NCT04530851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 25, 2020

Last Update Submit

August 25, 2020

Conditions

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

Keywords

ERASCesarean sectionLength of stay

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Compare pain of pregnant women after Cesarean section between ERAS protocol and conventional care

    1 year

  • Compare opioid use of pregnant women after Cesarean section between ERAS protocol and conventional care

    1 year

  • Compare complication of pregnant women after Cesarean section between ERAS protocol and conventional care

    1 year

  • Compare bowel function of pregnant women after Cesarean section between ERAS protocol and conventional care

    1 year

Study Arms (2)

Conventional care

NO INTERVENTION

This group is conventional care of pregnant women after Cesarean section

ERAS protocol

EXPERIMENTAL

This protocol for improve outcome of pregnant women after Cesarean section

Procedure: ERAS

Interventions

ERASPROCEDURE

* 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

ERAS protocol

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women who scheduled for elective Cesarean section at Rajavithi Hospital

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 28, 2020

Study Start

January 15, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations

TH(1)