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

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

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Retention
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 930

Contacts and Locations

Study Locations

• Slovakia
  • Slovensko
    • Bratislava, Slovensko, Slovakia, 83232
      • 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

primipara giving birth

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postvoiding residual volume	Volume of remaining urine in the urinary bladder after micturition - assessed by ultrasound, third day after delivery, and 6 weeks after delivery	6 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: postvoiding residual volume; early postpartum period
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: EC/002/2018/UNBRuzinov

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No