Trials / Completed
CompletedNCT04104165
Treatment of Postpartum Urinary Retention
Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 146 (actual)
- Sponsor
- Rambam Health Care Campus · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Foley Catheter | Foley catheter used for treatment of urinary retention |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2022-04-30
- Completion
- 2022-05-31
- First posted
- 2019-09-26
- Last updated
- 2022-08-16
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04104165. Inclusion in this directory is not an endorsement.