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

NCT ID: NCT03958279

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 930 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-12-31

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.

Conditions

Urinary Retention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Ultrasound measurement of residual volume in the urinary bladder

Intervention Type: DIAGNOSTIC_TEST

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.

Questionnaire

Intervention Type: DIAGNOSTIC_TEST

Simple questionaire concerning voiding problems, infectious complications, medicaments and breastfeeding during puerperium period (6weeks)

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Questionnaire

Simple questionaire concerning voiding problems, infectious complications, medicaments and breastfeeding during puerperium period (6weeks)

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Comenius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jozef Záhumenský, MD, PhD.

Role: STUDY_CHAIR

Comenius University, Faculty of Medicine, 2nd Department of Obstetrics and Gynecology

Locations

2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic

Bratislava, Slovensko, Slovakia

Countries

Slovakia

Other Identifiers

EC/002/2018/UNBRuzinov

Identifier Type: -

Identifier Source: org_study_id