Prediction, Prevention and Interventions for Preterm birth (The P3 Cohort)

Summary

Preterm birth (or premature birth or delivery before 37 weeks of pregnancy) is a significant cause of brain injury and disability and is the main reason for neonatal intensive care unit (NICU) admission.

The purpose of this research study is to be able to:
• predict which women will deliver preterm.
• provide opportunities to prevent preterm birth; and
• improve health outcomes for children who are born preterm.

We are recruiting women early in their pregnancy to take part in this study and only a small percentage of women (~8%) are expected to have a preterm delivery. We will be following all women to 12 months after their expected due date.

If you enroll in the study before 28 weeks of pregnancy, you will be invited to provide a blood sample and a urine sample. Biological samples will be collected by Alberta Public Laboratories staff at the time when you present for routine gestational diabetes screening. The blood work will not require an additional needle. In addition, cord blood will be collected at your delivery by delivery care providers.

You will be asked to complete five (5) questionnaires, which will take approximately 15 to 30 minutes to complete during the following times:
- At enrollment;
- 34 to 36 weeks of pregnancy;
- at 2 to 4 weeks after your baby's expected delivery date (this one will only take 5 minutes to complete);
- at 5 to 6 months after your baby’s expected delivery date; and
- at 11 to 12 months after your baby’s expected delivery date.

You may also be invited to participate in other substudies during your pregnancy and/or after your baby is born. It is completely up to you whether you decided to participate in other substudies.

If you have a partner, your partner will have the opportunity to participate in two questionnaires at enrollment and at 11-12 months after the expected delivery date. It is up to your partner to decide whether they wish to participate in the questionnaires.

Eligibility

Currently recruiting participants: Yes

Eligible gender: Female

Eligible ages: 16 to 60

Accepts healthy participants: Yes

Inclusion criteria:

Pregnant women who:
- live in the Calgary Zone of Alberta Health Services;
- are less than 32 weeks pregnant with one baby; and
- are able to complete written questionnaires in English.


Exclusion criteria:

You are not eligible to participate if:
• you have participated in this study during a prior pregnancy;
• if your unborn baby has been diagnosed with a fetal congenital or chromosomal anomaly prior to enrollment.

Participate

Fill out the following form if you want to participate in this research

Method of contact

Additional information

Contact information

Please email P3cohort@ucalgary.ca for more information about the study.

Principal investigator:

Amy Metcalfe

Clinical trial:

No

REB-ID:

REB20-1635