<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/NCT03242746</url>
  </required_header>
  <id_info>
    <org_study_id>2017-137</org_study_id>
    <nct_id>NCT03242746</nct_id>
  </id_info>
  <brief_title>Cervical Morphological Changes on Pregnancy Outcome</brief_title>
  <official_title>The Effect of Cervical Morphological Changes on Pregnancy Outcome After Loop Electrosurgical Excision Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Affiliated Hospital of Chongqing Medical 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>
      This study aims to assess how the proportion of the cervical volume/length removed during&#xD;
      treatment for cervical intraepithelial neoplasia (CIN) varies and whether this correlates to&#xD;
      the pregnancy duration at delivery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The high peak age of the Cervical intraepithelial neoplasia (CIN)patients was from 25 to 35&#xD;
      years old, which is the best women of childbearing age, Standard treatment for CIN is called&#xD;
      Loop electrosurgical excision procedure (LEEP),but the inappropriate conization may damage&#xD;
      the cervical function leading to infertility, abortion, preterm delivery and dystocia.&#xD;
      Therefore, reasonable and standard conization is very important for treating and preventing&#xD;
      the complication. The International Federation of Cervical Pathology and Colposcopy(IFCPC)&#xD;
      advocates the length of cervical conization should be decided by the type of cervical&#xD;
      transformation zone, however, the cervical lengths in female are different leading to the&#xD;
      same cervical conization lengths cause the diverse influences on the cervical&#xD;
      function.Therefore, individualized cervical conization therapies are very needed，At present,&#xD;
      there are still lack of objective data about cervical morphology of women at childbearing&#xD;
      age,besides the effects of cervical morphological changes caused by LEEP on pregnancy and&#xD;
      childbirth has not been reported.&#xD;
&#xD;
      Our hypothesis is that the proportion of the cervical tissue removed is likely to influence&#xD;
      both cervical healing and the cervical volume following surgery and as a result the risk of&#xD;
      prematurity in subsequent pregnancies. The present prospective study investigates the&#xD;
      variation in the proportion of the cervix removed during excisional treatment and provides&#xD;
      pilot data on pregnancy outcomes in a sample population for which the dimensions and&#xD;
      proportions of the cervical tissue excised are assessed at the time of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>pretreatment cervical dimensions/volume</measure>
    <time_frame>at 24months</time_frame>
    <description>The dimensions and volume of the cervix before treatment are calculated by two-dimensional transvaginal sonography (2D-TVS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cone dimensions/volume</measure>
    <time_frame>at 24months</time_frame>
    <description>The dimensions of the cone are measured with a measuring tape and a ruler before formalin fixation. The measurements included the length/depth, and the anteroposterior,transverse, and lateral diameters. A fluid filled volumetric cylindrical vial (tube) are subsequently used to measure the cone volume with the fluid displacement technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>posttreatment cervical dimensions/volume</measure>
    <time_frame>up to 12months</time_frame>
    <description>Assessment of the cervical dimensions and the cervical volume is repeated 1,3,6,12 months post-treatment follow-up visit, using the same imaging technique as that used pretreatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pregnancy outcome</measure>
    <time_frame>up to 48 months</time_frame>
    <description>In the event of a pregnancy, the prenatal management and outcomes are recorded. More specifically, it is recorded whether interventions such as cervical length ultrasound, cervical cerclage, or progesterone are used. The duration of pregnancy at delivery, the birth weight, and other obstetric outcomes and complications are recorded.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pregnancy Outcome</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>The study will include 150 women of reproductive age (21-45 years) who wished to have future pregnancies and had cervical biopsy or Pap test, without any other cervical procedure, in the same calendar year.&#xD;
a 3-years follow-up for pregnancy outcome&#xD;
Transvaginal ultrasound for pretreatment cervical dimensions/volume</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LEEP group</arm_group_label>
    <description>The study will include 150 women of reproductive age (21-45 years) planning for excisional treatment for CIN who wished to have future pregnancies. Women are included irrespective of their parity, previous obstetric history, and CIN grade.&#xD;
