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Randomized trial of the efficacy of intravaginal ulinastatin administration for the prevention of preterm birth in women with a singleton pregnancy and both cervical shortening and inflammation of lower genital tract
Author(s) -
Otsuki Katsufumi,
Kawabata Ikuno,
Matsuda Yoshio,
Nakai Akihito,
Shinozuka Norio,
Makino Yasuo,
Kamei Yoshimasa,
Iwashita Mitsutoshi,
Okai Takashi
Publication year - 2019
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/jog.13796
Subject(s) - medicine , placebo , gestation , obstetrics , pregnancy , ulinastatin , randomized controlled trial , sex organ , premature birth , gynecology , alternative medicine , pathology , biology , genetics
Aim To assess the preventive effect on preterm birth of intravaginal ulinastatin (urinary trypsin inhibitor; UTI) administration during the mid‐trimester in women with singleton pregnancy and both cervical shortening and lower genital infections. Methods Pregnant women with a short cervical length < 25 mm between 16 and 26 weeks of gestation and who had been diagnosed with a lower genital infection were randomly assigned for intravaginal UTI administration or placebo. All of the women were screened for infection or inflammation of the lower genital tract, and women with negative results were excluded. Results Of the 92 patients with a short cervical length who were assessed for eligibility for this study, 86 singleton patients were enrolled. All patients were randomized to one of two treatment groups: patients administered UTI ( n = 35) and placebo ( n = 35). There were no differences between the two groups in the incidence of preterm delivery before 28, 30, 32, 34 and 37 weeks of gestation and in perinatal outcomes. Conclusion For women diagnosed with a short cervical length < 25 mm) between 16 and 26 weeks of gestation and lower genital infection, who were at risk of preterm birth, administration of transvaginal UTI with vaginal irrigation showed no apparent benefit. Future research on the efficacy of UTI should evaluate modified modes of UTI application.