The Effect of Pelvic Floor Muscle Exercises on the Inferior Vena Cava

NCT05654324 | Completed

• 1 other identifier: İEÜ_SYY
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Supine Hypotensive Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  immediately after the intervention

• Change of Pulsatility index of IVC

  Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.

  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.

  immediately after the intervention

Secondary Outcomes (3)

• Change of the collapsibility index (%) of IVC

  5 minutes after the intervention

• Change of Pulsatility index of IVC

  5 minutes after the intervention

• Changes of IVC diameters

  5 minutes after the intervention

Study Arms (2)

Pregnant women

EXPERIMENTAL

Pregnant women aged 18-40, 20-40 weeks of gestation.

Other: pelvic floor muscle exercises

Non-Pregnant

ACTIVE COMPARATOR

Being a non-pregnant woman who is in the same age range as the experimental group.

Other: pelvic floor muscle exercises

Interventions

pelvic floor muscle exercises OTHER

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.

Non-Pregnant; Pregnant women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir University of Economics: lead

Study Sites (1)

Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic

Izmir, Turkey (Türkiye)

Location

Related Publications (12)

• Klein-Weigel PF, Elitok S, Ruttloff A, Reinhold S, Nielitz J, Steindl J, Lutfi P, Rehmenklau-Bremer L, Hillner B, Fuchs H, Wrase C, Herold T, Beyer L. Inferior vena cava-syndrome. Vasa. 2021 Jul;50(4):250-264. doi: 10.1024/0301-1526/a000919. Epub 2021 Jan 18.

  PMID: 33459041 BACKGROUND

• Gagne MP, Richebe P, Loubert C, Drolet P, Gobert Q, Denault A, Zaphiratos V. Ultrasound evaluation of inferior vena cava compression in tilted and supine term parturients. Can J Anaesth. 2021 Oct;68(10):1507-1513. doi: 10.1007/s12630-021-02051-w. Epub 2021 Jul 1.

  PMID: 34212308 BACKGROUND

• Fields JM, Catallo K, Au AK, Rotte M, Leventhal D, Weiner S, Ku BS. Resuscitation of the pregnant patient: What is the effect of patient positioning on inferior vena cava diameter? Resuscitation. 2013 Mar;84(3):304-8. doi: 10.1016/j.resuscitation.2012.11.011. Epub 2012 Nov 21.

  PMID: 23178869 BACKGROUND

• Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.

  PMID: 26580836 BACKGROUND

• Supine lying during pregnancy. Journal of Pelvic, Obstetric and Gynaecological Physiotherapy. 2018; 122:77-83

  BACKGROUND

• Jeffreys RM, Stepanchak W, Lopez B, Hardis J, Clapp JF 3rd. Uterine blood flow during supine rest and exercise after 28 weeks of gestation. BJOG. 2006 Nov;113(11):1239-47. doi: 10.1111/j.1471-0528.2006.01056.x. Epub 2006 Sep 15.

  PMID: 16978230 BACKGROUND

• Kim DR, Wang E. Prevention of supine hypotensive syndrome in pregnant women treated with transcranial magnetic stimulation. Psychiatry Res. 2014 Aug 15;218(1-2):247-8. doi: 10.1016/j.psychres.2014.04.001. Epub 2014 Apr 12.

  PMID: 24768354 BACKGROUND

• Finnerty NM, Panchal AR, Boulger C, Vira A, Bischof JJ, Amick C, Way DP, Bahner DP. Inferior Vena Cava Measurement with Ultrasound: What Is the Best View and Best Mode? West J Emerg Med. 2017 Apr;18(3):496-501. doi: 10.5811/westjem.2016.12.32489. Epub 2017 Feb 24.

  PMID: 28435502 BACKGROUND

• Shailja S, Gupta I, Suri V. Inferior vena cava diameters in pregnant women for prediction of pregnancy-induced hypertension. Int J Gynaecol Obstet. 2004 Feb;84(2):164-5. doi: 10.1016/S0020-7292(03)00157-7. No abstract available.

  PMID: 14871520 BACKGROUND

• Singh Y, Anand RK, Gupta S, Chowdhury SR, Maitra S, Baidya DK, Singh AK. Role of IVC collapsibility index to predict post spinal hypotension in pregnant women undergoing caesarean section. An observational trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):312-317. doi: 10.4103/sja.SJA_27_19.

  PMID: 31572075 BACKGROUND

• Dodhy AA. Inferior Vena Cava Collapsibility Index and Central Venous Pressure for Fluid Assessment in the Critically Ill Patient. J Coll Physicians Surg Pak. 2021 Nov;31(11):1273-1277. doi: 10.29271/jcpsp.2021.11.1273.

  PMID: 34689482 BACKGROUND

• Morkved S, Bo K, Schei B, Salvesen KA. Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a single-blind randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):313-9. doi: 10.1016/s0029-7844(02)02711-4.

  PMID: 12576255 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Dr

Model Details: 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).

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 16, 2022
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 2, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)