Abstract

Intrauterine infection/inflammation, a major cause of preterm birth, is known to be an exacerbating factor for perinatal mortality and morbidity, as well as childhood neurological morbidity. Treatment of intrauterine infection/inflammation is crucial in the prevention of preterm birth; however, the prevention of preterm birth using antimicrobial therapy is not recommended, amniocentesis for the diagnosis of intra-amniotic infection/inflammation is not commonly performed, and therapeutic intervention for intrauterine infection/inflammation is only provided when intra-amniotic infection/inflammation is confirmed by clinical findings. Thus, to date, intrauterine infection associated with preterm birth is still considered untreatable during pregnancy. However, several recent studies reporting successful treatment using multiple broad-spectrum antimicrobial drugs have led to disagreements regarding the necessity of treatment for intra-amniotic infection/inflammation during pregnancy. In recent years, technological innovations such as next-generation sequencing and quantitative polymerase chain reaction have led to the development of comprehensive methods for bacterial quantification. This has opened up the possibility of grasping the overall picture of pathological conditions occurring in human tissue and bacterial flora that may also be useful in general clinical settings. Thus, reassessment of several issues involved in the perinatal management of intrauterine infection/ inflammation including the 1) selection of antimicrobial agents, 2) evaluation of therapeutic efficacy, and 3) selection of patients to be treated, as well as the establishment of a new approach to this clinical practice, are required. Therefore, we aim to conduct a randomized controlled trial (phase II of the specified clinical research, jRCTs071210114) to address some of these issues.

Keywords: Preterm Birth; Intrauterine infection; Inflammation; Amniocentesis; Microbiome; Randomized Controlled Trial (RCT)