Treatment of Postpartum Urinary Retention

Rambam Health Care Campus

Status: Completed

Conditions: Retention, Urinary

Treatments: Device: Foley Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04104165

0515-19-RMB

Details and patient eligibility

About

The aim of the study is to evaluate what is the most effective catheterization duration to resolve covert and overt postpartum urinary retention following vaginal delivery and caesarean delivery, with the highest patients' satisfaction.

Full description

1. Women who are unable to micturate for more than 6-8 hours following vaginal delivery or within six to eight hours following removal of an indwelling catheter after cesarean delivery (overt postpartum urinary retention), or women with postvoid residual bladder volume of at least 150 mL (covert postpartum urinary retention) will be randomized into 2 groups: one group will include women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours. If at any time, post voiding residual volume is less than 150cc (assessed by ultrasound or by catheterization), no additional catheterization is needed. The second group will include women which will have an indwelling catheter inserted for 24 hours. The catheter will be removed 24 hours following its insertion and post voiding residual volume will be assessed 6 hours following the catheter removal (by ultrasound or by catheterization). In cases of post voiding residual volume more than 150 cc or women are unable to micturate spontaneously, an indwelling catheter will be inserted for additional 24 hours.
2. After 48 hours from postpartum urinary retention diagnosis, an indwelling catheter will be inserted for additional time that will be set at every center by its common protocol.

Enrollment: 146 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who deliver at one of the centers included in the study
• Overt postpartum urinary retention which refers to the absence of spontaneous micturition within six to eight hours of vaginal delivery; or within six to eight hours following removal of an indwelling catheter after cesarean delivery
• Covert postpartum urinary retention diagnosed by ultrasound or catheterization of more than 150cc

Exclusion criteria

• Spontaneous micturition 6-8 hours following vaginal or cesarean delivery
• postpartum urinary retention less than 150cc on ultrasound
• Known urinary tract infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Intermittent catheterization

Active Comparator group

Description:

women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours

Treatment:

Device: Foley Catheter

Continous catheterization

Active Comparator group

Description:

women which will have an indwelling catheter inserted for 24 hours

Treatment:

Device: Foley Catheter