<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03018860</url>
  </required_header>
  <id_info>
    <org_study_id>P150937</org_study_id>
    <nct_id>NCT03018860</nct_id>
  </id_info>
  <brief_title>Alternative to Intensive Management of the Active Phase of the Second Stage of Labor</brief_title>
  <acronym>PASST</acronym>
  <official_title>Alternative to Intensive Management of the Active Phase of the Second Stage of Labor : a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Active phase of the second stage of labor corresponds to period of maternal expulsive efforts&#xD;
      (i.e. pushing). An intensive management of this phase is usual in France. This study aims to&#xD;
      evaluate the impact of an alternative &quot;moderate&quot; management during this pushing phase on&#xD;
      neonatal and maternal issues and mode of delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Management of the active phase of the second stage of labor is not an evidence-based&#xD;
      practice. Management of this phase differs between countries. In France, national guidelines&#xD;
      recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians&#xD;
      (midwives and obstetricians) encourage usually women to push 3 times per contractions and to&#xD;
      push on every contraction in order to deliver into a 30 minutes timing.&#xD;
&#xD;
      This study aims to evaluate the impact of an alternative &quot;moderate&quot; management during this&#xD;
      pushing phase on neonatal and maternal issues and mode of delivery. In the intervention&#xD;
      group, i.e. &quot;moderate&quot; pushing, women are encouraged to push only 2 times per contractions,&#xD;
      to respect contractions without pushing and there is no limit of pushing duration.&#xD;
&#xD;
      The hypothesis is that &quot;moderate&quot; management of the active phase of the second stage allows&#xD;
      decreasing frequency of neonatal morbidity at birth, decreasing frequency of operative&#xD;
      delivery and increasing maternal satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">December 7, 2021</completion_date>
  <primary_completion_date type="Actual">March 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal morbidity composite measure</measure>
    <time_frame>at childbirth</time_frame>
    <description>number of participant with acidosis arterial cord pH &lt;7.15 and / or excess base&gt; 10 mmol / L and / or lactate&gt; 6 mmol / L and or an Apgar score at 5 minutes &lt;7 and or severe neonatal trauma defined by fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure) and or an Apgar score at 5 minutes &lt;7 and or severe neonatal trauma: fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>at childbirth</time_frame>
    <description>spontaneous vaginal, instrumental vaginal delivery or cesarean section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate postpartum complications</measure>
    <time_frame>2 hours after delivery</time_frame>
    <description>Perineal lesions with involvement of the anal sphincter (3rd and 4th degree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate postpartum complications</measure>
    <time_frame>2 hours after delivery</time_frame>
    <description>Episiotomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate postpartum complications</measure>
    <time_frame>2 hours after delivery</time_frame>
    <description>Cervical and vaginal lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate postpartum complications</measure>
    <time_frame>2 hours after delivery</time_frame>
    <description>Severe postpartum hemorrhage (blood loss estimated&gt; 1000 mL, using sulprostone, intrauterine bloating, transfusion, uterine artery embolization, vessel ligation, uterine upholstery, of hysterectomy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate postpartum complications</measure>
    <time_frame>2 hours after delivery</time_frame>
    <description>Postpartum Hemorrhage (blood loss estimated&gt; 500mLand &lt; 1000mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Women satisfaction assessed with the Labour Agentry scale</measure>
    <time_frame>2 hours after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Women satisfaction assessed with the ICIQ-UI Short Form</measure>
    <time_frame>6 months post partum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary and anal incontinence assessed with the Wexner Score</measure>
    <time_frame>6 months post partum</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1701</enrollment>
  <condition>Active Second Stage</condition>
  <arm_group>
