Cesarean SectionNCT04360382
Enhanced Recovery Versus Conventional Care After Cesarean Section
An observational study of Cesarean Section and Enhanced Recovery, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
A protocol of ERACS is introduced to our hospital aiming at saving a lot of time and money for the patients and the population at large .By this way ,free beds for more cases can be available for others patients, so the researcher is welling to study this research on women undergoing CS at Woman's Health University… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Enhanced Recovery
- What is being tested?
- ERACS and Regular care
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 1 Jun 2021
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Elective cesarean section for a pregnany woman.
Who may be able to join
- Women from 20- 40 years old .
- Women Undergoing elective cesarean Section.
- Low risk pregnancy; no medical ,surgical or obstetric problem.
Who cannot join
- Emergency cesarean section.
- Women who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery Versus Conventional Care After Cesarean Section: Role Of Nursing
A protocol of ERACS is introduced to our hospital aiming at saving a lot of time and money for the patients and the population at large .By this way ,free beds for more cases can be available for others patients, so the researcher is welling to study this research on women undergoing CS at Woman's Health University Hospital.
Read the detailed description
This study aims to assess the level of satisfaction of the women undergoing Enhanced Recovery Program (ERP) versus conventional care after cesarean section..
The study will be conducted at the woman's Health University Hospital at obstetrics ward and postpartum ward of that hospital,at the Assuit
The sample size for this study will be 300 randomized -controlled trails women and divided into two groups :
The first 150 of women will be enrolled to the control group, receiving conventional care and the second 150 of women will be recruited to the study group , receiving enhanced recovery program based care .
- Randomization will done by using computer -generated random table.
- After acceptance of eligible women to participate in the study ,they will assigned randomly to either one of the above groups.
Two tools will be used to collect data of this study:
Tool I: perioperative cesarean Section assessment tool:
This tool will be developed by the researcher based on reviewing available related literature and will be used to collect data regarding outcomes .
This tool will include the following parts:
Part 1:women's personal data: Consisted of 6 questions such as age, level of education , occupation, weight, height, indication for CS ,date ,time of admission and discharge .
Part 2: preoperative Data: Consisted of 13 questions such as present medical ,past and surgical histories, obstetric history ,smoking history , vital signs, investigations, patient advice and information ,breast feeding education ,discuss NPO status (reduced fasting times ),hemoglobin optimization ,contact women the day before delivery to review ERAS goals , bowel preparation, ,medications, time of transfer to theatre.
Part 3:Intraopreative Data: Consisted of 10 questions such as duration of operation , total fluid replacement ( including blood transfusion), vital signs ,urine output ,active warming, delayed cord clamping , skin to skin contact on operation table , minimally invasive surgical technique, anesthetic and analgesia medication .
Part 4:Post-operative Data: Consisted of 16 questions such as time of admission to ward, time of starting oral fluid, time of mobilization , time of remove urinary catheter ,duration of IV fluid ,use of chewing gum in early postoperative period ,pain intensity , use of analgesia drug and anibiotics,postoperative complication, pain intensity on discharge ,postoperative length of stay and reason of delayed postoperative length of stay.
Tool II: Patient's satisfaction tool:
This tool will be developed by researcher based on reviewing related literature including existing satisfaction tools, tested of validity ,piloted for internal consistency reliability ,scored and will utilize to assess patient's satisfaction about quality of perioperative care services. It is six domains and 40 items. Hospital admission procedure domain ( has 4 domains) such as women satisfied about ease of overall ,health care domain (has 10 domains) such as women satisfied about number of around made of doctor, physician services ,information provision domain (has 13 domains) such as women satisfied about information of breast feeding and pain management , ,the personal treatment domain (has 5 domains) such as women satisfied about kindness of staff , food domain (has 3 domains) such as women satisfied about served food quality (has 5 domains) such as women satisfied about cleanliness in the room and hospital facilities .
- Patient's satisfaction will measures by using four points Likert's scale ; Four point Likert's format that goes from strongly satisfied (4) to strongly dissatisfied (1), which helps in obtaining an ordinal measure of the strength of the satisfaction with each item. The tool score range from 40 to 160 .The score of ≤ 80 = dissatisfied, the range score > 80- 120 = satisfied , and the range score of > 120 - 160 = very satisfied (Ahmed et.al,2017).
