AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Egypt1 site
  • Woman's Health University Hospital

    Asyut, 71111

Other trials in Egypt

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

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 groups in NCT04360382
Study groupRoleWhat they receive
Enhanced recoveryPart 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 careusual 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.

  1. Postoperative length of hospital stays of stay.

    Hospital stay after CS in hours. The shorter stay is the better.

    Measured: 1 week

  2. Breast feeding initiation

    Physiologic scale: Amount and onset of milk secretion. The sufficient amount with early lactation is the better.

    Measured: 1 month

  3. Pain control

    Visual analogue pain scale. Minimal or low pain is the better.

    Measured: 1 month

Secondary outcomes (1)
  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.

  1. First posted24 Apr 2020
  2. Study start1 Feb 2020
  3. Primary completion1 May 2021
  4. Study completion1 Jun 2021

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in