 374 in high-intensity hospitals). There were no differences in disability (adjusted odds ratios 0.93 (95% CI 0.28 to 3.04) and 1.04 (95% CI 0.34 to 3.14) in medium- and high- compared to low-intensity hospitals, respectively). Compared to low-intensity hospitals, survival without sensorimotor disability was increased in the population of foetuses alive at maternal admission to hospital and in live-born babies, but there were no differences when considering only babies admitted to NICU or survivors. Conclusions No difference in sensorimotor outcome for survivors of extremely preterm birth at 2 years of age was found according to the intensity of perinatal care provision. Active management of periviable births was associated with increased survival without sensorimotor disability.
    Keywords Extreme prematurity ; Newborn ; Perinatal intensity ; Activity ; Obstetric ; Neonatal ; Medicine ; R
    Subject code 360
    Language English
    Publishing date 2018-12-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Individual and organisational determinants associated with maintenance tocolysis in the management of preterm labour

    Caroline Diguisto / Camille Le Ray / Françoise Maillard / Babak Khoshnood / Eric Verspyck / Franck Perrotin / François Goffinet / EVAPRIMA group

    PLoS ONE, Vol 7, Iss 12, p e

    a multilevel analysis.

    2012  Volume 50788

    Abstract: Background Clinical guidelines do not recommend maintenance tocolysis for the management of preterm labour. The French national survey EVAPRIMA revealed it was administered to more than 50% of women hospitalised for preterm labour. Our aim was to ... ...

    Abstract Background Clinical guidelines do not recommend maintenance tocolysis for the management of preterm labour. The French national survey EVAPRIMA revealed it was administered to more than 50% of women hospitalised for preterm labour. Our aim was to identify the individual and organisational determinants associated with maintenance tocolysis. Methods The study was a secondary analysis of the prospective population-based EVAPRIMA study database. Population study included every women hospitalised for preterm labour and at risk of receiving maintenance tocolysis, over a one month period, in 99 randomly selected French maternity units. Main outcome was the prescription of maintenance tocolysis. The association between maintenance tocolysis and individual (maternal or obstetrical) and organisational determinants were evaluated with multilevel analysis. Results Of the 531 women included, 68.9% (95% CI 0.65-0.73) received maintenance tocolysis. The only individual factor associated with maintenance tocolysis was gestational age at admission; the rate of maintenance tocolysis was higher among women hospitalised before 32 weeks of gestation. The significantly different rates between maternity units demonstrated the existence of a maternity unit effect. Maintenance tocolysis was also associated with organisational determinants and was more frequent in level 1 (ORa = 6.54[2.21-19.40]) and level 2 maternity units (ORa = 3.68[1.28-10.59]), in units with less than 1500 deliveries/year (ORa = 5.27[4.43-19.44]), and in specific areas of France. Conclusion A maternity unit effect, explained partly by the organisational characteristics of the units, plays a major role in the practice of maintenance tocolysis. Widespread dissemination of these results might improve adherence to clinical guidelines.
    Keywords Medicine ; R ; Science ; Q
    Subject code 690
    Language English
    Publishing date 2012-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Women and health professionals’ perspectives on a conditional cash transfer programme to improve pregnancy follow-up

