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
|Condition or disease||Intervention/treatment|
|Urinary Retention||Diagnostic Test: Ultrasound measurement of residual volume in the urinary bladder Diagnostic Test: Questionnaire|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|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|
primipara giving birth
The investigators involve every primipara giving birth in a period of two years.
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)
- 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
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
|Contact: Pavel Doležal, MDfirstname.lastname@example.org|
|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 email@example.com|
|Study Chair:||Jozef Záhumenský, MD, PhD.||Comenius University, Faculty of Medicine, 2nd Department of Obstetrics and Gynecology|