a 3-years follow-up for pregnancy outcome&#xD;
Transvaginal ultrasound for pretreatment cervical dimensions/volume&#xD;
Transvaginal ultrasound for posttreatment cervical dimensions/volume in the follow-up visit&#xD;
Estimation of cone dimensions/volume&#xD;
Calculation of the proportion of volume/length excised</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women (18-45 y) plan for excisional CIN treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Having fertility requirements,antecedent biopsy read as&#xD;
&#xD;
          1. cervical intraepithelial neoplasia (CIN) grade 2 or 3 or microinvasive cancer&#xD;
&#xD;
          2. adenocarcinoma in situ&#xD;
&#xD;
          3. persistent CIN 1&#xD;
&#xD;
          4. antecedent pap read as&#xD;
&#xD;
          5. high grade squamous intraepithelial lesion&#xD;
&#xD;
          6. atypical glandular cells&#xD;
&#xD;
          7. persistent low grade squamous intraepithelial lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. anatomy unsuitable for safe office loop excision based on operator judgement&#xD;
&#xD;
          2. inability to tolerate procedure under local anesthesia&#xD;
&#xD;
          3. pregnancy&#xD;
&#xD;
          4. age less than 21 years&#xD;
&#xD;
          5. refusal of consent&#xD;
&#xD;
          6. prisoner&#xD;
&#xD;
          7. mental incapacity&#xD;
&#xD;
          8. anticoagulant or antiplatelet therapy, or known bleeding diathesis&#xD;
&#xD;
          9. use of analgesics other than over the counter medications(OTC meds include NSAIDS or&#xD;
             Tylenol) within 7 days of scheduled LEEP.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lina Hu</last_name>
    <role>Study Chair</role>
    <affiliation>The Second Affiliated Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shufang Chang</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Affiliated Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hu Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Affiliated Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lina Hu</last_name>
    <phone>86-23-63693707</phone>
    <email>cqhulina@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hu Li</last_name>
    <phone>86-18580398481</phone>
    <email>lihulihu1007@foxmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>2ndChongqingMU</name>
      <address>
        <city>Yuzhong</city>
        <state>Chongqing</state>
        <zip>023</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Hu</last_name>
      <phone>86-18580398481</phone>
      <email>627439894@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Kalliala I, Anttila A, Nieminen P, Halttunen M, Dyba T. Pregnancy incidence and outcome before and after cervical intraepithelial neoplasia: a retrospective cohort study. Cancer Med. 2014 Dec;3(6):1512-6. doi: 10.1002/cam4.300. Epub 2014 Aug 21.</citation>
    <PMID>25146172</PMID>
  </reference>
  <reference>
    <citation>Kalliala I, Anttila A, Dyba T, Hakulinen T, Halttunen M, Nieminen P. Pregnancy incidence and outcome among patients with cervical intraepithelial neoplasia: a retrospective cohort study. BJOG. 2012 Jan;119(2):227-35. doi: 10.1111/j.1471-0528.2011.03042.x. Epub 2011 Jul 27.</citation>
    <PMID>21790950</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LEEP</keyword>
  <keyword>Loop Electrosurgical Excision Procedure</keyword>
  <keyword>Cervical Intraepithelial Neoplasia</keyword>
  <keyword>pregnancy outcome</keyword>
  <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/NCT03242746
org study id: 2017-137
nct id: NCT03242746
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to assess how the proportion of the cervical volume/length removed during
      treatment for cervical intraepithelial neoplasia (CIN) varies and whether this correlates to
      the pregnancy duration at delivery
The high peak age of the Cervical intraepithelial neoplasia (CIN)patients was from 25 to 35
      years old, which is the best women of childbearing age, Standard treatment for CIN is called
      Loop electrosurgical excision procedure (LEEP),but the inappropriate conization may damage
      the cervical function leading to infertility, abortion, preterm delivery and dystocia.
      Therefore, reasonable and standard conization is very important for treating and preventing
      the complication. The International Federation of Cervical Pathology and Colposcopy(IFCPC)
      advocates the length of cervical conization should be decided by the type of cervical
      transformation zone, however, the cervical lengths in female are different leading to the
      same cervical conization lengths cause the diverse influences on the cervical
      function.Therefore, individualized cervical conization therapies are very needed，At present,
      there are still lack of objective data about cervical morphology of women at childbearing
      age,besides the effects of cervical morphological changes caused by LEEP on pregnancy and
      childbirth has not been reported.

