<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/NCT03276000</url>
  </required_header>
  <id_info>
    <org_study_id>12345</org_study_id>
    <nct_id>NCT03276000</nct_id>
  </id_info>
  <brief_title>Misoprostol for Cervical Priming Before Office Hysteroscopy</brief_title>
  <official_title>Randomized Control Trial Comparing Patient Acceptability and Tolerance to Pain Using Oral Versus Vaginal Misoprostol for Cervical Priming Before Office Hysteroscopy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present study is to evaluate the appropriate route of administration of&#xD;
      misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of&#xD;
      office hysteroscopy and reduce patient discomfort to minimum&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample size calculation was done using the comparison of pain sensation represented through&#xD;
      VAS between oral and vaginal misoprostol for cervical ripening before office hysteroscopy. As&#xD;
      reported in previous publication (Sordia-Herna'ndez et al., 2011), the mean ±SD of VAS in&#xD;
      oral misoprostol group was approximately 6.04 ± 1.5, while in vaginal misoprostol group was&#xD;
      approximately 2.8 ± 1.2. Accordingly, we calculated that the minimum proper sample size was&#xD;
      23 women in each arm to be able to detect a real difference of 1 unit with 80% power at α =&#xD;
      0.05 level using Student's t test for independent samples. Sample size calculation was done&#xD;
      using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd.,&#xD;
      Cheshire, UK&#xD;
&#xD;
      However, the study population consists of 100 patients in reproductive age that requires&#xD;
      diagnostic hysteroscopy for investigation of infertility or AUB.&#xD;
&#xD;
      The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and&#xD;
      Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018.&#xD;
&#xD;
      The Patients will be allocated equally into 2 groups ( each group contain 50 patients)&#xD;
&#xD;
      Groups will be as follows:&#xD;
&#xD;
        1. Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before&#xD;
           the procedure.&#xD;
&#xD;
        2. Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the&#xD;
           procedure moistened with saline solution will be inserted in posterior fornix of vagina.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Other</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain sensation:</measure>
    <time_frame>The VAS will be applied immediately after the procedure ended.</time_frame>
    <description>the level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient acceptability</measure>
    <time_frame>The VAS will be applied immediately after the procedure ended.</time_frame>
    <description>according to a 10-point VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>during the procedure.</time_frame>
    <description>Bleeding during and after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>it will be reported immediately after the process ended</time_frame>
    <description>Procedure time from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of cervical entry by hysteroscopy</measure>
    <time_frame>The VAS will be applied immediately after the procedure ended.</time_frame>
    <description>Ease of cervical entry by hysteroscopy to evaluate the uterine cavity according to a 10-point VAS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Misoprostol Allergy</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy moistened with saline solution will be inserted in posterior fornix of vagina.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>office hysteroscopy</intervention_name>
    <description>A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Patients indicated for diagnostic hysteroscopy for infertility or AUB.&#xD;
&#xD;
          2. Reproductive age &gt;19 - 45yrs.&#xD;
&#xD;
          3. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Contraindicating the use of prostaglandins such as:-&#xD;
&#xD;
          1. Cardiovascular disease&#xD;
&#xD;
          2. Severe bronchial asthma.&#xD;
&#xD;
          3. Hypertension.&#xD;
&#xD;
          4. Renal failure.&#xD;
&#xD;
          5. Known sensitivity to Prostaglandins&#xD;
&#xD;
        Contraindication to office hysteroscopy such as:-&#xD;
&#xD;
          1. Pelvic inflammatory disease.&#xD;
&#xD;
          2. Marked cervical stenosis.&#xD;
&#xD;
          3. Known cervical malignancy.&#xD;
&#xD;
          4. pregnancy&#xD;
&#xD;
          5. profuse uterine bleeding&#xD;
&#xD;
          6. Recent uterine perforation.&#xD;
&#xD;
        Neurological disorders affecting the evaluation of pain.&#xD;
&#xD;
        Previous cervical surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sarah M Hassan, lecturer</last_name>
    <phone>01003733671</phone>
    <email>saramohamed7880@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kasr El Ainiy Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sarah M Hassan, Lecturer</last_name>
      <phone>01003733671</phone>
      <email>saramohamed7880@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Sordia-Hernandez LH, Rosales-Tristan E, Vazquez-Mendez J, Merino M, Iglesias JL, Garza-Leal JG, Morales A. Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients. Fertil Steril. 2011 Feb;95(2):759-61. doi: 10.1016/j.fertnstert.2010.07.1066. Epub 2010 Aug 21.</citation>
    <PMID>20728083</PMID>
  </reference>
  <reference>
    <citation>Bastu E, Celik C, Nehir A, Dogan M, Yuksel B, Ergun B. Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. Int Surg. 2013 Apr-Jun;98(2):140-4. doi: 10.9738/INTSURG-D-12-00024.1.</citation>
    <PMID>23701149</PMID>
  </reference>
  <reference>
    <citation>El-Mazny A, Abou-Salem N. A double-blind randomized controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy. Fertil Steril. 2011 Oct;96(4):962-5. doi: 10.1016/j.fertnstert.2011.04.049. Epub 2011 May 14.</citation>
    <PMID>21575939</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>October 14, 2017</last_update_submitted>
  <last_update_submitted_qc>October 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>sarah mohamed hassan</investigator_full_name>
    <investigator_title>lecturer of obstetrics and gynecology Cairo university</investigator_title>
  </responsible_party>
  <keyword>Misoprostol ,office hysteroscopy</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03276000
org study id: 12345
nct id: NCT03276000
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of the present study is to evaluate the appropriate route of administration of
      misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of
      office hysteroscopy and reduce patient discomfort to minimum
Sample size calculation was done using the comparison of pain sensation represented through
      VAS between oral and vaginal misoprostol for cervical ripening before office hysteroscopy. As
      reported in previous publication (Sordia-Herna'ndez et al., 2011), the mean ±SD of VAS in
      oral misoprostol group was approximately 6.04 ± 1.5, while in vaginal misoprostol group was
      approximately 2.8 ± 1.2. Accordingly, we calculated that the minimum proper sample size was
      23 women in each arm to be able to detect a real difference of 1 unit with 80% power at α =
      0.05 level using Student's t test for independent samples. Sample size calculation was done
      using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd.,
      Cheshire, UK

