Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol

IntroductionFollowing the detection of fetal growth restriction, there is no consensus about the criteria that should trigger delivery in the late preterm period. The consequences of inappropriate early or late delivery are potentially important yet practice varies widely around the world, with abno...

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Veröffentlicht in:BMJ open 2022-04, Vol.12 (4), p.e055543
Hauptverfasser: Thornton, Jim G, Mullins, Edward, Marlow, Neil, Hecher, Kurt, Ammari, Christina, Arabin, Birgit, Berger, Astrid, Bergman, Eva, Bhide, Amarnath, Bilardo, Caterina, Binder, Julia, Breeze, Andrew, Brodszki, Jana, Calda, Pavel, Cannings-John, Rebecca, Černý, Andrej, Cesari, Elena, Cetin, Irene, Dall'Asta, Andrea, Diemert, Anke, Ebbing, Cathrine, Eggebø, Torbjørn, Fantasia, Ilaria, Ferrazzi, Enrico, Frusca, Tiziana, Ghi, Tullio, Goodier, Jenny, Greimel, Patrick, Gyselaers, Wilfried, Hassan, Wassim, Von Kaisenberg, Constantin, Kholin, Alexey, Klaritsch, Philipp, Krofta, Ladislav, Lindgren, Peter, Lobmaier, Silvia, Marsal, Karel, Maruotti, Giuseppe M, Mecacci, Federico, Myklestad, Kirsti, Ostermayer, Eva, Papageorghiou, Aris, Potter, Claire, Prefumo, Federico, Raio, Luigi, Richter, Jute, Sande, Ragnar Kvie, Schlembach, Dietmar, Schleußner, Ekkehard, Stampalija, Tamara, Townson, Julia, Valensise, Herbert, Visser, Gerard HA, Wee, Ling, Wolf, Hans, Thomas, Abin, Sharp, Andrew, Simm, Andy, Ramoni, Angela, Lloyd, Barry, Masturzo, Bianca, Morfeld, Christine, Brezinka, Christoph, Lloyd, Christopher, Seidig, Claudia, Mantovani, Elena, Taricco, Emanuela, Bertucci, Emma, Macsali, Ferenc, Ferrari, Francesca, D'Antonio, Francesco, Cali, Giuseppe, Ramezzana, Ilaria Giuditta, Kyvernitakis, Ioannis, Melchiorre, Karen, Sarno, Laura, Jokubkiene, Ligita, Rajasalu, Liina, Jones, Louisa, Savvidou, Makrina, Stefopoulou, Maria, Kilby, Mark, Deole, Nishigandh, Pateisky, Petra, Palmrich, Pilar, Schild, Ralf, Devlieger, Roland, Ondrová, Sabina, Gumpert, Sarah, Simeone, Serena, Salvi, Silvia, Visentin, Silvia, Verlohren, Stefan, Groten, Tanja, Radaelli, Tatjana, Mesens, Tinne, Fanelli, Tiziana, Ganzevoort, Wessel, Heiman, Yvonne, Khodzhaeva, Zulfiya
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Sprache:eng
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Zusammenfassung:IntroductionFollowing the detection of fetal growth restriction, there is no consensus about the criteria that should trigger delivery in the late preterm period. The consequences of inappropriate early or late delivery are potentially important yet practice varies widely around the world, with abnormal findings from fetal heart rate monitoring invariably leading to delivery. Indices derived from fetal cerebral Doppler examination may guide such decisions although there are few studies in this area. We propose a randomised, controlled trial to establish the optimum method of timing delivery between 32 weeks and 36 weeks 6 days of gestation. We hypothesise that delivery on evidence of cerebral blood flow redistribution reduces a composite of perinatal poor outcome, death and short-term hypoxia-related morbidity, with no worsening of neurodevelopmental outcome at 2 years.Methods and analysisWomen with non-anomalous singleton pregnancies 32+0 to 36+6 weeks of gestation in whom the estimated fetal weight or abdominal circumference is
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2021-055543