Clinical trial NCT03958279: Normal and Pathological Values of Postvoiding Residual Volume in Early Postpartum Period and Their Predisposing Factors
Official title: Normal and Pathological Values of Postvoiding Residual Volume in Early Postpartum Period and Their Predisposing Factors (PAREZ - Partus - Residual Urine)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urinary Retention
Keywords: postvoiding residual volume
early postpartum period
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 930
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primipara giving birth

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.

Eligibility 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

Primary outcomes:
measure: Change in postvoiding residual volume
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
state: Slovensko
Study officials:
affiliation: Comenius University, Faculty of Medicine, 2nd Department of Obstetrics and Gynecology
name: Jozef Záhumenský, MD, PhD.
role: STUDY_CHAIR
References: