Vaginal Microbiome and Long and Short Outcomes of Cervical Balloon Catheter Induction of Labor: A Multicenter Prospective Cohort Study

Abstract

Background Considering that balloon catheter placement for IOL involves a reproductive tract operation, its effectiveness may be affected by the reproductive tract environment. However, there is currently a lack of relevant evidence to support whether vaginal microbiota affects the maternal and neonatal pregnancy outcomes of balloon catheter placement for IOL. Therefore, In this multicenter prospective cohort study, we investigated the characteristics of vaginal microbiota in late pregnancy women and their relationship with short-term and long-term outcomes of cervical balloon catheter induced abortion. Methods We enrolled pregnant women from five hospitals in different cities in Jiangsu Province, China—including Nanjing Maternal and Child Health Care Hospital, Changzhou Maternal and Child Health Care Hospital, Wuxi Maternal and Child Health Care Hospital, Changzhou Second People's Hospital, and Suzhou Municipal Hospital and had them and their descendants follow up at the same hospital. Assessments during pregnancy include demographic data, pregnancy characteristics, complications of pregnancy, examinations in the third trimester. Before the balloon catheter placement, samples of vaginal secretions and prenatal maternal serum/plasma were collected from the study participants. Then the balloon catheter insertion was performed by a professional obstetrician. At birth, the immediate situation of the mother and newborn was recorded and biological samples such as amniotic fluid, maternal serum/plasma samples, mbilical cord samples, infant plantar blood spots collected. All biological samples were stored at -80°C, and metagenomic sequencing and human genome sequencing were performed uniformly after all samples had been collected. The offspring of the participants will continue to be followed up for a longer period of time (until the age of 3 years) to monitor their growth and development as well as disease outcomes. A research assistant will conduct the follow-up through phone calls and regularly organize physical examinations. Discussion This study is novel from the focuse on the interaction between metagenomics, metabolomics, proteomics, and other multi-omics. Moreover, the study involves significant effort on performing follow-up examinations of offspring, which many previous studies lacked. The