{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T07:43:02Z","timestamp":1782459782192,"version":"3.54.5"},"reference-count":35,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2019,5,20]],"date-time":"2019-05-20T00:00:00Z","timestamp":1558310400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Morbidity in fetuses affected by gastroschisis is mainly the result of bowel ischaemic and inflammatory processes. Experimental studies on animal models show that clearing amniotic fluid from the digestive secretions by amnioexchange procedures reduces the inflammatory process. We evaluated the benefit of the amnioexchange procedure for fetal gastroschisis in humans.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Prospective, interventional, randomised study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Eight referral centres for fetal medicine.<\/jats:p><\/jats:sec><jats:sec><jats:title>Population<\/jats:title><jats:p>Pregnant women carrying a fetus with gastroschisis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We compared, <jats:italic>in utero<\/jats:italic>, amnioexchange with a sham procedure. The protocol included, in both arms, steroid injections at 30 weeks of gestation and the use of postnatal minimal enteral feeding.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>The primary outcome was a composite variable based on the duration of ventilation and parenteral nutrition. Secondary outcomes were the effectiveness and safety of the amnioexchange procedure, including the rate of perinatal death, time to full enteral feeding, primary closure, and late feeding disorders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sixty\u2010four patients were randomised. There was no difference in the composite criteria between the amnioexchange and control groups. Based on an intention\u2010to\u2010treat analysis, there were no significant between\u2010group differences in pregnancy outcome or complications. When studying the relationship between digestive compounds and amniotic fluid inflammatory markers, a clear correlation was found between bile acid and both ferritin and interleukin 1\u03b2 (<jats:styled-content style=\"fixed-case\">IL<\/jats:styled-content>1\u03b2).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In humans, amnioexchange, as described in our protocol, is not an option for fetal care; however, we provide supplementary proof of the involvement of inflammation in the pathogenicity of gastroschisis and suggest that future research should aim at reducing inflammation. ClinicalTrials.gov: <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00127946.<\/jats:p><\/jats:sec><jats:sec><jats:title>Tweetable abstract<\/jats:title><jats:p>A prospective, interventional, randomised study shows no benefit of amnioexchange for fetal gastroschisis in humans.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1471-0528.15804","type":"journal-article","created":{"date-parts":[[2019,4,29]],"date-time":"2019-04-29T11:41:42Z","timestamp":1556538102000},"page":"1233-1241","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["A randomised controlled trial of amnioexchange for fetal gastroschisis"],"prefix":"10.1111","volume":"126","author":[{"given":"D","family":"Luton","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynaecology AP\u2010HP Bichat Hospital Paris France"},{"name":"DHU Risks in Pregnancy Paris France"},{"name":"Department of Obstetrics and Gynaecology AP\u2010HP Bichat\u2010Claude Bernard Hospital Paris France"},{"name":"Universit\u00e9 Paris VII Paris Diderot Sorbonne Paris Cit\u00e9 Paris France"},{"name":"INSERM U1141 Robert\u2010Debr\u00e9 Hospital Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Mitanchez","sequence":"additional","affiliation":[{"name":"Department of Neonatal Pediatrics AP\u2010HP GHUEP Armand Trousseau Hospital Paris France"},{"name":"Faculty of Medicine Sorbonne University Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N","family":"Winer","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology University Hospital of Nantes CIC M\u00e8re enfant Nantes UMR 1280 INRA Physiologie des Adaptations Nutritionnelles Nantes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F","family":"Muller","sequence":"additional","affiliation":[{"name":"INSERM U1141 Robert\u2010Debr\u00e9 Hospital Paris France"},{"name":"Department of Biochemistry and Hormonology AP\u2010HP Robert Debr\u00e9 Hospital Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Gallot","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology CHU de Clermont\u2010Ferrand \u2013 H\u00f4pital d'Estaing Auvergne University Clermont\u2010Ferrand France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F","family":"Perrotin","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology CHRU de Tours Fran\u00e7ois Rabelais University Tours France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u2010M","family":"Jouannic","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology Faculty of Medicine AP\u2010HP Armand Trousseau Hospital Sorbonne University Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0909-3202","authenticated-orcid":false,"given":"F","family":"Bretelle","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology CHU de Marseille APHM Aix Marseille University Marseille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"de Lagausie","sequence":"additional","affiliation":[{"name":"INSERM U1141 Robert\u2010Debr\u00e9 Hospital Paris France"},{"name":"Department of Paediatrics Surgery AP\u2010HP Robert Debr\u00e9 Hospital Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y","family":"Ville","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology AP\u2010HP Necker\u2010Enfants Malades Paris Descartes University Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J","family":"Guibourdenche","sequence":"additional","affiliation":[{"name":"Department of Biochemistry and Hormonology AP\u2010HP Robert Debr\u00e9 Hospital Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u2010F","family":"Oury","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology AP\u2010HP Robert Debr\u00e9 Hospital Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"Alberti","sequence":"additional","affiliation":[{"name":"INSERM U1141 Robert\u2010Debr\u00e9 Hospital Paris France"},{"name":"AP\u2010HP, Inserm Univ. 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