Enhanced Recovery Versus Conventional Care After Cesarean Section

NCT04360382 | Completed DMC

• 1 other identifier: IRB approval number.258691
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 Hospital.

Conditions

Cesarean Section; Enhanced Recovery

Keywords

cesarean section; Nursing; Enhanced recovery

Outcome Measures

Primary Outcomes (3)

• Postoperative length of hospital stays of stay.

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

  1 week

• Breast feeding initiation

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

  1 month

• Pain control

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

  1 month

Secondary Outcomes (1)

• Financial cost score

  1 month

Study Arms (2)

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

Other: ERACS; Other: Regular care

Regular care

usual care for all cases of cesarean section at our hospital.

Other: ERACS; Other: Regular care

Interventions

ERACS OTHER

Pregnant women scheduled for cesarean section will be subjected to preoperative, intra-operative and postoperative nurse care aiming at early recovery.

Enhanced recovery; Regular care

Regular care OTHER

Usual care for all cases subjected to cesarean section at our hospital.

Enhanced recovery; Regular care

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Elective cesarean section for a pregnany woman.

You may qualify if:

• Women from 20- 40 years old .
• Women Undergoing elective cesarean Section.
• Low risk pregnancy; no medical ,surgical or obstetric problem.

You may not qualify if:

• Emergency cesarean section.
• Women who refuse to participate in the study

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

Location

Study Officials

• Atef Darwish

  Woman's Health University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: April 24, 2020
• Study Start: February 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

EG (1)