<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/NCT03770962</url>
  </required_header>
  <id_info>
    <org_study_id>2018/476</org_study_id>
    <nct_id>NCT03770962</nct_id>
  </id_info>
  <brief_title>One Plus One Equals Two, Will That do?</brief_title>
  <acronym>Oneplus</acronym>
  <official_title>One Plus One Equals Two - Will That do? A Randomized Controlled Trial to Evaluate Collegial Midwifery Practice to Prevent Perineal Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new clinical practice to reduce perineal trauma has been adopted by many maternity wards in&#xD;
      Sweden. This practice involves collegial midwifery assistance during the second stage of&#xD;
      labor and the birth of the baby. The midwife responsible for the birth is the primary carer&#xD;
      of the woman and the second midwife observes the birth or assists the primary midwife if&#xD;
      asked to. The hypothesis is that the presence and support of an extra midwife will reduce&#xD;
      severe perineal trauma (trauma to the anal sphincter (OASI)).&#xD;
&#xD;
      The objective of this trial is to evaluate whether collegial midwifery assistance during the&#xD;
      second stage reduces perineal trauma grade III-IV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most women sustain some form of perineal trauma when giving birth vaginally. Perineal&#xD;
      injuries are classified as grade I-IV. A first-degree tear only includes perineal skin or&#xD;
      mucosa, whereas a second-degree tear includes muscles in the perineal body. A tear involving&#xD;
      a part or the whole of the anal sphincter muscle complex is graded III-IV. Data from the&#xD;
      Swedish National Birth Register show that 4% of first-time mothers suffered a tear affecting&#xD;
      the anal sphincter. National registers in Sweden only collect data on severe perineal trauma&#xD;
      affecting the anal sphincter but in a recent regional Swedish study 78% of the primiparous&#xD;
      women experienced second-degree tears. The consequences of second-degree tears and severe&#xD;
      perineal trauma are pain, dyspareunia, and an increased risk of symptomatic pelvic organ&#xD;
      prolapse later in life. A severe consequence of perineal trauma is anal incontinence, mainly&#xD;
      caused by tears affecting the anal sphincter muscle. However, second-degree tears may also&#xD;
      lead to anal incontinence. This may be related to a lack of support from the perineal body&#xD;
      due to poor repair. Furthermore, perineal trauma is known to be misclassified, with&#xD;
      consequent under-reporting of injuries affecting the anal sphincter complex.&#xD;
&#xD;
      Risk factors for severe perineal trauma (grade III-IV) are giving birth vaginally for the&#xD;
      first time, having an assisted vaginal birth, giving birth vaginally after a previous&#xD;
      caesarean section, or giving birth to a baby that weighs more than 4000 g, and the risk&#xD;
      increases with age. Some of the midwifery care methods used to prevent perineal injuries have&#xD;
      been evaluated in clinical trials but there are still gaps in the investigator's knowledge.&#xD;
      Even if scientific evidence is lacking for most of the preventive strategies used by midwives&#xD;
      except for warm compresses held at the perineum, midwives believe that a slow and controlled&#xD;
      birth is a key factor in prevention. Several studies indicate that a combination of&#xD;
      strategies can be effective in preventing perineal trauma. Giving birth is a profound&#xD;
      experience for the woman and her partner and an experience that has significance for the&#xD;
      woman all her life. The second stage is considered to be the most stressful part of the labor&#xD;
      for the woman and her unborn baby, and consequently also for the midwife. Despite this, there&#xD;
      is still a lack of knowledge about how women experience the second stage and the methods&#xD;
      midwives use to facilitate birth and prevent perineal trauma. Traditionally midwives have&#xD;
      asked colleagues for a second opinion or to assist in complicated situations, or in obstetric&#xD;
      emergencies. Recently a new clinical practice has been introduced in approximately 50% of the&#xD;
      maternity wards in Sweden to reduce severe perineal trauma. This procedure involves two&#xD;
      midwives attending the woman during the second stage of labor. The midwife responsible for&#xD;
      the birth calls for the second midwife when the active phase of the second stage has started&#xD;
      and the presenting part of the baby is visible. The second midwife observes the birth and can&#xD;
      assist the midwife responsible for the birth if needed. An unpublished survey from one&#xD;
      maternity ward in Sweden showed that most of the midwives appreciated this way of working but&#xD;
      were uncertain as to whether it actually reduced the prevalence of severe perineal trauma.&#xD;
      Furthermore, this clinical practice might have negative side-effects or unintended&#xD;
