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Clinical Trials/JPRN-jRCTs071210114
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.

Registry
who.int
Start Date
January 19, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Miyamoto Shingo

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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