<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/NCT03246919</url>
  </required_header>
  <id_info>
    <org_study_id>209632</org_study_id>
    <nct_id>NCT03246919</nct_id>
  </id_info>
  <brief_title>Ideal Time of Oxytocin Infusion During Cesarean Section</brief_title>
  <acronym>I-TOPICS</acronym>
  <official_title>Ideal Time of Oxytocin Infusion During Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loyola University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loyola University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate if the timing of oxytocin administration in cesarean deliveries will&#xD;
      affect the amount of maternal blood loss. Half of participants will receive oxytocin after&#xD;
      delivery of the fetal anterior shoulder and the other half will receive oxytocin after&#xD;
      delivery of the placenta. We hypothesize that administering oxytocin after delivery of the&#xD;
      shoulder, will result in less overall maternal blood loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in&#xD;
      the third stage of labor, as part of standard of care in the United States. This medication&#xD;
      helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is&#xD;
      lacking to direct timing of oxytocin administration in cesarean deliveries.&#xD;
&#xD;
      This study will evaluate both estimated and quantitative blood loss for both groups of&#xD;
      patients. It will also compare the change from pre-operative to post-operative hemoglobin&#xD;
      levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI left Loyola and Sub-I graduated.&#xD;
  </why_stopped>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">February 24, 2020</completion_date>
  <primary_completion_date type="Actual">February 24, 2020</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double blind: Obstetricians, Anesthesiologists and patients will be blinded. Only nurses will be aware of timing of oxytocin administration</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total blood loss</measure>
    <time_frame>At the completion of the surgery when patient is transferred to recovery from the operating room</time_frame>
    <description>Both the estimated blood loss and quantitative blood loss will be determined</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of postpartum hemorrhage</measure>
    <time_frame>At the completion of the surgery when patient is transferred to recovery from the operating room</time_frame>
    <description>The number of women who lose 1,000 milliliters or more blood from cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for transfusion</measure>
    <time_frame>In the immediate 24 hours post surgery</time_frame>
    <description>The number of women who require a blood transfusion due to surgical blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pre-operative to post-operative hemoglobin levels</measure>
    <time_frame>Baseline and Post operative day number 1</time_frame>
    <description>Hemoglobin levels</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <condition>Postpartum Hemorrhage</condition>
  <condition>Bleed Pregnancy</condition>
  <condition>Pregnancy Related</condition>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>Control (Group A)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia. This amount of fluid is part of standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention (Group B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia. This amount of fluid is part of standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta</description>
    <arm_group_label>Intervention (Group B)</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be administered after delivery of the placenta</description>
    <arm_group_label>Control (Group A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing cesarean section at Loyola Hospital&#xD;
&#xD;
          -  Women who read and speak the English and/or Spanish language&#xD;
&#xD;
          -  Women age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who deliver vaginally&#xD;
&#xD;
          -  Gestation under 37 weeks and 0 days&#xD;
&#xD;
          -  Women with coagulopathies&#xD;
&#xD;
          -  Multiple gestation pregnancies&#xD;
&#xD;
          -  Antepartum hemorrhage for example abruption&#xD;
&#xD;
          -  Placental abnormalities for example previa, accreta&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thaddeus Waters, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loyola University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jackson KW Jr, Allbert JR, Schemmer GK, Elliot M, Humphrey A, Taylor J. A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum hemorrhage. Am J Obstet Gynecol. 2001 Oct;185(4):873-7. doi: 10.1067/mob.2001.117363.</citation>
    <PMID>11641669</PMID>
  </reference>
  <reference>
    <citation>Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2.</citation>
    <PMID>20687079</PMID>
  </reference>
  <reference>
    <citation>Fidan U, Keskin U, Ulubay M, Efendi Karaca R, Burcin Firatligil F, Goksen Kocagoz G, Ergun A. The effect of the use of oxytocin on blood loss during different postpartum periods. J Perinat Med. 2015 Jul;43(4):461-5. doi: 10.1515/jpm-2014-0111.</citation>
    <PMID>24897394</PMID>
  </reference>
  <reference>
    <citation>Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.</citation>
    <PMID>25108586</PMID>
  </reference>
  <reference>
    <citation>Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.</citation>
    <PMID>23467047</PMID>
  </reference>
  <reference>
    <citation>Khan FA, Khan M, Ali A, Chohan U. Estimation of blood loss during Caesarean section: an audit. J Pak Med Assoc. 2006 Dec;56(12):572-5.</citation>
    <PMID>17312645</PMID>
  </reference>
  <reference>
    <citation>Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.</citation>
    <PMID>17390600</PMID>
  </reference>
  <reference>
    <citation>WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/</citation>
    <PMID>23586122</PMID>
  </reference>
  <reference>
    <citation>National Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists</citation>
  </reference>
  <reference>
    <citation>Silverman, F. &amp; Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015</citation>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Blood Loss, Surgical</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <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/NCT03246919
org study id: 209632
nct id: NCT03246919
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will
      affect the amount of maternal blood loss. Half of participants will receive oxytocin after
      delivery of the fetal anterior shoulder and the other half will receive oxytocin after
      delivery of the placenta. We hypothesize that administering oxytocin after delivery of the
      shoulder, will result in less overall maternal blood loss.
Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in
      the third stage of labor, as part of standard of care in the United States. This medication
      helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is
      lacking to direct timing of oxytocin administration in cesarean deliveries.

      This study will evaluate both estimated and quantitative blood loss for both groups of
      patients. It will also compare the change from pre-operative to post-operative hemoglobin
      levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double blind: Obstetricians, Anesthesiologists and patients will be blinded. Only nurses will be aware of timing of oxytocin administration
measure: Total blood loss
time frame: At the completion of the surgery when patient is transferred to recovery from the operating room
description: Both the estimated blood loss and quantitative blood loss will be determined
measure: Incidence of postpartum hemorrhage
time frame: At the completion of the surgery when patient is transferred to recovery from the operating room
description: The number of women who lose 1,000 milliliters or more blood from cesarean delivery
measure: Need for transfusion
time frame: In the immediate 24 hours post surgery
description: The number of women who require a blood transfusion due to surgical blood loss
measure: Change in pre-operative to post-operative hemoglobin levels
time frame: Baseline and Post operative day number 1
description: Hemoglobin levels
arm group label: Control (Group A)
arm group type: Placebo Comparator
description: One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia. This amount of fluid is part of standard of care.
arm group label: Intervention (Group B)
arm group type: Active Comparator
description: One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia. This amount of fluid is part of standard of care.
intervention type: Drug
intervention name: Oxytocin
description: Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
arm group label: Intervention (Group B)
other name: Pitocin
intervention type: Drug
intervention name: Placebo
description: Placebo will be administered after delivery of the placenta
arm group label: Control (Group A)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thaddeus Waters, MD
role: Principal Investigator
affiliation: Loyola University
facility: 
country: United States
citation: Jackson KW Jr, Allbert JR, Schemmer GK, Elliot M, Humphrey A, Taylor J. A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum hemorrhage. Am J Obstet Gynecol. 2001 Oct;185(4):873-7. doi: 10.1067/mob.2001.117363.
PMID: 11641669
citation: Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2.
PMID: 20687079
citation: Fidan U, Keskin U, Ulubay M, Efendi Karaca R, Burcin Firatligil F, Goksen Kocagoz G, Ergun A. The effect of the use of oxytocin on blood loss during different postpartum periods. J Perinat Med. 2015 Jul;43(4):461-5. doi: 10.1515/jpm-2014-0111.
PMID: 24897394
citation: Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.
PMID: 25108586
citation: Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.
PMID: 23467047
citation: Khan FA, Khan M, Ali A, Chohan U. Estimation of blood loss during Caesarean section: an audit. J Pak Med Assoc. 2006 Dec;56(12):572-5.
PMID: 17312645
citation: Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.
PMID: 17390600
citation: WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
PMID: 23586122
citation: National Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists
citation: Silverman, F. & Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Oxytocin
sharing ipd: No