    Celine Chauleur / Jacob Hannigsberg / Philippe Merviel / Marc Bardou / Franck Perrotin / Thomas Schmitz / Olivier Picone / Jeanne Sibiude / Karine Chemin / Dominique Dallay / Frédéric Coatleven / Loïc Sentilhes / Céline Brochot / Astrid Eckman-Lacroix / Elise Thellier / Frédérique Falchier / Philippe Deruelle / Muriel Doret / Xavier Carcopino-Tusoli /
    Nicolas Meunier-Beillard / Hervé Fernandez / Vincent Villefranque / Caroline Diguisto / Damien Subtil / Clémence Houssin / Philippe Gillard / Laurent Mandelbrot / Aurelie Godard-Marceau / Nathalie Lesavre / Claude Virtos / Elodie Debras / Aude Bourtembourg / Claire Toubin / Danièle Addes / Véronique Uguen / Cleo Tourbot / Caroline Lelievre / Christophe Tremouilhac / Anne-Hélène Saliou / Aurelie Derrieu / Stephanie Auget / Anne Legourrierec / Anne Leroux / Julie Fort-Jacquier / Marion Serclerat / Nathalie Laurenceau / Audrey Renouleau / Eliane Catteau / Julie Blanc / Candice Ronin / Laurence Piechon / Séverine Puppo / Fanny Greco / Sandrine Pettazzoni / Muriel Athlani / Amina Desvignes / Annie Petiteau / Amina El Yaakoubi / Valérie Bechadergue / Valérie Vaugirard / Marie-Emmanuelle Neveu / Caroline Geyl / Marie-Victoire Senat / Claire Colmant / Marie Houllier / Myriam Virlouet / Marion Mir / Yasmina Bejaoui / Hélène Le Cornu / Lauriane Nikel / Elodie Gustave / Amandine Stadler / Ahmad Mehdi / Tiphaine Barjat / Suzanne Lima / Thomas Corsini / Anne Genod / Charlotte Vermesch / Cécile Fanget / Marianne Perrot / Manuela Munoz / Sylvie Pitaval / Fanny Magand / Françoise Baldi / Stephanie Bret / Anne-Lise Verdier / Christelle Denis / Carine Arlicot / Jérôme Potin / Stéphanie Chretien / Julie Paternotte / Nathalie Trignol / Élisabeth Blin / Camille Mathieu / Anne Dubreuil / Anne Viallon Pelletier / Catherine Guerin / Chloé Arthuis / Christophe Vayssieres / Olivier Parant / Marion Groussolles / Maria Denis / M Mathieu Morin / Marie-Thérèse Bavoux / Juliette Pelloux / Anne-Claire Jambon / Madeleine Santraine / Veronique Lebuffe / Pascale Broux / Thierry Dzukou / Magloire Gnansounou / Didier Hubert / Claire Djazet / Ludivine Destoop / Marine Derue / Pierrick Theret / Dominique Delzenne / Stéphanie Daussin / Alice Fraissinet / Mélanie Vannerum / Cyril Faraguet / Laurence Landais / Mariana Radu / Anne Rouget / Sena Al Sudani / Bernard Guillon / Estelle Wucher / Véronique Selva / Sandrine Reviron / Francis Schwetterlé / Cécile Chassande / Véronique Grandin / Eliane Krtoliza / Patrick Becher / Marie Sarrau / Claire Lecoq / Elsa Lutringer / Denis Roux / Noémie Berge / Clémentine Barbier / Anne Heron / Audrey Farina-Bracquart / Marie-Paule Curtet / Evelyne Lefebure / Marie-Hélène Le Douarin / Hassan Al Rayes / Émilie Magne / Nathalie Destampes / Émilie Ricard / Pascale Ghezzi / Catherine Guillen / Fanny Alazard / Marie-Thé Campanaro / Florence Mojard / Magalie David-Reynard / Patricia Fuma / Remy De Montgolfier / Capucine Neel / Guillaume Legendre / Isabelle Andre / Sylvie Nordstrom / Brigitte Guionnet / Catherine Crenn Hebert / Chloé Dussaux / Karine Achaintre / Anne Wagner / Martine Werveake / Eloïse De Gouville / George Theresin / Marie Pierre Couetoux / Lydia Caillaud / Marie-Pierre Fernandez / Sabrina Bottet / M Alain Almodovar / Elisa Etienne / Véronique Guiteras / Angélique Torres / N. Roche / Myriam Nassef / Christine Abel-Faure / Marie Louvet / Carole Ettori / Guillaume Ducarme / Valérie Bonnenfant-Mezeray / Laurence Szezot-Renaudeau / Marie-Pierre Berte / Elodie Netier-Herault / Stéphanie Manson-Gallone / Franck Mauviel / Nathalie Agostini / Marine Mazeaud / Jean-Claude Dausset / Isabelle De Murcia / Emilie Alliot / Anne-Marie Bes / Magali Biferi Magali / Hélène Heckenroth / Sophie Morange / Gersende Chiuot / Audrey Gnisci / Annie Allegre / Laetitia Lecq / Eva Balenbois / Claire Tourette / Aude Figarella / Dio Andriamanjay / Pauline Vignoles / Catherine Cazelles / Véronique Lejeune Saada / Benafsheh Kashani / Isabelle Chevalier / Muriel Terrieres / Audrey Cointement / Valérie Benhaïm / Najat Lindoune / Anne-Sophie Maisonneuve / M Frédéric Daubercy / Guilia Mencattini / Vanessa Combaud / Isabelle Moya / Xavier-Côme Donato / Raoul Desbriere / Marie Lafon / Véronique Baudet

    BMJ Open, Vol 13, Iss

    a qualitative analysis of the NAITRE randomised controlled study

    2023  Volume 3

    Abstract: Objectives Women of low socioeconomic status have been described as having suboptimal prenatal care, which in turn has been associated with poor pregnancy outcomes. Many types of conditional cash transfer (CCT) programmes have been developed, including ... ...

    Abstract Objectives Women of low socioeconomic status have been described as having suboptimal prenatal care, which in turn has been associated with poor pregnancy outcomes. Many types of conditional cash transfer (CCT) programmes have been developed, including programmes to improve prenatal care or smoking cessation during pregnancy, and their effects demonstrated. However, ethical critiques have included paternalism and lack of informed choice. Our objective was to determine if women and healthcare professionals (HPs) shared these concerns.Design Prospective qualitative research.Setting We included economically disadvantaged women, as defined by health insurance data, who participated in the French NAITRE randomised trial assessing a CCT programme during prenatal follow-up to improve pregnancy outcomes. The HP worked in some maternities participating in this trial.Participants 26 women, 14 who received CCT and 12 who did not, mostly unemployed (20/26), and - 7 HPs.Interventions We conducted a multicentre cross-sectional qualitative study among women and HPs who participated in the NAITRE Study to assess their views on CCT. The women were interviewed after childbirth.Results Women did not perceive CCT negatively. They did not mention feeling stigmatised. They described CCT as a significant source of aid for women with limited financial resources. HP described the CCT in less positive terms, for example, expressing concern about discussing cash transfer at their first medical consultation with women. Though they emphasised ethical concerns about the basis of the trial, they recognised the importance of evaluating CCT.Conclusions In France, a high-income country where prenatal follow-up is free, HPs were concerned that the CCT programme would change their relationship with patients and wondered if it was the best use of funding. However, women who received a cash incentive said they did not feel stigmatised and indicated that these payments helped them prepare for their baby’s birth.Trial registration number NCT02402855
    Keywords Medicine ; R
    Subject code 300
    Language English
    Publishing date 2023-03-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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