Two randomized controlled trials comparing the Hulka and Filshie Clips for tubal sterilization.
To compare the effectiveness and safety of the Filshie Clip System and Hulka Clip System when applied via minilaparotomy and laparoscopy, we conducted 2 multicenter randomized controlled trials of 2126 women (878 in the minilaparotomy study and 1248 in the laparoscopy study) who received either the Filshie or Hulka Clip. A physician other than the operator evaluated patients postoperatively and again at 1, 6, and 12 months after surgery. We compared the cumulative incidence of pregnancy and the frequency of safety related events for the device groups. Twenty-four month follow-up was planned for a subset of 599 women in the laparoscopy study. One woman who received the Filshie Clip and 6 women who received the Hulka Clip became pregnant within one year. The 12-month life-table pregnancy probability was 1.1 per 1000 women in the Filshie Clip group and 6.9 per 1000 women in the Hulka Clip group. The difference in the risk of pregnancy through 12 months between device groups neared statistical significance (p = 0.06). Among the extended follow-up subset, the 12- and 24-month cumulative pregnancy probabilities were 3.9 and 9.7 per 1000 women for the Filshie Clip group and 11.7 and 28.1 per 1000 women for the Hulka Clip group (p = 0.16 for comparison through 24 months). Both the Filshie and Hulka Clips are effective and safe for use in tubal occlusion.
Dominik
R
R
Family Health International, Research Triangle Park, NC 27709, USA. rdominik@fhi.org
Gates
D
D
Sokal
D
D
Cordero
M
M
Lasso de la Vega
J
J
Remes Ruiz
A
A
Thambu
J
J
Lim
D
D
Louissaint
S
S
Galvez
R S
RS
Uribe
L
L
Zighelboim
I
I
D005260:Female; D006801:Humans; D011247:Pregnancy; D013246:Sterilization, Tubal / Q000009:adverse effects / Q000295:instrumentation*