To evaluate whether the use of an atraumatic Allis clamp will result in less bleeding than the standard single-tooth tenaculum for cervical stabilization during intrauterine device (IUD) placement.
A single blinded randomized controlled trial was conducted during insertions of IUDs between March 2017 and March 2018. University of Kentucky Institutional Review Board (IRB 16-1110-P3K) approval was obtained. Physicians were randomized to use either an Allis clamp or a single-tooth tenaculum for cervical stabilization. A post-procedure questionnaire was used to collect outcome measures as well as demographic and obstetric related factors.
Of the ninety-five participants, there was no difference in age, self-identified race/ethnicity, or the evaluated obstetric factors between the groups. Bleeding was present after clamp removal in 3 (6.3%) insertions using an Allis clamp and 26 (55.3%) insertions using a single-tooth tenaculum (RR = 0.113, CI=[0.037, 0.3481], p < 0.0001). There was no difference in IUD insertion success rates between the two clamps. There was no difference in the number of interventions required for hemostasis when bleeding occurred after clamp removal. Pain scores did not differ based on clamp type or age of patient, but were significantly different based on parity (p < 0.001) and IUD type (p < 0.003).
The Allis clamp should be used instead of a single-tooth tenaculum for cervical stabilization because of decreased incidence of clamp site bleeding with unchanged insertion success.
The trial was retrospectively registered on 1/11/22 (trial registration number NCT05187078).