<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/NCT01708811</url>
  </required_header>
  <id_info>
    <org_study_id>LOF-KS1</org_study_id>
    <nct_id>NCT01708811</nct_id>
  </id_info>
  <brief_title>Hyponatremia and Myometrium Contractility. An Invitro Study</brief_title>
  <official_title>Will Reduction in Plasma Sodium Reduce Myometrium Contractility in Humans? An Invitro Study of Pregnant Myometrium at Term.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyponatremia during labour has been associated with prolonged labour, and increased incidence&#xD;
      of instrumental delivery and emergency caesarean section. Sodium influx in myometral cells&#xD;
      are involved in contractility,and and influence of hyponatraemia on contractility can be&#xD;
      suspected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biopsies will be obtained from pregnant women undergoing planned caesarean section at term.&#xD;
      The biopsies will divided into 3 strips that will be stored overnight in chilled NaCl 0.9%.&#xD;
      The following morning each strip will be mounted isometrically with one end fixed to a holder&#xD;
      and the other end to a force transducer. One strip will be maintained in a solution&#xD;
      containing 140mmol/L Na,acting as control, whereas the other two strips will be placed in&#xD;
      fluids with diminishing Na concentration, from 140 mmol/L, to 130 mmol/L and 120 mmol/L.&#xD;
      Contractility will be measured with force transducers and a polygraph&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Few biopsies showed the expected pattern We suspect erroeneous method.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Contractility</measure>
    <time_frame>24 hours</time_frame>
    <description>Contractility will be measured, and data analyzed.</description>
  </primary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Hyponatremia</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsies of pregant myometrium&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy women with singleton pregancies requiring delivery planned caesarean section.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy at term&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preeclampsia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunvor Ekman-Ordeberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Women and Child´s Health, Karolinska University Hospital, Solna</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Moen V, Brudin L, Rundgren M, Irestedt L. Hyponatremia complicating labour--rare or unrecognised? A prospective observational study. BJOG. 2009 Mar;116(4):552-61. doi: 10.1111/j.1471-0528.2008.02063.x. Epub 2009 Jan 27.</citation>
    <PMID>19175600</PMID>
  </reference>
  <reference>
    <citation>Kamizaki J, Shimizu K, Nakajyo S, Urakawa N. A comparative study on the contraction induced by high K+/Na+ deficient solution in rat uterus or urinary bladder. Jpn J Pharmacol. 1988 Jun;47(2):179-88. doi: 10.1254/jjp.47.179.</citation>
    <PMID>3199594</PMID>
  </reference>
  <reference>
    <citation>Sperelakis N, Inoue Y, Ohya Y. Fast Na+ channels and slow Ca2+ current in smooth muscle from pregnant rat uterus. Mol Cell Biochem. 1992 Sep 8;114(1-2):79-89.</citation>
    <PMID>1281264</PMID>
  </reference>
  <reference>
    <citation>Cheek TG, Samuels P, Miller F, Tobin M, Gutsche BB. Normal saline i.v. fluid load decreases uterine activity in active labour. Br J Anaesth. 1996 Nov;77(5):632-5. doi: 10.1093/bja/77.5.632.</citation>
    <PMID>8957980</PMID>
  </reference>
  <reference>
    <citation>Garite TJ, Weeks J, Peters-Phair K, Pattillo C, Brewster WR. A randomized controlled trial of the effect of increased intravenous hydration on the course of labor in nulliparous women. Am J Obstet Gynecol. 2000 Dec;183(6):1544-8. doi: 10.1067/mob.2000.107884.</citation>
    <PMID>11120525</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>October 12, 2015</last_update_submitted>
  <last_update_submitted_qc>October 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Vibeke Moen</investigator_full_name>
    <investigator_title>research fellow</investigator_title>
  </responsible_party>
  <keyword>Contractility</keyword>
  <keyword>human</keyword>
  <keyword>myometrium</keyword>
  <keyword>hyponatraemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyponatremia</mesh_term>
  </condition_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/NCT01708811
org study id: LOF-KS1
nct id: NCT01708811
lead sponsor: 
has dmc: No
Hyponatremia during labour has been associated with prolonged labour, and increased incidence
      of instrumental delivery and emergency caesarean section. Sodium influx in myometral cells
      are involved in contractility,and and influence of hyponatraemia on contractility can be
      suspected.
Biopsies will be obtained from pregnant women undergoing planned caesarean section at term.
      The biopsies will divided into 3 strips that will be stored overnight in chilled NaCl 0.9%.
      The following morning each strip will be mounted isometrically with one end fixed to a holder
      and the other end to a force transducer. One strip will be maintained in a solution
      containing 140mmol/L Na,acting as control, whereas the other two strips will be placed in
      fluids with diminishing Na concentration, from 140 mmol/L, to 130 mmol/L and 120 mmol/L.
      Contractility will be measured with force transducers and a polygraph
observational model: Case-Only
time perspective: Prospective
measure: Contractility
time frame: 24 hours
description: Contractility will be measured, and data analyzed.
Biopsies of pregant myometrium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: No
last name: Gunvor Ekman-Ordeberg, PhD
role: Principal Investigator
affiliation: Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden
facility: 
country: Sweden
citation: Moen V, Brudin L, Rundgren M, Irestedt L. Hyponatremia complicating labour--rare or unrecognised? A prospective observational study. BJOG. 2009 Mar;116(4):552-61. doi: 10.1111/j.1471-0528.2008.02063.x. Epub 2009 Jan 27.
PMID: 19175600
citation: Kamizaki J, Shimizu K, Nakajyo S, Urakawa N. A comparative study on the contraction induced by high K+/Na+ deficient solution in rat uterus or urinary bladder. Jpn J Pharmacol. 1988 Jun;47(2):179-88. doi: 10.1254/jjp.47.179.
PMID: 3199594
citation: Sperelakis N, Inoue Y, Ohya Y. Fast Na+ channels and slow Ca2+ current in smooth muscle from pregnant rat uterus. Mol Cell Biochem. 1992 Sep 8;114(1-2):79-89.
PMID: 1281264
citation: Cheek TG, Samuels P, Miller F, Tobin M, Gutsche BB. Normal saline i.v. fluid load decreases uterine activity in active labour. Br J Anaesth. 1996 Nov;77(5):632-5. doi: 10.1093/bja/77.5.632.
PMID: 8957980
citation: Garite TJ, Weeks J, Peters-Phair K, Pattillo C, Brewster WR. A randomized controlled trial of the effect of increased intravenous hydration on the course of labor in nulliparous women. Am J Obstet Gynecol. 2000 Dec;183(6):1544-8. doi: 10.1067/mob.2000.107884.
PMID: 11120525
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Vibeke Moen
investigator title: research fellow
mesh term: Hyponatremia