<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/NCT03006380</url>
  </required_header>
  <id_info>
    <org_study_id>oxytocin</org_study_id>
    <nct_id>NCT03006380</nct_id>
  </id_info>
  <brief_title>Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery</brief_title>
  <official_title>Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled study to assess the efficacy and safety of the timing of administration&#xD;
      of prophylactic oxytocin via intramuscular route (before compared to after placental&#xD;
      delivery) on blood loss in vaginal delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      400 patients will be recruited for the study,Informed consent will be obtained from all&#xD;
      patients following the research criteria once they are admitted in active labor, but they&#xD;
      will be enrolled and randomized only when they reach the second stage of labor (fully dilated&#xD;
      cervix) as it will be difficult in this stage to counsel patients.&#xD;
&#xD;
      The recruited patients will be subjected to the following:&#xD;
&#xD;
        -  History taking: with particular emphasis on past medical history (especially for&#xD;
           bleeding tendency), past obstetric history.&#xD;
&#xD;
        -  Checking vital signs, General and abdominal examination.&#xD;
&#xD;
        -  laboratory investigations: complete blood count (CBC)&#xD;
&#xD;
        -  Findings of the initial obstetric evaluation follow up, labor duration and the need for&#xD;
           oxytocin augmentation will be recorded through a partogram.&#xD;
&#xD;
        -  All deliveries will be attended by a senior resident in the hospital.&#xD;
&#xD;
        -  Included patients will receive the medication according to randomization tables.&#xD;
&#xD;
        -  After allocation, patients will be excluded only if they required cesarean section,&#xD;
           instrumental delivery or had multiple or deep vaginal tears that compromise estimation&#xD;
           of uterine blood loss.&#xD;
&#xD;
        -  All patients will undergo gentle traction to the umbilical cord while providing counter&#xD;
           traction against the uterine fundus after signs of placental separation; appearance of&#xD;
           bleeding, elongation of the cord.&#xD;
&#xD;
        -  All patients will undergo cord clamping and cutting within 30 seconds of delivery.&#xD;
&#xD;
        -  All patients will undergo uterine massage for 30 seconds after placental delivery.&#xD;
&#xD;
        -  Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours&#xD;
           after placental delivery.&#xD;
&#xD;
        -  CBC will be collected 6 hours after delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood loss in vaginal delivery</measure>
    <time_frame>blood loss in the third stage of labor (Up to 60 min after delivery of the baby)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>primary postpartum hemorrhage</measure>
    <time_frame>within 24 hours after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in hemoglobin and hematocrit</measure>
    <time_frame>before delivery and after 6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>retained placenta</measure>
    <time_frame>more than 30 minutes after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of 3rd stage of labor</measure>
    <time_frame>Up to 60 min from delivery of baby till delivery of placenta</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>manual removal of the placenta</measure>
    <time_frame>if not separated after 30 minutes from delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>to be measured before delivery after 15 minutes,1 hour,6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal pain</measure>
    <time_frame>during third stage of labor</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal nausea and vomiting</measure>
    <time_frame>during 3rd stage of labor</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>secondary postpartum hemorrhage</measure>
    <time_frame>after 24 hours and before 6 weeks from delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgical intervention to stop the bleeding</measure>
    <time_frame>within 24 hours after delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>oxytocin before placental delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oxytocin after placental delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxytocin</intervention_name>
    <description>Ecbolic used to reduce blood loss</description>
    <arm_group_label>oxytocin after placental delivery</arm_group_label>
    <arm_group_label>oxytocin before placental delivery</arm_group_label>
    <other_name>Syntocinon®, NOVARTIS, Egypt</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Multiparous women (had previous one, up to four deliveries)&#xD;
&#xD;
          2. Term pregnancy (37 completed weeks at least).&#xD;
&#xD;
          3. Singleton viable cephalic pregnancy.&#xD;
&#xD;
          4. Vaginal delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Primigravida.(first pregnancy)&#xD;
&#xD;
          2. Grand multiparous. (had previous 5 or more deliveries)&#xD;
&#xD;
          3. Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical&#xD;
             condition; hypertension, cardiac , renal problems)&#xD;
&#xD;
          4. Previous cesarean section, uterine surgery.&#xD;
&#xD;
          5. Patients with bleeding tendency.&#xD;
&#xD;
          6. Previous history of Ante-partum hemorrhage.&#xD;
&#xD;
          7. Previous history of postpartum hemorrhage.&#xD;
&#xD;
          8. Abnormal site of the placenta (detected by ultrasound)&#xD;
&#xD;
          9. Macrosomic baby (EFW more than 4000 gm estimated clinically or by ultrasound)&#xD;
&#xD;
         10. polyhydramnios.(detected by ultrasound)&#xD;
&#xD;
         11. Multiple gestation.&#xD;
&#xD;
         12. Chorioamnionitis.&#xD;
&#xD;
         13. Suspected fetal problem(anomaly, distress)&#xD;
&#xD;
         14. Instrumental delivery.&#xD;
&#xD;
         15. Multiple or deep vaginal tears that compromise the estimation of uterine blood loss.&#xD;
&#xD;
         16. Cesarean delivery&#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>Amr Yehia, MD, MRCOG</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reham Marie, MRCOG</last_name>
    <phone>+201212977339</phone>
    <email>rehamfarghal84@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ain Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amr Yehia, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>March 13, 2017</last_update_submitted>
  <last_update_submitted_qc>March 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>AMR HELMY YEHIA</investigator_full_name>
    <investigator_title>Associate Professor of obstetrics and gynecology</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>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03006380
org study id: oxytocin
nct id: NCT03006380
lead sponsor: 
has dmc: No
Randomized controlled study to assess the efficacy and safety of the timing of administration
      of prophylactic oxytocin via intramuscular route (before compared to after placental
      delivery) on blood loss in vaginal delivery.
400 patients will be recruited for the study,Informed consent will be obtained from all
      patients following the research criteria once they are admitted in active labor, but they
      will be enrolled and randomized only when they reach the second stage of labor (fully dilated
      cervix) as it will be difficult in this stage to counsel patients.

