NCT04058444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 19, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

April 13, 2019

Last Update Submit

September 8, 2019

Conditions

Cesarean Delivery

Keywords

cesarean deliveryERAS protocol

Outcome Measures

Primary Outcomes (1)

  • Post-Cesarean pain scoring

    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.

    Measured from postoperative day (PO) Day 0 to PO day 3 (72 hours)

Secondary Outcomes (2)

  • Hospital length of stay

    PO Day 0 until time of discharge PO Day 3-4 (72-96 hours)

  • Post-partal depression development

    Measured from the Cesarean Delivery to 6 weeks postoperatively

Study Arms (2)

ERAS Group

EXPERIMENTAL

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

Combination Product: ERAS protocol

Control Group

EXPERIMENTAL

Perioperative management follows the conventional program

Combination Product: ERAS protocol

Interventions

ERAS protocolCOMBINATION_PRODUCT

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

Control GroupERAS Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetric and Gynecology Hospital

Novi Sad, Vojvodina, 21000, Serbia

RECRUITING

Related Publications (3)

  • Gamez BH, Habib AS. Predicting Severity of Acute Pain After Cesarean Delivery: A Narrative Review. Anesth Analg. 2018 May;126(5):1606-1614. doi: 10.1213/ANE.0000000000002658.

    PMID: 29210789RESULT

  • Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.

    PMID: 25936786RESULT

  • Krohg A, Ullensvang K, Rosseland LA, Langesaeter E, Sauter AR. The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):559-565. doi: 10.1213/ANE.0000000000002648.

    PMID: 29135590RESULT

Study Officials

  • Borislava Pujic, PhD

    Obstetric and Gynecology Hospital, Novi Sad, Serbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Borislava Pujic, PhD

CONTACT

+381641503577borislava60@yahoo.com

Lidija Jovanovic, MD

CONTACT

+381641879293lidijanovisad@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Obstetrical Anesthesia

Study Record Dates

First Submitted

April 13, 2019

First Posted

August 15, 2019

Study Start

September 19, 2019

Primary Completion

March 1, 2020

Study Completion

June 1, 2020

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)