Cervical Ripening Balloon in Induction of Labour at Term (CRBII) - A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- Adverse events in the first 12 hours after Cook's Cervical Ripening Balloon insertion for induction of labour, in comparison to 1st prostin insertion
研究概览
简要总结
About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a lengthy process especially when cervical priming is required. Although mechanical method of induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic reviews comparing mechanical method against pharmacological and surgical IOL showed that mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled trial concluded that both cervical ripening balloon and prostaglandin are effective and complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined the effects of pain.
The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test the acceptability of women in Singapore in using the CRB as an alternative method of induction of labour while using a non-incremental balloon filling regime. Currently, there is no efficient method of induction that can be used safely in an outpatient setting. Through this study, the investigators hope to show that there are no major adverse events in the 12h after patients are induced with CRB, this potentially supports outpatient IOL with CRB which can reduce hospitalisation and medical costs. A non-incremental balloon filling regime will decrease time delays and may increase patient satisfaction during its use in induction of labour.
详细描述
This is a prospective cohort randomised controlled trial conducted at the KK Women's and Children's Hospital (KKH) and University Malaya Medical Centre (UMMC).
NICE guidelines on induction of labour defined uterine hyperstimulation as contractions more than 5 in 10 mins for more then 20 mins or contractions lasting more than 2 mins in duration. A retrospective study involving prostaglandin induction of labour showed that hyperstimulation occurred in 5.8% of cases. The sample size is calculated based on a 4.8% reduction in hyperstimulation in all induction of labour by CRB. At a level of significance of 5%, 80% power, 200 patients in each arm is required. Preliminary study by Tan TL et al had a dropout rate of 4.6%. Hence the proposed sample size is 420.
The investigators plan to collaborate on a multi-centre trial with the University Malaya Medical Centre. In which, each centre will recruit 210 patients for the study.
Randomization of the participants is achieved with third party sealed envelope allocation. 210 envelopes containing CRB allocation and another 210 identical envelopes containing prostin allocation will be prepared by a third party. The 420 envelops will be shuffled according to a computer randomisation code after sealing and labelled with a randomization allocation number from 1 to 420. The 210 envelops will then be handed to the each centre's PI, and will be kept in the clinical store on labour ward together with the stock of CRB and prostin.
Unfortunately, it is not possible to blind the allocation to the investigator or the patient. The investigator however has no part in observing any adverse events, the CTGs should be interpreted by the attending clinician and vet by team to avoid missing abnormal CTG. The patient herself will have to report contractions and pain scores and satisfaction scores with validated standard pain and satisfaction assessment tools to minimise the potential bias. The allocation will also be omitted from the database so as to blind the analyst in order to prevent manipulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 21 - 40 years old
- •Singleton pregnancy with no major fetal anomaly
- •Planned induction of labour at 37+0 weeks to 41+6 weeks gestation
- •Vaginal delivery is appropriate
- •Patient able to give informed consent to participate in the trial
排除标准
- •Spontaneous labour at start of planned induction
- •Bishop score <6 and cervical dilatation >=3 cm at start of induction
- •Confirmed rupture of membrane
- •Abnormal CTG at start of induction
- •Caesarean section delivery is indicated
- •Scarred uterus such as previous caesarean section
- •Malpresentation in labour
- •Latex allergy, severe asthma and glaucoma
- •Patient withdraw consent to participate in the trial
研究组 & 干预措施
Cervical Ripening Balloon
Cook® Cervical Ripening Balloon with Stylet Order number G19891 Reference Part Number J-CRBS-184000 Catheter (Fr) 18.0 Length (cm) 40 Balloon Volume (mL) 80
干预措施: Cervical Ripening Balloon (Device)
Prostin
Prostin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2. Prostaglandins are involved in naturally starting labour. Dose of Prostin is 3 mg vaginally.
干预措施: Prostin (Drug)
结局指标
主要结局
Adverse events in the first 12 hours after Cook's Cervical Ripening Balloon insertion for induction of labour, in comparison to 1st prostin insertion
时间窗: Up to 24 hours after induction of labour
次要结局
- Efficacy of Cook's Cervical Ripening Balloonas a devide for induction of labour, in comparison to prostin, in achieving vaginal deliveries(Up to 96 hours after delivery)
- Patient satisfaction of the Cook's Cervical Ripening Balloon as a devide for induction of labour, in comparison to prostin, by using a 10-point scale(From induction of labour to up to 4 days after delivery)
- Patients' experience of the Cook's Cervical Ripening Balloon as a devide for induction of labour, in comparison to prostin, by using a 10-point pain assessment scale(From induction of labour to up to 4 days after delivery)
研究者
Tagore Shephali
Senior Consultant
KK Women's and Children's Hospital