Validity of data collection tools Content validity of the data collection tools will be established by 5 experts in the field of the study .The necessary modifications will be done accordingly.
Pilot study:
A pilot study will be carried out on the first 10 % of the total sample to test the content validity, feasibility, clarity and objectively of the tool as well as estimate the time needed for data collection. Data will analyzed manually following pilot study. According to the result of pilot study the necessary modifications will be done accordingly.
procedure: An written official approval letter from Faculty of Nursing at the University of Assuit to the director of Women Health Hospital; this letter will include a brief explanation of the objective and permission to carry out the study .
Data will be collected from control group first and then from study group to prevent sample contamination. The control group will receive the conventional care while study group will receive developed enhanced recovery program care .
Phase 1: Conventional Care Assessment Perioperative data will be collected from this group by tool I .Every patient will be assessed at a day before operation to gather all preoperative data .the women's operative report is reviewed by researcher and required information will be recorded on data collection tool .After that women will be followed up till she is transferred to postpartum ward where patient will daily be reassessed during morning shift till patient discharge. The patient's satisfaction will be assessed at discharge using tool II .
Phase 2: Designing enhanced recovery program:
Based on reviewing related to literature; enhanced recovery program after cesarean section will be formulated by a designer team, which will consist of a supervisor and head nurse of ward, and researcher.
The established enhanced recovery pogram will consist of four parts:
Part I: Preoperative evaluation and preparation:
This part will include health history, physical examination, and diagnostic investigation, as well as pre-operative patient preparation.
Part II: Postoperative daily intervention:
This part will include the daily nursing and collaborative interventions such as assessment, nutrition, activities, medications, patient and family education, and discharge planning and instructions.
Part III: Expected daily outcome :
This part will include the patient's daily outcomes such as vital signs stability , pain control ,activities of daily living and mobility improvement; return bowel function, and meeting discharge criteria .
Phase three: Implementing enhanced recovery program:
The established pathway will implement on the study group by researcher from admission till discharge as conventional care group assessment in phase one.
Phase four: Evaluating enhanced recovery program outcomes:
The efficacy of enhanced recovery program will be determined by comparing outcomes for patients of both control and study groups
- Conditions
- Cesarean Section, Enhanced Recovery
- Being tested
- ERACS, Regular care
- Keywords
- cesarean section, Nursing, Enhanced recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERACSOther
Pregnant women scheduled for cesarean section will be subjected to preoperative, intra-operative and postoperative nurse care aiming at early recovery.
Regular careOther
Usual care for all cases subjected to cesarean section at our hospital.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery | Part I: Preoperative evaluation and preparation:
Part II: Postoperative daily intervention:
Part III: Expected daily outcome :
Phase three: Implementing enhanced recovery program:
The established pathway will implement on the study group by researcher from admission till discharge as conventional care group assessment in phase one.
Phase four: Evaluating enhanced recovery program outcomes:
The efficacy of enhanced recovery program will be determined by comparing outcomes for patients of both control and study groups Receives: Other: ERACS; Other: Regular care | |
| Regular care | usual care for all cases of cesarean section at our hospital. Receives: Other: ERACS; Other: Regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of hospital stays of stay.
Hospital stay after CS in hours. The shorter stay is the better.
Measured: 1 week
Breast feeding initiation
Physiologic scale: Amount and onset of milk secretion. The sufficient amount with early lactation is the better.
Measured: 1 month
Pain control
Visual analogue pain scale. Minimal or low pain is the better.
Measured: 1 month
Secondary outcomes (1)
Financial cost score
The less cost is the better.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Feb 2020
- Primary completion1 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Atef Darwish, Woman's Health University Hospital, Egypt
- Investigators
- Atef Darwish, Principal investigator, Woman's Health University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360382
- Sponsor's protocol ID
- IRB approval number.258691
- Status last verified
- Jun 2021
- First submitted
- 15 Feb 2020
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery Versus Conventional Care After Cesarean Section: Role Of Nursing
- ClinicalTrials.gov ID
- NCT04360382
- Acronym / sponsor ID
- IRB approval number.258691
- Conditions
- Cesarean Section, Enhanced Recovery
- Keywords
- cesarean section, Nursing, Enhanced recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 24 Apr 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.
