Cesarean DeliveryNCT04058444
The First ERAS Protocol for Cesarean Delivery in Serbia at the University Hospital
A study testing ERAS protocol in people with Cesarean Delivery, run by Pujic Borislava at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- ERAS protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSerbia
- Study dates
- 19 Sep 2019to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All healthy patients from 18-45 years for scheduled Cesarean Delivery
Who cannot join
- Age younger then 18 years old and older then 45 years
- Urgent and emergent Cesarean Delivery
- Preeclampsia
- Contraindications for spinal anesthesia
- Abnormal placentation
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Obstetric and Gynecology Hospital
Novi Sad, Vojvodina, 21000
Borislava Pujic, PhD, +381641503577, borislava60@yahoo.com
Lidija Jovanovic, MD, +381641879293, lidijanovisad@gmail.com
About this study
Official title: Implementation of ERAS Protocol for Cesarean Delivery in Clinical Center Vojvodina
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.
Read the 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.
- Conditions
- Cesarean Delivery
- Being tested
- ERAS protocol
- Keywords
- cesarean delivery, ERAS protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ERAS Group | Experimental | Perioperative management follows the ERAS (Enhanced Recovery After Surgery) protocol Receives: Combination Product: ERAS protocol |
| Control Group | Experimental | Perioperative management follows the conventional program Receives: Combination Product: ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured from postoperative day (PO) Day 0 to PO day 3 (72 hours)
Secondary outcomes (2)
Hospital length of stay
Length of stay might influence on cost savings. Investigator expects discharge hospital will be on the PO day 3.
Measured: PO Day 0 until time of discharge PO Day 3-4 (72-96 hours)
Post-partal depression development
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.
Measured: Measured from the Cesarean Delivery to 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start19 Sep 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pujic Borislava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pujic Borislava, University of Novi Sad
- Investigators
- Borislava Pujic, PhD, Principal investigator, Obstetric and Gynecology Hospital, Novi Sad, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058444
- Sponsor's protocol ID
- 0712960805046
- Status last verified
- Sep 2019
- First submitted
- 13 Apr 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29210789Valentine 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.
PubMed 25936786Krohg 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.
PubMed 29135590
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of ERAS Protocol for Cesarean Delivery in Clinical Center Vojvodina
- ClinicalTrials.gov ID
- NCT04058444
- Acronym / sponsor ID
- 0712960805046
- Conditions
- Cesarean Delivery
- Keywords
- cesarean delivery, ERAS protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pujic BorislavaUniversity, hospital or other
- Study start
- 19 Sep 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS Group | Experimental | Combination Product: ERAS protocolPerioperative management follows the ERAS (Enhanced Recovery After Surgery) protocol |
| Control Group | Experimental | Combination Product: ERAS protocolPerioperative management follows the conventional program |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All healthy patients from 18-45 years for scheduled Cesarean Delivery
Key exclusion criteria (5 listed)
- Age younger then 18 years old and older then 45 years
- Urgent and emergent Cesarean Delivery
- Preeclampsia
- Contraindications for spinal anesthesia
- Abnormal placentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS protocolNo 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 | Combination product | Control Group, ERAS Group |
Primary outcome
Post-Cesarean pain scoring
Time frame: 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.
2 secondary outcomes
Hospital length of stay
Time frame: PO Day 0 until time of discharge PO Day 3-4 (72-96 hours)
Post-partal depression development
Time frame: Measured from the Cesarean Delivery to 6 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Results publication: PubMed 29210789Gamez 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.
- Results publication: PubMed 25936786Valentine 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.
- Results publication: PubMed 29135590Krohg 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.
- Individual participant dataSharing planned: No
Related trials for Cesarean Delivery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borislava Pujic, PhD principal investigator
Obstetric and Gynecology Hospital, Novi Sad, Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocol in people with Cesarean Delivery, run by Pujic Borislava at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Borislava Pujic, PhD (+381641503577, borislava60@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Cesarean pain scoring (time frame: Measured from postoperative day (PO) Day 0 to PO day 3 (72 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04058444, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.