Cesarean Section ComplicationsNCT05786352
Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol
A study testing ERAS protocol in people with Cesarean Section Complications and ERAS, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
In recent years, a set of evidence-based recommendations called Enhanced Recovery After Surgery (ERAS) is being applied for care of cesarean sections. The effectiveness of ERAS in reducing the length of hospitalization, postoperative complications, the need for analgesics right away after surgery, and the financial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications, ERAS
- What is being tested?
- ERAS protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jun 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women who had cesarean delivery
- Gestational age >37/0 weeks
Who cannot join
- Diabetes
- Placenta accreta spectrum
- Hypertensive disorders of pregnancy
- Placental abruption
- Need for emergent/urgent cesarean
- Pregnancy complicated by an active infection
- History of allergic reaction to diclofenac sodium, paracetamol or metoclopramide
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Istanbul
About this study
Official title: Outcomes of Enhanced Recovery After Surgery (ERAS) vs. Standard of Care in Cesarean Deliveries: A Randomized-Controlled Trial
In recent years, a set of evidence-based recommendations called Enhanced Recovery After Surgery (ERAS) is being applied for care of cesarean sections. The effectiveness of ERAS in reducing the length of hospitalization, postoperative complications, the need for analgesics right away after surgery, and the financial cost in the context of cesarean sections has been shown in several studies. There is strong evidence that following ERAS protocols aids postoperative recovery positively. This will be a randomized trial to determine if there is a difference regarding adverse maternal outcomes between ERAS group and standard of care.
Read the detailed description
Cesarean section is one of the most common surgeries performed today with over one million performed in the United States annually. Our institiution is a tertiary maternity hospital with approximately 3500 cesarean sections annually. A standardized set of guidelines known as Enhanced Recovery After Surgery (ERAS) has been used in a variety of surgical specialties, including colorectal, urologic, gynecologic, and hepatobiliary surgery. The adoption of ERAS guidelines for the obstetric population now offers evidence-based recommendations for postoperative care following cesarean delivery.
At our institution, due to large volume of cesarean section, we encounter a variety of postoperative complications. Institutional standard of care for preoperative, intraoperative and postoperative care has been applied by all providers. In light of recent positive evidence when ERAS protocol is applied, our team aimed to design a randomized controlled trial for comparison of maternal outcomes in ERAS and standard of care.
- Conditions
- Cesarean Section Complications, ERAS
- Being tested
- ERAS protocol
- Keywords
- ERAS, ERAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolProcedure or surgery
The combination of interventions explained in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Experimental | ERAS Protocol
Preoperative:
1. Clear carbohydrate ( pulp free juice) drink 4 hours before cesarean. Water drinking is allowed until 4 hours before cesarean.
2. Prophylactic antibiotics 1 hour before cesarean ( Cephazole 2 g iv)
Intraoperative:
1. Hypothermia prevention (warming devices)
2. Pneuomatic compression stockings
3. Skin preparation with clorhexidine-alcohol
4. Vaginal preparation with povidone-iodine solution
Postoperative:
1. Regular diet within 2 hours after cesarean
2. Sugar-free gum chewing at postoperative 3rd, 5th and 7th hours, for 20 minutes
3. Tight control of capillary blood glucose
4. Mobilization at postoperative 4th hour.
5. Urinary catheter removal at postoperative 4th hour
6. Pneuomatic compression stockings
7. Prevention of nausea and vomiting with routine use of Metoclopramide.
8. Routine analgesia with Diclofenac sodium suppository application and oral Paracetamole. Receives: Procedure: ERAS protocol |
| SOC (Standard of Care) | No intervention | Preoperative: 1. Fasting until 6 hours before cesarean. 2. Prophylactic antibiotics post-delivery during cesarean per institutional protocol ( Cephazole 2 g iv) Intraoperative: 1. Pneuomatic compression stockings as needed 2. Skin preparation with povidone-iodine solution Postoperative: 1. Water intake at 4th hour after cesarean, traditional delayed feeding until return of intestinal function (bowel sounds or flatus) 2. Capillary glucose control 3. Mobilization at postoperative 6th hour. 4. Urinary catheter removal at postoperative 6th hour 5. Pneuomatic compression stockings as needed. 6. Analgesia with Diclofenac sodium intramuscular and oral Paracetamole as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse composite outcome
One or more of the following: Prolonged length of hospital stay, infectious complication (urinary tract, wound complications etc.), gastrointestinal complications (need for additional treatment for nausea-vomiting, delayed return of intestinal function, ileus etc.), thrombotic complications, readmission
Measured: Within postoperative 48 hours
Secondary outcomes (2)
Postoperative pain
Evaluated with visual analog scale (VAS) A pain scoring scale between 0-10 points, where 0 indicates no pain and 10 indicates the worst pain
Measured: At post operative 6th and 24th hour
Quality of recovery
Evaluated with Quality of recovery-15 (QoR-15) questionnaire
Measured: Immediately before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem boz izceyhan, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786352
- Sponsor's protocol ID
- 141
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Enhanced Recovery After Surgery (ERAS) vs. Standard of Care in Cesarean Deliveries: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT05786352
- Acronym / sponsor ID
- 141
- Conditions
- Cesarean Section Complications, ERAS
- Keywords
- ERAS, ERAC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 27 Mar 2023 (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.
