The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Non stress test
研究概览
简要总结
This study was conducted to examine the effects of different masks used by pregnant women on vital signs and non stress test (NST) during the COVID-19. This study was conducted as a single-blind randomized controlled trial. Healthy pregnant women aged 19 years and older, who were followed up on an outpatient basis, and who were in the 37-40th week of pregnancy, were included in the study. The study consisted of a single surgical mask group (n=30), double surgical mask group (n=30), and N95 mask group (n=31). Masks were given to the resting pregnant women 30 minutes before the NST, and they were provided to wear masks. After 30 minutes, the vital signs of the pregnant women were measured just before and after the NST, and the images of the NST traces were taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being 19 years or older
- •Being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy
- •Being followed on an outpatient basis
排除标准
- •Having a multiple pregnancy
- •Having a systemic, psychiatric disease or psychological problem (thyroid, heart, schizophrenia, etc.)
- •Being in the category of risky pregnancies (Preeclampsia, gestational diabetes, etc.)
- •Having alcohol and substance use
- •Never done NST before
- •Having an identified risk factor in the fetus
- •Having barriers to communication
- •Being a foreign national
- •Being in contact with, or having, or suspected of having COVID-19 and previously had COVID-19.
结局指标
主要结局
Non stress test
时间窗: Just after the NST was finished (after 20 minutes)
After the NST was finished, the images were taken by numbering the traces. A folder was created containing the NST traces that were imaged. After all the research data were collected, the NST tracing results (fetal heart rate (bpm), variability, acceleration, deceleration, contraction, reactivity, and non-reactivity) were evaluated by a Gynecology and Obstetrics physician who did not know which group the participants were in.
Vital signs
时间窗: 30 minutes later, just before the NST was performed.
Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)
次要结局
- Vital signs(Just after the NST was finished (after 20 minutes))
研究者
Yeter ŞENER
Principal Investigator
Bozok University