Influence of Prenatal Counseling on the Attitudes and Preferences Towards Invasive Prenatal Testing Among Women in Their First Trimester of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Preference for an invasive testing
研究概览
简要总结
It is well established that screening for Down syndrome should be offered in the first trimester to each pregnant woman. The most common screening method is nowadays the first trimester combined test which consists of a Bayesian analysis of the a priori risk of maternal age for Down's syndrome, and the posterior risk combining serum biomarkers such as beta fraction of the human chorionic gonadotropin (β-hCG), pregnancy-associated plasma protein-A (PAPP-A), and nuchal translucency measurement. Women at high risk for trisomy 21 or 18 using this combined test are eligible for chorionic villous sampling or amniocentesis for a final diagnosis. In recent years there has been a huge advance in prenatal screening for Down's syndrome with the advent of cell free DNA testing with higher sensitivity and specificity than the combined test, in which a positive result must be also confirmed by an invasive diagnostic procedure. But as the range of options broadens, also the need for health education to allow women to have an adequately informed decision process on which prenatal test better suits their needs. In multicultural cities, this has become especially important to integrate patient's values and expectations to an evidence-based decision regarding prenatal testing. There is high-quality evidence demonstrating that aversion to risk of fetal loss related to an invasive test may come from incomplete information, shaping the attitude towards which test to choose from the mother's point of view. And the disbelief that by taking cfDNA testing the risk of miscarriage would be reduced.
Many information is available about preferences and attitudes in prenatal testing from Northern European studies, but scarce information is available from Southern Europe, where the amniocentesis rate in the nineties was as high as 40% of the urban pregnant population.
The investigators hypothesize that when enough information is given before the initial screening, women will overcome aversion to invasive testing and will be more likely to choose this method as their first choice when compared to women having routine care.
详细描述
Study design:
This is a randomized open-label controlled trial evaluating the impact of an extra 15-minute prenatal counseling before the first trimester combined screening test for Down's syndrome, on the women's attitudes and preferences towards having invasive testing as the first-line option for the screening of chromosomal abnormalities.
Data will be collected by the study-site manager and stored in an electronic data-capture database. The coordinator of the study and the statistician will witness the accuracy of the data at the beginning, middle, and end of the study (on-site audit). Data will be captured in a paper form basis and then captured into the electronic database.
Sample size calculation has been made using an independent two-sample proportions likelihood-ratio test. The investigators expect a 10% of women willing to have an invasive procedure as a first-line test for aneuploidies in the control group, and a 25% difference to those in the experimental group that is given an extra 15-minute prenatal counseling, this yields a sample of 42 women per arm with a total of 84 subjects using a Type I error of 0.0501 and a power of 80% by a two-sided test.
Randomization and intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •any pregnant woman attending the first trimester combined screening test for chromosomal abnormalities
- •Singleton or twin pregnancies
- •Between 11+0 and 13+6 weeks' gestation
排除标准
- •women not willing to participate in the study
- •women without an answer in the question regarding which prenatal test would they choose (main outcome)
- •women with no sufficient knowledge of Spanish or Catalan to be able to read and understand the questionnaire
结局指标
主要结局
Preference for an invasive testing
时间窗: Through study completion, an average of 1 month
The primary outcome of the study is the desire to choose an invasive diagnostic testing as the first option of screening for chromosomal abnormalities. This will be measured in the questionnaire by asking the question: which prenatal test would you choose if given the opportunity? Women will be asked to choose only one answer between first trimester combined test, cell-free DNA, invasive testing in a yes/no format. The main outcome will be analized as the absolute risk increase along with tis 95% confidence interval.
次要结局
未报告次要终点
研究者
Raigam Jafet Martinez Portilla
Principal investigator
Hospital Clinic of Barcelona