PDF(Pubmed)
Abstract：
UNASSIGNED: Mechanical labour induction with a transcervical balloon is as effective as pharmacological methods, with fewer adverse effects. Its use has been limited to labour induction with an unfavourable cervix able to retain the balloon. We have developed an innovative approach using 2-3 balloons side-by-side to extend the benefits of mechanical labour induction/augmentation with a favourable cervix without having to resort to amniotomy or uterotonics.
UNASSIGNED: To assess the effectiveness of side-by-side balloons for extended labour induction/augmentation.
UNASSIGNED: We conducted a single arm proof of concept trial at Princess Marina Hospital (PMH) in Gaborone, Botswana. Participants were assessed as unsuitable for single balloon labour induction based on a modified Bishop cervical score of 7 or more. Three Foley catheters taped symmetrically side by side were passed through the cervix and inflated with 60mls each. Traction was applied with a weight of 250mls water suspended over the bed-end. The use of uterotonics, time from induction to birth, mode of birth, Apgar scores and adverse maternal and neonatal outcomes were recorded. Participants\' satisfaction with the method of labour induction was assessed using a descriptive scale.
UNASSIGNED: We enrolled 20 participants of whom two were nulliparous. Indications for labour induction were mainly late term (70%) and hypertensive disorders of pregnancy (25%). The mean cervical score was 7.2. Overall, 17 (85%) of the participants achieved a vaginal birth, of whom 5 required oxytocin for labour augmentation. Four of these had requested removal of the balloons, one due to discomfort and three felt the process was taking too long. Three participants underwent caesarean birth. The mean time from initiation of labour induction to vaginal birth was 16 h (standard deviation (SD) 8.4) and 20 h for caesarean birth (SD 10.5). There were no 5-minute Apgar scores below 7 nor neonatal admissions. One baby required brief resuscitation. There were no adverse maternal outcomes.
UNASSIGNED: This proof-of-concept study suggests that use of side-by-side balloons in participants with favourable cervix is effective in achieving vaginal birth in most participants without uterotonics or amniotomy. There were no adverse outcomes, though the study was too small to exclude the possibility of rare adverse outcomes. This offers a novel option for labour induction/augmentation, particularly where uterotonics or amniotomy are best avoided such as prior caesarean birth, vertical infection transmission risk and in settings with limited capacity for fetal surveillance. The results clearly justify larger randomized trials to evaluate this novel approach with greater precision. On the basis of the current study we are developing a purpose-designed balloon for extended balloon labour induction.
UNASSIGNED: To assess the effectiveness of side-by-side balloons for extended labour induction/augmentation.
UNASSIGNED: We conducted a single arm proof of concept trial at Princess Marina Hospital (PMH) in Gaborone, Botswana. Participants were assessed as unsuitable for single balloon labour induction based on a modified Bishop cervical score of 7 or more. Three Foley catheters taped symmetrically side by side were passed through the cervix and inflated with 60mls each. Traction was applied with a weight of 250mls water suspended over the bed-end. The use of uterotonics, time from induction to birth, mode of birth, Apgar scores and adverse maternal and neonatal outcomes were recorded. Participants\' satisfaction with the method of labour induction was assessed using a descriptive scale.
UNASSIGNED: We enrolled 20 participants of whom two were nulliparous. Indications for labour induction were mainly late term (70%) and hypertensive disorders of pregnancy (25%). The mean cervical score was 7.2. Overall, 17 (85%) of the participants achieved a vaginal birth, of whom 5 required oxytocin for labour augmentation. Four of these had requested removal of the balloons, one due to discomfort and three felt the process was taking too long. Three participants underwent caesarean birth. The mean time from initiation of labour induction to vaginal birth was 16 h (standard deviation (SD) 8.4) and 20 h for caesarean birth (SD 10.5). There were no 5-minute Apgar scores below 7 nor neonatal admissions. One baby required brief resuscitation. There were no adverse maternal outcomes.
UNASSIGNED: This proof-of-concept study suggests that use of side-by-side balloons in participants with favourable cervix is effective in achieving vaginal birth in most participants without uterotonics or amniotomy. There were no adverse outcomes, though the study was too small to exclude the possibility of rare adverse outcomes. This offers a novel option for labour induction/augmentation, particularly where uterotonics or amniotomy are best avoided such as prior caesarean birth, vertical infection transmission risk and in settings with limited capacity for fetal surveillance. The results clearly justify larger randomized trials to evaluate this novel approach with greater precision. On the basis of the current study we are developing a purpose-designed balloon for extended balloon labour induction.