      Our hypothesis is that the proportion of the cervical tissue removed is likely to influence
      both cervical healing and the cervical volume following surgery and as a result the risk of
      prematurity in subsequent pregnancies. The present prospective study investigates the
      variation in the proportion of the cervix removed during excisional treatment and provides
      pilot data on pregnancy outcomes in a sample population for which the dimensions and
      proportions of the cervical tissue excised are assessed at the time of treatment.
observational model: Cohort
time perspective: Prospective
measure: pretreatment cervical dimensions/volume
time frame: at 24months
description: The dimensions and volume of the cervix before treatment are calculated by two-dimensional transvaginal sonography (2D-TVS)
measure: cone dimensions/volume
time frame: at 24months
description: The dimensions of the cone are measured with a measuring tape and a ruler before formalin fixation. The measurements included the length/depth, and the anteroposterior,transverse, and lateral diameters. A fluid filled volumetric cylindrical vial (tube) are subsequently used to measure the cone volume with the fluid displacement technique
measure: posttreatment cervical dimensions/volume
time frame: up to 12months
description: Assessment of the cervical dimensions and the cervical volume is repeated 1,3,6,12 months post-treatment follow-up visit, using the same imaging technique as that used pretreatment
measure: Pregnancy outcome
time frame: up to 48 months
description: In the event of a pregnancy, the prenatal management and outcomes are recorded. More specifically, it is recorded whether interventions such as cervical length ultrasound, cervical cerclage, or progesterone are used. The duration of pregnancy at delivery, the birth weight, and other obstetric outcomes and complications are recorded.
arm group label: Control group
description: The study will include 150 women of reproductive age (21-45 years) who wished to have future pregnancies and had cervical biopsy or Pap test, without any other cervical procedure, in the same calendar year.
a 3-years follow-up for pregnancy outcome
Transvaginal ultrasound for pretreatment cervical dimensions/volume
arm group label: LEEP group
description: The study will include 150 women of reproductive age (21-45 years) planning for excisional treatment for CIN who wished to have future pregnancies. Women are included irrespective of their parity, previous obstetric history, and CIN grade.
a 3-years follow-up for pregnancy outcome
Transvaginal ultrasound for pretreatment cervical dimensions/volume
Transvaginal ultrasound for posttreatment cervical dimensions/volume in the follow-up visit
Estimation of cone dimensions/volume
Calculation of the proportion of volume/length excised
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: women
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: No
last name: Lina Hu
role: Study Chair
affiliation: The Second Affiliated Hospital of Chongqing Medical University
last name: Shufang Chang
role: Principal Investigator
affiliation: The Second Affiliated Hospital of Chongqing Medical University
last name: Hu Li
role: Principal Investigator
affiliation: The Second Affiliated Hospital of Chongqing Medical University
last name: Lina Hu
phone: 86-23-63693707
email: cqhulina@126.com
last name: Hu Li
phone: 86-18580398481
email: lihulihu1007@foxmail.com
facility: 
status: Recruiting
contact: 
country: China
citation: Kalliala I, Anttila A, Nieminen P, Halttunen M, Dyba T. Pregnancy incidence and outcome before and after cervical intraepithelial neoplasia: a retrospective cohort study. Cancer Med. 2014 Dec;3(6):1512-6. doi: 10.1002/cam4.300. Epub 2014 Aug 21.
PMID: 25146172
citation: Kalliala I, Anttila A, Dyba T, Hakulinen T, Halttunen M, Nieminen P. Pregnancy incidence and outcome among patients with cervical intraepithelial neoplasia: a retrospective cohort study. BJOG. 2012 Jan;119(2):227-35. doi: 10.1111/j.1471-0528.2011.03042.x. Epub 2011 Jul 27.
PMID: 21790950
responsible party type: Sponsor
sharing ipd: Undecided