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1. Management and outcomes of women with low fibrinogen concentration during pregnancy or immediately postpartum: A UK national population‐based cohort study.

Author

Diguisto, Caroline, Baker, Elfreda, Stanworth, Simon, Collins, Peter W., Collis, Rachel E., and Knight, Marian

Subjects
*AMNIOTIC fluid embolism, *ABRUPTIO placentae, *FIBRINOGEN, *BLOOD loss estimation, *PLACENTA accreta, *POSTPARTUM hemorrhage, *PUERPERIUM
Abstract

Introduction: Pregnant women with a fibrinogen level <2 g/L represent a high‐risk group that is associated with severe postpartum hemorrhage and other complications. Women who would qualify for fibrinogen therapy are not yet identified. Material and methods: A population‐based cross‐sectional study was conducted using the UK Obstetric Surveillance System between November 2017 and October 2018 in any UK hospital with a consultant‐led maternity unit. Any woman pregnant or immediately postpartum with a fibrinogen <2 g/L was included. Our aims were to determine the incidence of fibrinogen <2 g/L in pregnancy, and to describe its causes, management and outcomes. Results: Over the study period 124 women with fibrinogen <2 g/L were identified (1.7 per 10 000 maternities; 95% confidence interval 1.4–2.0 per 10 000 maternities). Less than 5% of cases of low fibrinogen were due to preexisting inherited dysfibrinogenemia or hypofibrinogenemia. Sixty percent of cases were due to postpartum hemorrhage caused by placental abruption, atony, or trauma. Amniotic fluid embolism and placental causes other than abruption (previa, accreta, retention) were associated with the highest estimated blood loss (median 4400 mL) and lowest levels of fibrinogen. Mortality was high with two maternal deaths due to massive postpartum hemorrhage, 27 stillbirths, and two neonatal deaths. Conclusions: Fibrinogen <2 g/L often, but not exclusively, affected women with postpartum hemorrhage due to placental abruption, atony, or trauma. Other more rare and catastrophic obstetrical events such as amniotic fluid embolism and placenta accreta also led to low levels of fibrinogen. Maternal and perinatal mortality was extremely high in our cohort. [ABSTRACT FROM AUTHOR]

Published
2024
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2. Circumstances, causes and timing of death in extremely preterm infants admitted to NICU: The EPIPAGE‐2 study

Author

Boileau, Pascal, primary, Letouzey, Mathilde, additional, Morgan, Andrei S., additional, Lorthe, Elsa, additional, Kaminski, Monique, additional, Coquelin, Anaëlle, additional, Azria, Elie, additional, Caeymaex, Laurence, additional, Rouget, Florence, additional, Diguisto, Caroline, additional, Claris, Olivier, additional, Tosello, Barthélémy, additional, Truffert, Patrick, additional, Bétrémieux, Pierre, additional, Benhammou, Valérie, additional, Marchand‐Martin, Laetitia, additional, Goffinet, François, additional, Ancel, Pierre‐Yves, additional, and Foix‐L'Hélias, Laurence, additional

Published
2023
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4. Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial

Author

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

Published
2023
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5. Balloon Catheters Versus Vaginal Prostaglandins for Labour Induction (CPI Collaborative):An Individual Participant Data Meta-analysis of Randomised Controlled Trials

Author

Jones, Madeleine N., Palmer, Kirsten R., Pathirana, Maleesa M., Cecatti, Jose Guilherme, Filho, Olimpio B. Moraes, Marions, Lena, Edlund, Måns, Prager, Martina, Pennell, Craig, Dickinson, Jan E., Sass, Nelson, Jozwiak, Marta, Ten Eikelder, Mieke, Rengerink, Katrien Oude, Bloemenkamp, Kitty W. M., Henry, Amanda, Løkkegaard, Ellen C. L., Christensen, Ib Jarle, Szychowski, Jeff M., Edwards, Rodney K., Beckmann, Michael, Diguisto, Caroline, Le Gouge, Amélie, Perrotin, Franck, Symonds, Ian, O'Leary, Sean, Rolnik, Daniel L., Mol, Ben W., Li, Wentao, Jones, Madeleine N., Palmer, Kirsten R., Pathirana, Maleesa M., Cecatti, Jose Guilherme, Filho, Olimpio B. Moraes, Marions, Lena, Edlund, Måns, Prager, Martina, Pennell, Craig, Dickinson, Jan E., Sass, Nelson, Jozwiak, Marta, Ten Eikelder, Mieke, Rengerink, Katrien Oude, Bloemenkamp, Kitty W. M., Henry, Amanda, Løkkegaard, Ellen C. L., Christensen, Ib Jarle, Szychowski, Jeff M., Edwards, Rodney K., Beckmann, Michael, Diguisto, Caroline, Le Gouge, Amélie, Perrotin, Franck, Symonds, Ian, O'Leary, Sean, Rolnik, Daniel L., Mol, Ben W., and Li, Wentao

Published
2023

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

Author

Diguisto, Caroline, Le Gouge, Amélie, Arthuis, Chloé, Winer, Norbert, Parant, Olivier, Poncelet, Christophe, Chauleur, Celine, Hannigsberg, Jacob, Ducarme, Guillaume, Gallot, Denis, Gabriel, Rene, Desbriere, Raoul, Beucher, Gael, Faraguet, Cyrille, Isly, Helene, Rozenberg, Patrick, Giraudeau, Bruno, and Perrotin, Franck

Subjects
Balloon dilatation -- Usage -- Comparative analysis, Pregnancy, Protracted -- Care and treatment, Dinoprostone -- Dosage and administration -- Comparative analysis, Labor, Induced (Obstetrics) -- Methods, Biological sciences
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, [greater than or equal to]41+0 and [less than or equal to]42+0 weeks' gestation, a Bishop score 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., Author(s): Caroline Diguisto 1,2,3,*, Amélie Le Gouge 4, Chloé Arthuis 5, Norbert Winer 5, Olivier Parant 6, Christophe Poncelet 7,8, Celine Chauleur 9,10, Jacob Hannigsberg 11, Guillaume Ducarme 12, Denis [...]

Published
2021
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9. 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

Author

Diguisto, Caroline, Le Gouge, Amelie, Marchand, Marie-Sara, Megier, Pascal, Ville, Yves, Haddad, Georges, Winer, Norbert, Arthuis, Chloé, Doret, Muriel, Debarge, Veronique Houfflin, Flandrin, Anaig, Delmas, Hélène Laurichesse, Gallot, Denis, Mares, Pierre, Vayssiere, Christophe, Sentilhes, Loïc, Cheve, Marie-Therese, Paumier, Anne, Durin, Luc, Schaub, Bruno, Equy, Veronique, Giraudeau, Bruno, Perrotin, Franck, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Maternité Olympe de Gouges [CHRU Tours], Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Régional d'Orléans (CHRO), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Descartes - Paris 5 (UPD5), Physiopathologie des Adaptations Nutritionnelles (PhAN), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Hospices Civils de Lyon (HCL), CHU Lille, Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Clermont-Ferrand, Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Aix-Marseille Université - École de maïeutique (AMU SMPM EM), Aix-Marseille Université - Faculté des sciences médicales et paramédicales (AMU SMPM), Aix Marseille Université (AMU)-Aix Marseille Université (AMU), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Centre Hospitalier Le Mans (CH Le Mans), Polyclinique de l’Atlantique, Partenaires INRAE, Elsan Polyclinique du Parc - Caen, CHU de la Martinique [Fort de France], CHU Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble, and Université de Tours (UT)

Subjects
Male, Uterine Artery, Pregnancy Trimester, First, Multidisciplinary, Pre-Eclampsia, Aspirin, Pregnancy, [SDV]Life Sciences [q-bio], Infant, Newborn, Humans, Birth Weight, Female
Abstract

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).

