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Completed

NCT Number: NCT04530851

Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi hospital

Bangkok, 10400, Thailand

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERAS

Procedure
  • 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

Primary outcomes

  1. Compare length of stay of pregnant women after Cesarean section between ERAS protocol and conventional care

    Time frame: 1 year

    The primary outcome is length of stay (Day)

Secondary outcomes

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

    Time frame: 1 year

    The outcome is pain score (visual analogue scale )

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

    Time frame: 1 year

    The outcome are opioid use (Meperidine, Tramadol, Morphine)

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

    Time frame: 1 year

    The outcome are complication after surgery such as fever, wound infection, wound dehiscence, metritis

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

    Time frame: 1 year

    The outcome is time to passing gas after surgery(hour)

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2020
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.