<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/NCT02983591</url>
  </required_header>
  <id_info>
    <org_study_id>16082016</org_study_id>
    <nct_id>NCT02983591</nct_id>
  </id_info>
  <brief_title>Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin</brief_title>
  <official_title>Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General Hospital</source>
  <brief_summary>
    <textblock>
      The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use&#xD;
      in the third stage of labor ineffective in reducing post partum blood loss as compared to&#xD;
      other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in&#xD;
      reducing post partum hemorrhage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study will be carried out at Makassed General Hospital, a tertiary-level maternity unit&#xD;
      performing about 1000 deliveries annually. After approval by the hospital Ethics and Research&#xD;
      Committee, women with single viable pregnancy, in cephalic presentation, at full term and&#xD;
      whom labor was induced by Oxytocin will be eligible for inclusion.&#xD;
&#xD;
      After informed consents is obtained, the parturients will be assigned randomly according to a&#xD;
      computer generated sequence in block lists of 25each time to receive either 1000mcg of&#xD;
      Misoprostol rectally or 20 units of Oxytocin intravenously to run at a rate of 150ml/hr. The&#xD;
      medications will be given just after cord clamping and before delivery of the placenta.&#xD;
      Active management of the third stage of labor will be carried out simultaneously with early&#xD;
      cord clamping, gentle downward traction of the placenta to hasten its delivery, and uterine&#xD;
      massage in addition to the uterotonic according to assignment of the patient. Assessment of&#xD;
      the uterine condition will be done by the obstetrician or his assistant, together with&#xD;
      visually estimating the amount of blood loss. Once uterine atony or estimated blood loss&#xD;
      (EBL) of more than 500 ml is noticed, another uterotonics will be administered according to&#xD;
      the condition and at the discretion of the obstetrician.&#xD;
&#xD;
      Failure to achieve adequate uterine contraction and to control post partum hemorrhage (PPH)&#xD;
      by the routine uterine massage will urge the use of either different uterotonics or surgical&#xD;
      intervention if necessary. Blood transfusion will be ordered for the cases whose visual&#xD;
      estimation of blood loss is more than 1000ml or when the patient was hemodynamically&#xD;
      unstable. In order to compare the effect of each medication alone on the amount of blood&#xD;
      loss, we will then exclude those patients who received blood transfusion or additional&#xD;
      uterotonics. A base line hemoglobin and hematocrit levels will be withdrawn on admission and&#xD;
      another reading 12 hours postpartum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin level</measure>
    <time_frame>12 to 24 hours post partum</time_frame>
    <description>10% or more drop in hemoglobin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean hemoglobin drop</measure>
    <time_frame>12 to 24 hours post partum</time_frame>
    <description>difference between pre and post partum hemoglobin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean estimated blood loss</measure>
    <time_frame>during the first hour post partum</time_frame>
    <description>visual estimation of blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>drop in hemoglobin</measure>
    <time_frame>12 to 24 hours post partum</time_frame>
    <description>2g/dl drop in hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effect of medication</measure>
    <time_frame>upto 48 hours after delivery</time_frame>
    <description>fever &gt; 38°C, diarrhea, and shivering</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Prevention of Post Partum Hemorrhage After Labor Induction</condition>
  <arm_group>
    <arm_group_label>Misoprostol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rectal misoprostol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous oxytocin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol after delivery</intervention_name>
    <description>Patients will receive 1000 mcg Misoprostol per rectum</description>
    <arm_group_label>Misoprostol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin after delivery</intervention_name>
    <description>Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h</description>
    <arm_group_label>Oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin before delivery</intervention_name>
    <description>All patients will receive oxytocin 0.5-1 milliUnit/min IV, titrated to 1-2 milliUnit/min every 15-60 min before delivery to induce labor</description>
    <arm_group_label>Misoprostol</arm_group_label>
    <arm_group_label>Oxytocin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with single viable pregnancy,&#xD;
&#xD;
          -  cephalic presentation,&#xD;
&#xD;
          -  at full term&#xD;
&#xD;
          -  whom labor was induced by Oxytocin were eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  delivery by cesarean section&#xD;
&#xD;
          -  received other prophylactic uterotonics&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 12, 2018</last_update_submitted>
  <last_update_submitted_qc>January 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Manal Hubeish</investigator_full_name>
    <investigator_title>OBGYN attending physician</investigator_title>
  </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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Oxytocin</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/NCT02983591
org study id: 16082016
nct id: NCT02983591
lead sponsor: 
The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use
      in the third stage of labor ineffective in reducing post partum blood loss as compared to
      other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in
      reducing post partum hemorrhage.
Our study will be carried out at Makassed General Hospital, a tertiary-level maternity unit
      performing about 1000 deliveries annually. After approval by the hospital Ethics and Research
      Committee, women with single viable pregnancy, in cephalic presentation, at full term and
      whom labor was induced by Oxytocin will be eligible for inclusion.

      After informed consents is obtained, the parturients will be assigned randomly according to a
      computer generated sequence in block lists of 25each time to receive either 1000mcg of
      Misoprostol rectally or 20 units of Oxytocin intravenously to run at a rate of 150ml/hr. The
      medications will be given just after cord clamping and before delivery of the placenta.
      Active management of the third stage of labor will be carried out simultaneously with early
      cord clamping, gentle downward traction of the placenta to hasten its delivery, and uterine
      massage in addition to the uterotonic according to assignment of the patient. Assessment of
      the uterine condition will be done by the obstetrician or his assistant, together with
      visually estimating the amount of blood loss. Once uterine atony or estimated blood loss
      (EBL) of more than 500 ml is noticed, another uterotonics will be administered according to
      the condition and at the discretion of the obstetrician.

      Failure to achieve adequate uterine contraction and to control post partum hemorrhage (PPH)
      by the routine uterine massage will urge the use of either different uterotonics or surgical
      intervention if necessary. Blood transfusion will be ordered for the cases whose visual
      estimation of blood loss is more than 1000ml or when the patient was hemodynamically
      unstable. In order to compare the effect of each medication alone on the amount of blood
      loss, we will then exclude those patients who received blood transfusion or additional
      uterotonics. A base line hemoglobin and hematocrit levels will be withdrawn on admission and
      another reading 12 hours postpartum.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Hemoglobin level
time frame: 12 to 24 hours post partum
description: 10% or more drop in hemoglobin
measure: mean hemoglobin drop
time frame: 12 to 24 hours post partum
description: difference between pre and post partum hemoglobin levels
measure: mean estimated blood loss
time frame: during the first hour post partum
description: visual estimation of blood loss
measure: drop in hemoglobin
time frame: 12 to 24 hours post partum
description: 2g/dl drop in hemoglobin
measure: side effect of medication
time frame: upto 48 hours after delivery
description: fever > 38°C, diarrhea, and shivering
arm group label: Misoprostol
arm group type: Experimental
description: Rectal misoprostol
arm group label: Oxytocin
arm group type: Experimental
description: intravenous oxytocin
intervention type: Drug
intervention name: Misoprostol after delivery
description: Patients will receive 1000 mcg Misoprostol per rectum
arm group label: Misoprostol
intervention type: Drug
intervention name: Oxytocin after delivery
description: Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h
arm group label: Oxytocin
intervention type: Drug
intervention name: Oxytocin before delivery
description: All patients will receive oxytocin 0.5-1 milliUnit/min IV, titrated to 1-2 milliUnit/min every 15-60 min before delivery to induce labor
arm group label: Misoprostol
arm group label: Oxytocin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Manal Hubeish
investigator title: OBGYN attending physician
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Misoprostol
mesh term: Oxytocin