Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica AN24) While Undergoing Labour Induction.
研究概览
简要总结
In order to confirm the feasibility of home monitoring with Monica AN 24, a licensed portable device for measuring fetal and maternal electrocardiogram (ECG), and the feasibility of inpatient monitoring with Monica AN 24 in patients with Propess (a vaginal licensed drug delivery system used for induction of labour), we will perform a pilot study that will include 20 women in each arm.
Feasibility of monitoring with Monica AN 24 both in hospital and at home will be confirmed in a pilot study. The success will be defined as at least 10 minutes of continuous satisfactory trace in any given hour in at least 80% of the patient.
A main study will then be conducted to assess the feasibility and acceptability of the Propess and Monica AN24package of care for women undergoing induction of labour.
The research questions are:
- Is outpatient induction with continuous monitoring technically feasible?
- Does the Propess and Monica AN24 care package of care provide adequate clinical information in line with the UK National Institute of Clinical Evidence (NICE) Guideline for Induction of labour?
- Is outpatient induction a concept that appeals to women?
- What do women consider to be the advantages and disadvantages of this package of care?
- What would women consider to be positive and/or negative outcome in future clinical trials of outpatient induction?
- Do fetuses with abnormal electrocardiogram (ECG) patterns have evidence of subclinically impaired cardiac function (feasibility study)?
- Do elevated concentrations of white blood cell components in the umbilical cord blood at birth influence fetal electrocardiogram (feasibility study)?
详细描述
Inclusion criteria
Women with singleton pregnancy and cephalic presentation booked for induction of labour with unfavourable cervix (Bishop score <6) and normal pre-induction fetal monitoring.
Low risk women in the context of this study include:
- Uncomplicated pregnancy requiring induction of labour after completed 37 weeks of of pregnancy with normal fetal assessment including:
- Social inductions/maternal requests
- Induction of labour for symphysis pubic dysfunction
- Obstetric Cholestasis
- Nonspecific Proteinuria (without any other medical problems)
- Parity < 4
- Intact membranes at study entry
- Living within a reasonable distance from the hospital (i.e., not more than approximately 60 minutes driving time)
- Caregiver present at all times while at home
- Easy access to a safe method of transport for return to hospital
- Easy access to a telephone (either land line or mobile with good service)
- Agrees to remove the pessary herself following instructions in the patient leaflet
- Written informed consent
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Propess and Monica AN24 care package
Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour
干预措施: Dinoprostone (Drug)
Propess and Monica AN24 care package
Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour
干预措施: Monica AN 24 (Device)
结局指标
主要结局
Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica AN24) While Undergoing Labour Induction.
时间窗: 6 months
Outpatient induction is when women recieve medication to induce labour at the hospital, but can then go home for monitoring until labour progresses. When 'standard' Doppler Ultrasound FHR technology is used, women may feel restrained as the Doppler-FHR machine (which is bench-top device) is connected to the transducer which is then mounted on the woman's abdomen and attached by an elastic belt, which is known to be uncomfortable for pregnant woman. The AN 24 device is portable and attaches to the patients abdomen allowing remote fetal monitoring whilst the women are at home.
次要结局
- Number of Participants Who Were Satisfied With Monitoring at Home(6 months)