The PROB-PROM is funded by the Canadian Institutes of Health Research (CIHR). It will not receive any external corporate funding.  

This study focuses on pregnant women between 24 and 33 weeks of pregnancy who have a preterm water breaking. These women will be recruited from participating hospitals. 

You may derive certain benefits from participating in the study, but we cannot guarantee this.

There are some disadvantages to participating in the PROB-PROM study. They are considered minimal: 

•  Discomfort associated with sample collection: During the study, you will be asked to provide regular samples of vaginal secretions and, after the birth, stool samples from your baby. Although these sampling procedures are not painful, they may cause some discomfort. 

•  Side effects: It is possible to experience minor side effects when taking vaginal probiotics. The research team will provide information about this to the participants concerned before the start of the study. 

•  Time commitment: At the beginning of the study, participants will be asked to complete questionnaires and subsequently to provide samples at regular intervals until 28 days after delivery. 

Two types of samples are required for the study:

• Vaginal secretions: Participants will be asked to regularly provide vaginal secretion samples throughout the study, including after delivery.

• Baby stools: After the birth, samples of the baby’s stools will also be required, usually at the first bowel movement (meconium) and at 7 days of life.

There is no financial compensation for participating in the study.

• To protect your identity, all data collected (including personal information and samples) will remain confidential to the extent prescribed by the law.

• Specifically, you will be identified by a code number (not your name), and the key code linking your name to your research file will be accessible only to the researcher responsible for this research project. In addition, your samples will be destroyed after the retention period specified in the study.

• You have the right to request at any time to consult this data or to have it deleted.

Your participation in the study is voluntary, and you may withdraw at any time without giving a reason. Your decision to withdraw will not affect the quality of care you receive. If you choose to withdraw, we suggest that you participate in a final evaluation to ensure your health.

Chorioamnionitis is an infection of the placenta that can cause premature birth.

Antibiotics are a synthetic substance that destroys bacteria or inhibits their growth.