In recent years, a set of evidence-based recommendations called Enhanced Recovery After Surgery (ERAS) is being applied for care of cesarean sections. The effectiveness of ERAS in reducing the length of hospitalization, postoperative complications, the need for analgesics right away after surgery, and the financial cost in the context of cesarean sections has been shown in several studies. There is strong evidence that following ERAS protocols aids postoperative recovery positively. This will be a randomized trial to determine if there is a difference regarding adverse maternal outcomes between ERAS group and standard of care.
Detailed description
Cesarean section is one of the most common surgeries performed today with over one million performed in the United States annually. Our institiution is a tertiary maternity hospital with approximately 3500 cesarean sections annually. A standardized set of guidelines known as Enhanced Recovery After Surgery (ERAS) has been used in a variety of surgical specialties, including colorectal, urologic, gynecologic, and hepatobiliary surgery. The adoption of ERAS guidelines for the obstetric population now offers evidence-based recommendations for postoperative care following cesarean delivery.
At our institution, due to large volume of cesarean section, we encounter a variety of postoperative complications. Institutional standard of care for preoperative, intraoperative and postoperative care has been applied by all providers. In light of recent positive evidence when ERAS protocol is applied, our team aimed to design a randomized controlled trial for comparison of maternal outcomes in ERAS and standard of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS | Experimental | Procedure: ERAS protocolERAS Protocol Preoperative: 1. Clear carbohydrate ( pulp free juice) drink 4 hours before cesarean. Water drinking is allowed until 4 hours before cesarean. 2. Prophylactic antibiotics 1 hour before cesarean ( Cephazole 2 g iv) Intraoperative: 1. Hypothermia prevention (warming devices) 2. Pneuomatic compression stockings 3. Skin preparation with clorhexidine-alcohol 4. Vaginal preparation with povidone-iodine solution Postoperative: 1. Regular diet within 2 hours after cesarean 2. Sugar-free gum chewing at postoperative 3rd, 5th and 7th hours, for 20 minutes 3. Tight control of capillary blood glucose 4. Mobilization at postoperative 4th hour. 5. Urinary catheter removal at postoperative 4th hour 6. Pneuomatic compression stockings 7. Prevention of nausea and vomiting with routine use of Metoclopramide. 8. Routine analgesia with Diclofenac sodium suppository application and oral Paracetamole. |
| SOC (Standard of Care) | No intervention | –Preoperative: 1. Fasting until 6 hours before cesarean. 2. Prophylactic antibiotics post-delivery during cesarean per institutional protocol ( Cephazole 2 g iv) Intraoperative: 1. Pneuomatic compression stockings as needed 2. Skin preparation with povidone-iodine solution Postoperative: 1. Water intake at 4th hour after cesarean, traditional delayed feeding until return of intestinal function (bowel sounds or flatus) 2. Capillary glucose control 3. Mobilization at postoperative 6th hour. 4. Urinary catheter removal at postoperative 6th hour 5. Pneuomatic compression stockings as needed. 6. Analgesia with Diclofenac sodium intramuscular and oral Paracetamole as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women who had cesarean delivery
- Gestational age >37/0 weeks
Key exclusion criteria (7 listed)
- Diabetes
- Placenta accreta spectrum
- Hypertensive disorders of pregnancy
- Placental abruption
- Need for emergent/urgent cesarean
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 protocolThe combination of interventions explained in arm descriptions. | Procedure or surgery | ERAS |
Primary outcome
Adverse composite outcome
Time frame: Within postoperative 48 hours
One or more of the following: Prolonged length of hospital stay, infectious complication (urinary tract, wound complications etc.), gastrointestinal complications (need for additional treatment for nausea-vomiting, delayed return of intestinal function, ileus etc.), thrombotic complications, readmission
2 secondary outcomes
Postoperative pain
Time frame: At post operative 6th and 24th hour
Quality of recovery
Time frame: Immediately before discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Section Complications and ERAS, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 27 Mar 2023. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse composite outcome (time frame: Within postoperative 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2023.