Cervical Morphological Changes on Pregnancy Outcome

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effect of Cervical Morphological Changes on Pregnancy Outcome After Loop Electrosurgical Excision Procedure

Conditions
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Pregnancy Outcome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having fertility requirements,antecedent biopsy read as cervical intraepithelial neoplasia (CIN) grade 2 or 3 or microinvasive cancer adenocarcinoma in situ persistent CIN 1 antecedent pap read as high grade squamous intraepithelial lesion atypical glandular cells persistent low grade squamous intraepithelial lesion Exclusion Criteria: anatomy unsuitable for safe office loop excision based on operator judgement inability to tolerate procedure under local anesthesia pregnancy age less than 21 years refusal of consent prisoner mental incapacity anticoagulant or antiplatelet therapy, or known bleeding diathesis use of analgesics other than over the counter medications(OTC meds include NSAIDS or Tylenol) within 7 days of scheduled LEEP.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>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 | |
| LEEP group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pretreatment cervical dimensions/volume | The dimensions and volume of the cervix before treatment are calculated by two-dimensional transvaginal sonography (2D-TVS) | at 24months | 
| cone dimensions/volume | 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 | at 24months | 
| posttreatment cervical dimensions/volume | 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 | up to 12months | 
| Pregnancy outcome | 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. | up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LEEP, Loop Electrosurgical Excision Procedure, Cervical Intraepithelial Neoplasia, pregnancy outcome