Postoperative CareNCT07851558
Early Mobilization and No Urinary Catheter After Cesarean for Improved Post Operative Recovery: A Randomized Trial
A study testing Enhanced Recovery protocol in people with Postoperative Care, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
ERAS (Enhanced Recovery After Surgery) is a set of steps used around surgery to help patients recover faster and better. ERAS guidelines have been adopted in several surgical fields, and evidence-based recommendations have recently been developed for cesarean delivery as well. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Care
- What is being tested?
- Enhanced Recovery protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Oct 2021to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- elective surgery
- Singleton
Who cannot join
- placenta accreta
- Limited mobility
- Allergy to nsaids/paracetamol/optalgin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Promoting Early Mobilization and Eliminating Urinary Catheterization on Post-Cesarean Recovery: A Randomized Control Trial
ERAS (Enhanced Recovery After Surgery) is a set of steps used around surgery to help patients recover faster and better. ERAS guidelines have been adopted in several surgical fields, and evidence-based recommendations have recently been developed for cesarean delivery as well.
These guidelines address multiple parts of post-operative care, including prevention of nausea and vomiting, pain control, thromboprophylaxis, early mobilization, urinary catheter use, and discharge counseling.
Read more
Early mobilization is a key element of ERAS, but there is currently limited high-quality evidence about its specific benefits after cesarean delivery. In theory, mobilizing earlier may reduce thromboembolic events, shorten hospitalization, and speed up return of bowel function.
Another important ERAS component is avoiding routine urinary catheter use. Evidence suggests that a no-catheter policy can shorten the time to first mobilization, first eating, and first bowel movement, and can reduce overall hospital stay compared with routine catheter use around cesarean delivery. In a randomized controlled trial of 300 women assigned to immediate versus delayed (12-hour) catheter removal after cesarean delivery, immediate removal reduced bacteriuria and urinary symptoms (dysuria, frequency, urgency), and also shortened time to first mobilization and length of stay. A systematic review also found that inserting a catheter before cesarean delivery increases the risk of urinary tract infection without improving surgical ease. A 2014 Cochrane review concluded that routine catheter use increases time to first urination, increases discomfort, delays mobilization, and prolongs hospital stay.
The aim of the present study is to compare early mobilization combined with no urinary catheter in women undergoing planned cesarean delivery versus standard perioperative care, to improve recovery after surgery.
Read the detailed description
Procedure
According to our department policy, the protocol for women undergoing a planned cesarean delivery includes prophylactic intravenous antibiotics with cefazolin 2 g given within 60 minutes of the start of surgery, together with 500-1000 mL of lactated Ringer's solution before surgery. Spinal anesthesia is then performed using 10 mg hyperbaric bupivacaine with 100 micrograms intrathecal morphine. Immediately afterward, a Foley urinary catheter is inserted into the bladder.
The surgical technique is at the discretion of the surgeon and is usually performed using the Misgav Ladach method. During the operation, the patient receives intravenous ondansetron to prevent nausea and vomiting, and phenylephrine is given to treat episodes of hypotension. Skin closure is performed using a continuous subcuticular suture. After surgery, the woman receives thromboprophylaxis according to her risk factors. Eight hours after surgery, the urinary catheter is removed and the woman gets out of bed for the first time, accompanied by a nurse, to go to the toilet or shower.
All women receive scheduled, around-the-clock analgesia during the first 24 hours: 1,000 mg intravenous paracetamol plus 400 mg ibuprofen every 8 hours, with the option to add dipyrone, tramadol, or morphine for breakthrough pain according to the VAS score. After that, pain treatment is given on request. Women are usually discharged on postoperative day 3.
A woman who agrees to participate in the study will sign an informed consent form and will be randomized to one of two groups. Women in the control group will receive the routine care described above. The intervention group will receive different perioperative care: no urinary catheter will be inserted, and the woman will be asked to void immediately before transfer to the operating room. Preoperative fluids will be limited to 200-300 mL of lactated Ringer's, and the woman will receive phenylephrine during surgery to maintain blood pressure. After surgery, the woman will get out of bed after 4 hours for her first void and to shower. All other perioperative care will be identical to the control group, including antibiotics, spinal anesthesia, pain control, and antithrombotic prophylaxis.
