Cervical Morphological Changes on Pregnancy Outcome

Chongqing Medical University

Status: Unknown

Conditions: Pregnancy Outcome

Study type: Observational

Funder types: Other

Identifiers

NCT03242746

2017-137

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Control group

Description:

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

Description:

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