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

Implementation of ERAS Protocol for Cesarean Delivery in Clinical Center Vojvodina

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04058444
Enrollment
200
Registered
2019-08-15
Start date
2019-09-19
Completion date
2020-06-30
Last updated
2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery

Keywords

cesarean delivery, ERAS protocol

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.

Interventions

COMBINATION_PRODUCTERAS 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

Sponsors

Pujic Borislava
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Post-Cesarean pain scoringMeasured 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

MeasureTime frameDescription
Hospital length of stayPO 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 developmentMeasured from the Cesarean Delivery to 6 weeks postoperativelyInadequate 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.

Countries

Serbia

Contacts

Primary ContactBorislava Pujic, PhD
borislava60@yahoo.com+381641503577
Backup ContactLidija Jovanovic, MD
lidijanovisad@gmail.com+381641879293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026