Randomization will be performed according to a computerized list, and allocation will be placed in an opaque, sequentially numbered envelope. After the patient signs the consent form, the envelope will be opened.
-
Data collection
Demographic and obstetric data will be collected from the women's medical records. The primary outcome will be a composite outcome that includes: the QoR-15 (Quality of Recovery 15) questionnaire score completed 24 hours after delivery, the number of steps during the first 24 hours as counted by a smartwatch , and opioid consumption beyond the scheduled regimen during the first postoperative day. A positive outcome will be recorded if the participant meets 2 of the following 3 criteria:
- QoR-15 score > 118
- More than 454 steps per day (one standard deviation below the mean)
- Opioid consumption during the first 24 hours after surgery (beyond the scheduled regimen)
Secondary outcomes will include the number of steps in the first 24 hours, and VAS pain scores at 2, 4, 8, 12, 24, and 48 hours. VAS scores at 4 and 8 hours will be recorded at rest and immediately after the first mobilization. Additional secondary outcomes will include inability to mobilize to the shower after the first time out of bed, patient satisfaction, use of analgesics, breastfeeding and time to first breastfeeding, intraoperative and postoperative complications, and length of hospital stay. Intraoperative complications will include bladder or bowel injury and postpartum hemorrhage. Postoperative complications will include urinary retention, need for blood transfusion, wound infection, endometritis, urinary tract infection, paralytic ileus, hematoma requiring drainage, need for repeat laparotomy, and readmission during the first two weeks after surgery.
-
Sample size calculation
Assuming a composite outcome rate of 80% in the control group, and a hypothesized clinically meaningful improvement of 15% in the intervention group, with an alpha error of 5% and power of 80%, the calculated sample size is 260 participants (130 in each group).
- Conditions
- Postoperative Care
- Being tested
- Enhanced Recovery protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery protocolProcedure or surgery
Omission of urinary catheter and early ambulation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Urine catheter at surgery and regular ambulation after 8 hours |
| enhanced ERAS | Experimental | Omission of urinary catheter and early ambulation after 4 hours Receives: Procedure: Enhanced Recovery protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced recovery
composite outcome scoring positive on 2/3 components: Recovery questionnaire score above 118, step count above 454 and non opioid use
Measured: 24 hours
Secondary outcomes (11)
Inability to Ambulate on First Postoperative Attempt
Number of participants unable to ambulate on the first attempted postoperative ambulation.
Measured: At first postoperative ambulation attempt- between 4-8 hours postoperative
Pre and post ambulation Pain Score on the Visual Analog Scale
Pain assessed immediately before and after first ambulation using a Visual Analog Scale from 0 to 10, where 0 indicates no pain and 10 indicates worst pain. Higher scores indicate greater pain.
Measured: Immediately before and after first postoperative ambulation
Postoperative Pain Score at 2-12 Hours
Score at 2, 4, 8, 12 Hours Pain assessed using a Visual Analog Scale from 0 to 10, where 0 indicates no pain and 10 indicates worst pain. Higher scores indicate greater pain.
Measured: 2-12 hours after surgery
Maternal Satisfaction Score at 24 Hours and 1 week after surgery and in comparison to previous Cesarean Section
Maternal satisfaction assessed on a 1-10 scale, where higher scores indicate greater satisfaction.
Measured: 24 hours and 1 week after surgery
Post-surgical Complication Within 7 Days of surgery
Number of participants with one or more post-surgical complications during the first postoperative week and specification of each complication
Measured: From surgery through postoperative day 7
Hospital Length of Stay
Number of days from surgery/delivery to hospital discharge.
Measured: From surgery/delivery through hospital discharge
Participants Rehospitalized Within 1 Week
Number of participants rehospitalized within 1 week after surgery.
Measured: From discharge/surgery through postoperative day 7
Neonates With Late Neonatal Complications Within 7 Days
Number of neonates with late neonatal complications and specification of the different complications that occurred.
Measured: Birth through neonatal day 7
breastfeeding at 1 day and 1 week after surgery
number of participants breastfeeding at 1 day and 1 week postpartum among women who intended to breastfeed. Women not interested in breastfeeding were excluded from this analysis.
