JPRN-jRCTs071210114
Recruiting
Phase 2
Phase II clinical study for high-risk patients with chorioamnionitis using the integrated treatment of antibiotics
Miyamoto Shingo0 sites24 target enrollmentJanuary 19, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Preterm labor
- Sponsor
- Miyamoto Shingo
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients diagnosed with preterm labor less than 34 weeks gestation.
- •2\) Patients without obvious premature rupture of membrane.
- •3\) Patients with sufficient major organ capacity.
- •4\) The test value shall be within three months before the registration date.
- •(1\) White blood cell count \> 3,000 /mcl or neutrophil count \> 1,000 /mcl
- •(2\) Platelet count \> 100,000 /mcl
- •(3\) Hemoglobin \> 8\.0 g/dl
- •(4\) AST, ALT \< 100 IU/ml
- •(5\) Serum creatinine \< 1\.0 mg/dl
- •(6\) Serum bilirubin \< 1\.0 mg/dl
Exclusion Criteria
- •1\) Patients with body temperature of 38 degree celsius or higher at rest.
- •2\) Patients with a heart rate of 120 /min or higher and a white blood cell count of 20,000 /mcl or higher.
- •3\) Patients diagnosed with clinical chorioamnionitis according to the diagnostic criteria of Lencki et al.
- •4\) When there is maternal fever (\> 38 degree celsius) (1\) Maternal tachycardia (\> 100 bpm) (2\) Uterine tenderness (3\) Vaginal discharge / amniotic fluid malodor (4\) Leukocytosis (\> 15,000 /mcl), there must be at least one item in four items (1\-4\). Alternatively, there must be all four items from (1\) to (4\) if there is no maternal fever (\> 38 degree celsius).
- •5\) Patients with psychiatric disorders requiring treatment.
- •6\) Patients with uncontrolled diabetes.
- •7\) Patients with active or uncontrollable infections.
- •8\) Patients with a history of severe drug hypersensitivity.
- •9\) Patients with malignant tumors requiring treatment and with a history of malignant tumors within five years (excluding intraepithelial neoplasia).
- •10\) Patients with cancer or receiving chemotherapy, radiation therapy, or other cancer therapies.
Outcomes
Primary Outcomes
Not specified
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