Early Mobilization and No Urinary Catheter After Cesarean for Improved Post Operative Recovery: A Randomized Trial

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.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Care
• Intervention / Treatment: Procedure: Enhanced Recovery protocol

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.

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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:

1. QoR-15 score > 118
2. More than 454 steps per day (one standard deviation below the mean)
3. 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.

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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 Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Bnei Zion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• elective surgery
• Singleton

Exclusion Criteria:

• placenta accreta
• Limited mobility
• Allergy to nsaids/paracetamol/optalgin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Urine catheter at surgery and regular ambulation after 8 hours
Experimental: enhanced ERAS; Omission of urinary catheter and early ambulation after 4 hours	Procedure: Enhanced Recovery protocol; Omission of urinary catheter and early ambulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enhanced recovery	composite outcome scoring positive on 2/3 components: Recovery questionnaire score above 118, step count above 454 and non opioid use	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inability to Ambulate on First Postoperative Attempt	Number of participants unable to ambulate on the first attempted postoperative ambulation.	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.	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.	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.	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	From surgery through postoperative day 7
Hospital Length of Stay	Number of days from surgery/delivery to hospital discharge.	From surgery/delivery through hospital discharge
Participants Rehospitalized Within 1 Week	Number of participants rehospitalized within 1 week after surgery.	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.	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.	1 day and 1 week postpartum
Participants Rehospitalized Within 1 Week	Number of participants rehospitalized within 1 week after surgery.	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	Day of surgery through postoperative day 7

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): January 6, 2025
• Study Completion (Actual): September 10, 2025

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: September 28, 2026
• First Posted (Actual): October 1, 2026

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 28, 2026
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: REC-SP-CS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

May 2026

IPD Sharing Access Criteria

ualified researchers may request access to de-identified individual participant data and supporting information by contacting the study team at liannapinsky@gmail.com. Requests will be reviewed by the investigators, and access will be granted for scientifically valid research purposes after approval of the request and completion of a data access/use agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No