Cervical Ripening Clinical Trial
Official title:
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.
Background:
Approximately 1/3 of first-time mothers (nulliparous women) undergoing induction of labour
deliver by cesarean. Cesarean delivery can have negative consequences to the initial and
subsequent pregnancies. Women who have a cesarean in their first pregnancy are more likely to
have a cesarean in their following pregnancies and this group is the largest contributor to
the overall cesarean delivery rate. Therefore, targeting interventions that prevent cesareans
in nulliparous women undergoing induction of labour will have a substantial impact on the
overall cesarean delivery rate.
Adequate ripening or preparing the cervix before induction has been found to decrease the
risk of cesarean. This can be done by a variety of methods, such as prostaglandins (a
chemical messenger) or a Foley filled to a moderate volume of fluid. These methods have been
found to be equal regarding the risk of cesarean delivery. However, a meta-analysis by our
team discovered a trend towards a decreased risk of cesarean when cervical ripening is
undertaken with Foleys filled to a high volume of fluid (80cc) compared to those filled to a
low volume (30cc).Most Canadian Obstetricians use prostaglandins for cervical ripening. To
assess if 80cc Foleys result in a lower risk of cesarean, they need to be compared to the
Canadian standard of prostaglandins. Therefore a randomized controlled trial is required.
The Greater-Toronto-Area Obstetric (GTA-OB) Network is a group of hospitals committed to
facilitating research and will be the setting for the planned large scale trial. The large
scale trial will aim to demonstrate a difference in the rate of cesarean from 38% to 31%,
which will require the enrollment of 1442 women. It has been estimated that there are 5,437
women who will meet entry criteria in the GTA-OB network each year, if ½ are approached, 20%
will need to consent to complete the trial in 3 years. Therefore, this pilot study will
determine if this recruitment rate is potentially achievable and will inform design
strategies to ensure its success.
The discovery of a simple, non- pharmacological, cost effective manner of cervical ripening
that decreases the risk of cesarean would change clinical practice and significantly improve
safety for the 33,000 Canadian women and their babies who undergo cervical ripening each
year. This pilot trial is a crucial step towards this discovery.
Objectives:
The primary objective for this pilot trial is to determine the probability that an eligible
woman will agree to be randomized into the trial comparing 80cc Foleys to prostaglandins for
cervical ripening. This study aims to assess if it is possible to obtain a recruitment rate
of 20%.
The secondary objective will be a systematic evaluation of the pilot trial process to guide
full-scale study design.
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