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                <term xml:lang="en">suspected fetal macrosomia</term>
                <term xml:lang="en">weight</term>
                <term xml:lang="en">gestation</term>
                <term xml:lang="en">neonatal morbidity</term>
                <term xml:lang="en">cesarean delivery</term>
                <term xml:lang="en">shoulder dystocia</term>
                <term xml:lang="fr">outcomes</term>
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              <p>Background Macrosomic fetuses are at increased risk of shoulder dystocia. We aimed to compare induction of labour with expectant management for large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity associated with macrosomia. Methods We did this pragmatic, randomised controlled trial between Oct 1, 2002, and Jan 1, 2009, in 19 tertiary-care centres in France, Switzerland, and Belgium. Women with singleton fetuses whose estimated weight exceeded the 95th percentile, were randomly assigned (1:1), via computer-generated permuted-block randomisation (block size of four to eight) to receive induction of labour within 3 days between 37+0 weeks and 38+6 weeks of gestation, or expectant management. Randomisation was stratified by centre. Participants and caregivers were not masked to group assignment. Our primary outcome was a composite of clinically significant shoulder dystocia, fracture of the clavicle, brachial plexus injury, intracranial haemorrhage, or death. We did analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00190320. Findings We randomly assigned 409 women to the induction group and 413 women to the expectant management group, of whom 407 women and 411 women, respectively, were included in the final analysis. Mean birthweight was 3831 g (SD 324) in the induction group and 4118 g (392) in the expectant group. Induction of labour significantly reduced the risk of shoulder dystocia or associated morbidity (n=8) compared with expectant management (n=25; relative risk [RR] 0·32, 95% CI 0·15–0·71; p=0·004). We recorded no brachial plexus injuries, intracranial haemorrhages, or perinatal deaths. The likelihood of spontaneous vaginal delivery was higher in women in the induction group than in those in the expectant management group (RR 1·14, 95% CI 1·01–1·29). Caesarean delivery and neonatal morbidity did not differ significantly between the groups. Interpretation Induction of labour for suspected large-for-date fetuses is associated with a reduced risk of shoulder dystocia and associated morbidity compared with expectant management. Induction of labour does not increase the risk of caesarean delivery and improves the likelihood of spontaneous vaginal delivery. These benefits should be balanced with the effects of early-term induction of labour.</p>
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          <desc>
            <address>
              <addrLine>Grenoble</addrLine>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-257328" type="direct"/>
          </listRelation>
        </org>
        <org type="institution" xml:id="struct-300137" status="VALID">
          <idno type="ISNI">0000 0004 0593 6676</idno>
          <idno type="ROR">https://ror.org/01e8kn913</idno>
          <orgName>Hôpital Jeanne de Flandre [Lille]</orgName>
          <desc>
            <address>
              <addrLine>Avenue Eugène Avinée, 59000 Lille</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chu-lille.fr/hopital-jeanne-de-flandre/</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-300073" status="VALID">
          <idno type="ROR">https://ror.org/002cp4060</idno>
          <orgName>Assistance Publique - Hôpitaux de Marseille</orgName>
          <orgName type="acronym">APHM</orgName>
          <desc>
            <address>
              <addrLine>Direction générale AP-HM80, rue Brochier13 354 Marseille Cedex 5</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://fr.ap-hm.fr/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-300156" status="VALID">
          <idno type="ROR">https://ror.org/03fdnmv92</idno>
          <orgName>AP-HP - Hôpital Bichat - Claude Bernard [Paris]</orgName>
          <desc>
            <address>
              <addrLine>46 Rue Henri Huchard, 75018 Paris</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://hupnvs.aphp.fr/bichat-claude-bernard/</ref>
          </desc>
          <listRelation>
            <relation active="#struct-300068" type="direct"/>
          </listRelation>
        </org>
        <org type="institution" xml:id="struct-349371" status="INCOMING">
          <orgName>Centre Hospitalier Regional</orgName>
          <desc>
            <address>
              <country key="FR"/>
            </address>
          </desc>
        </org>
        <org type="laboratory" xml:id="struct-499442" status="VALID">
          <orgName>Service de Gynécologie [CHU Clermont-Ferrand]</orgName>
          <desc>
            <address>
              <addrLine>CHU Clermont-Ferrand - Site Estaing, 1 Rue Lucie et Raymond Aubrac, 63100 Clermont-Ferrand</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chu-clermontferrand.fr/Pages/Presentation_Service/Service_075.aspx</ref>
          </desc>
          <listRelation>
            <relation active="#struct-380171" type="direct"/>
            <relation active="#struct-300144" type="indirect"/>
          </listRelation>
        </org>
        <org type="institution" xml:id="struct-417872" status="VALID">
          <idno type="ISNI">0000 0004 0638 9491 </idno>
          <idno type="ROR">https://ror.org/00s7v8q53</idno>
          <orgName>Hôpital de la Conception [CHU - APHM]</orgName>
          <orgName type="acronym">LA CONCEPTION</orgName>
          <date type="start">1985-01-01</date>
          <desc>
            <address>
              <addrLine>147 Boulevard Baille 13005 Marseille</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://fr.ap-hm.fr/nos-hopitaux/hopital-de-la-conception</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-357391" status="VALID">
          <idno type="ROR">https://ror.org/04e1w6923</idno>