A protocol of ERACS is introduced to our hospital aiming at saving a lot of time and money for the patients and the population at large .By this way ,free beds for more cases can be available for others patients, so the researcher is welling to study this research on women undergoing CS at Woman's Health University Hospital.
Detailed description
This study aims to assess the level of satisfaction of the women undergoing Enhanced Recovery Program (ERP) versus conventional care after cesarean section..
The study will be conducted at the woman's Health University Hospital at obstetrics ward and postpartum ward of that hospital,at the Assuit
The sample size for this study will be 300 randomized -controlled trails women and divided into two groups :
The first 150 of women will be enrolled to the control group, receiving conventional care and the second 150 of women will be recruited to the study group , receiving enhanced recovery program based care .
- Randomization will done by using computer -generated random table.
- After acceptance of eligible women to participate in the study ,they will assigned randomly to either one of the above groups.
Two tools will be used to collect data of this study:
Tool I: perioperative cesarean Section assessment tool:
This tool will be developed by the researcher based on reviewing available related literature and will be used to collect data regarding outcomes .
This tool will include the following parts:
Part 1:women's personal data: Consisted of 6 questions such as age, level of education , occupation, weight, height, indication for CS ,date ,time of admission and discharge .
Part 2: preoperative Data: Consisted of 13 questions such as present medical ,past and surgical histories, obstetric history ,smoking history , vital signs, investigations, patient advice and information ,breast feeding education ,discuss NPO status (reduced fasting times ),hemoglobin optimization ,contact women the day before delivery to review ERAS goals , bowel preparation, ,medications, time of transfer to theatre.
Part 3:Intraopreative Data: Consisted of 10 questions such as duration of operation , total fluid replacement ( including blood transfusion), vital signs ,urine output ,active warming, delayed cord clamping , skin to skin contact on operation table , minimally invasive surgical technique, anesthetic and analgesia medication .
Part 4:Post-operative Data: Consisted of 16 questions such as time of admission to ward, time of starting oral fluid, time of mobilization , time of remove urinary catheter ,duration of IV fluid ,use of chewing gum in early postoperative period ,pain intensity , use of analgesia drug and anibiotics,postoperative complication, pain intensity on discharge ,postoperative length of stay and reason of delayed postoperative length of stay.
Tool II: Patient's satisfaction tool:
This tool will be developed by researcher based on reviewing related literature including existing satisfaction tools, tested of validity ,piloted for internal consistency reliability ,scored and will utilize to assess patient's satisfaction about quality of perioperative care services. It is six domains and 40 items. Hospital admission procedure domain ( has 4 domains) such as women satisfied about ease of overall ,health care domain (has 10 domains) such as women satisfied about number of around made of doctor, physician services ,information provision domain (has 13 domains) such as women satisfied about information of breast feeding and pain management , ,the personal treatment domain (has 5 domains) such as women satisfied about kindness of staff , food domain (has 3 domains) such as women satisfied about served food quality (has 5 domains) such as women satisfied about cleanliness in the room and hospital facilities .
- Patient's satisfaction will measures by using four points Likert's scale ; Four point Likert's format that goes from strongly satisfied (4) to strongly dissatisfied (1), which helps in obtaining an ordinal measure of the strength of the satisfaction with each item. The tool score range from 40 to 160 .The score of ≤ 80 = dissatisfied, the range score > 80- 120 = satisfied , and the range score of > 120 - 160 = very satisfied (Ahmed et.al,2017).
Validity of data collection tools Content validity of the data collection tools will be established by 5 experts in the field of the study .The necessary modifications will be done accordingly.
