<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/NCT02232035</url>
  </required_header>
  <id_info>
    <org_study_id>chuaiyunhai-002</org_study_id>
    <nct_id>NCT02232035</nct_id>
  </id_info>
  <brief_title>Diazepam at the Active Phase of Labor</brief_title>
  <official_title>Intravenous Injection of Diazepam at the Beginning of Active Phase of Labor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Navy General Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Navy General Hospital, Beijing</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to&#xD;
      increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and&#xD;
      asphyxia and requires early detection and appropriate clinical response. The risks for&#xD;
      complications of prolonged labour are much greater in poor resource settings. Active&#xD;
      management of labour versus physiological, expectant management, has shown to decrease the&#xD;
      occurrence of prolonged labour. Administering sedatives during labour could also lead to&#xD;
      faster and more effective dilatation of the cervix. Interventions to shorten labour, such as&#xD;
      sedatives, can be used as a preventative or a treatment strategy in order to decrease the&#xD;
      incidence of prolonged labour. As the evidence to support this is still largely anecdotal&#xD;
      around the world. (Cochrane Database of Systematic Reviews 2013,CD009243.pub3.; Cochrane&#xD;
      Database of Systematic Reviews 2012, CD009223.pub2.)&#xD;
&#xD;
      Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of labor</measure>
    <time_frame>labor</time_frame>
    <description>Duration of first stage of labor. Duration of second stage of labour. Duration of third stage of labor. Total duration of labor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of cervical dilatation</measure>
    <time_frame>at the active phase of labor</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain relief</measure>
    <time_frame>every 30 minutes during the 3-hour period after administration of the trial drug</time_frame>
    <description>Pain severity during the last contraction was assessed using a Visual Analogue Scale (VAS) (with anchor points of 0 = no pain at all and 10 = the most excruciating pain) every 30 minutes during the 3-hour period after administration of the trial drug. This information was used to derive measures of pain relief at each time-point using absolute change in pain intensity (on a 10-cm VAS) from pre-analgesia (baseline). In addition to analysing all the time-points together (as described in the section on statistical analysis), a specific analysis of pain relief at 60 minutes was conducted, because it was anticipated that the maximum analgesic effect would occur then. (Wee MYK, Tuckey JP, Thomas PW, Burnard S. A comparison of intramuscular diamorphine and intramuscular pethidine for labour analgesia: a two-centre randomised blinded controlled trial. BJOG 2014;121:447-456.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of delivery</measure>
    <time_frame>post partum, immediately</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Maternal adverse events</measure>
    <time_frame>two weeks after childbirth</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal adverse events</measure>
    <time_frame>two weeks after childbirth</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Maternal satisfaction</measure>
    <time_frame>post partum, immediately</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Pain</condition>
  <condition>Prolonged Labour</condition>
  <arm_group>
    <arm_group_label>normal saline, active phase of labor</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single dose intravenous injection of normal saline (2ml) at the beginning of active phase of labor in the group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diazepam, active phase of labor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose intravenous injection of diazepam (10mg, 2ml) at the beginning of active phase of labor in the group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline/diazepam at the active phase of labor</intervention_name>
    <description>A single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor.</description>
    <arm_group_label>diazepam, active phase of labor</arm_group_label>
    <arm_group_label>normal saline, active phase of labor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primigravida&#xD;
&#xD;
          -  at term&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  cephalic presentation&#xD;
&#xD;
          -  spontaneous labour&#xD;
&#xD;
          -  intact membranes at the beginning of active phase&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  induced labour&#xD;
&#xD;
          -  spontaneous rupture of membranes at randomisation&#xD;
&#xD;
          -  obstetric complications, or medical complications&#xD;
&#xD;
          -  previous uterine scarring, or cervical surgery&#xD;
&#xD;
          -  cervical dilatation of more than 5 cm&#xD;
&#xD;
          -  other antispasmodics in the first stage&#xD;
&#xD;
          -  malpresentation, macrosomia, cephalopelvic disproportion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aiming Wang, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Navy General Hospital, Beijing</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yunhai Chuai, Dr</last_name>
    <phone>+86-18810892004</phone>
    <email>wangyh85@foxmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Navy General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100048</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yunhai Chuai, Dr</last_name>
      <phone>+86-18810892004</phone>
      <email>wangyh85@foxmail.com</email>
    </contact>
    <investigator>
