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

Terminated

• Conditions: Urinary Retention
• Interventions: Diagnostic Test: Ultrasound measurement of residual volume in the urinary bladder; Diagnostic Test: Questionnaire

• Registration Number: NCT03958279
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-22
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 930

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
primipara giving birth	Questionnaire	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
primipara giving birth	Ultrasound measurement of residual volume in the urinary bladder	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic; 🇸🇰 Bratislava, Slovensko, Slovakia