    <arm_group_label>&quot;Moderate&quot; management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women are encouraged by physicians to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Intensive&quot; management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual obstetrical care in France</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>&quot;Moderate&quot; management</intervention_name>
    <description>After randomization, women allocated to the intervention group, i.e. &quot;moderate&quot; pushing, are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.</description>
    <arm_group_label>&quot;Moderate&quot; management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>&quot;Intensive&quot; management</intervention_name>
    <description>This group corresponds to usual obstetrical management of active second stage in France. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.</description>
    <arm_group_label>&quot;Intensive&quot; management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria :&#xD;
&#xD;
          -  primiparous women&#xD;
&#xD;
          -  singleton fetus&#xD;
&#xD;
          -  fetal cephalic presentation&#xD;
&#xD;
          -  ≥37 gestational weeks&#xD;
&#xD;
          -  living fetus&#xD;
&#xD;
          -  Patient with epidural analgesia&#xD;
&#xD;
          -  Major Female&#xD;
&#xD;
          -  Women understand French&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Abnormal fetal heart rate requiring hastening childbirth&#xD;
&#xD;
          -  cervical dilatation &lt; 8 cm&#xD;
&#xD;
          -  intrauterine fetal growth restriction &lt;5e percentile,&#xD;
&#xD;
          -  Fetal malformation,&#xD;
&#xD;
          -  history of gynecological surgery with uterine scar&#xD;
&#xD;
          -  Women do not understand French,&#xD;
&#xD;
          -  women with psychiatric condition&#xD;
&#xD;
          -  contraindication to intensive management of active second stage (severe myopia,&#xD;
             respiratory or cardiac failure)&#xD;
&#xD;
          -  no affiliation to a social security scheme (beneficiary or assignee)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre-Yves ANCEL, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cochin Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Le Ray C, Audibert F. [Duration of pushing in labor: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2008 Jun;37(4):325-8. doi: 10.1016/j.jgyn.2008.02.009. Epub 2008 Apr 10. French.</citation>
    <PMID>18406074</PMID>
  </reference>
  <reference>
    <citation>Nordstrom L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8. doi: 10.1111/j.1471-0528.2001.00034.x.</citation>
    <PMID>11281466</PMID>
  </reference>
  <reference>
    <citation>Le Ray C, Audibert F, Goffinet F, Fraser W. When to stop pushing: effects of duration of second-stage expulsion efforts on maternal and neonatal outcomes in nulliparous women with epidural analgesia. Am J Obstet Gynecol. 2009 Oct;201(4):361.e1-7. doi: 10.1016/j.ajog.2009.08.002.</citation>
    <PMID>19788968</PMID>
  </reference>
  <reference>
    <citation>Cheng YW, Hopkins LM, Caughey AB. How long is too long: Does a prolonged second stage of labor in nulliparous women affect maternal and neonatal outcomes? Am J Obstet Gynecol. 2004 Sep;191(3):933-8. doi: 10.1016/j.ajog.2004.05.044.</citation>
    <PMID>15467567</PMID>
  </reference>
  <reference>
    <citation>Dionne MD, Deneux-Tharaux C, Dupont C, Basso O, Rudigoz RC, Bouvier-Colle MH, Le Ray C. Duration of Expulsive Efforts and Risk of Postpartum Hemorrhage in Nulliparous Women: A Population-Based Study. PLoS One. 2015 Nov 10;10(11):e0142171. doi: 10.1371/journal.pone.0142171. eCollection 2015.</citation>
    <PMID>26555447</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>December 9, 2021</last_update_submitted>
  <last_update_submitted_qc>December 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Active second stage</keyword>
  <keyword>Neonatal morbidity</keyword>
  <keyword>Operative delivery</keyword>
  <keyword>Labor</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018860
org study id: P150937
nct id: NCT03018860
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Active phase of the second stage of labor corresponds to period of maternal expulsive efforts
      (i.e. pushing). An intensive management of this phase is usual in France. This study aims to
      evaluate the impact of an alternative "moderate" management during this pushing phase on
      neonatal and maternal issues and mode of delivery.
Management of the active phase of the second stage of labor is not an evidence-based
      practice. Management of this phase differs between countries. In France, national guidelines
      recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians
      (midwives and obstetricians) encourage usually women to push 3 times per contractions and to
      push on every contraction in order to deliver into a 30 minutes timing.

