Verification of the efficacy of intravaginal ulinastatin administration in patients with cervical shortening

UMIN ID: UMIN000001871

Registered date:15/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Pregnant women with subclinical infection and cervical length 25 mm as diagnosed by transvaginal ultrasonography in a maternity health examination conducted during the second trimester of pregnancy (between week 16 day 0 and week 26 day 6 of gestation)
• Date of first enrollment: 2005/11/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group administered intravaginal ulinastatin
Group administered placebo

Outcome(s)

• Primary Outcome: Gestational week of delivery Neonatal mortality rate Neonatal morbidity
• Secondary Outcome: Percentage of patients using a tocolytic agent (ritodrine hydrochloride preparation, magnesium sulfate preparation) Mean birth weight

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: (1) Multiple pregnancy involving more than 3 fetuses (2) Placenta previa (3) Premature separation of normally implanted placenta (4) Serious fetal abnormality (5) Patients in whom fetal well-being cannot be confirmed (6) Patients who previously underwent cervical cerclage during current pregnancy (7) Patients with signs of threatened premature delivery*2 (8) Patients with complications of psychiatric disease or psychiatric symptoms whose participation in the trial is judged to be infeasible (9) Other patients judged to be ineligible by attending physician

Related Information

• Primary Sponsor: Japan Organization of Prevention of Preterm Delivery
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare: Multidisciplinary Research Project on Children and Family