Study to Evaluate the Learning Curve to Anchor GYN-CS® Device

University Hospital, Ghent7 enrolled

Overview

GYN-CS® is a new concept in intrauterine device technology. It is fixed to the uterine fundus, is frameless and entirely flexible. The GYN-CS® 3 has a lifespan of 3 years and GYN-CS® 10 has lifespan of 10 years, both used in this study. The primary objectives are: Analyse the learning curve of the surgeon and the ease of insertion of the device.

This study is a mono-center, open-label, single-arm (non-randomized trial, in which each participant receives GYN-CS® 3 or GYN-CS® 10) prospective study for the insertion evaluation of GYN-CS®. Providing no complications occur, the women will remain in the study for 3 years. The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section. The learning curve parameters are the time of the procedure (starts after removal of the placenta when the uterus is completely empty and ends when the device is correctly inserted) and a scale for the ease of insertion of the device. Following insertion of GYN-CS® 3 and 10, women will be reexamined at discharge, at 6-8 weeks, at 1, 2 and 3 years after insertion. At 3 years after insertion of the GYN-CS® 3, it will be removed during the follow-up visit. At 3 years after insertion of the GYN-CS® 10, the device doesn't need to be removed at the follow-up visit. During every visit a vaginal ultrasound and gynecological examination are performed as well as a satisfactory scale of the IUD is questioned at the patient.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Learning Curve Caesarean Section Intra-uterine Device

Interventions

GYN-CSDEVICE

placement of the GYN-CS device

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Generally healthy, women, * Pregnant women in the second trimester * 18-48 years of age * Birth by Caesarean section planned * Be willing to stay in the study for 3 years * Return for follow-up at the designated times * Signed informed consent Exclusion Criteria: * The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out) * Suspicion of endometrial or uterine pathology such as congenital malformation of the uterus * Large uterine fibromata (\> 3 cm in diameter) * Acute leukemia * Severe blood clotting disorders and undiagnosed genital tract bleeding * Significant medical disease that in the medical opinion of the investigator is likely to interfere with patient ability to complete the entire trial * Participants receiving corticosteroid therapy (hydrocortisone\>40mg/d or an equivalent) or immunosuppressive drugs * Caesarean section \< 36 weeks

Locations (1)

Ghent University Hospital

Ghent, Belgium

Outcomes

Primary Outcomes

Analyse the learning curve of the placement of the IUD by the surgeon

procedure time: the time of the device placement starts after removal of the placenta when the uterus is completely empty and ends when the device is correctly inserted

Time frame: During the placement of the IUD

Analyse the learning curve of the placement of the IUD by the surgeon

successful insertion with adequate position during follow-up evaluations. The adequate position of the IUD will be checked by visualisation of the IUD by performing a vaginal ultrasound.

Time frame: During the placement of the IUD

Ease of insertion of the IUD

The ease of insertion of the IUD will be measured, using the following scale: * 1\. The insertion of the device went smoothly * 2\. I had little trouble inserting the device, but experienced this as a not important delay in my surgical act * 3\. The insertion of the device was rather difficult * 4\. The insertion of the device was time consuming, difficult and dangerous * 5\. The insertion of the device wasn't possible due to technical issues or medical reasons

Time frame: During the placement of the IUD

Secondary Outcomes

Safety of insertion

All complications during the insertion of the IUD will be saved in a log

Time frame: During the insertion of the device until the end of the procedure of IUD placement

Expulsion rate and causes

At every follow-up visit, expulsion of the IUD will be asked and the reason will be described in a log.

Time frame: During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)

Continuation rate

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.