Clinical trial NCT04435496: Study to Evaluate the Learning Curve to Anchor GYN-CS® Device
Official title: Study to Evaluate the Learning Curve to Anchor a Frameless Copper-releasing Device (GYN-CS®) During Caesarean Section With a Follow-up of 3 Years Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Learning Curve
Caesarean Section
Intra-uterine Device
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Analyse the learning curve of the placement of the IUD by the surgeon
timeFrame: During the placement of the IUD
measure: Analyse the learning curve of the placement of the IUD by the surgeon
timeFrame: During the placement of the IUD
measure: Ease of insertion of the IUD
timeFrame: During the placement of the IUD
Secondary outcomes:
measure: Safety of insertion
timeFrame: During the insertion of the device until the end of the procedure of IUD placement
measure: Expulsion rate and causes
timeFrame: During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)
measure: Continuation rate
timeFrame: during the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)
measure: Patient satisfaction: Likert scale
timeFrame: at every follow-up visit during the trial (4 days after the insertion of the IUD, 6-8 weeks after placement, 1 year after placement, 2 years after placement, 3 years after placement of the IUD)
measure: Ease if removal of the IUD
timeFrame: at every follow-up visite (4 days after the insertion of the IUD, 6-8 weeks after placement, 1 year after placement, 2 years after placement, 3 years after placement of the IUD)
measure: The pain of the patient during removal of the IUD: VAS scale
timeFrame: 3 years after insertion of the IUD
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Kristien Roelens, MD
role: PRINCIPAL_INVESTIGATOR
References: