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Trial record 2 of 1655 for:    Slovakia

Normal and Pathological Values of Postvoiding Residual Volume in Early Postpartum Period and Their Predisposing Factors (PAREZ)

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ClinicalTrials.gov Identifier: NCT03958279
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Comenius University

Brief Summary:
Aim of this study is to asses post voiding residual volume by ultrasound scan 3th day after delivery with consecutive scan after 6 weeks, and determination of data dispersion among the population of primiparas. In women with excessive retention (+2SD), risk factors such as duration of labour, use of epidural analgesia, instrumental delivery, maternal birth injury and weight of the newborn will be noted down.

Condition or disease Intervention/treatment
Urinary Retention Diagnostic Test: Ultrasound measurement of residual volume in the urinary bladder Diagnostic Test: Questionnaire

Detailed Description:

Pregnancy itself and vaginal delivery are well known risk factors for pelvic floor dysfunction. The rise in progesterone related to pregnancy has an inhibitory effect on bladder smooth muscle - decreased smooth muscle tonus in lower urinary tract. Weight and pressure of pregnant uterus and loosening of some of the pelvic ligaments changes the statics of pelvic floor. In addition, delivery itself influence lower urinary tract; an overdistension of urinary bladder can occur easily, also as oedema of urethra or urethral hinge apparatus injury during "crowning" of the fetal head.

All of these factors can affect consecutive function of lower urinary tract right after delivery. It is known that in 1,5% of women giving birth, symptomatic urinary retention develop in early postpartum period, with necessity of insertion of an indwelling catheter. Discussed risk factors are: epidural analgesia, instrumental delivery and primiparity. The investigators can assume that every woman in early postpartum period has (to some extend) even in normal circumstances postvoiding residual volume. There is few evidence in a literature about this postpartum residual volume and its predisposing factors.

Postvoiding residual volume can be risk factor for postpartum urinary infection, which forms second largest part in infectious morbidity of women. By determination of risk factors (for increased post voiding residual volume) the investigators could narrow the group of women which necessitate increased attention in postpartal monitoring.


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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Normal and Pathological Values of Postvoiding Residual Volume in Early Postpartum Period and Their Predisposing Factors (PAREZ - Partus - Residual Urine)
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
primipara giving birth

The investigators involve every primipara giving birth in a period of two years.

Exclusion criteria:

  • a) Unwilling to participate
  • b) Minors (under 18 years old)
  • c) Foetus mortus or perinatal death of the newborn
  • d) Admission of the newborn to the ICU
  • e) Unfamiliar with slovak language
  • f) Multiple pregnancy
Diagnostic Test: Ultrasound measurement of residual volume in the urinary bladder
Aim of this study is to asses post voiding residual volume by ultrasound scan 3th day after delivery with consecutive scan after 6 weeks, and determination of data dispersion among the population of primiparas.

Diagnostic Test: Questionnaire
Simple questionaire concerning voiding problems, infectious complications, medicaments and breastfeeding during puerperium period (6weeks)




Primary Outcome Measures :
  1. Change in postvoiding residual volume [ Time Frame: 6 weeks ]
    Volume of remaining urine in the urinary bladder after micturition - assessed by ultrasound, third day after delivery, and 6 weeks after delivery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   primipara giving birth
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
primipara giving birth
Criteria

Inclusion Criteria:

  • The investigators involve every primipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years

Exclusion Criteria:

  • Unwilling to participate
  • Minors (under 18 years old)
  • Foetus mortus or perinatal death of the newborn
  • Admission of the newborn to the ICU
  • Unfamiliar with slovak language
  • Multiple pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958279


Contacts
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Contact: Pavel Doležal, MD +4219010579496 palodolezal@hotmail.com

Locations
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Slovakia
2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic Recruiting
Bratislava, Slovensko, Slovakia, 83232
Contact: Pavol Doležal, MD    +421910579496    palodolezal@hotmail.com   
Sponsors and Collaborators
Comenius University
Investigators
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Study Chair: Jozef Záhumenský, MD, PhD. Comenius University, Faculty of Medicine, 2nd Department of Obstetrics and Gynecology

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Responsible Party: Comenius University
ClinicalTrials.gov Identifier: NCT03958279     History of Changes
Other Study ID Numbers: EC/002/2018/UNBRuzinov
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Comenius University:
postvoiding residual volume
early postpartum period
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases