<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/NCT03780985</url>
  </required_header>
  <id_info>
    <org_study_id>IUD-Zahraa</org_study_id>
    <nct_id>NCT03780985</nct_id>
  </id_info>
  <brief_title>Post-placental Intrauterine Device Insertion During Cesarean Section</brief_title>
  <official_title>Hang-up Versus Non-fixation Technique for Immediate Post-placental Intrauterine Device Insertion During Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy&#xD;
      and poor perinatal outcome in a subsequent pregnancy especially in women delivered by&#xD;
      cesarean section.The traditional 6-week postpartum visits not evidenced based and may not&#xD;
      meet patient needs, particularly with respect to provision of contraception.Intrauterine&#xD;
      device placement after delivery of the placenta is an appealing strategy for increasing&#xD;
      access to postpartum Intrauterine device because it does not require a separate postpartum&#xD;
      visit.&#xD;
&#xD;
      Advantage of post-placental Intrauterine device insertion, Intrauterine devices are&#xD;
      recommended as first-line contraceptives by the American Academy of Pediatricians. The&#xD;
      Centers for Disease Control and Prevention united state . Medical Eligibility Criteria for&#xD;
      Contraceptive Use places no restrictions on use, and states advantages generally outweigh the&#xD;
      risks for immediate postpartum use of Intrauterine devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of displaced intrauterine device after insertion in both groups</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Intrauterine Device Migration</condition>
  <arm_group>
    <arm_group_label>intrauterine device insertion with a suture fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intruterine device through hysterotomy incision during cesarean section with a suture fixation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intrauterine device insertion without a suture fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IUD through hysterotomy incision during cesarean section without a suture fixation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intrauterine device insertion</intervention_name>
    <description>Post-placental insertion of intrauterine device during Cesarean section</description>
    <arm_group_label>intrauterine device insertion with a suture fixation</arm_group_label>
    <arm_group_label>intrauterine device insertion without a suture fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cesarean section</intervention_name>
    <description>to delivery of the fetus</description>
    <arm_group_label>intrauterine device insertion with a suture fixation</arm_group_label>
    <arm_group_label>intrauterine device insertion without a suture fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suture</intervention_name>
    <description>to fix the intrauterine device</description>
    <arm_group_label>intrauterine device insertion with a suture fixation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age group : 18-40 years&#xD;
&#xD;
          2. Women who will be willing to undergo elective cesarean section&#xD;
&#xD;
          3. women desire using Copper IUD as long acting contraceptive method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Intrauterine infection.&#xD;
&#xD;
          2. Fundal Myoma.&#xD;
&#xD;
          3. Hemorrhagic disorder&#xD;
&#xD;
          4. Genital tract malignancy&#xD;
&#xD;
          5. Uterine atony&#xD;
&#xD;
          6. Sexually transmitted infection.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Woman's Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 9, 2021</last_update_submitted>
  <last_update_submitted_qc>September 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Abdelrahman Mahmoud Mohammed</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intrauterine Device Migration</mesh_term>
  </condition_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/NCT03780985
org study id: IUD-Zahraa
nct id: NCT03780985
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy
      and poor perinatal outcome in a subsequent pregnancy especially in women delivered by
      cesarean section.The traditional 6-week postpartum visits not evidenced based and may not
      meet patient needs, particularly with respect to provision of contraception.Intrauterine
      device placement after delivery of the placenta is an appealing strategy for increasing
      access to postpartum Intrauterine device because it does not require a separate postpartum
      visit.

      Advantage of post-placental Intrauterine device insertion, Intrauterine devices are
      recommended as first-line contraceptives by the American Academy of Pediatricians. The
      Centers for Disease Control and Prevention united state . Medical Eligibility Criteria for
      Contraceptive Use places no restrictions on use, and states advantages generally outweigh the
      risks for immediate postpartum use of Intrauterine devices.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of displaced intrauterine device after insertion in both groups
time frame: 2 weeks
arm group label: intrauterine device insertion with a suture fixation
arm group type: Active Comparator
description: Intruterine device through hysterotomy incision during cesarean section with a suture fixation
arm group label: intrauterine device insertion without a suture fixation
arm group type: Active Comparator
description: IUD through hysterotomy incision during cesarean section without a suture fixation
intervention type: Procedure
intervention name: Intrauterine device insertion
description: Post-placental insertion of intrauterine device during Cesarean section
arm group label: intrauterine device insertion with a suture fixation
arm group label: intrauterine device insertion without a suture fixation
intervention type: Procedure
intervention name: Cesarean section
description: to delivery of the fetus
arm group label: intrauterine device insertion with a suture fixation
arm group label: intrauterine device insertion without a suture fixation
intervention type: Procedure
intervention name: Suture
description: to fix the intrauterine device
arm group label: intrauterine device insertion with a suture fixation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Abdelrahman Mahmoud Mohammed
investigator title: Assistant Lecturer
mesh term: Intrauterine Device Migration
sharing ipd: Undecided