Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059353) titled 'Efficacy of Expectant Management for Preterm Subclinical Intra-Amniotic Infection' on March 31.
Study Type:
Observational
Primary Sponsor:
Institute - NHO Saga Hospital
Condition:
Condition - Preterm Subclinical Intra-Amniotic Infection
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study assessed the efficacy of expectant management in patients with intra-amniotic infections diagnosed treated at our institution.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - (1) singleton gestation between 20+0 and 33+6 weeks; (2) transabdominal amniocentesis performed to assess microbiological and inflammatory status of the amniotic cavity; (3) diagnosis of intra-amniotic infection; and (4) expectant management.
Key exclusion criteria - (1) decision to terminate pregnancy after a diagnosis of intra-amniotic infection; (2) antimicrobial administration within seven days prior to amniocentesis; (3) secondary intra-amniotic infection; (4) fetal congenital structural or chromosomal abnormalities; and (5) induction of labor within 48 h of infection diagnosis due to oligohydramnios or infection itself.
Target Size - 42
Recruitment Status:
Recruitment status - Main results already published
Date of protocol fixation - 2025 Year 01 Month 16 Day
Date of IRB - 2025 Year 01 Month 22 Day
Anticipated trial start date - 2025 Year 02 Month 01 Day
Last follow-up date - 2025 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067885
Disclaimer: Curated by HT Syndication.
