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

NCT07851558 | Completed

• 1 other identifier: REC-SP-CS-001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Inability to Ambulate on First Postoperative Attempt

  At first postoperative ambulation attempt- between 4-8 hours postoperative

• Pre and post ambulation Pain Score on the Visual Analog Scale

  Immediately before and after first postoperative ambulation

• Postoperative Pain Score at 2-12 Hours

  2-12 hours after surgery

• Maternal Satisfaction Score at 24 Hours and 1 week after surgery and in comparison to previous Cesarean Section

  24 hours and 1 week after surgery

• Post-surgical Complication Within 7 Days of surgery

  From surgery through postoperative day 7

Study Arms (2)

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

Procedure: Enhanced Recovery protocol

Interventions

Enhanced Recovery protocol PROCEDURE

Omission of urinary catheter and early ambulation

enhanced ERAS

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• elective surgery
• Singleton

You may not qualify if:

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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnei Zion

Haifa, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: October 1, 2026
• Study Start: October 21, 2021
• Primary Completion: January 6, 2025
• Study Completion: September 10, 2025
• Last Updated: October 1, 2026

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: May 2026
• 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.

Locations

IL (1)