Caesarean Section, Intra-uterine Device, Learning Curve
Conditions
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.
Interventions
DEVICEGYN-CS
placement of the GYN-CS device
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyse the learning curve of the placement of the IUD by the surgeon | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Expulsion rate and causes | During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up) | At every follow-up visit, expulsion of the IUD will be asked and the reason will be described in a log. |
| Continuation rate | during the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up) | What is the reason for drop-out of the study? |
| The pain of the patient during removal of the IUD: VAS scale | 3 years after insertion of the IUD | The pain will be measured using a VAS scale (1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain) |
| 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) | At removal, the ease of this action by the following scale for the physicians: * 1\. I had little trouble with removing the device, but experienced this as a not important delay in my surgical act * 2\. The removal of the device went smoothly * 3\. The removal of the device was rather difficult * 4\. The removal of the device was time consuming, difficult and dangerous * 5\. The removal of the device wasn't possible due to technical issues or medical reasons |
| 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) | Patient satisfaction by Likert scale at every follow up: very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. At removal, the ease of this action by the following scale for the physicians: * 1\. I had little trouble with removing the device, but experienced this as a not important delay in my surgical act * 2\. The removal of the device went smoothly * 3\. The removal of the device was rather difficult * 4\. The removal of the device was time consuming, difficult and dangerous * 5\. The removal of the device wasn't possible due to technical issues or medical reasons |
| Safety of insertion | During the insertion of the device until the end of the procedure of IUD placement | All complications during the insertion of the IUD will be saved in a log |
Countries
Belgium
Outcome results
None listed