Published
2022

10. Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative):an individual participant data meta-analysis of randomised controlled trials

Author

Jones, Madeleine N., Palmer, Kirsten R., Pathirana, Maleesa M., Cecatti, Jose Guilherme, Filho, Olimpio B.Moraes, Marions, Lena, Edlund, Måns, Prager, Martina, Pennell, Craig, Dickinson, Jan E., Sass, Nelson, Jozwiak, Marta, Eikelder, Mieke Ten, Rengerink, Katrien Oude, Bloemenkamp, Kitty W.M., Henry, Amanda, Løkkegaard, Ellen C.L., Christensen, Ib Jarle, Szychowski, Jeff M., Edwards, Rodney K., Beckmann, Michael, Diguisto, Caroline, Gouge, Amélie Le, Perrotin, Franck, Symonds, Ian, O'Leary, Sean, Rolnik, Daniel L., Mol, Ben W., Li, Wentao, Jones, Madeleine N., Palmer, Kirsten R., Pathirana, Maleesa M., Cecatti, Jose Guilherme, Filho, Olimpio B.Moraes, Marions, Lena, Edlund, Måns, Prager, Martina, Pennell, Craig, Dickinson, Jan E., Sass, Nelson, Jozwiak, Marta, Eikelder, Mieke Ten, Rengerink, Katrien Oude, Bloemenkamp, Kitty W.M., Henry, Amanda, Løkkegaard, Ellen C.L., Christensen, Ib Jarle, Szychowski, Jeff M., Edwards, Rodney K., Beckmann, Michael, Diguisto, Caroline, Gouge, Amélie Le, Perrotin, Franck, Symonds, Ian, O'Leary, Sean, Rolnik, Daniel L., Mol, Ben W., and Li, Wentao

Abstract

Background: Induction of labour is one of the most common obstetric interventions globally. Balloon catheters and vaginal prostaglandins are widely used to ripen the cervix in labour induction. We aimed to compare the effectiveness and safety profiles of these two induction methods. Methods: We did an individual participant data meta-analysis comparing balloon catheters and vaginal prostaglandins for cervical ripening before labour induction. We systematically identified published and unpublished randomised controlled trials that completed data collection between March 19, 2019, and May 1, 2021, by searching the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and PubMed. Further trials done before March 19, 2019, were identified through a recent Cochrane review. Data relating to the combined use of the two methods were not included, only data from women with a viable, singleton pregnancy were analysed, and no exclusion was made based on parity or membrane status. We contacted authors of individuals trials and participant-level data were harmonised and recoded according to predefined definitions of variables. Risk of bias was assessed with the ROB2 tool. The primary outcomes were caesarean delivery, indication for caesarean delivery, a composite adverse perinatal outcome, and a composite adverse maternal outcome. We followed the intention-to-treat principle for the main analysis. The primary meta-analysis used two-stage random-effects models and the sensitivity analysis used one-stage mixed models. All models were adjusted for maternal age and parity. This meta-analysis is registered with PROSPERO (CRD42020179924). Findings: Individual participant data were available from 12 studies with a total of 5460 participants. Balloon catheters, compared with vaginal prostaglandins, did not lead to a significantly different rate of caesarean delivery (12 trials, 5414 women; crude incidence 27·0%; adjusted OR [aOR] 1·09, 95% CI 0·95

Published
2022

11. Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials

Author

Datamanagement 1, Research UMC Utrecht, CTM & Statistical consultation, MS Verloskunde, Child Health, Jones, Madeleine N., Palmer, Kirsten R., Pathirana, Maleesa M., Cecatti, Jose Guilherme, Filho, Olimpio B.Moraes, Marions, Lena, Edlund, Måns, Prager, Martina, Pennell, Craig, Dickinson, Jan E., Sass, Nelson, Jozwiak, Marta, Eikelder, Mieke Ten, Rengerink, Katrien Oude, Bloemenkamp, Kitty W.M., Henry, Amanda, Løkkegaard, Ellen C.L., Christensen, Ib Jarle, Szychowski, Jeff M., Edwards, Rodney K., Beckmann, Michael, Diguisto, Caroline, Gouge, Amélie Le, Perrotin, Franck, Symonds, Ian, O'Leary, Sean, Rolnik, Daniel L., Mol, Ben W., Li, Wentao, Datamanagement 1, Research UMC Utrecht, CTM & Statistical consultation, MS Verloskunde, Child Health, Jones, Madeleine N., Palmer, Kirsten R., Pathirana, Maleesa M., Cecatti, Jose Guilherme, Filho, Olimpio B.Moraes, Marions, Lena, Edlund, Måns, Prager, Martina, Pennell, Craig, Dickinson, Jan E., Sass, Nelson, Jozwiak, Marta, Eikelder, Mieke Ten, Rengerink, Katrien Oude, Bloemenkamp, Kitty W.M., Henry, Amanda, Løkkegaard, Ellen C.L., Christensen, Ib Jarle, Szychowski, Jeff M., Edwards, Rodney K., Beckmann, Michael, Diguisto, Caroline, Gouge, Amélie Le, Perrotin, Franck, Symonds, Ian, O'Leary, Sean, Rolnik, Daniel L., Mol, Ben W., and Li, Wentao

