Implementation of a Model for Predicting Early Pregnancy Outcome in Women With Pregnancy of Uncertain Viability: a Psychological Impact Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- A change in self-reported psychological well-being from diagnosis to follow-up between the two groups.
研究概览
简要总结
This study will evaluate if providing women diagnosed with an intrauterine pregnancy of uncertain viability with a percentage likelihood of ongoing viability of their pregnancy at the time of the follow-up ultrasound, will result in improved psychological well-being (reduced anxiety and depression). Recruited women will be randomised to either receive the prediction score (intervention arm) or not (control arm).
详细描述
Intrauterine pregnancy of uncertain viability (IPUVI) affects 10-28% of women seen in the Early Pregnancy Assessment Unit (EPAU). Such women have a pregnancy correctly sited within the uterus but the viability of the pregnancy cannot be determined at the initial scan. This finding may represent a normally developing (but early) pregnancy. However, approximately 50% of these pregnancies will eventually miscarry. The current recommendation from The National Institute for Health and Care Excellence (NICE) is to offer a confirmatory scan after 14 days.
This 14-day interval is particularly distressing for women and diagnostic uncertainty in early pregnancy is associated with heightened levels of anxiety and depression. NICE Evidence Update 71 (2014) suggests that provision of more information about the likely outcome of the pregnancy (prior to the repeat ultrasound) may benefit psychological health.
The investigators have previously developed, validated and published a mathematical tool to predict pregnancy viability after diagnosis of IPUVI (549 participants). The tool (which takes account of maternal age, vaginal bleeding score and ultrasound measurements) is established as an accurate research tool having been externally validated in a different test population. Having established its performance, the investigators would like to provide women with this individualised prediction of their pregnancy outcome. If psychologically beneficial (and not harmful) this tool may help up to a third of the EPAU population.
This will be a single centre, prospective non-blind randomised control study. All eligible women with IPUVI ultrasound classification at Chelsea and Westminster Hospital will be identified and invited to be recruited to the study.
Following recruitment, a woman will be randomised by random computer generator to either Group I (intervention group - receive the prediction score) or Group II (control group - do not receive the prediction score).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years+
- •Diagnosis of IPUVI on initial ultrasound
排除标准
- •Current mental health condition (anxiety, depression, eating disorder). The condition will be considered current if it has required one or more consultations with a medical professional (including a psychologist) over the past 6 months (women with past mental health condition will not be excluded)
- •The patient is planning a termination
- •Multiple order pregnancies
- •Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study
研究组 & 干预措施
Prediction of pregnancy outcome
Women will receive an individualised prediction score of the pregnancy being viable at the follow-up ultrasound generated from the prediction tool.
干预措施: Prediction of pregnancy outcome (Diagnostic Test)
Control
Women will not receive the prediction score
结局指标
主要结局
A change in self-reported psychological well-being from diagnosis to follow-up between the two groups.
时间窗: 14 days
To assess and compare if there is any significant difference in symptoms of anxiety and depression during the uncertain period, as measured by the Hospital and Anxiety Depression Score in the two groups of women all diagnosed with IPUVI. The two groups will be; 1) women randomised to receive the prediction tool and 2) women randomised to not receive the prediction tool. 2. To assess and compare whether the symptoms of anxiety and depression in the two groups of women change over three defined time points: immediately after the initial ultrasound/ diagnosis, at 72 hours post ultrasound and immediately prior to the follow-up ultrasound at 14 days. The questionnaire has two components, one relating to anxiety symptoms (HADS-A) and one relating to depressive symptoms (HADS-D). Each component comprises seven statements. Each statement is scored 0-3 yielding a total of 0-21 points for each component.
次要结局
- Patient Experience of the prediction tool(14 days)