Measurement of the Cervix During Pregnancy According to Age of Conization

• Conditions: Cervix; Pregnancy
• Interventions: Other: Previous conization; Other: no previous conization

• Registration Number: NCT03472066
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-02-19
• Status Verified: 2018-03
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-14
• Last Update Submitted: 2018-03-14
• Study First Posted: 2018-03-21
• Last Update Posted: 2018-03-21
• Primary Completion: 2019-07-19
• Study Completion: 2019-08-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
a group of women who have been conized	Previous conization	Previous conization
control group with asymptomatic patients	no previous conization	on routine second trim no previous conization

Primary Outcome Measures

Name	Time	Method
The main objective is to study the correlation between the size of the cervix and the age at conization. age at conization	1 day	Cervix length Measured during the second semester echography

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Amiens, France