Measured: 1 day and 1 week postpartum
Participants Rehospitalized Within 1 Week
Number of participants rehospitalized within 1 week after surgery.
Measured: Rehospitalization within a week after discharge
Post-surgical Complication Within 7 Days of surgery
Number of participants with one or more post-surgical complications during the first postoperative week and specification of each complication
Measured: Day of surgery through postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start21 Oct 2021
- Primary completion6 Jan 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851558
- Sponsor's protocol ID
- REC-SP-CS-001
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including data dictionary) will be shared. Requests may be submitted to liannapinsky@gmail.co. Access will be provided to qualified researchers for analyses under a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Promoting Early Mobilization and Eliminating Urinary Catheterization on Post-Cesarean Recovery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07851558
- Acronym / sponsor ID
- REC-SP-CS-001
- Conditions
- Postoperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ERAS (Enhanced Recovery After Surgery) is a set of steps used around surgery to help patients recover faster and better. ERAS guidelines have been adopted in several surgical fields, and evidence-based recommendations have recently been developed for cesarean delivery as well.
These guidelines address multiple parts of post-operative care, including prevention of nausea and vomiting, pain control, thromboprophylaxis, early mobilization, urinary catheter use, and discharge counseling.
Early mobilization is a key element of ERAS, but there is currently limited high-quality evidence about its specific benefits after cesarean delivery. In theory, mobilizing earlier may reduce thromboembolic events, shorten hospitalization, and speed up return of bowel function.
Another important ERAS component is avoiding routine urinary catheter use. Evidence suggests that a no-catheter policy can shorten the time to first mobilization, first eating, and first bowel movement, and can reduce overall hospital stay compared with routine catheter use around cesarean delivery. In a randomized controlled trial of 300 women assigned to immediate versus delayed (12-hour) catheter removal after cesarean delivery, immediate removal reduced bacteriuria and urinary symptoms (dysuria, frequency, urgency), and also shortened time to first mobilization and length of stay. A systematic review also found that inserting a catheter before cesarean delivery increases the risk of urinary tract infection without improving surgical ease. A 2014 Cochrane review concluded that routine catheter use increases time to first urination, increases discomfort, delays mobilization, and prolongs hospital stay.
The aim of the present study is to compare early mobilization combined with no urinary catheter in women undergoing planned cesarean delivery versus standard perioperative care, to improve recovery after surgery.
Detailed description
Procedure
According to our department policy, the protocol for women undergoing a planned cesarean delivery includes prophylactic intravenous antibiotics with cefazolin 2 g given within 60 minutes of the start of surgery, together with 500-1000 mL of lactated Ringer's solution before surgery. Spinal anesthesia is then performed using 10 mg hyperbaric bupivacaine with 100 micrograms intrathecal morphine. Immediately afterward, a Foley urinary catheter is inserted into the bladder.
The surgical technique is at the discretion of the surgeon and is usually performed using the Misgav Ladach method. During the operation, the patient receives intravenous ondansetron to prevent nausea and vomiting, and phenylephrine is given to treat episodes of hypotension. Skin closure is performed using a continuous subcuticular suture. After surgery, the woman receives thromboprophylaxis according to her risk factors. Eight hours after surgery, the urinary catheter is removed and the woman gets out of bed for the first time, accompanied by a nurse, to go to the toilet or shower.
All women receive scheduled, around-the-clock analgesia during the first 24 hours: 1,000 mg intravenous paracetamol plus 400 mg ibuprofen every 8 hours, with the option to add dipyrone, tramadol, or morphine for breakthrough pain according to the VAS score. After that, pain treatment is given on request. Women are usually discharged on postoperative day 3.
A woman who agrees to participate in the study will sign an informed consent form and will be randomized to one of two groups. Women in the control group will receive the routine care described above. The intervention group will receive different perioperative care: no urinary catheter will be inserted, and the woman will be asked to void immediately before transfer to the operating room. Preoperative fluids will be limited to 200-300 mL of lactated Ringer's, and the woman will receive phenylephrine during surgery to maintain blood pressure. After surgery, the woman will get out of bed after 4 hours for her first void and to shower. All other perioperative care will be identical to the control group, including antibiotics, spinal anesthesia, pain control, and antithrombotic prophylaxis.