      However, the study population consists of 100 patients in reproductive age that requires
      diagnostic hysteroscopy for investigation of infertility or AUB.

      The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and
      Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018.

      The Patients will be allocated equally into 2 groups ( each group contain 50 patients)

      Groups will be as follows:

        1. Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before
           the procedure.

        2. Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the
           procedure moistened with saline solution will be inserted in posterior fornix of vagina.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Care Provider)
measure: Pain sensation:
time frame: The VAS will be applied immediately after the procedure ended.
description: the level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).
measure: Patient acceptability
time frame: The VAS will be applied immediately after the procedure ended.
description: according to a 10-point VAS
measure: Bleeding
time frame: during the procedure.
description: Bleeding during and after the procedure.
measure: Procedure time
time frame: it will be reported immediately after the process ended
description: Procedure time from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity.
measure: Ease of cervical entry by hysteroscopy
time frame: The VAS will be applied immediately after the procedure ended.
description: Ease of cervical entry by hysteroscopy to evaluate the uterine cavity according to a 10-point VAS.
arm group label: Group A
arm group type: Active Comparator
description: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy
arm group label: group B
arm group type: Active Comparator
description: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy moistened with saline solution will be inserted in posterior fornix of vagina.
intervention type: Procedure
intervention name: office hysteroscopy
description: A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.
arm group label: Group A
arm group label: group B
criteria: 
gender: Female
gender based: Yes
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: No
last name: Sarah M Hassan, lecturer
phone: 01003733671
email: saramohamed7880@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Sordia-Hernandez LH, Rosales-Tristan E, Vazquez-Mendez J, Merino M, Iglesias JL, Garza-Leal JG, Morales A. Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients. Fertil Steril. 2011 Feb;95(2):759-61. doi: 10.1016/j.fertnstert.2010.07.1066. Epub 2010 Aug 21.
PMID: 20728083
citation: Bastu E, Celik C, Nehir A, Dogan M, Yuksel B, Ergun B. Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. Int Surg. 2013 Apr-Jun;98(2):140-4. doi: 10.9738/INTSURG-D-12-00024.1.
PMID: 23701149
citation: El-Mazny A, Abou-Salem N. A double-blind randomized controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy. Fertil Steril. 2011 Oct;96(4):962-5. doi: 10.1016/j.fertnstert.2011.04.049. Epub 2011 May 14.
PMID: 21575939
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: sarah mohamed hassan
investigator title: lecturer of obstetrics and gynecology Cairo university
sharing ipd: No