Measurement of the Cervix During Pregnancy According to Age of Conization

NCT ID: NCT03472066

Last Updated: 2018-03-21

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-19

Study Completion Date

2019-08-19

Brief Summary

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Treatment of precancerous lesions of the cervix by conization has been shown to increase the risk of premature delivery and premature rupture of the membranes. It has now been clearly established that the cervix is a growing organ during adolescence and early adulthood, It has been hypothetized that cervical conization during the growth phase reduced its growth potential, and induced shorter cervix during the upcoming pregnancy. No studies have been conducted investigating the age at which conization no longer had an impact on cervical size during pregnancy. This will help to identify the age at conisation below which patients will be identified as being at risk event, and thus offer increased monitoring and possibly prophylactic management by programmed strapping. We propose to measure the length of the cervix of pregnant patients who have benefited from conization, which is currently recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the investigators will use a control group consisting of non-con conical, parity-matched pregnant patients in whom a cervical measurement will also be performed.

Detailed Description

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Conditions

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Cervix; Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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a group of women who have been conized

Previous conization

Previous conization

Intervention Type OTHER

a group of women who have been conized,

control group with asymptomatic patients

on routine second trim no previous conization

no previous conization

Intervention Type OTHER

group with asymptomatic patients on routine second trimester echography

Interventions

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Previous conization

a group of women who have been conized,

Intervention Type OTHER

no previous conization

group with asymptomatic patients on routine second trimester echography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient referred since January 2008 with pregnancy between 2008 and 2017
2. Pregnancy after conisation
3. Cervix size between 21 and 24 SA before any obstetric event
4. Control group: parity matching, asymptomatic patients

Exclusion Criteria

1. Threat of late miscarriage,
2. Premature rupture of membranes before cervical echography,
3. Other pregnancies after study of 1st pregnancy after conisation,
4. No measurement of the conization specimen,
5. Lost to follow-up,
6. Age \<18
7. Twin Pregnancies
8. Patient under guardianship
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens-Picardie

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julien CHEVREAU, Doctor

Role: CONTACT

03.22.08.74.52

Facility Contacts

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Julien CHEVREAU, Doctor

Role: primary

03.22.08.74.52

Other Identifiers

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PI2017_843_0021

Identifier Type: -

Identifier Source: org_study_id

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