xml: <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/NCT06023849</url>
    </required_header>
    <id_info>
      <org_study_id>Trans CS IUCD insertion</org_study_id>
      <nct_id>NCT06023849</nct_id>
    </id_info>
    <brief_title>Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion</brief_title>
    <acronym>IUDinsertion</acronym>
    <official_title>Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Azhar University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To compare immediate post-placental intrauterine contraceptive device insertion versus&#xD;
        conventional placement at 6 weeks interval (often referred to as delayed or interval&#xD;
        insertion) as regard to:-&#xD;
  &#xD;
          1. Patient satisfaction.&#xD;
  &#xD;
          2. Expulsion rate.&#xD;
  &#xD;
          3. Complications&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Until the 1960s, Intrauterine devices (IUCDs) and condoms were the only artificial methods&#xD;
        for the control of fertility. Nowadays ,despite the presence of 12 contraceptive methods&#xD;
        which include 9 modern methods (pill, IUD, injectable, implant, vaginal methods (diaphragm&#xD;
        and contraceptive foam or jelly), male condom, female sterilization, male sterilization, and&#xD;
        emergency contraception) and 3 traditional methods (periodic abstinence, withdrawal, and&#xD;
        prolonged breastfeeding , the insertion of an IUCD still the second most prevalent method of&#xD;
        family planning used worldwide (13.6%), after female sterilization (20.5%), among women of&#xD;
        reproductive age who are married or cohabiting.&#xD;
  &#xD;
        In Egypt, Egypt Demographic and Health Survey 2014 findings revealed that 59 percent of&#xD;
        currently married women in Egypt are currently using a contraceptive method. The most widely&#xD;
        used method is the IUD, followed by the pill and injectables. Thirty percent of currently&#xD;
        married women are using the IUD, 16 percent are relying on the pill, and 9 percent are&#xD;
        employing injectables. Relatively small proportions of women are using other modern methods,&#xD;
        e.g., 1 percent reported currently using female sterilization. Two percent of women report&#xD;
        use of traditional methods.&#xD;
  &#xD;
        There are two ways used in IUD insertion, in the postpartum period or immediate&#xD;
        post-placental IUD insertion, in which the insertion of IUD occurs within ten minutes after&#xD;
        placenta delivery and after the puerperium (after puerperal or interval period). Intrauterine&#xD;
        device insertion during cesarean section was first introduced in 1967 by Zerzavy by suturing&#xD;
        the IUD to the posterior uterine fundus. Research in China and Belgium introduced&#xD;
        post-placental IUD insertion technique during cesarean delivery with placed an IUD as high as&#xD;
        possible in the fundus without suturing the fundus wall.&#xD;
  &#xD;
        Intrauterine device insertion during early postpartum period is the most effective reversible&#xD;
        contraceptive methods for many mothers because the contraception motivation is high, and it&#xD;
        doesn't interfere with breast feeding. On the other hand, without an effective contraception&#xD;
        in the first six weeks, woman may be accidentally pregnant. Hence, the mother prefers to&#xD;
        insert IUD during cesarean delivery.&#xD;
  &#xD;
        As cesarean section (CS) rates are rising in all countries, IUD insertion at the time of CS&#xD;
        creates an opportunity to increase access to long-acting reversible contraception methods.&#xD;
        Conversely, a previous CS scar may deter access to interval insertion of an IUD if a previous&#xD;
        CS may result in difficulty with insertion and/or future IUD problems.&#xD;
  &#xD;
        Inserting an IUD at the time of CS is a very attractive option; It adds very little time and&#xD;
        cost to the procedure. The patient does not have to come back especially for follow-up, and&#xD;
        there is no risk of primary perforation (secondary perforation is possible) as it is&#xD;
        performed under direct vision.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>1-Patient satisfaction and complication.</measure>
      <time_frame>6 months</time_frame>
      <description>assessment of patient satisfaction using a questionnaire as follow:&#xD;
  Will you use the same method of contraception after the next delivery?&#xD;
  Will you recommend the same method to your fellows?&#xD;
  Are you happy or not with this procedure? give score from 1 to 10, 1 mean you are very unhappy while 10 mean you are very happy.&#xD;
  have you developed any complication?</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>IUD</condition>
    <arm_group>
      <arm_group_label>PPIUD</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>trans cesarean IUD insertion immediately post placental</description>
    </arm_group>
    <arm_group>
      <arm_group_label>interval</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>IUD insertion 6 weeks interval post-partum</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>IUD insertion</intervention_name>
      <description>Trans Caesarean Intra Uterine Contraceptive Device Insertion and Conventional Postpartum 6 Weeks Insertion</description>
      <arm_group_label>PPIUD</arm_group_label>
      <arm_group_label>interval</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 18-40years.&#xD;
  &#xD;
            -  Full term pregnancies delivered by cesarean section.&#xD;
  &#xD;
            -  Desire to have intrauterine contraceptive device (Cu T) as a contraceptive option.&#xD;
  &#xD;
            -  Agree to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergy to copper.&#xD;
  &#xD;
            -  Ante- or intra-partum hemorrhage.&#xD;
  &#xD;
            -  Ruptured of membranes for more than 18 h prior to delivery or Chorioamnionitis.&#xD;
  &#xD;
            -  Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.&#xD;
  &#xD;
            -  History of ectopic pregnancy.&#xD;
  &#xD;
            -  Desire for pregnancy within 1 year of delivery.&#xD;
  &#xD;
            -  Intrapartum fever &gt;38 c.&#xD;
  &#xD;
            -  Sever thrombocytopenia.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ahmed osman, M.B.B.Ch</last_name>
      <phone>01145883770</phone>
      <email>AhmedOsman.2244@azhar.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Selim Ahmed, Assistant Professor</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Medicin</name>
        <address>
          <city>Assiut</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>selim silem, professor</last_name>
        <phone>01145883770</phone>
      </contact>
      <contact_backup>
        <last_name>ahmed osman, MBBCH</last_name>
        <phone>01068677095</phone>
        <email>AhmedOsman.2244@azhar.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Hem E, Bordahl PE. Max Sanger - father of the modern caesarean section. Gynecol Obstet Invest. 2003;55(3):127-9. doi: 10.1159/000071524.</citation>
      <PMID>12865589</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Ahmed M.Osman</investigator_full_name>
      <investigator_title>doctor</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023849
  org study id: Trans CS IUCD insertion
  nct id: NCT06023849
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To compare immediate post-placental intrauterine contraceptive device insertion versus
        conventional placement at 6 weeks interval (often referred to as delayed or interval
        insertion) as regard to:-
  
          1. Patient satisfaction.
  
          2. Expulsion rate.
  
          3. Complications
  Until the 1960s, Intrauterine devices (IUCDs) and condoms were the only artificial methods
        for the control of fertility. Nowadays ,despite the presence of 12 contraceptive methods
        which include 9 modern methods (pill, IUD, injectable, implant, vaginal methods (diaphragm
        and contraceptive foam or jelly), male condom, female sterilization, male sterilization, and
        emergency contraception) and 3 traditional methods (periodic abstinence, withdrawal, and
        prolonged breastfeeding , the insertion of an IUCD still the second most prevalent method of
        family planning used worldwide (13.6%), after female sterilization (20.5%), among women of
        reproductive age who are married or cohabiting.
  
        In Egypt, Egypt Demographic and Health Survey 2014 findings revealed that 59 percent of
        currently married women in Egypt are currently using a contraceptive method. The most widely
        used method is the IUD, followed by the pill and injectables. Thirty percent of currently
        married women are using the IUD, 16 percent are relying on the pill, and 9 percent are
        employing injectables. Relatively small proportions of women are using other modern methods,
        e.g., 1 percent reported currently using female sterilization. Two percent of women report
        use of traditional methods.
  
        There are two ways used in IUD insertion, in the postpartum period or immediate
        post-placental IUD insertion, in which the insertion of IUD occurs within ten minutes after
        placenta delivery and after the puerperium (after puerperal or interval period). Intrauterine
        device insertion during cesarean section was first introduced in 1967 by Zerzavy by suturing
        the IUD to the posterior uterine fundus. Research in China and Belgium introduced
        post-placental IUD insertion technique during cesarean delivery with placed an IUD as high as
        possible in the fundus without suturing the fundus wall.
  
        Intrauterine device insertion during early postpartum period is the most effective reversible
        contraceptive methods for many mothers because the contraception motivation is high, and it
        doesn't interfere with breast feeding. On the other hand, without an effective contraception
        in the first six weeks, woman may be accidentally pregnant. Hence, the mother prefers to
        insert IUD during cesarean delivery.
  
        As cesarean section (CS) rates are rising in all countries, IUD insertion at the time of CS
        creates an opportunity to increase access to long-acting reversible contraception methods.
        Conversely, a previous CS scar may deter access to interval insertion of an IUD if a previous
        CS may result in difficulty with insertion and/or future IUD problems.
  
        Inserting an IUD at the time of CS is a very attractive option; It adds very little time and
        cost to the procedure. The patient does not have to come back especially for follow-up, and
        there is no risk of primary perforation (secondary perforation is possible) as it is
        performed under direct vision.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: 1-Patient satisfaction and complication.
  time frame: 6 months
  description: assessment of patient satisfaction using a questionnaire as follow:
  Will you use the same method of contraception after the next delivery?
  Will you recommend the same method to your fellows?
  Are you happy or not with this procedure? give score from 1 to 10, 1 mean you are very unhappy while 10 mean you are very happy.
  have you developed any complication?
  arm group label: PPIUD
  arm group type: Active Comparator
  description: trans cesarean IUD insertion immediately post placental
  arm group label: interval
  arm group type: Active Comparator
  description: IUD insertion 6 weeks interval post-partum
  intervention type: Device
  intervention name: IUD insertion
  description: Trans Caesarean Intra Uterine Contraceptive Device Insertion and Conventional Postpartum 6 Weeks Insertion
  arm group label: PPIUD
  arm group label: interval
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed osman, M.B.B.Ch
  phone: 01145883770
  email: AhmedOsman.2244@azhar.edu.eg
  last name: Selim Ahmed, Assistant Professor
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  citation: Hem E, Bordahl PE. Max Sanger - father of the modern caesarean section. Gynecol Obstet Invest. 2003;55(3):127-9. doi: 10.1159/000071524.
  PMID: 12865589
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Ahmed M.Osman
  investigator title: doctor