      This study aims to evaluate the impact of an alternative "moderate" management during this
      pushing phase on neonatal and maternal issues and mode of delivery. In the intervention
      group, i.e. "moderate" pushing, women are encouraged to push only 2 times per contractions,
      to respect contractions without pushing and there is no limit of pushing duration.

      The hypothesis is that "moderate" management of the active phase of the second stage allows
      decreasing frequency of neonatal morbidity at birth, decreasing frequency of operative
      delivery and increasing maternal satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Neonatal morbidity composite measure
time frame: at childbirth
description: number of participant with acidosis arterial cord pH <7.15 and / or excess base> 10 mmol / L and / or lactate> 6 mmol / L and or an Apgar score at 5 minutes <7 and or severe neonatal trauma defined by fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure) and or an Apgar score at 5 minutes <7 and or severe neonatal trauma: fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure)
measure: Mode of delivery
time frame: at childbirth
description: spontaneous vaginal, instrumental vaginal delivery or cesarean section
measure: Immediate postpartum complications
time frame: 2 hours after delivery
description: Perineal lesions with involvement of the anal sphincter (3rd and 4th degree)
measure: Immediate postpartum complications
time frame: 2 hours after delivery
description: Episiotomy
measure: Immediate postpartum complications
time frame: 2 hours after delivery
description: Cervical and vaginal lesion
measure: Immediate postpartum complications
time frame: 2 hours after delivery
description: Severe postpartum hemorrhage (blood loss estimated> 1000 mL, using sulprostone, intrauterine bloating, transfusion, uterine artery embolization, vessel ligation, uterine upholstery, of hysterectomy)
measure: Immediate postpartum complications
time frame: 2 hours after delivery
description: Postpartum Hemorrhage (blood loss estimated> 500mLand < 1000mL)
measure: Women satisfaction assessed with the Labour Agentry scale
time frame: 2 hours after delivery
measure: Women satisfaction assessed with the ICIQ-UI Short Form
time frame: 6 months post partum
measure: Urinary and anal incontinence assessed with the Wexner Score
time frame: 6 months post partum
arm group label: "Moderate" management
arm group type: Experimental
description: Women are encouraged by physicians to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.
arm group label: "Intensive" management
arm group type: Active Comparator
description: Usual obstetrical care in France
intervention type: Procedure
intervention name: "Moderate" management
description: After randomization, women allocated to the intervention group, i.e. "moderate" pushing, are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.
arm group label: "Moderate" management
intervention type: Procedure
intervention name: "Intensive" management
description: This group corresponds to usual obstetrical management of active second stage in France. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.
arm group label: "Intensive" management
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre-Yves ANCEL, MD, PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
citation: Le Ray C, Audibert F. [Duration of pushing in labor: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2008 Jun;37(4):325-8. doi: 10.1016/j.jgyn.2008.02.009. Epub 2008 Apr 10. French.
PMID: 18406074
citation: Nordstrom L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8. doi: 10.1111/j.1471-0528.2001.00034.x.
PMID: 11281466
citation: Le Ray C, Audibert F, Goffinet F, Fraser W. When to stop pushing: effects of duration of second-stage expulsion efforts on maternal and neonatal outcomes in nulliparous women with epidural analgesia. Am J Obstet Gynecol. 2009 Oct;201(4):361.e1-7. doi: 10.1016/j.ajog.2009.08.002.
PMID: 19788968
citation: Cheng YW, Hopkins LM, Caughey AB. How long is too long: Does a prolonged second stage of labor in nulliparous women affect maternal and neonatal outcomes? Am J Obstet Gynecol. 2004 Sep;191(3):933-8. doi: 10.1016/j.ajog.2004.05.044.
PMID: 15467567
citation: Dionne MD, Deneux-Tharaux C, Dupont C, Basso O, Rudigoz RC, Bouvier-Colle MH, Le Ray C. Duration of Expulsive Efforts and Risk of Postpartum Hemorrhage in Nulliparous Women: A Population-Based Study. PLoS One. 2015 Nov 10;10(11):e0142171. doi: 10.1371/journal.pone.0142171. eCollection 2015.
PMID: 26555447
responsible party type: Sponsor
sharing ipd: No