      consequences. The maternity wards that practise this method have not increased the number of&#xD;
      midwives. It could be argued that there is a risk that other women in labor will be left&#xD;
      unattended for longer periods when two midwives assist at births. How midwives share the&#xD;
      responsibility and communicate are factors that needs to be evaluated scientifically.&#xD;
&#xD;
      The objective of this trial is to evaluate whether collegial midwifery assistance during the&#xD;
      second stage reduces perineal trauma grade III-IV.&#xD;
&#xD;
      Data from the National Birth Register show that 4.1% of first-time mothers suffered severe&#xD;
      perineal trauma (OASI) in Sweden 2017. To be able to detect a reduction from 4.1 to 2.0% (50%&#xD;
      reduction) with 80% power and a 95% level of significance, 1052 women in each group will be&#xD;
      needed. The 50% reduction is based on regional figures after a change in practice and is&#xD;
      therefore clinically significant. Allowing for a possible 40% drop-out rate including&#xD;
      possible cases of obstetric emergencies where another midwife will be needed regardless of&#xD;
      randomization, this will result in 2946 women in total. To ensure that there are no adverse&#xD;
      side-effects of the intervention interim analyses will be performed every 6 months until the&#xD;
      end of the trial. In the interim analysis, the distribution of the intervention and standard&#xD;
      care will be estimated among women with no perineal tears, women diagnosed with a third- or&#xD;
      fourth-degree tear (OASI), and neonatal outcome (apgar score at 5 minutes and arterial blood&#xD;
      gas from the nuchal cord).&#xD;
&#xD;
      Women will be asked to participate in the trial when arriving to the maternity ward. The&#xD;
      randomization will take place when the woman enters the second stage. It will not be possible&#xD;
      to blind either women or midwives in this study. The participants will be randomly allocated&#xD;
      (1:1) to the intervention group or to the standard care group. To allow for equal&#xD;
      distribution between the groups, block randomization in blocks of ten (five to the&#xD;
      intervention and five to the control group) will be used.&#xD;
&#xD;
      After the birth the tear will be diagnosed together with a midwife or an obstetrician who has&#xD;
      not been involved in the birth. Tears will be sutured according to the guidelines at each&#xD;
      participating study site. The midwife responsible for the birth will complete a questionnaire&#xD;
      which will contain questions regarding the woman; labor and birth variables, methods of&#xD;
      preventing perineal trauma, questions regarding the baby, diagnosis of the tear and how the&#xD;
      tear was sutured. If a second midwife has been present during the second stage (intervention)&#xD;
      the responsible midwife will also complete questions on the assistance she got from the&#xD;
      second midwife and how this assistance was experienced. Data will also be retrieved from the&#xD;
      participating women's records by using the local database of each study site. When the&#xD;
      intervention has taken place the second midwife will also complete a questionnaire.&#xD;
&#xD;
      The women in the trial will be sent a questionnaire one month and one year after the birth.&#xD;
      The follow-up questionnaire after one month will contain questions regarding their experience&#xD;
      of the intervention and their experience of the methods used during the second stage and&#xD;
      women's well-being (EPDS, Pain relief, sexual intercourse resumption, breastfeeding&#xD;
      initiation), after birth.&#xD;
&#xD;
      For the one-year follow-up the following validated questionnaires will be used: Pelvic Floor&#xD;
      Impact Questionnaire (PFIQ7), Pelvic Floor Distress Inventory - short form (PFDI-20), Pelvic&#xD;
      Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) Female Sexual&#xD;
      Function Index FSFI, Edinburgh Postnatal Depression Scale (EPDS) and breastfeeding duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">July 13, 2021</completion_date>
  <primary_completion_date type="Actual">March 21, 2020</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>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The statistician who performs the statistical analysis will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of women with obstetric anal sphincter injury</measure>
    <time_frame>4 hour</time_frame>
    <description>Tear of the external and/or internal anal sphincter at any degree, ICD-10 O70.2 and O70.3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of women with perineal tear grade II</measure>
    <time_frame>4 hour</time_frame>
    <description>Tear of the muscles of the perineum and/or deeper vaginal tears. ICD-10 O70.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women with postpartum bleeding</measure>
    <time_frame>6 hour</time_frame>
    <description>Postpartum bleeding in millilitres evaluated 6 hours after birth. ICD-10 O72.0, O72.1 (O72.1a, O72.1b)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birthposition at the time of birth</measure>
