Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care

Study Overview
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Brief Summary
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Research objective to compare outcome(Length of stay, pain score, opioid drug use, Bowel function and complication ) of ERAS protocol and conventional care in pregnant women after elective cesarean section in Rajavithi hospital.

Detailed Description
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Research design is Randomized control trial. The pregnant women who go to elective cesarean section don't know the allocation. The group of ERAS protocol was separated from Conventional care in patient care unit. The Pregnant are randomly in two group. In the ERAS group the pregnant receive the the intervention for preoperative care(Counselin, H2- antagonist and metroclopramide for prevent aspiration, Drink clear liquid until 2 hour before surgery), Intraoperative care (first generation cephalosporin in 60 minute before surgery, Clorhexidine for skin cleansing and Povidine for vaginal cleansing, regional anesthesia, keep warming, blunt expansion of uterine incision, do not peritoneal suture and subcuticular suture if less than 2 cm, local wound anesthesia.), post operative care ( Paracetamol and NSAIDs for for pain control, early remove catheter and ambulation, 5-HT3 antagonist for prevent nausea)

Official Title
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Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care in Rajavithi Hospital

Conditions
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To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean Section

Intervention / Treatment
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* Procedure: ERAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who scheduled for elective Cesarean section at Rajavithi Hospital Exclusion Criteria: Pregnant women who has preeclampsia with severe feature Pregnant women who has diabetes mellitus with uncontrolled blood sugar Pregnant women who has blood loss > 1,500 ml after surgery Pregnant women who has chrioamnionitis. Pregnant women who has severe medical disease Pregnant women who has BMI >= 40 kg/m2 Pregnant women who has placenta adherence.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional care<br>This group is conventional care of pregnant women after Cesarean section | |
| Experimental: ERAS protocol<br>This protocol for improve outcome of pregnant women after Cesarean section | Procedure: ERAS<br>* Counseling H2- antagonist and metroclopramide for prevent aspiration Drink clear liquid until 2 hour before surgery First generation cephalosporin in 60 minute before surgery Clorhexidine for skin cleansing and Povidine for vaginal cleansing Regional anesthesia Keep warming Blunt expansion of uterine incision Do not peritoneal suture and subcuticular suture if less than 2 cm Local wound anesthesia. Paracetamol and NSAIDs for for pain control Early remove catheter and ambulation 5-HT3 antagonist for prevent nausea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare length of stay of pregnant women after Cesarean section between ERAS protocol and conventional care | The primary outcome is length of stay (Day) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare pain of pregnant women after Cesarean section between ERAS protocol and conventional care | The outcome is pain score (visual analogue scale ) | 1 year | 
| Compare opioid use of pregnant women after Cesarean section between ERAS protocol and conventional care | The outcome are opioid use (Meperidine, Tramadol, Morphine) | 1 year | 
| Compare complication of pregnant women after Cesarean section between ERAS protocol and conventional care | The outcome are complication after surgery such as fever, wound infection, wound dehiscence, metritis | 1 year | 
| Compare bowel function of pregnant women after Cesarean section between ERAS protocol and conventional care | The outcome is time to passing gas after surgery(hour) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Cesarean section, Length of stay