Measurement of the Cervix During Pregnancy According to Age of Conization

NCT03472066 | Unknown

• 1 other identifier: PI2017_843_0021
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

a group of women who have been conized

Previous conization

Other: Previous conization

control group with asymptomatic patients

on routine second trim no previous conization

Other: no previous conization

Interventions

Previous conization OTHER

a group of women who have been conized,

a group of women who have been conized

no previous conization OTHER

group with asymptomatic patients on routine second trimester echography

control group with asymptomatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Including 84 evaluable patients for the primary endpoint would show a Pearson correlation of at least 0.3 between cervical size and age at conization. These calculations were carried out with a 5% risk of first bilateral species and 80% power. Taking into account the risk of incomplete data, we plan to include 90 patients. A control group of 90 patients will also be recruited.

You may qualify if:

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

You may not qualify if:

• Threat of late miscarriage,
• Premature rupture of membranes before cervical echography,
• Other pregnancies after study of 1st pregnancy after conisation,
• No measurement of the conization specimen,
• Lost to follow-up,
• Age \<18
• Twin Pregnancies
• Patient under guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

Central Study Contacts

Julien CHEVREAU, Doctor

CONTACT

03.22.08.74.52; chevreau.julien@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: February 19, 2018
• Primary Completion: July 19, 2019
• Study Completion: August 19, 2019
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

FR (1)