    <time_frame>2 hours</time_frame>
    <description>The position of the woman when giving birth as recorded in the local birth register</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women with an episiotomy</measure>
    <time_frame>4 hour</time_frame>
    <description>Number of women who had an episiotomy performed during birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women with perineal injury subtypes</measure>
    <time_frame>4 hour</time_frame>
    <description>Labial lacerations, periurethral tears, perinal tears grade I, and superficial vaginal tears. ICD-10 070.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar scores at birth, 1 and 5 min after birth</measure>
    <time_frame>10 minutes</time_frame>
    <description>Apgar score assessed by the midwife a 1,5.10 minutes after the baby is born</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH in umbilical artery</measure>
    <time_frame>Blood sample is drawn from the umbilical cord within 1 minute after the birth of the baby and evaluated within 30 minutes</time_frame>
    <description>Arterial pH in the umbilical cord</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding within 2 hours after birth</measure>
    <time_frame>2 hours</time_frame>
    <description>Number of women who breastfeed within 2 hours after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women with an assisted Instrumental delivery</measure>
    <time_frame>Recorded after birth (2 hours)</time_frame>
    <description>Number of women with an instrumental delivery (vacuum extraction or forceps)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midwives experiences of the intervention</measure>
    <time_frame>One month</time_frame>
    <description>Midwives no 1 and no 2 will complete a study record after birth. The study record will contain question regarding what midwife no 2 assisted with during the second stage of labour and how it was perceived by midwife no 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Women's experiences of midwifery methods used during the second stage of labor</measure>
    <time_frame>One month</time_frame>
    <description>Study specific questions sent to women one month after the birth. A questionnaire with questions regarding midwifery methods used (YES or NO) during the second stage of labor and how they were perceived by the participating women. Questions with Likert scale answers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women with urinary incontinence 1 year after birth</measure>
    <time_frame>1 year</time_frame>
    <description>Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFIQ) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women with anal incontinence 1 year after birth</measure>
    <time_frame>1 year</time_frame>
    <description>Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFIQ) will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Female Sexual Function Index (FSFI) one year after birth</measure>
    <time_frame>1 year</time_frame>
    <description>Questionnaire 12 months after the birth. Sexual Function Questionnaire (FSFI) will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women with pelvic organ prolapse symptoms 1 year after birth</measure>
    <time_frame>1 year</time_frame>
    <description>Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFDI-20) will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women who scored 12 point or above on the Edinburgh Postnatal Depression Scale</measure>
    <time_frame>one month</time_frame>
    <description>Depressive symptoms 1 month after birth as reported on the Edinburgh Postnatal Depression Scale (EPDS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women who scored 12 point or above on the Edinburgh Postnatal Depression Scale</measure>
    <time_frame>1 year</time_frame>
    <description>Depressive symptoms 1 year after birth as reported on the Edinburgh Postnatal Depression Scale (EPDS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3058</enrollment>
  <condition>Sphincter (Anal); Perineal Rupture, Obstetric</condition>
  <condition>Perineal Tear</condition>
  <condition>Pelvic Floor Disorders</condition>
  <condition>Experience, Life</condition>
  <condition>Second Stage of Labor</condition>
  <arm_group>
    <arm_group_label>Two midwives</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two midwives will be present during the active phase of the second stage and the birth of the baby. &quot;Midwife no 1&quot; is the midwife who has been responsible for the care of the woman and &quot;midwife no 2&quot; will observe the birth or give any assistance needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One midwife</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is standard care. One midwife is responsible for the care of the woman and her unborn baby during labor and birth.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Two midwives</intervention_name>
