Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530851
• Other study ID #: 103/2562
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2020
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare pain of pregnant women after Cesarean section between ERAS protocol and conventional care	The outcome is pain score (visual analogue scale )	1 year
Secondary	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
Secondary	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
Secondary	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