Using Telemedicine to Improve Early Medical Abortion at Home
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- NHS Lothian
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Efficacy of medical abortion
研究概览
简要总结
The investigators plan a trial comparing telephone consultations for women requesting early medical abortion (EMA - under 10 weeks pregnant) to regular face-to-face consultations.
In Scotland, 7 out of 10 women having an abortion choose EMA. The clinic visit to discuss EMA is lengthy (2-3 hours). Much time is spent between having tests and waiting to consult a doctor or nurse. Women can struggle with time off work or childcare for lengthy daytime appointments.
There is some evidence from other countries that telephone consultations for EMA are a safe and acceptable alternative.
In this study, women seeking EMA will be randomised to face-to-face (standard care) or a planned telephone consultation (in advance of the clinic visit).
The investigators will determine the success of the EMA in both groups, women' satisfaction with the consultation and possible advantages and disadvantages. If telephone consultations prove to be effective and acceptable then this will change EMA provision throughout Scotland.
详细描述
This study is a randomised controlled trial comparing telephone consultation to face-to-face consultation prior to early medical abortion at home (EMA).
The majority of patients seeking abortion care in NHS Lothian will self-refer by telephone to the Lothian Abortion Referral Service (LARS).
Routinely, patients are asked the date of their last menstrual period (LMP) by administrative staff. They then collect basic contact information and book an appointment to come to clinic within 5-7 days.
For all women who self report an LMP that is less than 10 weeks to the date of the appointment they are offered, the administrative staff at LARS will read a short statement describing the project and ask if the patient is happy to be contacted by a member of the research team to discuss further. If they agree, they will also be directed to the LARS webpage where a copy of the Participant Information Sheet (PIS) will be available. The patient's contact details will be passed to the research nurse or doctor who will then call the patient back.
At call back, the researcher will confirm that the patient has read the PIS and answer any questions and give further information as required. If the patient wishes to participate, verbal consent will be obtained using a standard form.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-reported last menstrual period (LMP) less than 10 weeks on day of appointment
- •Self-referral to Lothian Abortion Referral Service (LARS)
- •Aged 16 or over at the time of procedure
- •Preference for EMA
- •Ability to give informed consent
排除标准
- •Requires interpreter
- •Patient preference for surgical method of abortion
结局指标
主要结局
Efficacy of medical abortion
时间窗: 2 weeks after administration of abortion medications (via telephone)
Complete abortion as assessed by self-performed low-sensitivity urinary pregnancy test
次要结局
- Unscheduled contact(4 weeks after administration of abortion medications)
- Ineligibility for EMA(Within 1 week of randomisation (on day of clinic attendance))
- Time taken(Within 1 week of randomisation (on day of clinic attendance))
- Preparedness for medical abortion(Within 1 week of randomisation (on day of clinic attendance))
- Satisfaction with consultation(2 weeks after administration of abortion medications (via telephone))
- Contraception(Case note review at 2 weeks)