    <description>Two midwives will be present during the active phase of the second stage and the birth of the baby. &quot;Midwife no 1&quot; is the midwife who has been responsible for the care of the woman and &quot;midwife no 2&quot; will assist her.</description>
    <arm_group_label>Two midwives</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous women&#xD;
&#xD;
          -  Primiparous women with one previous cesarean section who plan for a vaginal birth&#xD;
&#xD;
          -  &gt;37+0 week of gestational age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiparous women&#xD;
&#xD;
          -  Twin pregnancies&#xD;
&#xD;
          -  Planned breech delivery&#xD;
&#xD;
          -  Preterm birth&#xD;
&#xD;
          -  Nulliparous women with planned elective cesarean section&#xD;
&#xD;
          -  Not able to understand oral and written information regarding the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>47 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Rubertsson, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institution of Health Sciences, The Faculty of Medicine, Lund University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pia Teleman, Ass.prof</last_name>
    <role>Study Chair</role>
    <affiliation>Region Skåne SUS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lund Delivery Ward, SUS Region Skåne</name>
      <address>
        <city>Lund</city>
        <state>Skåne</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malmö Delivery Ward, SUS Region Skåne</name>
      <address>
        <city>Malmö</city>
        <state>Skåne</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karlstad delivery ward</name>
      <address>
        <city>Karlstad</city>
        <state>Värmland</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PO Pregnancy and Birth, Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://www.medscinet.com/GR/uploads/hemsida/dokumentarkiv/GR_%C3%85rsrrapport_2017_4.0.pdf</url>
    <description>The Swedish birthregister. Annual Report 2017 (Swedish)</description>
  </link>
  <link>
    <url>http://www.diva-portal.org/smash/get/diva2:901989/FULLTEXT01.pdf</url>
    <description>Midwives' experiences of collegial presence during the second stage of labour (Swedish)</description>
  </link>
  <link>
    <url>https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-29.pdf</url>
    <description>The Management of Third- and Fourth-Degree Perineal Tears. RCOG Green-top Guideline No.29</description>
  </link>
  <reference>
    <citation>Baghestan E, Irgens LM, Bordahl PE, Rasmussen S. Trends in risk factors for obstetric anal sphincter injuries in Norway. Obstet Gynecol. 2010 Jul;116(1):25-34. doi: 10.1097/AOG.0b013e3181e2f50b.</citation>
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    <citation>Edqvist M, Hildingsson I, Mollberg M, Lundgren I, Lindgren H. Midwives' Management during the Second Stage of Labor in Relation to Second-Degree Tears-An Experimental Study. Birth. 2017 Mar;44(1):86-94. doi: 10.1111/birt.12267. Epub 2016 Nov 14.</citation>
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  </reference>
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    <citation>Rathfisch G, Dikencik BK, Kizilkaya Beji N, Comert N, Tekirdag AI, Kadioglu A. Effects of perineal trauma on postpartum sexual function. J Adv Nurs. 2010 Dec;66(12):2640-9. doi: 10.1111/j.1365-2648.2010.05428.x. Epub 2010 Aug 23.</citation>
    <PMID>20735499</PMID>
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    <citation>Tegerstedt G, Miedel A, Maehle-Schmidt M, Nyren O, Hammarstrom M. Obstetric risk factors for symptomatic prolapse: a population-based approach. Am J Obstet Gynecol. 2006 Jan;194(1):75-81. doi: 10.1016/j.ajog.2005.06.086.</citation>
    <PMID>16389012</PMID>
  </reference>
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    <citation>Woodman PJ, Graney DO. Anatomy and physiology of the female perineal body with relevance to obstetrical injury and repair. Clin Anat. 2002 Aug;15(5):321-34. doi: 10.1002/ca.10034.</citation>
    <PMID>12203375</PMID>
  </reference>
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    <citation>Schei B, Johannessen HH, Rydning A, Sultan A, Morkved S. Anal incontinence after vaginal delivery or cesarean section. Acta Obstet Gynecol Scand. 2019 Jan;98(1):51-60. doi: 10.1111/aogs.13463. Epub 2018 Oct 29.</citation>
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  </reference>
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    <citation>Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200. doi: 10.1111/j.1471-0528.2006.00799.x.</citation>
    <PMID>16411998</PMID>
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    <citation>Raisanen S, Vehvilainen-Julkunen K, Cartwright R, Gissler M, Heinonen S. A prior cesarean section and incidence of obstetric anal sphincter injury. Int Urogynecol J. 2013 Aug;24(8):1331-9. doi: 10.1007/s00192-012-2006-6. Epub 2012 Dec 5.</citation>
    <PMID>23212242</PMID>
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    <citation>Raisanen SH, Vehvilainen-Julkunen K, Gissler M, Heinonen S. Lateral episiotomy protects primiparous but not multiparous women from obstetric anal sphincter rupture. Acta Obstet Gynecol Scand. 2009;88(12):1365-72. doi: 10.3109/00016340903295626.</citation>
