Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2017-09-15
2021-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
45 Years
FEMALE
No
Sponsors
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The Second Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Principal Investigators
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Lina Hu
Role: STUDY_CHAIR
The Second Affiliated Hospital of Chongqing Medical University
Shufang Chang
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Chongqing Medical University
Hu Li
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Chongqing Medical University
Locations
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2ndChongqingMU
Yuzhong, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2017-137
Identifier Type: -
Identifier Source: org_study_id
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