The First ERAS Protocol for Cesarean Delivery in Serbia at the University Hospital

Not Applicable

• Conditions: Cesarean Delivery
• Interventions: Combination Product: ERAS protocol

• Registration Number: NCT04058444
• Lead Sponsor: Pujic Borislava

Brief Summary

This study is designed to help us with ERAS (Enhanced Recovery After Surgery) Protocol for Cesarean Delivery implementation with goal to improve patient satisfaction and decrease length of stay at hospital. This will improve patient treatment and decrease total hospital costs.

Detailed Description

ERAS assumes cooperation between obstetricians, anesthesiologists and parturient. This is the new concept because patient have an active role in the whole process. Pregnant patient receives the first information about ERAS from obstetrician and anesthesiologist before the scheduled cesarean delivery. Patient condition optimization is necessary. Antibiotic prophylaxis, no bowel preparation and arriving to the hospital on the day of surgery are basic principles. All patients are done under spinal anesthesia. DVT (Deep Venous Thrombosis) prophylaxis starts postoperatively. Early mobilization, early oral intake and urinary catheter removal on the day of surgery with multimodal analgesia is mandatory.

Study Timeline

• Study First Submitted: 2019-04-13
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-08
• Last Update Posted: 2019-09-10
• Study Start: 2019-09-19
• Primary Completion: 2020-03
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• All healthy patients from 18-45 years for scheduled Cesarean Delivery

Exclusion Criteria

• Age younger then 18 years old and older then 45 years
• Urgent and emergent Cesarean Delivery
• Preeclampsia
• Contraindications for spinal anesthesia
• Abnormal placentation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS Group	ERAS protocol	Perioperative management follows the ERAS (Enhanced Recovery After Surgery) protocol
Control Group	ERAS protocol	Perioperative management follows the conventional program

Primary Outcome Measures

Name	Time	Method
Post-Cesarean pain scoring	Measured from postoperative day (PO) Day 0 to PO day 3 (72 hours)	Visual Analog Scale (VAS) for pain assessment (scale from 0-10). Score 0 to 5 is satisfactory pain control. Score 6 to 10 is not a good pain control and is necessary to add medication.

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	PO Day 0 until time of discharge PO Day 3-4 (72-96 hours)	Length of stay might influence on cost savings. Investigator expects discharge hospital will be on the PO day 3.
Post-partal depression development	Measured from the Cesarean Delivery to 6 weeks postoperatively	Inadequate postoperative treatment could cause chronic pain which could be the reason for post- partal depression development. Six weeks after delivery investigator will call mothers for interview and fill the Edinburgh Postnatal Depression Scale. Score 10 and more is suspect for depression risk.

Trial Locations

Locations (1)

Obstetric and Gynecology Hospital; 🇷🇸 Novi Sad, Vojvodina, Serbia