Clinical trial NCT05654324: The Effect of Pelvic Floor Muscle Exercises on the Inferior Vena Cava
Official title: Investigation of Acute Effect of Pelvic Floor Muscle Exercises on Inferior Vena Cava
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supine Hypotensive Syndrome
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research is a prospective and controlled study. The data of the study will be collected from pregnant women (Experimental group) and non-pregnant women (Control group).
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effect of pelvic floor muscle exercises on the hemodynamic responses of the vena cava inferior in pregnant and non-pregnant women.

Detailed description: The IVC is responsible for approximately two-thirds of the total venous return to the heart. The blood flow in the IVC is affected by the respiratory and cardiac cycle. One of the factors affecting blood flow is pregnancy. Studies have shown that the hemodynamic responses of the IVC may vary depending on the position, and that the supine position puts pressure on the IVC during pregnancy.

Compression of the growing fetus against the IVC can cause supine hypotensive syndrome and fetal danger. However, there is no definite finding about the effects of exercise performed in the supine position. Jefferys et al. reported that the reduction in blood flow at rest is twice that that occurs during exercise and that the level of blood flow should not be a cause for concern in healthy asymptomatic women who choose to exercise in the supine position in late pregnancy. Based on this information, we predict that pelvic floor muscle exercises can change the hemodynamic responses of the IVC and reduce the compression on it.

In order to evaluate the effect of pelvic floor muscle exercises on hemodynamic responses of IVC and compression on it, pregnant and non-pregnant women will be measured by ultrasonography. Women eligible for the study will be seated and rested for 30 minutes before taking the measurement. Then, he will be taken to the supine position, rested for 2 minutes, and the first measurements will be taken at the 3rd minute. pelvic floor muscle exercises will be applied for 5 minutes as stated in the literature. Ultrasonographic measurements will be repeated in the supine position immediately after the pelvic floor exercises and 5 minutes after the exercise. Measurements will be applied to all participants in the same order. During the exercises blood pressure, heart rate and peripheral oxygen saturation will be monitored. Before and after the exercises, the heart rate and blood pressure parameters of the women will be recorded.

Eligibility criteria: Inclusion Criteria:

Experimental group

* Being pregnant between the ages of 18-40,
* At least primary school graduate and able to read and write,
* The gestational age is 20-40 weeks,
* Not having any mental problems that prevent cooperation and understanding.

Control group

* Being a non-pregnant woman who is in the same age range as the experimental group,
* At least primary school graduate and able to read and write,
* Not having any mental problems that prevent cooperation and understanding.

Exclusion Criteria:

* Pregnant women with acute or chronic diseases with poor placental adaptation and vascular damage such as diabetes, chronic arterial hypertension and preeclampsia, as the fetus is closer to the threshold of hypoxia and acidemia and adaptive phenomena may fail,
* Pregnant women with intra-uterine growth restriction and fetal anomaly,
* Pregnant women with cardiovascular disease,
* Pregnant women considered as high risk by the obstetrician,
* Pregnant women with premature, premature birth or miscarriage risk,
* Pregnant women diagnosed with neurological disease,
* Obese women (body mass index \> 30),
* Women whose IVC measurements cannot be made with ultrasonography,
* Women with severe low back pain (not able to do housework regularly),
* Women who have been diagnosed with a psychiatric illness,
* Women with a history of gynecological surgery,
* Women with pelvic floor dysfunction,
* Women who cannot lie in the supine position.

Primary outcomes:
measure: Change of the collapsibility index (%) of IVC
timeFrame: immediately after the intervention
measure: Change of Pulsatility index of IVC
timeFrame: immediately after the intervention
measure: Changes of IVC diameters
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Change of the collapsibility index (%) of IVC
timeFrame: 5 minutes after the intervention
measure: Change of Pulsatility index of IVC
timeFrame: 5 minutes after the intervention
measure: Changes of IVC diameters
timeFrame: 5 minutes after the intervention
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic
Study officials:
References:
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