Pregnant women with subclinical infection and cervical length &
Conditions
Interventions
Group administered intravaginal ulinastatin
Group administered placebo
Sponsors
Japan Organization of Prevention of Preterm Delivery
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (2) Cervical length less than 25.0 mm as diagnosed by transvaginal ultrasonography (3) Pregnant women testing positive for subclinical infection*1 who do not have infection that could potentially determine the mode of delivery (such as HIV, HSV, or condyloma, etc.) (4) Patients who have voluntarily provided written consent to participate in this trial, after having been thoroughly briefed, and informed of the nature of the trial (if the patient is under 20 years old, written consent must be obtained from the spouse (if the spouse is younger than 20 years old) or parent of the minor) (5) Patients with stable functionality of major organs, confirmed by meeting the following laboratory test standards: 1)White blood cell count more than 3,000/mm3, less than 20,000/mm3 2) Platlet count more than 50,000/mm3 3) Hemoglobin more than 8.0g/dL 4)AST (GOT) <2.5 times upper limit of standard level of each test center 5) ALT (GPT) <2.5 times upper limit of standard level of each test center 6) BUN less than 25 mg/dL 7) Serum creatinine less than 2 mg/dL
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gestational week of delivery Neonatal mortality rate Neonatal morbidity | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients using a tocolytic agent (ritodrine hydrochloride preparation, magnesium sulfate preparation) Mean birth weight | — |
Countries
Japan
Contacts
Public ContactNorio SHINOZUKA
Showa University Obstetrics anc Gynecology
Outcome results
None listed