Pilot study:
A pilot study will be carried out on the first 10 % of the total sample to test the content validity, feasibility, clarity and objectively of the tool as well as estimate the time needed for data collection. Data will analyzed manually following pilot study. According to the result of pilot study the necessary modifications will be done accordingly.
procedure: An written official approval letter from Faculty of Nursing at the University of Assuit to the director of Women Health Hospital; this letter will include a brief explanation of the objective and permission to carry out the study .
Data will be collected from control group first and then from study group to prevent sample contamination. The control group will receive the conventional care while study group will receive developed enhanced recovery program care .
Phase 1: Conventional Care Assessment Perioperative data will be collected from this group by tool I .Every patient will be assessed at a day before operation to gather all preoperative data .the women's operative report is reviewed by researcher and required information will be recorded on data collection tool .After that women will be followed up till she is transferred to postpartum ward where patient will daily be reassessed during morning shift till patient discharge. The patient's satisfaction will be assessed at discharge using tool II .
Phase 2: Designing enhanced recovery program:
Based on reviewing related to literature; enhanced recovery program after cesarean section will be formulated by a designer team, which will consist of a supervisor and head nurse of ward, and researcher.
The established enhanced recovery pogram will consist of four parts:
Part I: Preoperative evaluation and preparation:
This part will include health history, physical examination, and diagnostic investigation, as well as pre-operative patient preparation.
Part II: Postoperative daily intervention:
This part will include the daily nursing and collaborative interventions such as assessment, nutrition, activities, medications, patient and family education, and discharge planning and instructions.
Part III: Expected daily outcome :
This part will include the patient's daily outcomes such as vital signs stability , pain control ,activities of daily living and mobility improvement; return bowel function, and meeting discharge criteria .
Phase three: Implementing enhanced recovery program:
The established pathway will implement on the study group by researcher from admission till discharge as conventional care group assessment in phase one.
Phase four: Evaluating enhanced recovery program outcomes:
The efficacy of enhanced recovery program will be determined by comparing outcomes for patients of both control and study groups
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery | – | Other: ERACS, Other: Regular carePart I: Preoperative evaluation and preparation: Part II: Postoperative daily intervention: Part III: Expected daily outcome : Phase three: Implementing enhanced recovery program: The established pathway will implement on the study group by researcher from admission till discharge as conventional care group assessment in phase one. Phase four: Evaluating enhanced recovery program outcomes: The efficacy of enhanced recovery program will be determined by comparing outcomes for patients of both control and study groups |
| Regular care | – | Other: ERACS, Other: Regular careusual care for all cases of cesarean section at our hospital. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Elective cesarean section for a pregnany woman.
Key inclusion criteria (3 listed)
- Women from 20- 40 years old .
- Women Undergoing elective cesarean Section.
- Low risk pregnancy; no medical ,surgical or obstetric problem.
Key exclusion criteria (2 listed)
- Emergency cesarean section.
- Women who refuse to participate in the study
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 |
|---|---|---|
| ERACSPregnant women scheduled for cesarean section will be subjected to preoperative, intra-operative and postoperative nurse care aiming at early recovery. | Other | Enhanced recovery, Regular care |
| Regular careUsual care for all cases subjected to cesarean section at our hospital. | Other | Enhanced recovery, Regular care |
Primary outcome
Postoperative length of hospital stays of stay.
Time frame: 1 week
Hospital stay after CS in hours. The shorter stay is the better.
Breast feeding initiation
Time frame: 1 month
Physiologic scale: Amount and onset of milk secretion. The sufficient amount with early lactation is the better.
Pain control
Time frame: 1 month
Visual analogue pain scale. Minimal or low pain is the better.
1 secondary outcome
Financial cost score
Time frame: 1 month
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 11 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section
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Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
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Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
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Prevalence of Pain During Cesarean Section
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Lateral QL Block vs Intrathecal Morphine for Cesarean Section
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Asphyxia Neonatorum, Fetal Hypoxia
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.
Atef Darwish principal investigator
Woman's Health University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Enhanced Recovery, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
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 3 inclusion and 2 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 11 Jun 2021. 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 Egypt. 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?
Postoperative length of hospital stays of stay. (time frame: 1 week). The study lists 3 primary outcomes in all. 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 11 Jun 2021.