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临床试验/NCT06633692
NCT06633692已完成不适用

Female Pelvic Blood Flow Under Simulated Microgravity

Ceren UNAL2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Internal iliac artery Doppler indices before and after HDT

研究概览

简要总结

Spaceflight is characterized by unique physiological adaptations. Cardiovascular system response to the microgravity includes major changes. During spaceflight, body fluids are displaced in the cephalad direction due to changes in gravity, resulting in altered vascular dynamics and the redistribution of the blood circulation.

As the investigators approach crewed Moon and Mars missions and commercial spaceflights become more frequent, understanding the impact of space travel on women's health is crucial. Despite the known importance of these vascular dynamics in both clinical and research settings, there is limited information on the pelvic blood flow under microgravity. The aim of this project is to fill this gap by analyzing the impact of simulated microgravity on the perfusion of female reproductive organs using Doppler velocimetry. Head-down tilt (HDT) position is an established model in literature for simulated microgravity on Earth.

This prospective study will assess pelvic organ blood flow in the supine position after a period of acclimation as a control. After completing Doppler measurements in the supine position, the participant will be placed in the HDT position. Following a period of acclimation, Doppler measurements will be repeated on the same vessels.During both supine and simulated microgravity conditions, vital signs (i.e., blood pressure, heart rate, oxygen saturation) will be collected.

详细描述

Cardiovascular system response to the microgravity includes major changes. During spaceflight, body fluids are displaced in the cephalad direction due to changes in gravity, resulting in altered vascular dynamics and the redistribution of the blood circulation. Redistribution of fluids triggers baroreceptor reflex and autonomic response initiates. Cardiovascular response to the microgravity environment is affected by gender. Women tend to lose more plasma volume and have less peripheral vascular resistance in response to microgravity analogue situations like bed rest.

Simulated microgravity leads to increased stiffness and remodeling of the aorta, a major vessel supplying blood to the abdomen, pelvis, and lower extremities. Pelvic organs are located in the lower abdomen and have rich blood supply through these major blood vessels and anastomosis. Mathematical modeling for microgravity showed a 6% mean flow rate variation in the last part of abdominal aorta. Furthermore, mean flow rate variations and resistance changed based on the branching arteries, such as internal iliac arteries. The uterine and ovarian arteries branch from the internal iliac arteries and abdominal aorta, respectively. Blood supply to an organ and tissue perfusion are vital for the proper functioning of the organs and tissues.

As the investigators approach crewed Moon and Mars missions and commercial spaceflights become more frequent, understanding the impact of space travel on women's health is crucial. Despite the known importance of these vascular dynamics in both clinical and research settings, there is limited information on the pelvic blood flow under microgravity. Our aim is to fill this gap by analyzing the impact of simulated microgravity on the perfusion of female reproductive organs using Doppler velocimetry. Head-down tilt (HDT) position is an established model in literature for simulated microgravity on Earth.

This prospective study will be conducted at Koç University Hospital. Adult women of reproductive age (18-44 years) undergoing abdominal ultrasound will be recruited. Participants will be selected from a cohort presenting for their well-woman visit; there will be no additional visits. Ultrasound and Doppler spectrometry evaluations will be carried out with convex and linear probes of the GE Loqic S8 device. The researchers will assess pelvic organ blood flow in the supine position after a period of acclimation as a control. After completing Doppler measurements in the supine position, the participant will be placed in the HDT position. Following a period of acclimation, Doppler measurements will be repeated on the same vessels. During both supine and simulated microgravity conditions, vital signs (i.e., blood pressure, heart rate, oxygen saturation) will be collected. Pre- and post-HDT Doppler measurements will be compared and analyzed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-44 years old healthy female individuals

排除标准

  • History of hysterectomy and/or oophorectomy
  • Pregnancy
  • Premature ovarian insufficiency
  • Women with reproductive tract pathologies
  • Cardiovascular diseases

结局指标

主要结局

Internal iliac artery Doppler indices before and after HDT

时间窗: through study completion, an average of 1 year

Internal iliac artery Doppler flow indices will be obtained in supine and HDT positions after acclimation periods

次要结局

  • Ovarian artery Doppler indices before and after HDT(through study completion, an average of 1 year)

研究者

发起方
Ceren UNAL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ceren UNAL

M.D.

Koc University Hospital

研究点 (2)

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