    <PMID>19852569</PMID>
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    <citation>Elvander C, Ahlberg M, Edqvist M, Stephansson O. Severe perineal trauma among women undergoing vaginal birth after cesarean delivery: A population-based cohort study. Birth. 2019 Jun;46(2):379-386. doi: 10.1111/birt.12402. Epub 2018 Oct 22.</citation>
    <PMID>30350424</PMID>
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    <citation>Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.</citation>
    <PMID>28608597</PMID>
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    <citation>Laine K, Pirhonen T, Rolland R, Pirhonen J. Decreasing the incidence of anal sphincter tears during delivery. Obstet Gynecol. 2008 May;111(5):1053-7. doi: 10.1097/AOG.0b013e31816c4402.</citation>
    <PMID>18448735</PMID>
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    <citation>Basu M, Smith D, Edwards R; STOMP project team. Can the incidence of obstetric anal sphincter injury be reduced? The STOMP experience. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:55-9. doi: 10.1016/j.ejogrb.2016.04.033. Epub 2016 Apr 30.</citation>
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    <citation>Basu M, Smith D. Long-term outcomes of the Stop Traumatic OASI Morbidity Project (STOMP). Int J Gynaecol Obstet. 2018 Sep;142(3):295-299. doi: 10.1002/ijgo.12565. Epub 2018 Jul 5.</citation>
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  </reference>
  <reference>
    <citation>Simkin P. Just another day in a woman's life? Women's long-term perceptions of their first birth experience. Part I. Birth. 1991 Dec;18(4):203-10. doi: 10.1111/j.1523-536x.1991.tb00103.x.</citation>
    <PMID>1764149</PMID>
  </reference>
  <reference>
    <citation>Kopas ML. A review of evidence-based practices for management of the second stage of labor. J Midwifery Womens Health. 2014 May-Jun;59(3):264-76. doi: 10.1111/jmwh.12199.</citation>
    <PMID>24850283</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>July 13, 2021</last_update_submitted>
  <last_update_submitted_qc>July 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Midwifery intervention</keyword>
  <keyword>Birth experience</keyword>
  <keyword>Obstetric anal sphincter injuries</keyword>
  <keyword>Perineal tears</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Floor Disorders</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03770962/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03770962
org study id: 2018/476
nct id: NCT03770962
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
A new clinical practice to reduce perineal trauma has been adopted by many maternity wards in
      Sweden. This practice involves collegial midwifery assistance during the second stage of
      labor and the birth of the baby. The midwife responsible for the birth is the primary carer
      of the woman and the second midwife observes the birth or assists the primary midwife if
      asked to. The hypothesis is that the presence and support of an extra midwife will reduce
      severe perineal trauma (trauma to the anal sphincter (OASI)).

      The objective of this trial is to evaluate whether collegial midwifery assistance during the
      second stage reduces perineal trauma grade III-IV.
Most women sustain some form of perineal trauma when giving birth vaginally. Perineal
      injuries are classified as grade I-IV. A first-degree tear only includes perineal skin or
      mucosa, whereas a second-degree tear includes muscles in the perineal body. A tear involving
      a part or the whole of the anal sphincter muscle complex is graded III-IV. Data from the
      Swedish National Birth Register show that 4% of first-time mothers suffered a tear affecting
      the anal sphincter. National registers in Sweden only collect data on severe perineal trauma
      affecting the anal sphincter but in a recent regional Swedish study 78% of the primiparous
      women experienced second-degree tears. The consequences of second-degree tears and severe
      perineal trauma are pain, dyspareunia, and an increased risk of symptomatic pelvic organ
      prolapse later in life. A severe consequence of perineal trauma is anal incontinence, mainly
      caused by tears affecting the anal sphincter muscle. However, second-degree tears may also
      lead to anal incontinence. This may be related to a lack of support from the perineal body
      due to poor repair. Furthermore, perineal trauma is known to be misclassified, with
      consequent under-reporting of injuries affecting the anal sphincter complex.

      Risk factors for severe perineal trauma (grade III-IV) are giving birth vaginally for the
      first time, having an assisted vaginal birth, giving birth vaginally after a previous
      caesarean section, or giving birth to a baby that weighs more than 4000 g, and the risk
      increases with age. Some of the midwifery care methods used to prevent perineal injuries have
      been evaluated in clinical trials but there are still gaps in the investigator's knowledge.
