Cervical Morphological Changes on Pregnancy Outcome

Pregnancy Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03242746
• Other study ID #: 2017-137
• Status: Recruiting
• Start date: September 15, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2017
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Lina Hu
• Phone: 86-23-63693707
• Email: cqhulina[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Outcome

Locations

Country	Name	City	State
China	2ndChongqingMU	Yuzhong	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pretreatment cervical dimensions/volume	The dimensions and volume of the cervix before treatment are calculated by two-dimensional transvaginal sonography (2D-TVS)	at 24months
Primary	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
Primary	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
Primary	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