Randomization will be performed according to a computerized list, and allocation will be placed in an opaque, sequentially numbered envelope. After the patient signs the consent form, the envelope will be opened.
-
Data collection
Demographic and obstetric data will be collected from the women's medical records. The primary outcome will be a composite outcome that includes: the QoR-15 (Quality of Recovery 15) questionnaire score completed 24 hours after delivery, the number of steps during the first 24 hours as counted by a smartwatch , and opioid consumption beyond the scheduled regimen during the first postoperative day. A positive outcome will be recorded if the participant meets 2 of the following 3 criteria:
- QoR-15 score > 118
- More than 454 steps per day (one standard deviation below the mean)
- Opioid consumption during the first 24 hours after surgery (beyond the scheduled regimen)
Secondary outcomes will include the number of steps in the first 24 hours, and VAS pain scores at 2, 4, 8, 12, 24, and 48 hours. VAS scores at 4 and 8 hours will be recorded at rest and immediately after the first mobilization. Additional secondary outcomes will include inability to mobilize to the shower after the first time out of bed, patient satisfaction, use of analgesics, breastfeeding and time to first breastfeeding, intraoperative and postoperative complications, and length of hospital stay. Intraoperative complications will include bladder or bowel injury and postpartum hemorrhage. Postoperative complications will include urinary retention, need for blood transfusion, wound infection, endometritis, urinary tract infection, paralytic ileus, hematoma requiring drainage, need for repeat laparotomy, and readmission during the first two weeks after surgery.
-
Sample size calculation
Assuming a composite outcome rate of 80% in the control group, and a hypothesized clinically meaningful improvement of 15% in the intervention group, with an alpha error of 5% and power of 80%, the calculated sample size is 260 participants (130 in each group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Urine catheter at surgery and regular ambulation after 8 hours |
| enhanced ERAS | Experimental | Procedure: Enhanced Recovery protocolOmission of urinary catheter and early ambulation after 4 hours |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- elective surgery
- Singleton
Key exclusion criteria (3 listed)
- placenta accreta
- Limited mobility
- Allergy to nsaids/paracetamol/optalgin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery protocolOmission of urinary catheter and early ambulation | Procedure or surgery | enhanced ERAS |
Primary outcome
Enhanced recovery
Time frame: 24 hours
composite outcome scoring positive on 2/3 components: Recovery questionnaire score above 118, step count above 454 and non opioid use
11 secondary outcomes
Inability to Ambulate on First Postoperative Attempt
Time frame: At first postoperative ambulation attempt- between 4-8 hours postoperative
Pre and post ambulation Pain Score on the Visual Analog Scale
Time frame: Immediately before and after first postoperative ambulation
Postoperative Pain Score at 2-12 Hours
Time frame: 2-12 hours after surgery
Maternal Satisfaction Score at 24 Hours and 1 week after surgery and in comparison to previous Cesarean Section
Time frame: 24 hours and 1 week after surgery
Post-surgical Complication Within 7 Days of surgery
Time frame: From surgery through postoperative day 7
Hospital Length of Stay
Time frame: From surgery/delivery through hospital discharge
Participants Rehospitalized Within 1 Week
Time frame: From discharge/surgery through postoperative day 7
Neonates With Late Neonatal Complications Within 7 Days
Time frame: Birth through neonatal day 7
breastfeeding at 1 day and 1 week after surgery
Time frame: 1 day and 1 week postpartum
Participants Rehospitalized Within 1 Week
Time frame: Rehospitalization within a week after discharge
Post-surgical Complication Within 7 Days of surgery
Time frame: Day of surgery through postoperative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including data dictionary) will be shared. Requests may be submitted to liannapinsky@gmail.co. Access will be provided to qualified researchers for analyses under a data use agreement.
Related trials for Postoperative Care
Not yet recruitingPhase 4
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Heart Failure, Cardiac Surgery
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery protocol in people with Postoperative Care, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced recovery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.