      Even if scientific evidence is lacking for most of the preventive strategies used by midwives
      except for warm compresses held at the perineum, midwives believe that a slow and controlled
      birth is a key factor in prevention. Several studies indicate that a combination of
      strategies can be effective in preventing perineal trauma. Giving birth is a profound
      experience for the woman and her partner and an experience that has significance for the
      woman all her life. The second stage is considered to be the most stressful part of the labor
      for the woman and her unborn baby, and consequently also for the midwife. Despite this, there
      is still a lack of knowledge about how women experience the second stage and the methods
      midwives use to facilitate birth and prevent perineal trauma. Traditionally midwives have
      asked colleagues for a second opinion or to assist in complicated situations, or in obstetric
      emergencies. Recently a new clinical practice has been introduced in approximately 50% of the
      maternity wards in Sweden to reduce severe perineal trauma. This procedure involves two
      midwives attending the woman during the second stage of labor. The midwife responsible for
      the birth calls for the second midwife when the active phase of the second stage has started
      and the presenting part of the baby is visible. The second midwife observes the birth and can
      assist the midwife responsible for the birth if needed. An unpublished survey from one
      maternity ward in Sweden showed that most of the midwives appreciated this way of working but
      were uncertain as to whether it actually reduced the prevalence of severe perineal trauma.
      Furthermore, this clinical practice might have negative side-effects or unintended
      consequences. The maternity wards that practise this method have not increased the number of
      midwives. It could be argued that there is a risk that other women in labor will be left
      unattended for longer periods when two midwives assist at births. How midwives share the
      responsibility and communicate are factors that needs to be evaluated scientifically.

      The objective of this trial is to evaluate whether collegial midwifery assistance during the
      second stage reduces perineal trauma grade III-IV.

      Data from the National Birth Register show that 4.1% of first-time mothers suffered severe
      perineal trauma (OASI) in Sweden 2017. To be able to detect a reduction from 4.1 to 2.0% (50%
      reduction) with 80% power and a 95% level of significance, 1052 women in each group will be
      needed. The 50% reduction is based on regional figures after a change in practice and is
      therefore clinically significant. Allowing for a possible 40% drop-out rate including
      possible cases of obstetric emergencies where another midwife will be needed regardless of
      randomization, this will result in 2946 women in total. To ensure that there are no adverse
      side-effects of the intervention interim analyses will be performed every 6 months until the
      end of the trial. In the interim analysis, the distribution of the intervention and standard
      care will be estimated among women with no perineal tears, women diagnosed with a third- or
      fourth-degree tear (OASI), and neonatal outcome (apgar score at 5 minutes and arterial blood
      gas from the nuchal cord).

      Women will be asked to participate in the trial when arriving to the maternity ward. The
      randomization will take place when the woman enters the second stage. It will not be possible
      to blind either women or midwives in this study. The participants will be randomly allocated
      (1:1) to the intervention group or to the standard care group. To allow for equal
      distribution between the groups, block randomization in blocks of ten (five to the
      intervention and five to the control group) will be used.

      After the birth the tear will be diagnosed together with a midwife or an obstetrician who has
      not been involved in the birth. Tears will be sutured according to the guidelines at each
      participating study site. The midwife responsible for the birth will complete a questionnaire
      which will contain questions regarding the woman; labor and birth variables, methods of
      preventing perineal trauma, questions regarding the baby, diagnosis of the tear and how the
      tear was sutured. If a second midwife has been present during the second stage (intervention)
      the responsible midwife will also complete questions on the assistance she got from the
      second midwife and how this assistance was experienced. Data will also be retrieved from the
      participating women's records by using the local database of each study site. When the
      intervention has taken place the second midwife will also complete a questionnaire.

      The women in the trial will be sent a questionnaire one month and one year after the birth.
      The follow-up questionnaire after one month will contain questions regarding their experience
      of the intervention and their experience of the methods used during the second stage and
      women's well-being (EPDS, Pain relief, sexual intercourse resumption, breastfeeding
      initiation), after birth.

