<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/NCT04501809</url>
  </required_header>
  <id_info>
    <org_study_id>6276/14-7-2020</org_study_id>
    <nct_id>NCT04501809</nct_id>
  </id_info>
  <brief_title>Second Trimester Pregnancy Termination in Women With Previous Caesarean Sections</brief_title>
  <official_title>Vaginal Misoprostol Versus Combined Intracervical Foley's Catheter and Oxytocin Infusion for Second Trimester Pregnancy Termination in Women With Previous Caesarean Sections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      it is a randomized controlled trial comparing the safety and efficacy of Vaginal Misoprostol&#xD;
      versus combined Intracervical Foley's Catheter and Oxytocin Infusion for Second Trimester&#xD;
      Pregnancy Termination. the patients will be sorted into 2 groups, Group I (Misoprostol&#xD;
      group): seventy-nine patients and Group II (Combined group): seventy- nine patients. safety&#xD;
      and efficacy of the procedure will be followed up and documented.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: prospective randomized controlled trial Sitting: department of Obstetrics and&#xD;
      Gynecology Faculty of Medicine, Zagazig University, Zagazig, Egypt Sample size calculation:&#xD;
      thoroughly reviewing the use of vaginal misoprostol and intracervical Foleys catheter alone&#xD;
      or in combination for mid trimester pregnancy termination, Rezk et al 2014 showed that the&#xD;
      percentage of complications &quot;fever and diarrhea&quot; in the first group (misoprostol) was 30 %&#xD;
      versus complications in the second group (intra cervical Foleys group)&quot; cervical laceration&#xD;
      &quot;was 13.3 %. Therefore, at confidence level 95% and power 80%, using Epi info 7 the Sample&#xD;
      size will be one hundred fifty-eight (158) patients.&#xD;
&#xD;
      Study participants: the study will include women indicated for termination of pregnancy&#xD;
      between 14weeks-23 weeks and 6 days of gestation. The investigators will involve patients&#xD;
      with a singleton pregnancy with one or multiple cesarean delivery. The investigators will&#xD;
      exclude all patients with critical co-morbidities: bleeding disorders, chorioamnionitis,&#xD;
      low-lying placenta, rupture uterus, myomectomy and contraindication to misoprostol or latex&#xD;
      allergy. All women will undergo history taking, general examination, and local assessment for&#xD;
      the cervix. Departmental US to confirm the diagnosis and indication for termination and&#xD;
      position of the placenta. Blood tests will be done including blood group, full blood count&#xD;
      matching, Antibodies screening and viral markers.&#xD;
&#xD;
      Randomization: After meeting eligibility criteria all participants will be counseled to the&#xD;
      clinical trial. A signed documented consent form will be attached to their medical records.&#xD;
      The patients will be sorted into two groups using a computerized random number generator in a&#xD;
      sequence of sealed, numbered opaque envelopes, with a 1:1randomization ratio.&#xD;
&#xD;
      Group I (Misoprostol group): seventy-nine patients will receive a loading dose of moistened&#xD;
      misoprostol tablets (cytotec pfizer 400 mg) inserted vaginally and it will be followed by&#xD;
      maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of&#xD;
      effective uterine contraction with maximum five doses in 24 hours duration .&#xD;
&#xD;
      Group II (Combined group): seventy- nine patients will get intracervical Foleys Catheter&#xD;
      insertion .Exposure of the cervix by means of a sterile speculum, a 16F Foley catheter will&#xD;
      be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed&#xD;
      through inflation of the balloon with 30 milliliters of sterile solution when the catheter&#xD;
      will be beyond the internal cervical os. Slight traction of the catheter will be exerted&#xD;
      through tapping it to the inner thigh. After six hours of Foleys catheter fixation, The&#xD;
      investigators will start infusion of 10 IU of oxytocin on 500 ml ringer lactate by rate 125&#xD;
      ml\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by&#xD;
      5IU each time until achieving regular uterine contraction, maximum five doses in twenty -four&#xD;
      hours duration. Therefore the maximum dose of oxytocin 100 IU over 24 hrs duration to avoid&#xD;
      water intoxication.&#xD;
&#xD;
      Failed induction of abortion is considered if no fetal expulsion occurred within twenty for&#xD;
      hours from the use of primary method of termination. The Demographic data and serial clinical&#xD;
      monitoring will be recorded by the assigned on duty registrar.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time to cervical dilatation in hours</measure>
    <time_frame>24 hours</time_frame>
    <description>time between starting the medications and the real cervical dilatation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>induction abortion interval in hours</measure>
    <time_frame>48 hours</time_frame>
    <description>time between induction of abortion and expulsion of the products of conception</description>
  </primary_outcome>
  <primary_outcome>
    <measure>need for surgical evacuation</measure>
    <time_frame>48 hours</time_frame>
    <description>some cases may be presented with retained products of conception with the need for surgical evacuation of the uterus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sever hemorrhage</measure>
