For Participants
If you are receiving (or planning to receive) antenatal care at Mount Sinai Hospital (MSH), you may be asked to take part in the Ontario Birth Study (OBS), an ongoing study of pregnant people coming to MSH for prenatal care.
The study creates a resource for researchers to study factors that contribute to pregnancy and child health and explore how events during pregnancy and early postnatal life relate to later life health, learning and social functioning. We developed OBS Kids in 2018, allowing us to follow-up with previous OBS participants and their children.
One of our goals is to make it easier to participate in research by integrating research activities with the routine prenatal care you receive at MSH during your pregnancy. Participation in the OBS is completely voluntary. With your consent, we collect data from questionnaires and medical charts as well as biological samples (biospecimens), which are gathered as part of your routine care. Eventually, we hope to offer all women seeking prenatal care at MSH the opportunity to participate in the OBS.
If you have been approached or are interested in participating, we encourage you to reach out to the study staff to ask questions and take the time you need to decide whether you want to participate. We encourage you to discuss the OBS with your doctor or anyone you wish prior to making a decision.
If you decide not to participate, or if you participate and then change your mind and withdraw from the study, this will not affect the quality of care that you would normally receive during your pregnancy and after birth. Choosing not to participate in the OBS will not prevent you from participating in other studies at Mount Sinai Hospital.
OBS Research Procedure
Presently, potential participants are approached by research staff after they have been referred to the staff by MSH Obstetrics Clinics. They have the study explained to them and their immediate questions answered. Upon agreeing to take part, you will be given a paper consent form or emailed a link to a secure consent form. Our OBS staff then follow-up by telephone to answer questions you might still have.
Once enrolled in the OBS, we would ask you to:
- Provide us with permission to access your patient chart for medical information about your pregnancy and birth.
- Provide an extra 20-40 mL of blood (about 2-3 tablespoons) at the time of routine blood collections.
- Provide us with permission to collect one extra blood spot card from your baby during their routine blood spot card collection at birth.
The table shows what you can expect to happen at different time points throughout your participation in the OBS. Expected routine care visit times are listed by gestational age.
You will not need to remember these dates. Throughout your participation in our study, research staff will track your clinic appointments to:
- Ensure you receive the online questionnaires by email at the appropriate intervals with paper or electronic versions available during appointments at MSH.
- Provide MSH staff with the supplemental OBS blood collection kits in preparation for your routine blood sampling.
| Visit Time | Blood Work | Questionnaire | Approximate Time |
|---|---|---|---|
| Weeks 11-14 | 20-40 cc | Lifestyle Questionnaire 1 | 45 minutes |
| Weeks 16-20 | 20-40 cc | Diet History Questionnaire | 45 minutes |
| Weeks 24-28 | 20-40 cc | Lifestyle Questionnaire 2 | 30 minutes |
| Delivery | 30 cc; Infant blood spot card* | 10 minutes | |
| 6 weeks postpartum | Lifestyle Questionnaire 3 | 30 minutes | |
You may be approached at time of birth by a research staff member asking if they can collect samples of your placenta. You can choose not to provide these samples without affecting your participation in the OBS.
After Giving Birth
At six weeks post-partum, we will ask you to complete an online questionnaire. If you consented to receive furutre communications from the OBS [and we hope you do!], you will be invited to continue your participation in the OBS Kids. The OBS Kids is a follow-up study which aims to understand how factors after birth such as parental lifestyle, pregnancy conditions and neonatal medical history may affect children’s growth and brain development. You can also choose to take part by contacting OBS study staff at any time. As with other parts of the OBS, OBS Kids is completely voluntary and you are free to withdraw from the study at any point.
OBS Kids participants will be contacted around when your child reaches the ages of:
- 8 months
- 24 months
- 36 months
- 4.5 years
The table details the items collected at each time point.
| Visit Time | Interview Format | Interview Content | Approximate Time |
|---|---|---|---|
| 8 months | Phone | Child’s sleep, health and breastfeeding; Childcare arrangements; Questions about parents | 15 minutes |
| 24 months | Phone/Home Visit | Updates on child health; Collaborative task between parent and child; Infant saliva sample | 45 minutes |
| 36 months | Phone | Updates on child health | 15 minutes |
| 4.5 years | Phone/Home Visit | Updates on child health; Shape and colour matching; Infant saliva sample; Sibling information; Questions about parents; Parent-child interactive activity | 45 minutes |
Your Impact
Your participation helps provide new knowledge and invaluable insight into a wide range of pregnancy-related conditions. It assists in developing useful recommendations during pregnancy and improved healthcare delivery. It also helps us develop new studies about pregnancy and its impact on the long-term health of children, as well as the long-term health on individuals who have been pregnant.
We aim to create a resource that allows researchers to determine the causes of pregnancy complications and to identify factors related to child development as well as long-term health outcomes. Studies are already being undertaken to examine the drivers and biomarkers of pregnancy complications including growth restriction, preeclampsia, and preterm birth. Other studies are determining how what happens during pregnancy and early postnatal life relate to later life health, learning and social functioning. OBS will allow the development of strategies that promote long-term trajectories towards life-long health.
Through the participation of pregnant individuals in this study, we have been able to learn more about fetal development, biomarkers and pregnancy complications.
Participant Resources
At the OBS, we aim to provide our participants with resources to ensure their well-being. Below is a link to family resources, as well as a list of emotional support services for parents and learning/entertainment resources for children.
Data Protection and Ethics
If you have any questions about your rights as a research participant or have any concerns about this study, please contact the Mount Sinai Hospital Research Ethics Board (REB) at 416-586-4875. The REB is a group of people who oversee the ethical conduct of research studies. These people are not part of the study team. Everything that you discuss will be kept confidential.
Your questionnaire responses and biospecimens are identified with your study ID and all identifiers are removed before data is provided to researchers who have received ethical approval and whose projects have been reviewed and approved by the OBS Steering Committee. All parts of the data are stored securely with access limited to the OBS study team.
Questions about the OBS
If you have any questions, concerns, suggestions or would like to speak to the study team for any reason, please contact us.