Cervical Morphological Changes on Pregnancy Outcome

NCT03242746 | Unknown DMC

• 1 other identifier: 2017-137
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Outcome

Keywords

LEEP; Loop Electrosurgical Excision Procedure; Cervical Intraepithelial Neoplasia; pregnancy outcome

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control group

1. 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. 2. a 3-years follow-up for pregnancy outcome 3. Transvaginal ultrasound for pretreatment cervical dimensions/volume

LEEP group

1. 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. 2. a 3-years follow-up for pregnancy outcome 3. Transvaginal ultrasound for pretreatment cervical dimensions/volume 4. Transvaginal ultrasound for posttreatment cervical dimensions/volume in the follow-up visit 5. Estimation of cone dimensions/volume 6. Calculation of the proportion of volume/length excised

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

2ndChongqingMU

Yuzhong, Chongqing Municipality, 023, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lina Hu

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

• Shufang Chang

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

• Hu Li

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Hu

CONTACT

86-23-63693707; cqhulina@126.com

Hu Li

CONTACT

86-18580398481; lihulihu1007@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2017
• First Posted: August 8, 2017
• Study Start: September 15, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: June 27, 2018

Record last verified: 2017-09

Locations

CN (1)