To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean SectionNCT04530851
Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care
A study testing ERAS in people with To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean Section, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean Section
- What is being tested?
- ERAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jan 2020to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women who scheduled for elective Cesarean section at Rajavithi Hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean Section
- Being tested
- ERAS
- Keywords
- ERAS, Cesarean section, Length of stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: ERAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare length of stay of pregnant women after Cesarean section between ERAS protocol and conventional care
The primary outcome is length of stay (Day)
Measured: 1 year
Secondary outcomes (4)
Compare pain of pregnant women after Cesarean section between ERAS protocol and conventional care
The outcome is pain score (visual analogue scale )
Measured: 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)
Measured: 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
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start15 Jan 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530851
- Sponsor's protocol ID
- 103/2562
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care in Rajavithi Hospital
- ClinicalTrials.gov ID
- NCT04530851
- Acronym / sponsor ID
- 103/2562
- Conditions
- To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean Section
- Keywords
- ERAS, Cesarean section, Length of stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional care | No intervention | –This group is conventional care of pregnant women after Cesarean section |
| ERAS protocol | Experimental | Procedure: ERASThis protocol for improve outcome of pregnant women after Cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women who scheduled for elective Cesarean section at Rajavithi Hospital
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | ERAS protocol |
Primary outcome
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)
4 secondary outcomes
Compare pain of pregnant women after Cesarean section between ERAS protocol and conventional care
Time frame: 1 year
Compare opioid use of pregnant women after Cesarean section between ERAS protocol and conventional care
Time frame: 1 year
Compare complication of pregnant women after Cesarean section between ERAS protocol and conventional care
Time frame: 1 year
Compare bowel function of pregnant women after Cesarean section between ERAS protocol and conventional care
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS in people with To Determine Whether ERAS Can Reduce Length of Stay in Pregnant Women After Cesarean Section, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare length of stay of pregnant women after Cesarean section between ERAS protocol and conventional care (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.