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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University Hospital, Ghent
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Analyse the learning curve of the placement of the IUD by the surgeon
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 48 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
GYN-CS insertion
GYN-CS device will be inserted in women during their c-section. The study patient can chose between a lifespan of 3 years (GYN-CS 3) and a lifespan of 10 years (GYN-CS 10) of the device.
Intervention: GYN-CS (Device)
Outcomes
Primary Outcomes
Analyse the learning curve of the placement of the IUD by the surgeon
Time Frame: During the placement of the IUD
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
Ease of insertion of the IUD
Time Frame: During the placement 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
Secondary Outcomes
- Patient satisfaction: Likert scale(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))
- Ease if removal of the IUD(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))
- Safety of insertion(During the insertion of the device until the end of the procedure of IUD placement)
- Continuation rate(during the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up))
- The pain of the patient during removal of the IUD: VAS scale(3 years after insertion of the IUD)
- Expulsion rate and causes(During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up))