Published
2022

12. Maternal mortality in eight European countries with enhanced surveillance systems: Descriptive population based study

Author

MS Verloskunde, Child Health, Geboortecentrum voorzitterschap, Diguisto, Caroline, Saucedo, Monica, Kallianidis, Athanasios, Bloemenkamp, Kitty, Bødker, Birgit, Buoncristiano, Marta, Donati, Serena, Gissler, Mika, Johansen, Marianne, Knight, Marian, Korbel, Miroslav, Kristufkova, Alexandra, Nyflot, Lill T., Deneux-Tharaux, Catherine, MS Verloskunde, Child Health, Geboortecentrum voorzitterschap, Diguisto, Caroline, Saucedo, Monica, Kallianidis, Athanasios, Bloemenkamp, Kitty, Bødker, Birgit, Buoncristiano, Marta, Donati, Serena, Gissler, Mika, Johansen, Marianne, Knight, Marian, Korbel, Miroslav, Kristufkova, Alexandra, Nyflot, Lill T., and Deneux-Tharaux, Catherine

Published
2022

13. Antibiotic prophylaxis in preterm premature rupture of membranes at 24–31 weeks’ gestation: Perinatal and 2‐year outcomes in the EPIPAGE‐2 cohort

Author

Lorthe, Elsa, Letouzey, Mathilde, Torchin, Héloïse, Foix L'Helias, Laurence, Gras‐le Guen, Christèle, Benhammou, Valérie, Boileau, Pascal, Charlier, Caroline, Kayem, Gilles, Ancel, Pierre‐yves, Arnaud, Catherine, Blanc, Julie, Debillon, Thierry, Delorme, Pierre, D’ercole, Claude, Desplanches, Thomas, Diguisto, Caroline, Gascoin, Géraldine, Gire, Catherine, Goffinet, François, Langer, Bruno, Maisonneuve, Emeline, Marret, Stéphane, Monier, Isabelle, Morgan, Andrei, Rozé, Jean‐christophe, Schmitz, Thomas, Sentilhes, Loïc, Subtil, Damien, Tosello, Barthélémy, Vayssière, Christophe, Winer, Norbert, Zeitlin, Jennifer, Astruc, D, Kuhn, P, Matis, J, Ramousset, C, Hernandorena, X, Chabanier, P, Joly‐pedespan, L, Costedoat, Mj, Leguen, A, Lecomte, B, Lemery, D, Vendittelli, F, Beucher, G, Dreyfus, M, Guillois, B, Toure, Y, Burguet, A, Couvreur, S, Gouyon, Jb, Sagot, P, Colas, N, Sizun, J, Beuchée, A, Pladys, P, Rouget, F, Dupuy, Rp, Soupre, D, Charlot, F, Roudaut, S, Favreau, A, Saliba, E, Reboul, L, Bednarek, N, Morville, P, Verrière, V, Thiriez, G, Balamou, C, Marpeau, L, Barbier, C, Durrmeyer, X, Granier, M, Ayoubi, M, Baud, O, Carbonne, B, Jarreau, Ph, Mitanchez, D, Duffaut, C, Cornu, L, Moras, R, Boulot, P, Cambonie, G, Daudé, H, Badessi, A, Tsaoussis, N, Bédu, A, Mons, F, Bahans, C, Binet, Mh, Fresson, J, Hascoët, Jm, Milton, A, Morel, O, Vieux, R, Hilpert, L, Alberge, C, Baron, M, Charkaluk, Ml, Pierrat, V, Truffert, P, Akowanou, S, Simeoni, U, Bongain, A, Deschamps, M, Branger, B, Rouger, V, Dupont, C, Gondry, Jean, Krim, G, Baby, B, Debeir, M, Claris, O, Picaud, Jc, Rubio‐gurung, S, Cans, C, Ego, A, Patural, H, Rannaud, A, Janky, E, Poulichet, A, Rosenthal, Jm, Coliné, E, Favre, A, Joly, N, Châlons, S, Pignol, J, Laurence, Pl, Robillard, Py, Samperiz, S, Ramful, D, Blondel, B, Bonet, M, Brinis, A, Coquelin, A, Durox, M, Kaminski, M, Khemache, K, Khoshnood, B, Lebeaux, C, Marchand‐martin, L, Rousseau, J, Saurel‐cubizolles, Mj, Tran, D, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier universitaire de Nantes (CHU Nantes), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), Unité de Parasitologie-Mycologie, Service de Microbiologie [Hôpital Necker-Enfants-Malades, Paris], Assistance Publique - Hôpitaux de Paris, CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service Epidémiologie clinique et santé publique [CHU Toulouse], Pôle Santé publique et médecine publique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Unité de biostatistiques [Centre Georges-François Leclerc], Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, Médecine Néonatale et Réanimation Pédiatrique CHU Grenoble, CHU Grenoble, Service de gynécologie-obstétrique [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Service de Gynécologie Obstétrique, Médecine Foetale et Stérilité Conjugale - Chirurgie Gynécologie et Oncologique [CHU de Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service de Néonatologie, Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Recherches épidémiologiques en santé périnatale et santé des femmes, Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie des Adaptations Nutritionnelles (PhAN), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), Groupe de Recherche sur l'Analyse Multimodale de la Fonction Cérébrale - UMR INSERM_S 1105 (GRAMFC), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Amiens-Picardie, Funding information:This work was partly supported by a postdoctoral grant from the Fondation des Treilles to EL. EPIPAGE-2 was funded by the French Institute of Public Health Research (IRESP TGIR 2009-01 programme)/Institute of Public Health and its partners: the French Health Ministry, the National Institute of Health and Medical Research (INSERM), the National Institute of Cancer, and the National Solidarity Fund for Autonomy (CNSA), the National Research Agency through the French EQUIPEX programme of investments for the future (grant number ANR-11-EQPX-0038), and the PREMUP Foundation. Additional funding was obtained from Fondation pour la Recherche Medicale (grant number SPF 20160936356) and Fondation de France (grant numbers 00050329, Grand Prix R18202KK]). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript., ANR-11-EQPX-0038,RE-CO-NAI,Plateforme de REcherche sur les COhortes d'enfants suivis depuis la NAIssance(2011), Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Education, Formation, Travail, Savoirs (EFTS), Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université de Toulouse (UT)-École Nationale Supérieure de Formation de l'Enseignement Agricole de Toulouse-Auzeville (ENSFEA), École Nationale Supérieure de Formation de l'Enseignement Agricole de Toulouse-Auzeville (ENSFEA), Centre Hospitalier Universitaire [Grenoble] (CHU), Modélisation et Évaluation des données complexes en Santé Publique (TIMC-MESP), Translational Innovation in Medicine and Complexity / Recherche Translationnelle et Innovation en Médecine et Complexité - UMR 5525 (TIMC ), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Grenoble Alpes (UGA)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Grenoble Alpes (UGA), CHU Dijon, Hôpital Nord [CHU - APHM], Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS), Aix Marseille Université (AMU), Department of Obstetrics and Gynecology, Les Hôpitaux Universitaires de Strasbourg (HUS), EPIPAGE-2 Study Group, and Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Fetal Membranes, Premature Rupture, obstetric intervention, [SDV]Life Sciences [q-bio], Gestational Age, antenatal management, Cohort Studies, Pregnancy, Escherichia coli, Humans, Prospective Studies, latency, amoxicillin, neurodevelopment, macrolides, prematurity, Infant, Newborn, Pregnancy Outcome, Obstetrics and Gynecology, Infant, prophylactic antibiotics, Antibiotic Prophylaxis, Anti-Bacterial Agents, perinatal outcome, cephalosporins, Premature Birth, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Neonatal Sepsis, Infant, Premature
Abstract

To compare different antibiotic prophylaxis administered after preterm premature rupture of membranes to determine whether any were associated with differences in obstetric and/or neonatal outcomes and/or neurodevelopmental outcomes at 2 years of corrected age.Prospective, nationwide, population-based EPIPAGE-2 cohort study of preterm infants.France, 2011.We included 492 women with a singleton pregnancy and a diagnosis of preterm premature rupture of membranes at 24-31 weeks. Exclusion criteria were contraindication to expectant management or indication for antibiotic therapy other than preterm premature rupture of membranes. Antibiotic prophylaxis was categorised as amoxicillin (n = 345), macrolide (n = 30), third-generation cephalosporin (n = 45) or any combinations covering Streptococcus agalactiae and90% of Escherichia coli (n = 72), initiated within 24 hours after preterm premature rupture of membranes.Population-averaged robust Poisson models.Survival at discharge without severe neonatal morbidity, 2-year neurodevelopment.With amoxicillin, macrolide, third-generation cephalosporin and combinations, 78.5%, 83.9%, 93.6% and 86.0% of neonates were discharged alive without severe morbidity. The administration of third-generation cephalosporin or any E. coli-targeting combinations was associated with improved survival without severe morbidity (adjusted risk ratio 1.25 [95% confidence interval 1.08-1.45] and 1.10 [95 % confidence interval 1.01-1.20], respectively) compared with amoxicillin. We evidenced no increase in neonatal sepsis related to third-generation cephalosporin-resistant pathogen.In preterm premature rupture of membranes at 24-31 weeks, antibiotic prophylaxis based on third-generation cephalosporin may be associated with improved survival without severe neonatal morbidity when compared with amoxicillin, with no evidence of increase in neonatal sepsis related to third-generation cephalosporin-resistant pathogen.Antibiotic prophylaxis after PPROM at 24-31 weeks: 3rd-generation cephalosporins associated with improved neonatal outcomes.

Published
2022

14. MOESM2 of Intensity of perinatal care for extremely preterm babies and outcomes at a higher gestational age: evidence from the EPIPAGE-2 cohort study

Author

Morgan, Andrei, Khoshnood, Babak, Diguisto, Caroline, L’Helias, Laurence Foix, Marchand-Martin, Laetitia, Kaminski, Monique, Zeitlin, Jennifer, Bréart, Gérard, Goffinet, François, and Pierre-Yves Ancel

Subjects
digestive system diseases
Abstract

Additional file 2 S2 appendix: Supplementary results relating to intensity of perinatal care for extremely preterm babies and outcomes at a higher gestational age.

Published
2020
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17. Prenatal parental involvement in decision for delivery room management at 22-26 weeks of gestation in France - The EPIPAGE-2 Cohort Study

Author

Levaillant, Cerise, Caeymaex, Laurence, Behal, Hélène, Kaminski, Monique, Diguisto, Caroline, Tosello, Barthélémy, Azria, Elie, Claris, Olivier, Bétrémieux, Pierre, Foix L'Hélias, Laurence, Truffert, Patrick, Gestionnaire, Hal Sorbonne Université, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Intercommunal de Créteil (CHIC), Centre d'Etudes des discours, Images, Textes, Ecrits, Communications (CEDITEC), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université de Lille, Université Sorbonne Paris Cité (USPC), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM), Aix Marseille Université (AMU), EFS, Centre hospitalier Saint-Joseph [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hospices Civils de Lyon (HCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, CHU Pontchaillou [Rennes], Service de néonatologie [CHU Trousseau], CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], CHU Lille, Centre Hospitalier Régional Universitaire [Lille] [CHRU Lille], METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694, Centre d'Etudes des discours, Images, Textes, Ecrits, Communications [CEDITEC], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS], Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique [CRESS - U1153], Université Claude Bernard Lyon 1 [UCBL], Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Groupe hospitalier Paris Saint-Joseph - Hôpital, and Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Trousseau [APHP]-Sorbonne Université (SU)

Subjects
Male, Parents, Critical Care and Emergency Medicine, Physiology, Maternal Health, Resuscitation, Decision Making, Social Sciences, Gestational Age, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Pediatrics, Families, Labor and Delivery, Cognition, Pregnancy, Medicine and Health Sciences, Humans, Psychology, Birth Weight, Public Health Surveillance, Children, Delivery Rooms, Body Weight, Infant, Newborn, Cognitive Psychology, Disease Management, Infant, Biology and Life Sciences, Neonates, Obstetrics and Gynecology, Delivery, Obstetric, [SDV.MHEP.GEO] Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Physiological Parameters, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Age Groups, Infant, Extremely Premature, People and Places, Birth, Cognitive Science, Women's Health, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Population Groupings, France, Infants, Research Article, Developmental Biology, Neuroscience
Abstract

International audience; 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.

Published
2019

18. Additional file 1 of Intensity of perinatal care, extreme prematurity and sensorimotor outcome at 2 years corrected age: evidence from the EPIPAGE-2 cohort study

Author

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

Subjects
body regions, nervous system, fungi, digestive system, digestive system diseases
Abstract

S1 Appendix. Creating a ratio to measure intensity of active perinatal care. (PDF 143 kb)

Published
2018
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19. Additional file 3 of Intensity of perinatal care, extreme prematurity and sensorimotor outcome at 2 years corrected age: evidence from the EPIPAGE-2 cohort study

Author

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

Subjects
body regions, nervous system, fungi, digestive system, digestive system diseases
Abstract

S3 Appendix. Results from sensitivity analyses using populations delivered at 24–26 weeks gestation. (PDF 108 kb)

Published
2018
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21. Additional file 2 of Intensity of perinatal care, extreme prematurity and sensorimotor outcome at 2 years corrected age: evidence from the EPIPAGE-2 cohort study

Author

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

Abstract

S2 Appendix. Methods for multiple imputation. (PDF 84 kb)

Published
2018
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22. Neurodevelopment at 2 years and umbilical artery Doppler in cases of very preterm birth after prenatal hypertensive disorder or suspected fetal growth restriction: EPIPAGE-2 prospective population-based cohort study.

Author

Delorme, P., Kayem, G., Lorthe, E., Sentilhes, L., Zeitlin, J., Subtil, D., Rozé, J. C., Vayssière, C., Durox, M., Ancel, P. Y., Pierrat, V., Goffinet, F., Arnaud, Catherine, Blanc, Julie, Boileau, Pascal, Debillon, Thierry, D'Ercole, Claude, Desplanches, Thomas, Diguisto, Caroline, and Foix‐L'Hélias, Laurence

Subjects
UMBILICAL arteries, FETAL growth disorders, PREMATURE labor, NEURAL development, SENSORY disorders, LOGISTIC regression analysis
Abstract

Objective: To investigate the association between absent or reversed end-diastolic flow (ARED) on umbilical artery Doppler ultrasound and poor neurological outcome at 2 years of age after very preterm birth associated with suspected fetal growth restriction (FGR) or maternal hypertensive disorders.Methods: The study population comprised all very preterm (22-31 completed weeks) singleton pregnancies delivered because of suspected FGR and/or maternal hypertensive disorders that had umbilical artery Doppler and 2-year follow-up available included in EPIPAGE-2, a prospective, nationwide, population-based cohort of preterm births in France in 2011. Univariate and two-level multivariable logistic regression analyses were used to assess the association of ARED in the umbilical artery, as compared with normal or reduced end-diastolic flow, with severe or moderate neuromotor and/or sensory disability and with an Ages and Stages Questionnaire (ASQ) score below a threshold. This was defined as a score more than 2 SD below the mean in any of the five domains, at age 2, adjusting for gestational age at delivery. ASQ is used to identify children at risk of developmental delay requiring reinforced follow-up and further evaluation. Descriptive statistics and bivariate tests were weighted according to the duration of the inclusion periods.Results: The analysis included 484 children followed up at 2 years of age, for whom prenatal umbilical artery Doppler ultrasound was available. Among them, 8/484 (1.6%) had severe or moderate neuromotor and/or sensory disability, and 156/342 (45.4%) had an ASQ score below the threshold. Compared with normal or reduced end-diastolic flow in the umbilical artery (n = 305), ARED (n = 179) was associated with severe or moderate neuromotor and/or sensory disability (adjusted odds ratio (OR), 11.3; 95% CI, 1.4-93.2) but not with an ASQ score below the threshold (adjusted OR, 1.2; 95% CI, 0.8-1.9).Conclusion: Among children delivered before 32 weeks of gestation due to suspected FGR and/or maternal hypertensive disorder who survived until 2 years of age, prenatal ARED in the umbilical artery was associated with a higher incidence of severe or moderate neuromotor and/or sensory disability. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Published
2020
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24. Individual and Organisational Determinants Associated with Maintenance Tocolysis in the Management of Preterm Labour: A Multilevel Analysis.

