Clinical trial · Observational
Cervical Morphological Changes on Pregnancy Outcome
The Effect of Cervical Morphological Changes on Pregnancy Outcome After Loop Electrosurgical Excision Procedure
NCT03242746CI-TRIAL-00033455unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pregnancy Outcome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 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
- label
- 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
Primary outcomes (4)
- measure
- pretreatment cervical dimensions/volume
- timeFrame
- at 24months
- description
- The dimensions and volume of the cervix before treatment are calculated by two-dimensional transvaginal sonography (2D-TVS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDKalliala 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
- BACKGROUNDKalliala 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