The Effect of Biweekly Follow up Along With at Home Ultrasound on the Anxiety of Pregnant Women Following Recurrent Pregnancy Loss.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Anxiety levels
研究概览
简要总结
Spontaneous pregnancy loss is a relatively common phenomenon, with 10-15% of clinically recognized pregnancies ending in miscarriage.1 Recurrent pregnancy loss (RPL) is a disorder defined by two or more failed pregnancies2. According to various studies, pregnancy loss has been described as a traumatic event for couples even if the loss occurs at a very early stage of pregnancy.
Few controlled studies dealt with the effects of the miscarriage on the psychological condition of women during a subsequent pregnancy, 4,6-8.
This study aimed to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss.
i. Inclusion criteria:
- Patients with recurrent pregnancy losses in first trimester
- Current pregnancy gestational age 12-14 week of gestation
- Singleton pregnancy ii. Exclusion criteria:
1. Female subjects who refuse to participate 2. Female subjects who don't speak Hebrew
Device details:
Pulsenmore Specifications:
Compatible with: Android mobile phones with USB type C connector (Samsung S8+, Nokia 8, Nokia 7.1) ApplicatThe aim of this study is to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss.ion: PulseNmore ES™, downloadable from Google Play™ Store.
详细描述
Background:
Spontaneous pregnancy loss is a relatively common phenomenon, with 10-15% of clinically recognized pregnancies ending in miscarriage.1 Recurrent pregnancy loss (RPL) is a disorder defined by two or more failed pregnancies2. According to various studies, pregnancy loss has been described as a traumatic event for couples even if the loss occurs at a very early stage of pregnancy.3-5 Few controlled studies dealt with the effects of the miscarriage on the psychological condition of women during a subsequent pregnancy4,6-8. These studies establish proof of considerably increased pregnancy specific anxiety in pregnant women with a history of spontaneous abortion, compared to pregnant women with no history of spontaneous abortion. As in the study of Bergner et al. women after early miscarriages are under pressure in a new pregnancy due to emotional disorders in the shape of pregnancy-specific anxiety, mostly before the critical point in the pregnancy when the previous miscarriage took place is passed.6 In order to offer pregnant women who have previously suffered miscarriages, apart from adequate psychological support alongside workup to find the RPL etiology, some reassurance and comfort this study aimed to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss.
Study primary objectives/hypotheses:
Of all interventions that can alleviate the stress during pregnancy, we wish to learn the effect of "at home ultrasound" used by patients and feedback by clinician.
The aim of this study is to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss. We hypothesize that couples would feel calmer and more reassured regarding their pregnancy.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with recurrent pregnancy losses in first trimester
- •Current pregnancy gestational age 12-14 week of gestation
- •Singleton pregnancy
排除标准
- •Female subjects who refuse to participate
- •Female subjects who don't speak Hebrew
研究组 & 干预措施
Experimental: PulseNmore ES™
Experimental: PulseNmore ES™:
The study population will be recruited between 12 and 14 weeks of gestation. These patients will be followed using a twice weekly virtual visit by a member of the study team. This visit will include a short survey of obstetrical complaints such as contractions leakage of fluid and decreased fetal movements, as well as a brief sonographic survey using the portable ultrasound device.
干预措施: PulseNmore ES™ (Device)
Control Standard Ultrasound
A population of patients between 12 and 22 weeks of gestation with history of recurrent pregnancy losses who will be subjected to routine antenatal care as per clinic protocol. These patients will not receive the additional intervention.
干预措施: Standard Ultrasound (Device)
结局指标
主要结局
Anxiety levels
时间窗: 10 weeks
The delta between The State-Trait Anxiety Inventory (STAI:Y-1) score filled at recruitment and at 20-22 weeks of gestation (when patient start fill fetal movements).
次要结局
未报告次要终点
研究者
Michal Levy, MD
Principal Investigator
Wolfson Medical Center