Postpartum Acute Urinary Retention, Postpartum Care, Urinary Retention, Urinary Tract Infection (Diagnosis), Voiding Dysfunction
Conditions
Keywords
catheterization, foley, catheter, urinary retention, voiding dysfunction, epidural, labor, bladder catheterization
Brief summary
At least ten percent of patients have postpartum urinary retention or difficulty urinating after birth, which can cause incontinence and other urinary problems long-term. After getting an epidural placed, patients should be numb in their pelvic region. This numbness makes it difficult to feel the need to urinate, so patients need a urinary catheter placed to empty the bladder. Some patients have one catheter placed throughout their labor and others have a catheter placed to empty the bladder then removed every few hours. The investigators are studying whether placing a catheter once or catheterizing multiple times affects the rate of postpartum urinary problems and infection.
Detailed description
This is a randomized controlled trial to assess the effect of bladder catheterization method during labor with epidural anesthesia on the rate of postpartum urinary retention.
Interventions
PROCEDUREIntermittent catheterization
intermittent bladder catheterization every four hours, or shorter intervals if volume exceeds 500mL per expert recommendation
PROCEDUREContinuous catheterization
One catheter is placed in the bladder until pushing
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
While the patient, nursing team, and delivery providers will not be blinded to the catheterization method, the provider making the diagnosis of postpartum urinary retention will be blinded to the exposure group.
Intervention model description
Allocation will be determined based on a previously generated randomization scheme created by the NCI Clinical Trials Randomization Tool.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant patients planning vaginal delivery presenting in labor or for induction of labor * Age 18 years and older * Live fetus * Receive epidural anesthesia
Exclusion criteria
* those under 18 years old * those with stillbirth * those with baseline overactive bladder symptoms, neurogenic bladder diagnoses, or otherwise using bladder catheterization during pregnancy Patients will be excluded from UTI analyses if: * they received antibiotics intrapartum * had bacteriuria diagnosed by a clean catch specimen showing \>100,000 CFU/mL of a single bacterial species, regardless of symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum urinary retention | Three days postpartum | Urinary retention defined as overt inability to void at six hours after last bladder emptying postpartum or symptomatic incomplete emptying, or covert retention of \>150cc urine in the bladder after voiding Collecting number of participants who experience this |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum urinary tract infection | One week postpartum | Culture-proven urinary tract infection without pre-existing infection documented on admission for delivery Collecting number of participants who experience this |
| Patient satisfaction | Immediately postpartum | Title: Patient satisfaction Minimum rating 1, maximum 5, with 5 corresponding to better outcome Each question will be interpreted alone rather than aggregated |
| Nurse satisfaction | Immediately postpartum | Title: Nurse satisfaction Minimum rating 1, maximum 5, with 5 corresponding to better outcome Each question will be interpreted alone rather than aggregated |
| Voiding function at 2 weeks | 2 weeks postpartum | Urinary Distress Inventory-6 questionnaire answers, to be analyzed individually (0-4) and also summed, with higher total score indicating worse function from 0 to 24 |
| Voiding function at 6 weeks | 6 weeks postpartum | Urinary Distress Inventory-6 questionnaire answers, to be analyzed individually (0-4) and also summed, with higher total score indicating worse function from 0 to 24 |
| Voiding function at 6 months | 6 months postpartum | Urinary Distress Inventory-6 questionnaire answers, to be analyzed individually (0-4) and also summed, with higher total score indicating worse function from 0 to 24 |
| Voiding function at one year | one year postpartum | Urinary Distress Inventory-6 questionnaire answers, to be analyzed individually (0-4) and also summed, with higher total score indicating worse function from 0 to 24 |
Countries
United States
Contacts
STUDY_CHAIRAnna Binstock, MD
UPMC Magee-Womens Hospital
Outcome results
None listed