Novel 'extended labour induction' balloon to improve safety of labour induction: Prototype development and preliminary clinical study
Lead Research Organisation:
University of Birmingham
Department Name: Institute of Applied Health Research
Abstract
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Technical Summary
Summary
Context
Artificial initiation of labour (labour induction) plays a major and increasing role in childbirth globally. A third of all labours in England are induced artificially and this is mirrored in most high- and medium-income countries. There is good evidence that labour induction reduces foetal risk in many situations, such as advanced gestational age, without increasing the likelihood of caesarean birth. The increasing global prevalence of labour induction justifies investment in research to improve the effectiveness, acceptability and safety of labour induction methods.
Why is there a need for innovation?
Starting labour off artificially can be difficult and stressful for the parents concerned. There are two main methods; using a chemical taken by mouth or inserted into the vagina or using mechanical means with a balloon which can be passed through the mouth of the womb and then inflated. Research has shown that balloon induction of labour can reduce risk to the baby without increasing caesarean birth rates. The balloon method is therefore becoming more popular than chemical methods. However, the balloon method relies on a bladder catheter used off-label (or a similar spherically shaped purpose-designed balloon) which often falls out before labour is established. One then needs to resort to stimulating drugs or breaking the waters, both of which entail risks to the mother and/or baby, and require intensified monitoring of the baby's condition.
A device is needed which can be inflated inside the womb and will not fall out of the mouth of the womb until it has opened up sufficiently to establish labour irreversibly.
Our proposed solution
Given the well-established safety benefits of balloons over other methods, our innovative concept is to extend the use of balloon labour induction when a standard catheter balloon cannot be used effectively. Increasing the size of a single spherical balloon could be counter-productive by displacing the head of the baby from the pelvis. We therefore propose a novel 'ring' balloon shape to achieve a wide diameter balloon without increase in vertical height, plus a trailing second balloon forming an open cylindrical shape to assist dilatation of the cervix. To establish preliminary 'proof of concept', we have conducted simulation and clinical studies using multiple (usually 3) Foley balloons side by side, with promising results. Twelve of twenty women gave birth naturally with no need for further intervention.
Aims and Objectives
To develop a prototype 'extended labour induction' balloon based on our experience with side by side balloons and conduct a preliminary clinical trial, to form the basis for subsequent substantial trials (not part of this application).
Context
Artificial initiation of labour (labour induction) plays a major and increasing role in childbirth globally. A third of all labours in England are induced artificially and this is mirrored in most high- and medium-income countries. There is good evidence that labour induction reduces foetal risk in many situations, such as advanced gestational age, without increasing the likelihood of caesarean birth. The increasing global prevalence of labour induction justifies investment in research to improve the effectiveness, acceptability and safety of labour induction methods.
Why is there a need for innovation?
Starting labour off artificially can be difficult and stressful for the parents concerned. There are two main methods; using a chemical taken by mouth or inserted into the vagina or using mechanical means with a balloon which can be passed through the mouth of the womb and then inflated. Research has shown that balloon induction of labour can reduce risk to the baby without increasing caesarean birth rates. The balloon method is therefore becoming more popular than chemical methods. However, the balloon method relies on a bladder catheter used off-label (or a similar spherically shaped purpose-designed balloon) which often falls out before labour is established. One then needs to resort to stimulating drugs or breaking the waters, both of which entail risks to the mother and/or baby, and require intensified monitoring of the baby's condition.
A device is needed which can be inflated inside the womb and will not fall out of the mouth of the womb until it has opened up sufficiently to establish labour irreversibly.
Our proposed solution
Given the well-established safety benefits of balloons over other methods, our innovative concept is to extend the use of balloon labour induction when a standard catheter balloon cannot be used effectively. Increasing the size of a single spherical balloon could be counter-productive by displacing the head of the baby from the pelvis. We therefore propose a novel 'ring' balloon shape to achieve a wide diameter balloon without increase in vertical height, plus a trailing second balloon forming an open cylindrical shape to assist dilatation of the cervix. To establish preliminary 'proof of concept', we have conducted simulation and clinical studies using multiple (usually 3) Foley balloons side by side, with promising results. Twelve of twenty women gave birth naturally with no need for further intervention.
Aims and Objectives
To develop a prototype 'extended labour induction' balloon based on our experience with side by side balloons and conduct a preliminary clinical trial, to form the basis for subsequent substantial trials (not part of this application).
