Cervical Morphological Changes on Pregnancy Outcome

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

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

Study Overview

• Status: Unknown
• Conditions: Pregnancy Outcome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Lina Hu; Phone Number: 86-23-63693707; Email: cqhulina@126.com
• Study Contact Backup: Name: Hu Li; Phone Number: 86-18580398481; Email: lihulihu1007@foxmail.com

Study Locations

• China
  • Chongqing
    • Yuzhong, Chongqing, China, 023
      • Recruiting
      • 2ndChongqingMU
      • Contact: Li Hu; Phone Number: 86-18580398481; Email: 627439894@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women (18-45 y) plan for excisional CIN treatment

Description

Inclusion Criteria:

Having fertility requirements,antecedent biopsy read as

1. cervical intraepithelial neoplasia (CIN) grade 2 or 3 or microinvasive cancer
2. adenocarcinoma in situ
3. persistent CIN 1
4. antecedent pap read as
5. high grade squamous intraepithelial lesion
6. atypical glandular cells
7. persistent low grade squamous intraepithelial lesion

Exclusion Criteria:

1. anatomy unsuitable for safe office loop excision based on operator judgement
2. inability to tolerate procedure under local anesthesia
3. pregnancy
4. age less than 21 years
5. refusal of consent
6. prisoner
7. mental incapacity
8. anticoagulant or antiplatelet therapy, or known bleeding diathesis
9. use of analgesics other than over the counter medications(OTC meds include NSAIDS or Tylenol) within 7 days of scheduled LEEP.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group; 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; 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?

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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: Lina Hu, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Shufang Chang, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Hu Li, The Second Affiliated Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 30, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Cervical Intraepithelial Neoplasia; pregnancy outcome; LEEP; Loop Electrosurgical Excision Procedure
• Other Study ID Numbers: 2017-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No