Cesarean Section Complications Clinical Trial
Official title:
Outcomes of Enhanced Recovery After Surgery (ERAS) vs. Standard of Care in Cesarean Deliveries: A Randomized-Controlled Trial
Verified date | March 2023 |
Source | Zeynep Kamil Maternity and Pediatric Research and Training Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 1200 |
Est. completion date | June 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant women who had cesarean delivery - Gestational age >37/0 weeks Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Zeynep Kamil Women and Children's Diseases Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Zeynep Kamil Maternity and Pediatric Research and Training Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Within postoperative 48 hours | |
Secondary | 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 | At post operative 6th and 24th hour | |
Secondary | Quality of recovery | Evaluated with Quality of recovery-15 (QoR-15) questionnaire | Immediately before discharge |
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