Author

Diguisto, Caroline, Ray, Camille Le, Maillard, Françoise, Khoshnood, Babak, Verspyck, Eric, Perrotin, Franck, and Goffinet, François

Subjects
*PREMATURE labor, *MOTHERHOOD, *HOSPITAL patients, *GESTATIONAL age, *PREMATURE infants
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. [ABSTRACT FROM AUTHOR]

Published
2012
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25. 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.

Author

Diguisto C, Le Gouge A, Marchand MS, Megier P, Ville Y, Haddad G, Winer N, Arthuis C, Doret M, Debarge VH, Flandrin A, Delmas HL, Gallot D, Mares P, Vayssiere C, Sentilhes L, Cheve MT, Paumier A, Durin L, Schaub B, Equy V, Giraudeau B, and Perrotin F

Subjects
Infant, Newborn, Female, Pregnancy, Humans, Birth Weight, Aspirin therapeutic use, Pregnancy Trimester, First, Uterine Artery diagnostic imaging, Pre-Eclampsia prevention & control, Pre-Eclampsia drug therapy
Abstract

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)., Competing Interests: The authors have declared that no competing interests exist.

Published
2022
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26. MRI evaluation of residual breast cancer after neoadjuvant chemotherapy: influence of patient, tumor and chemotherapy characteristics on the correlation with pathological response.

Author

Diguisto C, Ouldamer L, Arbion F, Vildé A, and Body G

Subjects
Adult, Anthracyclines therapeutic use, Antibiotics, Antineoplastic therapeutic use, Breast Neoplasms drug therapy, Carcinoma, Ductal, Breast drug therapy, Carcinoma, Intraductal, Noninfiltrating drug therapy, Chemotherapy, Adjuvant, Female, Humans, Magnetic Resonance Imaging, Middle Aged, Neoadjuvant Therapy, Neoplasm, Residual, Retrospective Studies, Sensitivity and Specificity, Treatment Outcome, Breast Neoplasms diagnosis, Carcinoma, Ductal, Breast diagnosis, Carcinoma, Intraductal, Noninfiltrating diagnosis
Abstract

Aim: The aim of this study was to evaluate the correlation between the residual tumor measured on magnetic resonance imaging and pathological results and to assess whether this correlation varies according to patient, tumor or chemotherapy characteristics., Patients and Methods: The study population included women treated for breast cancer with indication of neoadjuvant chemotherapy in our tertiary breast cancer Unit between January 2008 and December 2011. Factors related to patients, tumor and chemotherapy were studied. Pearson's correlation coefficient between the size of the tumor on MRI and pathological response was calculated for the entire population. It was also calculated according to patient, tumor and chemotherapy characteristics., Results: During the study period, 107 consecutive women were included. The size of residual tumor on the MRI significantly correlated with the size on pathological result with a Pearson correlation coefficient of 0.52 (p<0.001). The correlation was stronger for women aged 50 years and older (r=0.64, p<0.001) and for post-menopausal women (r=0.61, p<0.001). The correlation was stronger for those with triple-negative tumors (r=0.69, p=0.002) but weaker for those with tumors with a ductal carcinoma in situ component (r =0.18, p=0.42)., Conclusion: The size of breast cancer obtained by MRI is significantly correlated to the pathological size of the tumor. This correlation was stronger among women aged 50 years and more, among post-menopausal women, and among women who had triple-negative tumors., (Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)

Published
2015

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