      <last_name>Aiming Wang, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yunhai Chuai, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wen Jiang, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.</citation>
    <PMID>23737030</PMID>
  </reference>
  <results_reference>
    <citation>Othman M, Jones L, Neilson JP. Non-opioid drugs for pain management in labour. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009223. doi: 10.1002/14651858.CD009223.pub2.</citation>
    <PMID>22786524</PMID>
  </results_reference>
  <results_reference>
    <citation>Davies JM, Rosen M. Intramuscular diazepam in labour. A double-blind trial in multiparae. Br J Anaesth. 1977 Jun;49(6):601-4. doi: 10.1093/bja/49.6.601.</citation>
    <PMID>326281</PMID>
  </results_reference>
  <results_reference>
    <citation>Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6. No abstract available.</citation>
    <PMID>4893003</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Navy General Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>Yunhai Chuai</investigator_full_name>
    <investigator_title>Department of Obstetrics and Gynecology, Navy General Hospital, Beijing</investigator_title>
  </responsible_party>
  <keyword>diazepam</keyword>
  <keyword>active phase</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diazepam</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02232035
org study id: chuaiyunhai-002
nct id: NCT02232035
lead sponsor: 
has dmc: Yes
Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to
      increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and
      asphyxia and requires early detection and appropriate clinical response. The risks for
      complications of prolonged labour are much greater in poor resource settings. Active
      management of labour versus physiological, expectant management, has shown to decrease the
      occurrence of prolonged labour. Administering sedatives during labour could also lead to
      faster and more effective dilatation of the cervix. Interventions to shorten labour, such as
      sedatives, can be used as a preventative or a treatment strategy in order to decrease the
      incidence of prolonged labour. As the evidence to support this is still largely anecdotal
      around the world. (Cochrane Database of Systematic Reviews 2013,CD009243.pub3.; Cochrane
      Database of Systematic Reviews 2012, CD009223.pub2.)

      Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Duration of labor
time frame: labor
description: Duration of first stage of labor. Duration of second stage of labour. Duration of third stage of labor. Total duration of labor.
measure: Rate of cervical dilatation
time frame: at the active phase of labor
measure: Pain relief
time frame: every 30 minutes during the 3-hour period after administration of the trial drug
description: Pain severity during the last contraction was assessed using a Visual Analogue Scale (VAS) (with anchor points of 0 = no pain at all and 10 = the most excruciating pain) every 30 minutes during the 3-hour period after administration of the trial drug. This information was used to derive measures of pain relief at each time-point using absolute change in pain intensity (on a 10-cm VAS) from pre-analgesia (baseline). In addition to analysing all the time-points together (as described in the section on statistical analysis), a specific analysis of pain relief at 60 minutes was conducted, because it was anticipated that the maximum analgesic effect would occur then. (Wee MYK, Tuckey JP, Thomas PW, Burnard S. A comparison of intramuscular diamorphine and intramuscular pethidine for labour analgesia: a two-centre randomised blinded controlled trial. BJOG 2014;121:447-456.)
measure: Type of delivery
time frame: post partum, immediately
measure: Maternal adverse events
time frame: two weeks after childbirth
measure: Neonatal adverse events
time frame: two weeks after childbirth
measure: Maternal satisfaction
time frame: post partum, immediately
arm group label: normal saline, active phase of labor
arm group type: Placebo Comparator
description: A single dose intravenous injection of normal saline (2ml) at the beginning of active phase of labor in the group.
arm group label: diazepam, active phase of labor
arm group type: Experimental
description: A single dose intravenous injection of diazepam (10mg, 2ml) at the beginning of active phase of labor in the group.
intervention type: Drug
intervention name: normal saline/diazepam at the active phase of labor
description: A single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor.
arm group label: diazepam, active phase of labor
arm group label: normal saline, active phase of labor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aiming Wang, Dr
role: Principal Investigator
affiliation: Navy General Hospital, Beijing
last name: Yunhai Chuai, Dr
phone: +86-18810892004
email: wangyh85@foxmail.com
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: China
citation: Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.
PMID: 23737030
citation: Othman M, Jones L, Neilson JP. Non-opioid drugs for pain management in labour. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009223. doi: 10.1002/14651858.CD009223.pub2.
PMID: 22786524
citation: Davies JM, Rosen M. Intramuscular diazepam in labour. A double-blind trial in multiparae. Br J Anaesth. 1977 Jun;49(6):601-4. doi: 10.1093/bja/49.6.601.
PMID: 326281
citation: Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6. No abstract available.
PMID: 4893003
responsible party type: Principal Investigator
investigator affiliation: Navy General Hospital, Beijing
investigator full name: Yunhai Chuai
investigator title: Department of Obstetrics and Gynecology, Navy General Hospital, Beijing
mesh term: Diazepam