      For the one-year follow-up the following validated questionnaires will be used: Pelvic Floor
      Impact Questionnaire (PFIQ7), Pelvic Floor Distress Inventory - short form (PFDI-20), Pelvic
      Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) Female Sexual
      Function Index FSFI, Edinburgh Postnatal Depression Scale (EPDS) and breastfeeding duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
masking description: The statistician who performs the statistical analysis will be blinded.
measure: Number of women with obstetric anal sphincter injury
time frame: 4 hour
description: Tear of the external and/or internal anal sphincter at any degree, ICD-10 O70.2 and O70.3.
measure: Number of women with perineal tear grade II
time frame: 4 hour
description: Tear of the muscles of the perineum and/or deeper vaginal tears. ICD-10 O70.1
measure: Number of women with postpartum bleeding
time frame: 6 hour
description: Postpartum bleeding in millilitres evaluated 6 hours after birth. ICD-10 O72.0, O72.1 (O72.1a, O72.1b)
measure: Birthposition at the time of birth
time frame: 2 hours
description: The position of the woman when giving birth as recorded in the local birth register
measure: Number of women with an episiotomy
time frame: 4 hour
description: Number of women who had an episiotomy performed during birth
measure: Number of women with perineal injury subtypes
time frame: 4 hour
description: Labial lacerations, periurethral tears, perinal tears grade I, and superficial vaginal tears. ICD-10 070.0
measure: Apgar scores at birth, 1 and 5 min after birth
time frame: 10 minutes
description: Apgar score assessed by the midwife a 1,5.10 minutes after the baby is born
measure: pH in umbilical artery
time frame: Blood sample is drawn from the umbilical cord within 1 minute after the birth of the baby and evaluated within 30 minutes
description: Arterial pH in the umbilical cord
measure: Breastfeeding within 2 hours after birth
time frame: 2 hours
description: Number of women who breastfeed within 2 hours after birth
measure: Number of women with an assisted Instrumental delivery
time frame: Recorded after birth (2 hours)
description: Number of women with an instrumental delivery (vacuum extraction or forceps)
measure: Midwives experiences of the intervention
time frame: One month
description: Midwives no 1 and no 2 will complete a study record after birth. The study record will contain question regarding what midwife no 2 assisted with during the second stage of labour and how it was perceived by midwife no 1
measure: Women's experiences of midwifery methods used during the second stage of labor
time frame: One month
description: Study specific questions sent to women one month after the birth. A questionnaire with questions regarding midwifery methods used (YES or NO) during the second stage of labor and how they were perceived by the participating women. Questions with Likert scale answers.
measure: Number of women with urinary incontinence 1 year after birth
time frame: 1 year
description: Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFIQ) will be used.
measure: Number of women with anal incontinence 1 year after birth
time frame: 1 year
description: Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFIQ) will be used
measure: Female Sexual Function Index (FSFI) one year after birth
time frame: 1 year
description: Questionnaire 12 months after the birth. Sexual Function Questionnaire (FSFI) will be used
measure: Number of women with pelvic organ prolapse symptoms 1 year after birth
time frame: 1 year
description: Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFDI-20) will be used
measure: Number of women who scored 12 point or above on the Edinburgh Postnatal Depression Scale
time frame: one month
description: Depressive symptoms 1 month after birth as reported on the Edinburgh Postnatal Depression Scale (EPDS)
measure: Number of women who scored 12 point or above on the Edinburgh Postnatal Depression Scale
time frame: 1 year
description: Depressive symptoms 1 year after birth as reported on the Edinburgh Postnatal Depression Scale (EPDS)
arm group label: Two midwives
arm group type: Experimental
description: Two midwives will be present during the active phase of the second stage and the birth of the baby. "Midwife no 1" is the midwife who has been responsible for the care of the woman and "midwife no 2" will observe the birth or give any assistance needed.
arm group label: One midwife
arm group type: No Intervention
description: This is standard care. One midwife is responsible for the care of the woman and her unborn baby during labor and birth.
intervention type: Behavioral
intervention name: Two midwives
description: Two midwives will be present during the active phase of the second stage and the birth of the baby. "Midwife no 1" is the midwife who has been responsible for the care of the woman and "midwife no 2" will assist her.
