Very Early Medical Abortion - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Complete Abortion Rate (efficacy)
研究概览
简要总结
The research question begin addressed by this study is "Is Very Early Medical Abortion (VEMA - before a pregnancy is visible on ultrasound scan) as effective as medical abortion when performed later and an intrauterine pregnancy can be visualised with ultrasound?".
This is important to patients and public, because delays to abortion care can cause mental distress, and pain and bleeding are worse at later gestations.
The study is examining whether earlier or delayed administration of abortion medications affects the efficacy and side effects of the medical abortion process, in women with very early pregnancies.
Any women who had a positive pregnancy test, requesting abortion, but did not have a visible pregnancy on ultrasound scan could take part in the study. Women with signs, symptoms or ultrasound findings suggesting ectopic pregnancy would not be included.
This study will be conducted at a community sexual and reproductive health centre that provides abortion care.
The participants will be involved in the study for a maximum period of 4 weeks. They will be randomly allocated to either immediate abortion care or delayed abortion care. In each arm of the study they will receive clinical care that they would otherwise routinely receive. In addition to this, they will receive a telephone call follow up with a short questionnaire to complete over the phone.
This study is being conducted in Scotland but the results will be combined with findings from similar research groups across Europe as part of a consortium of researchers. This consortium is coordinated by the Karolinska Institutet in Sweden under the EuDRACT ID: 2018-003675-35
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
- •Women 18 years old or above opting for medical abortion with a pregnancy estimated by gynaecological history and Last Menstrual Period (LMP - if known) to be less than 6 weeks
- •No signs of ectopic pregnancy, miscarriage or other pathological pregnancy
- •Transvaginal ultrasound (part of the clinical protocol at the abortion visit) shows no confirmed Intrauterine Pregnancy (IUP see definitions below)
- •Willing and able to return to the clinic for possible delayed treatment and at 1 to 2 weeks after the start of treatment for follow up
- •Capable of giving their informed consent to participate.
排除标准
- •Women with visible (confirmed) IUP
- •Women with contraindications to medical abortion including diagnosed pathological pregnancy at the initial examination.
- •Inability to give informed consent.
- •The following definitions will be used according to the consensus statement on nomenclature, definitions and outcomes in pregnancy of unknown location (Barnhart et al, Fertil Steril. 2011;95:857-66):
- •Confirmed IUP: Ultrasound shows an intrauterine yolk sac or fetal structure with or without cardiac echo.
- •Not confirmed IUP: This group includes cases where:
- •ultrasound shows an empty uterine cavity (frequently referred to as PUL: Pregnancy of Unknown Location) or
- •ultrasound shows a gestational sac, or sac like structure, but without a yolk sac.
结局指标
主要结局
Complete Abortion Rate (efficacy)
时间窗: Within 30 days of treatment initiation
Rate of complete abortion without surgical intervention, as reported by patients using a self-administered low-sensitivity pregnancy test at 2 weeks after treatment. This will be collected via telephone questionnaire.
次要结局
- Visual Analogue Pain score(Within 30 days of treatment initiation)
- Acceptability of method(Within 30 days of treatment initiation)
- Complication Rate(Within 30 days of treatment initiation)
- Duration of post-abortion bleeding(Within 30 days of treatment initiation)
研究者
John Reynolds-Wright
Clinical Research Fellow
University of Edinburgh