Safety and efficacy of a suction cervical stabilizer for IUD insertion: Results from a multicenter post-marketing study.

OBJECTIVE

To evaluate the experiences with an atraumatic device (Carevix®) for intrauterine device (IUD) placement in routine clinical practice.

METHODS

Our prospective, post-marketing study was conducted in 19 centers in Europe, Brazil and the USA. IUD insertions using Carevix device were documented for completion rates, patient-reported pain scores, cervical bleeding, and operator and patient satisfaction. Demographics, uterine position, and menstrual cycle phase were also recorded.

RESULTS

A total of 1123 IUD placements were analyzed. Most participants (819/992; 83%) were 18-40 years old; 46% (513/1123) were nulliparous and 47% (526/1123) were menstruating at the time of the procedure. The procedure was completed with Carevix alone in 82% (925/1123) of participants. Additional tenaculum use was mostly due to spontaneous vacuum loss (194/1123). Completion rates without a tenaculum were lower in nulliparous than in parous women (78% versus 86%). Average visual analog pain scores were lower with Carevix alone (35 ± 21) than when a tenaculum was required (43 ± 21). Most participants (73%) reported less pain than expected, and only 3% reported more pain. Among providers, 82% were satisfied with Carevix, citing ease of use, visibility, and low patient discomfort.

CONCLUSIONS

In a multicenter real-world setting, the novel, atraumatic device demonstrated feasibility and safety, with high completion rates and high satisfaction among both operators and patients.