arm group label: Two midwives
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 47 Years
healthy volunteers: No
last name: Christine Rubertsson, Professor
role: Principal Investigator
affiliation: Institution of Health Sciences, The Faculty of Medicine, Lund University
last name: Pia Teleman, Ass.prof
role: Study Chair
affiliation: Region Skåne SUS
facility: 
facility: 
facility: 
facility: 
country: Sweden
url: https://www.medscinet.com/GR/uploads/hemsida/dokumentarkiv/GR_%C3%85rsrrapport_2017_4.0.pdf
description: The Swedish birthregister. Annual Report 2017 (Swedish)
url: http://www.diva-portal.org/smash/get/diva2:901989/FULLTEXT01.pdf
description: Midwives' experiences of collegial presence during the second stage of labour (Swedish)
url: https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-29.pdf
description: The Management of Third- and Fourth-Degree Perineal Tears. RCOG Green-top Guideline No.29
citation: Baghestan E, Irgens LM, Bordahl PE, Rasmussen S. Trends in risk factors for obstetric anal sphincter injuries in Norway. Obstet Gynecol. 2010 Jul;116(1):25-34. doi: 10.1097/AOG.0b013e3181e2f50b.
PMID: 20567164
citation: Edqvist M, Hildingsson I, Mollberg M, Lundgren I, Lindgren H. Midwives' Management during the Second Stage of Labor in Relation to Second-Degree Tears-An Experimental Study. Birth. 2017 Mar;44(1):86-94. doi: 10.1111/birt.12267. Epub 2016 Nov 14.
PMID: 27859542
citation: Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
PMID: 15507941
citation: Rathfisch G, Dikencik BK, Kizilkaya Beji N, Comert N, Tekirdag AI, Kadioglu A. Effects of perineal trauma on postpartum sexual function. J Adv Nurs. 2010 Dec;66(12):2640-9. doi: 10.1111/j.1365-2648.2010.05428.x. Epub 2010 Aug 23.
PMID: 20735499
citation: Tegerstedt G, Miedel A, Maehle-Schmidt M, Nyren O, Hammarstrom M. Obstetric risk factors for symptomatic prolapse: a population-based approach. Am J Obstet Gynecol. 2006 Jan;194(1):75-81. doi: 10.1016/j.ajog.2005.06.086.
PMID: 16389012
citation: Woodman PJ, Graney DO. Anatomy and physiology of the female perineal body with relevance to obstetrical injury and repair. Clin Anat. 2002 Aug;15(5):321-34. doi: 10.1002/ca.10034.
PMID: 12203375
citation: Schei B, Johannessen HH, Rydning A, Sultan A, Morkved S. Anal incontinence after vaginal delivery or cesarean section. Acta Obstet Gynecol Scand. 2019 Jan;98(1):51-60. doi: 10.1111/aogs.13463. Epub 2018 Oct 29.
PMID: 30204238
citation: Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200. doi: 10.1111/j.1471-0528.2006.00799.x.
PMID: 16411998
citation: Raisanen S, Vehvilainen-Julkunen K, Cartwright R, Gissler M, Heinonen S. A prior cesarean section and incidence of obstetric anal sphincter injury. Int Urogynecol J. 2013 Aug;24(8):1331-9. doi: 10.1007/s00192-012-2006-6. Epub 2012 Dec 5.
PMID: 23212242
citation: Raisanen SH, Vehvilainen-Julkunen K, Gissler M, Heinonen S. Lateral episiotomy protects primiparous but not multiparous women from obstetric anal sphincter rupture. Acta Obstet Gynecol Scand. 2009;88(12):1365-72. doi: 10.3109/00016340903295626.
PMID: 19852569
citation: Elvander C, Ahlberg M, Edqvist M, Stephansson O. Severe perineal trauma among women undergoing vaginal birth after cesarean delivery: A population-based cohort study. Birth. 2019 Jun;46(2):379-386. doi: 10.1111/birt.12402. Epub 2018 Oct 22.
PMID: 30350424
citation: Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.
PMID: 28608597
citation: Laine K, Pirhonen T, Rolland R, Pirhonen J. Decreasing the incidence of anal sphincter tears during delivery. Obstet Gynecol. 2008 May;111(5):1053-7. doi: 10.1097/AOG.0b013e31816c4402.
PMID: 18448735
citation: Basu M, Smith D, Edwards R; STOMP project team. Can the incidence of obstetric anal sphincter injury be reduced? The STOMP experience. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:55-9. doi: 10.1016/j.ejogrb.2016.04.033. Epub 2016 Apr 30.
PMID: 27164486
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PMID: 24850283
responsible party type: Sponsor
mesh term: Pelvic Floor Disorders
mesh term: Rupture
sharing ipd: No
provided document: 