      The recruited patients will be subjected to the following:

        -  History taking: with particular emphasis on past medical history (especially for
           bleeding tendency), past obstetric history.

        -  Checking vital signs, General and abdominal examination.

        -  laboratory investigations: complete blood count (CBC)

        -  Findings of the initial obstetric evaluation follow up, labor duration and the need for
           oxytocin augmentation will be recorded through a partogram.

        -  All deliveries will be attended by a senior resident in the hospital.

        -  Included patients will receive the medication according to randomization tables.

        -  After allocation, patients will be excluded only if they required cesarean section,
           instrumental delivery or had multiple or deep vaginal tears that compromise estimation
           of uterine blood loss.

        -  All patients will undergo gentle traction to the umbilical cord while providing counter
           traction against the uterine fundus after signs of placental separation; appearance of
           bleeding, elongation of the cord.

        -  All patients will undergo cord clamping and cutting within 30 seconds of delivery.

        -  All patients will undergo uterine massage for 30 seconds after placental delivery.

        -  Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours
           after placental delivery.

        -  CBC will be collected 6 hours after delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: blood loss in vaginal delivery
time frame: blood loss in the third stage of labor (Up to 60 min after delivery of the baby)
measure: primary postpartum hemorrhage
time frame: within 24 hours after delivery
measure: changes in hemoglobin and hematocrit
time frame: before delivery and after 6 hours
measure: retained placenta
time frame: more than 30 minutes after delivery
measure: length of 3rd stage of labor
time frame: Up to 60 min from delivery of baby till delivery of placenta
measure: manual removal of the placenta
time frame: if not separated after 30 minutes from delivery
measure: blood pressure
time frame: to be measured before delivery after 15 minutes,1 hour,6 hours
measure: maternal pain
time frame: during third stage of labor
measure: maternal nausea and vomiting
time frame: during 3rd stage of labor
measure: secondary postpartum hemorrhage
time frame: after 24 hours and before 6 weeks from delivery
measure: surgical intervention to stop the bleeding
time frame: within 24 hours after delivery
arm group label: oxytocin before placental delivery
arm group type: Experimental
description: patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta.
arm group label: oxytocin after placental delivery
arm group type: Experimental
description: patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence)
intervention type: Drug
intervention name: oxytocin
description: Ecbolic used to reduce blood loss
arm group label: oxytocin after placental delivery
arm group label: oxytocin before placental delivery
other name: Syntocinon®, NOVARTIS, Egypt
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amr Yehia, MD, MRCOG
role: Study Director
affiliation: Ain Shams University
last name: Reham Marie, MRCOG
phone: +201212977339
email: rehamfarghal84@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: AMR HELMY YEHIA
investigator title: Associate Professor of obstetrics and gynecology
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Oxytocin
sharing ipd: Undecided