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

Sponsor

Pujic Borislava (Other)

Overall Status

Unknown status

CT.gov ID

NCT04058444

Collaborator

(none)

200

Enrollment

Location

Arms

8.4

Anticipated Duration (Months)

23.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Delivery	Combination Product: ERAS protocol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Implementation of ERAS Protocol for Cesarean Delivery in Clinical Center Vojvodina

Anticipated Study Start Date :

Sep 19, 2019

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ERAS Group Perioperative management follows the ERAS (Enhanced Recovery After Surgery) protocol	Combination Product: ERAS protocol No routine bowel preparation Antibiotics prophylaxis PONV (Postoperative Nausea and Vomiting) prophylaxis Spinal anesthesia Post- Cesarean analgesia (Acetaminophen 1g IV q6h, Tramadol 50mg IV q6h, Quadratus lumborum Block Oral pain relief medication Pain scores every day (VAS) Hospital length of stay Patient satisfaction
Experimental: Control Group Perioperative management follows the conventional program	Combination Product: ERAS protocol No routine bowel preparation Antibiotics prophylaxis PONV (Postoperative Nausea and Vomiting) prophylaxis Spinal anesthesia Post- Cesarean analgesia (Acetaminophen 1g IV q6h, Tramadol 50mg IV q6h, Quadratus lumborum Block Oral pain relief medication Pain scores every day (VAS) Hospital length of stay Patient satisfaction

Arm

Intervention/Treatment

Experimental: ERAS Group

Perioperative management follows the ERAS (Enhanced Recovery After Surgery) protocol

Combination Product: ERAS protocol

No routine bowel preparation Antibiotics prophylaxis PONV (Postoperative Nausea and Vomiting) prophylaxis Spinal anesthesia Post- Cesarean analgesia (Acetaminophen 1g IV q6h, Tramadol 50mg IV q6h, Quadratus lumborum Block Oral pain relief medication Pain scores every day (VAS) Hospital length of stay Patient satisfaction

Experimental: Control Group

Perioperative management follows the conventional program

Combination Product: ERAS protocol

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetric and Gynecology Hospital	Novi Sad	Vojvodina	Serbia	21000

Sponsors and Collaborators

Pujic Borislava

Investigators

Principal Investigator: Borislava Pujic, PhD, Obstetric and Gynecology Hospital, Novi Sad, Serbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pujic Borislava, Director of Obstetrical Anesthesia, University of Novi Sad

ClinicalTrials.gov Identifier:

NCT04058444

Other Study ID Numbers:

0712960805046

First Posted:

Aug 15, 2019

Last Update Posted:

Sep 10, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pujic Borislava, Director of Obstetrical Anesthesia, University of Novi Sad

cesarean delivery

ERAS protocol

Study Results

No Results Posted as of Sep 10, 2019