Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care

Not Applicable

Completed

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

• Registration Number: NCT04530851
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

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)

Study Timeline

• Study Start: 2020-01-15
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Last Update Submitted: 2020-08-25
• Study First Posted: 2020-08-28
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS protocol	ERAS	This protocol for improve outcome of pregnant women after Cesarean section

Primary Outcome Measures

Name	Time	Method
Compare length of stay of pregnant women after Cesarean section between ERAS protocol and conventional care	1 year	The primary outcome is length of stay (Day)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rajavithi hospital; 🇹🇭 Bangkok, Thailand