          <orgName>Hôpital de Hautepierre [Strasbourg]</orgName>
          <desc>
            <address>
              <addrLine>Avenue Molière67200 Strasbourg</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.chru-strasbourg.fr/Hopital-de-Hautepierre</ref>
          </desc>
          <listRelation>
            <relation active="#struct-211628" type="direct"/>
          </listRelation>
        </org>
        <org type="institution" xml:id="struct-225749" status="OLD">
          <orgName>Groupe Hospitalier de l'Institut Catholique de Lille</orgName>
          <orgName type="acronym">GHICL</orgName>
          <date type="end">2012-01-01</date>
          <desc>
            <address>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-300877" type="direct"/>
          </listRelation>
        </org>
        <org type="institution" xml:id="struct-300075" status="VALID">
          <orgName>Centre Hospitalier Universitaire de Toulouse</orgName>
          <orgName type="acronym">CHU Toulouse</orgName>
          <desc>
            <address>
              <addrLine>regroupe les hôpitaux  Purpan, Rangueil, Pierre-Paul Riquet, Larey, Paule de Viguier, Hôtel Dieu Saint-Jacques, La Grave, etc.</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chu-toulouse.fr</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-306775" status="INCOMING">
          <orgName>Hôpital de l'Hôtel-Dieu</orgName>
          <desc>
            <address>
              <country key="FR"/>
            </address>
          </desc>
        </org>
        <org type="institution" xml:id="struct-1088220" status="VALID">
          <orgName>Hôpital Erasme = Erasmus Hospital = Erasmus Ziekenhuis</orgName>
          <orgName type="acronym">HUB-ULB</orgName>
          <desc>
            <address>
              <addrLine>Rte de Lennik 808, 1070 Bruxelles</addrLine>
              <country key="BE"/>
            </address>
            <ref type="url">https://www.erasme.ulb.ac.be/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-437941" status="INCOMING">
          <orgName>Centre Hospitalier Universitaire Ambroise Paré</orgName>
          <orgName type="acronym">CHU Ambroise Paré</orgName>
          <desc>
            <address>
              <country key="FR"/>
            </address>
          </desc>
        </org>
        <org type="institution" xml:id="struct-1038633" status="INCOMING">
          <orgName>Hopital Universitaire Brugmann</orgName>
          <desc>
            <address>
              <country key="BE"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-1031275" type="direct"/>
          </listRelation>
        </org>
        <org type="institution" xml:id="struct-1031440" status="INCOMING">
          <orgName>Centre Hospitalier iItercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy]</orgName>
          <desc>
            <address>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-1031275" type="direct"/>
          </listRelation>
        </org>
        <org type="regroupinstitution" xml:id="struct-300068" status="VALID">
          <idno type="ROR">https://ror.org/00pg5jh14</idno>
          <orgName>Assistance publique - Hôpitaux de Paris (AP-HP)</orgName>
          <orgName type="acronym">AP-HP</orgName>
          <desc>
            <address>
              <country key="FR"/>
            </address>
          </desc>
        </org>
        <org type="institution" xml:id="struct-257328" status="VALID">
          <idno type="IdRef">034137076</idno>
          <idno type="ROR">https://ror.org/041rhpw39</idno>
          <orgName>CHU de Grenoble-Alpes - Centre Hospitalier Universitaire CHU Grenoble</orgName>
          <orgName type="acronym">CHUGA</orgName>
          <desc>
            <address>
              <addrLine>CS 1021738043 Grenoble cedex 9</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chu-grenoble.fr/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-380171" status="VALID">
          <orgName>CHU Estaing [Clermont-Ferrand]</orgName>
          <desc>
            <address>
              <addrLine>1 Rue Lucie et Raymond Aubrac, 63100 Clermont-Ferrand</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chu-clermontferrand.fr/les-sites/site-estaing</ref>
          </desc>
          <listRelation>
            <relation active="#struct-300144" type="direct"/>
          </listRelation>
        </org>
        <org type="regroupinstitution" xml:id="struct-300144" status="VALID">
          <idno type="IdRef">026606836</idno>
          <idno type="ISNI">0000000406394151</idno>
          <idno type="ROR">https://ror.org/02tcf7a68</idno>
          <orgName>CHU Clermont-Ferrand</orgName>
          <desc>
            <address>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chu-clermontferrand.fr/</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-211628" status="VALID">
          <idno type="IdRef">030378842</idno>
          <idno type="ROR">https://ror.org/04bckew43</idno>
          <orgName>Hôpitaux Universitaires de Strasbourg</orgName>
          <orgName type="acronym">HUS</orgName>
          <desc>
            <address>
              <addrLine>1 place de l'hôpital BP 426 67091 Strasbourg cedex</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chru-strasbourg.fr/</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-300877" status="VALID">
          <idno type="IdRef">026582481</idno>
          <idno type="ROR">https://ror.org/025s1b152</idno>
          <orgName>Université catholique de Lille</orgName>
          <orgName type="acronym">UCL</orgName>
          <desc>
            <address>
              <addrLine>60 boulevard Vauban - 59800 Lille</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.univ-catholille.fr/</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-1031275" status="INCOMING">
          <orgName>Partenaires INRAE</orgName>
          <desc>
            <address>
              <addrLine>Cette structure regroupe l'ensemble des structures créées pour la reprise des données ProdInra</addrLine>
              <country key="FR"/>
            </address>
          </desc>
        </org>
      </listOrg>
    </back>
  </text>
</TEI>