An interventional study of pelvic floor muscle exercises in Supine Hypotensive Syndrome, sponsored by Izmir University of Economics. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Izmir University of Economics · Not applicable, Interventional, and Prevention
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.
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.
Izmir University of Economics is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
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Experimental group
Control group
Exclusion Criteria:
Pregnant women aged 18-40, 20-40 weeks of gestation.
Other: pelvic floor muscle exercises
Being a non-pregnant woman who is in the same age range as the experimental group.
Other: pelvic floor muscle exercises
Before the pelvic floor exercises are taught to all women participating in the study, a brief informational training about the function and structure of the pelvic floor and pelvis will be given using visuals. The application protocol will be given by experienced specialist physiotherapists who have received special training on pelvic floor muscle training. In this study, the training protocol described by Mørkved et al and Bø et al will be used. An exercise series will consist of slow and fast muscle contractions of the pelvic floor muscles. The exercise series will include 10 reps of maximum pelvic floor muscle contraction held for 6 seconds followed by three rapid muscle contractions. A 10-second rest period will be given between each exercise series. A total of 5 minutes, 4 repetitions of pelvic floor muscle contraction series will be applied, including the rest period.
Change of the collapsibility index (%) of IVC
The collapsibility index (%) of IVC will be calculated using the formula: \[(Maximum IVC diameter - Minimum IVC diameter)/Maximum IVC diameter\] × 100.
Time frame: immediately after the intervention
Change of Pulsatility index of IVC
Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.
Time frame: immediately after the intervention
Changes of IVC diameters
M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.
Time frame: immediately after the intervention
Change of the collapsibility index (%) of IVC
The collapsibility index (%) of IVC will be calculated using the formula: \[(Maximum IVC diameter - Minimum IVC diameter)/Maximum IVC diameter\] × 100.
Time frame: 5 minutes after the intervention
Change of Pulsatility index of IVC
Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.
Time frame: 5 minutes after the intervention
Changes of IVC diameters
M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.
Time frame: 5 minutes after the intervention
Plan to share: No
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Izmir University of Economics