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

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

Tracking Information
First Submitted Date November 6, 2018
First Posted Date May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date February 1, 2018
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population primipara giving birth
Condition Urinary Retention
Intervention
  • 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)
Study Groups/Cohorts 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
Interventions:
  • Diagnostic Test: Ultrasound measurement of residual volume in the urinary bladder
  • Diagnostic Test: Questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 17, 2019)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: primipara giving birth
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Pavel Doležal, MD +4219010579496 palodolezal@hotmail.com
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03958279
Other Study ID Numbers EC/002/2018/UNBRuzinov
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Comenius University
Study Sponsor Comenius University
Collaborators Not Provided
Investigators
Study Chair: Jozef Záhumenský, MD, PhD. Comenius University, Faculty of Medicine, 2nd Department of Obstetrics and Gynecology
PRS Account Comenius University
Verification Date May 2019