Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care

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

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.

Study Overview

• Status: Completed
• Conditions: To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean Section
• Intervention / Treatment: Procedure: ERAS

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Conventional care; This group is conventional care of pregnant women after Cesarean section
EXPERIMENTAL: ERAS protocol; This protocol for improve outcome of pregnant women after Cesarean section	Procedure: ERAS; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2020
• Primary Completion (ACTUAL): July 30, 2020
• Study Completion (ACTUAL): July 30, 2020

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (ACTUAL): August 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cesarean section; ERAS; Length of stay
• Other Study ID Numbers: 103/2562

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No