Last reviewed · How we verify
High Volume Foleys Increasing Vaginal Birth (High FIVe Birth) Pilot Trial
It is currently unknown if there is a way to decrease the risk of cesarean delivery when undergoing cervical ripening and induction of labour. Some research suggests a Foley catheter placed through the cervix and filled to 80cc may decrease this risk. We wish to run a large scale trial to see if Foleys filled to 80cc decrease the risk of Cesarean section compared to the commonly used medication for cervical ripening, prostaglandins. Before we can undertake a large trial, we need to do a pilot to see if women will agree to participate in this type of study. As well, a pilot will help with trouble shooting prior to a large trail, to improve the chances of successfully answering this clinically important question.
Details
| Lead sponsor | Sunnybrook Health Sciences Centre |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 130 |
| Start date | 2016-12 |
| Completion | 2019-12 |
Conditions
- Labour; Induced
- Pilot Study
- Cervical Ripening
Interventions
- Foley catheter filled to 80cc
- prostaglandin of the clinician's choice
Primary outcomes
- The percentage of eligible women who are approached to participate in the study that are enrolled and randomized to either the use of a high volume Foley or prostaglandin for cervical ripening — 15 months
The primary outcome measure of percent of women recruited will be captured by the number of women who undergo the randomized intervention divided by the number of women who are approached.