摘要：
■经颈球囊机械引产与药理学方法一样有效，副作用较少。它的使用仅限于具有能够保持球囊的不利子宫颈的引产。我们开发了一种创新的方法，使用2-3个并排的气球来扩展具有良好子宫颈的机械引产/扩大的好处，而不必诉诸羊膜切开术或子宫内膜术。
■评估并排球囊用于延长引产/延长的有效性。
■我们在哈博罗内的滨海公主医院（PMH）进行了单臂概念验证试验，博茨瓦纳。根据改良的Bishop宫颈评分为7或更高，评估参与者不适合单球囊引产。对称地并排粘贴的三个Foley导管穿过子宫颈并每个充气60ml。用悬浮在床端上的250ml重的水施加牵引。子宫内膜的使用，从引产到出生的时间，出生模式,记录Apgar评分和不良母婴结局。使用描述性量表评估参与者对引产方法的满意度。
■我们登记了20名参与者，其中2名是未产的。引产的指征主要是晚期（70％）和妊娠高血压疾病（25％）。平均宫颈评分为7.2。总的来说,17（85％）的参与者实现了阴道分娩，其中5人需要催产素来增加分娩。其中四个要求移除气球，一个是因为不舒服，三个人觉得这个过程太长。三名参与者接受了剖腹产。从开始引产到阴道分娩的平均时间为16小时（标准偏差（SD）8.4），剖腹产为20小时（SD10.5）。没有5分钟Apgar得分低于7分，也没有新生儿入院。一个婴儿需要短暂的复苏。没有不良的产妇结局。
■这项概念验证研究表明，在子宫颈良好的参与者中使用并排气球可以有效地实现大多数参与者的阴道分娩，而无需子宫内膜或羊膜切开术。没有不良后果，尽管该研究规模太小，无法排除罕见不良结局的可能性。这为引产/增加提供了一种新颖的选择，特别是在最好避免子宫收缩术或羊膜切开术的地方，例如先前的剖腹产，垂直感染传播风险和胎儿监测能力有限的环境。结果清楚地证明了更大的随机试验以更高的精度评估这种新方法。在当前研究的基础上，我们正在开发一种专门设计的球囊，用于延长球囊引产。
■评估并排球囊用于延长引产/延长的有效性。
■我们在哈博罗内的滨海公主医院（PMH）进行了单臂概念验证试验，博茨瓦纳。根据改良的Bishop宫颈评分为7或更高，评估参与者不适合单球囊引产。对称地并排粘贴的三个Foley导管穿过子宫颈并每个充气60ml。用悬浮在床端上的250ml重的水施加牵引。子宫内膜的使用，从引产到出生的时间，出生模式,记录Apgar评分和不良母婴结局。使用描述性量表评估参与者对引产方法的满意度。
■我们登记了20名参与者，其中2名是未产的。引产的指征主要是晚期（70％）和妊娠高血压疾病（25％）。平均宫颈评分为7.2。总的来说,17（85％）的参与者实现了阴道分娩，其中5人需要催产素来增加分娩。其中四个要求移除气球，一个是因为不舒服，三个人觉得这个过程太长。三名参与者接受了剖腹产。从开始引产到阴道分娩的平均时间为16小时（标准偏差（SD）8.4），剖腹产为20小时（SD10.5）。没有5分钟Apgar得分低于7分，也没有新生儿入院。一个婴儿需要短暂的复苏。没有不良的产妇结局。
■这项概念验证研究表明，在子宫颈良好的参与者中使用并排气球可以有效地实现大多数参与者的阴道分娩，而无需子宫内膜或羊膜切开术。没有不良后果，尽管该研究规模太小，无法排除罕见不良结局的可能性。这为引产/增加提供了一种新颖的选择，特别是在最好避免子宫收缩术或羊膜切开术的地方，例如先前的剖腹产，垂直感染传播风险和胎儿监测能力有限的环境。结果清楚地证明了更大的随机试验以更高的精度评估这种新方法。在当前研究的基础上，我们正在开发一种专门设计的球囊，用于延长球囊引产。
