Measurement of the Cervix During Pregnancy According to Age of Conization

Cervix; Pregnancy Clinical Trial

— MesCon  

Official title:

Measurement of the Cervix During Pregnancy According to Age of Conization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03472066
• Other study ID #: PI2017_843_0021
• Status: Recruiting
• First received: March 14, 2018
• Last updated: March 14, 2018
• Start date: February 19, 2018
• Est. completion date: August 19, 2019

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Julien CHEVREAU , Doctor
• Phone: 03.22.08.74.52
• Email: chevreau.julien[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervix; Pregnancy

Intervention

Other:
• Previous conization
a group of women who have been conized,
• no previous conization
group with asymptomatic patients on routine second trimester echography

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main objective is to study the correlation between the size of the cervix and the age at conization. age at conization	Cervix length Measured during the second semester echography	1 day