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

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

Recruiting
18-48 years
Female
Phase N/A

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 details
    Cesarean section
    Learning Curve
    Intrauterine Device
    Intrauterine Device

NCT04435496

University Hospital, Ghent

19 February 2024

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