    <time_frame>48 hours</time_frame>
    <description>comparing the prevalence of severe hemorrhage by postoperative hemoglobin percent in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients satisfaction</measure>
    <time_frame>72 hours</time_frame>
    <description>by patient written questionnaire about patient discomfort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-abortive infection</measure>
    <time_frame>7 days</time_frame>
    <description>Number of participants with post-abortive infection is predicted by post-abortive C reactive protein (CRP) level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rupture uterus</measure>
    <time_frame>48 hours</time_frame>
    <description>comparing the incidence of rupture uterus (clinically by sever abdominal pain and loss of uterine contractions and presence of free fluid by ultrasound) in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">158</enrollment>
  <condition>Second Trimester Abortion</condition>
  <arm_group>
    <arm_group_label>Group I (Misoprostol group):</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>seventy-nine patients will receive a loading dose of moistened misoprostol tablets ( Cytotec pfizer 400 mg) inserted vaginally and it will be followed by maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of effective uterine contraction with maximum five doses in 24 hours duration .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (Combined group):</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>seventy- nine patients will get intracervical Foleys Catheter insertion .a 16F (french units) Foley catheter will be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed through inflation of the balloon with 30 milliliters of sterile solution when the catheter will be beyond the internal cervical os. After six hours of Foleys catheter fixation, we will start infusion of 10 international units (IU) of oxytocin on 500 ml ringer lactate by rate 125 ml\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by 5 IU each time until achieving regular uterine contraction, maximum five doses in twenty -four hours duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>compare misoprostol with combined oxytocin and cervical foly catheter</intervention_name>
    <description>we will compare using misoprostol alone in one group with oxytocin and cervical catheter in the other group</description>
    <arm_group_label>Group I (Misoprostol group):</arm_group_label>
    <arm_group_label>Group II (Combined group):</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women indicated for termination of pregnancy between 14weeks-23 weeks and 6 days of&#xD;
             gestation&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  one or multiple cesarean delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bleeding disorders&#xD;
&#xD;
          -  chorioamnionitis&#xD;
&#xD;
          -  low-lying placenta&#xD;
&#xD;
          -  history of rupture uterus&#xD;
&#xD;
          -  history of myomectomy&#xD;
&#xD;
          -  contraindication to misoprostol&#xD;
&#xD;
        latex allergy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <state>East</state>
        <zip>44511</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>tolba ewida street 2 zagazig, 2</last_name>
      <phone>002/01004132040</phone>
      <email>basem@zu.edu.eg</email>
    </contact>
    <contact_backup>
      <email>basemhamedobgyne@yahoo.com.sg</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Tolba Ewida Street</name>
      <address>
        <city>Zagazig</city>
        <state>Sharkia</state>
        <zip>44511</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>basem hamed</last_name>
      <phone>01004132040</phone>
      <email>basem@zu.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>basem mohamed hamed khalil</investigator_full_name>
    <investigator_title>lecturer of obstetrics and gynecology/ MD ob/gyn / consultant of obstetrics and gynecology</investigator_title>
  </responsible_party>
  <keyword>abortion</keyword>
  <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/NCT04501809
org study id: 6276/14-7-2020
nct id: NCT04501809
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
it is a randomized controlled trial comparing the safety and efficacy of Vaginal Misoprostol
      versus combined Intracervical Foley's Catheter and Oxytocin Infusion for Second Trimester
      Pregnancy Termination. the patients will be sorted into 2 groups, Group I (Misoprostol
      group): seventy-nine patients and Group II (Combined group): seventy- nine patients. safety
      and efficacy of the procedure will be followed up and documented.
Design: prospective randomized controlled trial Sitting: department of Obstetrics and
      Gynecology Faculty of Medicine, Zagazig University, Zagazig, Egypt Sample size calculation:
      thoroughly reviewing the use of vaginal misoprostol and intracervical Foleys catheter alone
      or in combination for mid trimester pregnancy termination, Rezk et al 2014 showed that the
      percentage of complications "fever and diarrhea" in the first group (misoprostol) was 30 %
      versus complications in the second group (intra cervical Foleys group)" cervical laceration
      "was 13.3 %. Therefore, at confidence level 95% and power 80%, using Epi info 7 the Sample
      size will be one hundred fifty-eight (158) patients.

      Study participants: the study will include women indicated for termination of pregnancy
      between 14weeks-23 weeks and 6 days of gestation. The investigators will involve patients
      with a singleton pregnancy with one or multiple cesarean delivery. The investigators will
      exclude all patients with critical co-morbidities: bleeding disorders, chorioamnionitis,
      low-lying placenta, rupture uterus, myomectomy and contraindication to misoprostol or latex
      allergy. All women will undergo history taking, general examination, and local assessment for
      the cervix. Departmental US to confirm the diagnosis and indication for termination and
      position of the placenta. Blood tests will be done including blood group, full blood count
      matching, Antibodies screening and viral markers.

      Randomization: After meeting eligibility criteria all participants will be counseled to the
      clinical trial. A signed documented consent form will be attached to their medical records.
      The patients will be sorted into two groups using a computerized random number generator in a
      sequence of sealed, numbered opaque envelopes, with a 1:1randomization ratio.

      Group I (Misoprostol group): seventy-nine patients will receive a loading dose of moistened
      misoprostol tablets (cytotec pfizer 400 mg) inserted vaginally and it will be followed by
      maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of
      effective uterine contraction with maximum five doses in 24 hours duration .

      Group II (Combined group): seventy- nine patients will get intracervical Foleys Catheter
      insertion .Exposure of the cervix by means of a sterile speculum, a 16F Foley catheter will
      be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed
      through inflation of the balloon with 30 milliliters of sterile solution when the catheter
      will be beyond the internal cervical os. Slight traction of the catheter will be exerted
      through tapping it to the inner thigh. After six hours of Foleys catheter fixation, The
      investigators will start infusion of 10 IU of oxytocin on 500 ml ringer lactate by rate 125
      ml\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by
      5IU each time until achieving regular uterine contraction, maximum five doses in twenty -four
      hours duration. Therefore the maximum dose of oxytocin 100 IU over 24 hrs duration to avoid
      water intoxication.

      Failed induction of abortion is considered if no fetal expulsion occurred within twenty for
      hours from the use of primary method of termination. The Demographic data and serial clinical
      monitoring will be recorded by the assigned on duty registrar.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time to cervical dilatation in hours
time frame: 24 hours
description: time between starting the medications and the real cervical dilatation
measure: induction abortion interval in hours
time frame: 48 hours
description: time between induction of abortion and expulsion of the products of conception
measure: need for surgical evacuation
time frame: 48 hours
description: some cases may be presented with retained products of conception with the need for surgical evacuation of the uterus
measure: sever hemorrhage
time frame: 48 hours
description: comparing the prevalence of severe hemorrhage by postoperative hemoglobin percent in both groups.
measure: patients satisfaction
time frame: 72 hours
description: by patient written questionnaire about patient discomfort.
measure: post-abortive infection
time frame: 7 days
description: Number of participants with post-abortive infection is predicted by post-abortive C reactive protein (CRP) level
measure: rupture uterus
time frame: 48 hours
description: comparing the incidence of rupture uterus (clinically by sever abdominal pain and loss of uterine contractions and presence of free fluid by ultrasound) in both groups
arm group label: Group I (Misoprostol group):
arm group type: Active Comparator
description: seventy-nine patients will receive a loading dose of moistened misoprostol tablets ( Cytotec pfizer 400 mg) inserted vaginally and it will be followed by maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of effective uterine contraction with maximum five doses in 24 hours duration .
arm group label: Group II (Combined group):
arm group type: Active Comparator
description: seventy- nine patients will get intracervical Foleys Catheter insertion .a 16F (french units) Foley catheter will be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed through inflation of the balloon with 30 milliliters of sterile solution when the catheter will be beyond the internal cervical os. After six hours of Foleys catheter fixation, we will start infusion of 10 international units (IU) of oxytocin on 500 ml ringer lactate by rate 125 ml\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by 5 IU each time until achieving regular uterine contraction, maximum five doses in twenty -four hours duration.
intervention type: Procedure
intervention name: compare misoprostol with combined oxytocin and cervical foly catheter
description: we will compare using misoprostol alone in one group with oxytocin and cervical catheter in the other group
arm group label: Group I (Misoprostol group):
arm group label: Group II (Combined group):
criteria: 
gender: Female
minimum age: 17 Years
maximum age: 42 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: basem mohamed hamed khalil
investigator title: lecturer of obstetrics and gynecology/ MD ob/gyn / consultant of obstetrics and gynecology
mesh term: Misoprostol
mesh term: Oxytocin