Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study.

ABSTRACT

OBJECTIVES: To compare patient-reported pain, bleeding, and device safety between intrauterine contraceptive device (IUD) insertion procedures employing a suction cervical stabilizer or single-tooth tenaculum. STUDY DESIGN: This was a randomized, prospective, single-blinded study conducted at two centers, enrolling women aged 18 years or older, eligible for IUD insertion. The primary end point measure was patient-reported pain, measured on a 100-mm Visual Analogue Scale. Safety was assessed on the amount of bleeding, adverse events, and serious adverse events. RESULTS: One hundred women were randomized, 48 to the investigational device and 52 to control. There were no statistically significant differences between the groups in factors potentially associated with pain on IUD insertion. IUD insertion was successful in 94% of all subjects. Subjects in the investigational device group reported pain scores ≥14 points lower than in the control group at cervix grasping (14.9 vs 31.3; p < 0.001) and traction (17.0 vs 35.9; p < 0.001), and smaller differences in pain scores at the IUD insertion (31.5 vs 44.9; p = 0.021) and cervix-release (20.6 vs 30.9; p = 0.049) steps. Nulliparous women experienced the greatest pain differences to control. Mean blood loss was 0.336 (range 0.022-2.189) grams in the investigational device group and 1.336 (range 0.201-11.936) grams in the control group, respectively (p = 0.03 for the comparison). One adverse event (bruising and minor bleeding) in the investigational device group was considered causally related to the study device. CONCLUSIONS: The suction cervical stabilizer had a reassuring safety profile and its use was associated with significant reductions in pain during the IUD insertion procedure compared with standard single-tooth tenaculum use, particularly among nulliparous women. IMPLICATIONS Pain can be an important barrier to greater use of IUD devices among prescribers and users, particularly nulliparous women. The suction cervical stabilizer may provide an appealing alternative to currently available tenacula, filling an important unmet need.