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Two randomized controlled trials comparing the Hulka and Filshie Clips for tubal sterilization.

Abstract

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.

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  • Authors+Show Affiliations

    ,

    Family Health International, Research Triangle Park, NC 27709, USA. rdominik@fhi.org

    , , , , , , , , , ,

    Source

    Contraception 62:4 2000 Oct pg 169-75

    MeSH

    Female
    Humans
    Pregnancy
    Sterilization, Tubal

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, Non-P.H.S.

    Language

    eng

    PubMed ID

    11137070

    Citation

    TY - JOUR T1 - Two randomized controlled trials comparing the Hulka and Filshie Clips for tubal sterilization. AU - Dominik,R, AU - Gates,D, AU - Sokal,D, AU - Cordero,M, AU - Lasso de la Vega,J, AU - Remes Ruiz,A, AU - Thambu,J, AU - Lim,D, AU - Louissaint,S, AU - Galvez,R S, AU - Uribe,L, AU - Zighelboim,I, PY - 2001/1/4/pubmed PY - 2001/3/3/medline PY - 2001/1/4/entrez SP - 169 EP - 75 JF - Contraception JO - Contraception VL - 62 IS - 4 N2 - 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. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/11137070/Two_randomized_controlled_trials_comparing_the_Hulka_and_Filshie_Clips_for_tubal_sterilization_ L2 - http://linkinghub.elsevier.com/retrieve/pii/S0010-7824(00)00166-9 ER -