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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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)

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Study Chair: Jozef Záhumenský, MD, PhD.; Comenius University, Faculty of Medicine, 2nd Department of Obstetrics and Gynecology

More Information

• Responsible Party: Comenius University
• ClinicalTrials.gov Identifier: NCT03958279 History of Changes
• Other Study ID Numbers: EC/002/2018/UNBRuzinov
• First Posted: May 22, 2019
• Last Update Posted: May 22, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Urinary Retention; Urination Disorders; Urologic Diseases