Evaluation of Early Discharge After Cesarean Section

NCT05679323 | Completed DMC

• 1 other identifier: 8
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The rate of cesarean delivery is increasing, in developing countries, its rate ranges from 13 to 47% of all cases of delivery. This huge volume of cesarean deliveries has a great financial burden on the healthcare system. Rising hospital costs have led to the implementation of an early discharge policy after surgeries.

Conditions

Early Discharge of Patients After Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Activities of daily living

  Objective assessment is made by the KATZ index of independence of activities of daily living. The Katz index measures six self-care tasks including; bathing, dressing, toileting, transferring, maintaining continence, and feeding using a dichotomous rating (dependent-0/independent-1). Six points are considered independent and 0 points are considered fully dependent

  The first week after cesarean section

Secondary Outcomes (4)

• Wound assessment

  First postpartum visit 1 week after the cesarean section

• Return to normal bowel activities

  First 48 hours after cesarean section

• initiation of successful breast feeding

  First postpartum visit 1 week after the cesarean section

• Neonatal readmission

  First postpartum visit 1 week after the cesarean section

Study Arms (2)

Early discharge

Patients who will be discharged 24 hours after cesarean section

Other: KATZ index of independence in activities of daily living

Traditional discharge

Patients who will be discharged 48 hours after cesarean section

Other: KATZ index of independence in activities of daily living

Interventions

KATZ index of independence in activities of daily living OTHER

KATZ index measures self-care tasks using a dichotomous rating (dependent-0/independent-1) including; bathing, dressing, toileting, transferring to and from a chair, maintaining continence, and feeding. Six points are considered independent and 0 points are considered fully dependent. Assessment of each patient is made through a phone call at day 1, 3 and 5 after discharge

Early discharge; Traditional discharge

Eligibility Criteria

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

Study Population

Pregnant women admitted to Ain Shams University Maternity Hospital scheduled for elective lower-segment cesarean section

You may qualify if:

• BMI ≤ 35 kg/m2
• Gestational age at delivery from 37 0/7 to 42 0/7 weeks of gestation
• Uncomplicated pregnancy
• Cesarean section under spinal anesthesia with no intra-operative complications
• Uneventful postoperative course

You may not qualify if:

• Complicated pregnancy (Multiple pregnancies, Polyhydramions, Abnormal placenta, Premature rupture of membranes).
• Medical disorders (diabetes, hypertension, cardiac, renal, endocrinological disorders).

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

AinShams university maternity hospital

Cairo, Egypt

Location

Related Publications (6)

• Fikrie A, Zeleke R, Bekele H, Seyoum W, Hailu D, Wayessa ZJ, Tufa G, Utura T, Matie M, Oda GD. Time-to-recovery after cesarean section delivery among women who gave birth through cesarean section at Hawassa University Comprehensive Specialized Hospital, South Ethiopia: A prospective cohort study. PLOS Glob Public Health. 2022 Oct 5;2(10):e0000696. doi: 10.1371/journal.pgph.0000696. eCollection 2022.

  PMID: 36962571 BACKGROUND

• Sakai-Bizmark R, Ross MG, Estevez D, Bedel LEM, Marr EH, Tsugawa Y. Evaluation of Hospital Cesarean Delivery-Related Profits and Rates in the United States. JAMA Netw Open. 2021 Mar 1;4(3):e212235. doi: 10.1001/jamanetworkopen.2021.2235.

  PMID: 33739430 BACKGROUND

• Kruse AR, Lauszus FF, Forman A, Kesmodel US, Rugaard MB, Knudsen RK, Persson EK, Uldbjerg N, Sundtoft IB. Effect of early discharge after planned cesarean section on recovery and parental sense of security. A randomized clinical trial. Acta Obstet Gynecol Scand. 2021 May;100(5):955-963. doi: 10.1111/aogs.14041. Epub 2020 Dec 25.

  PMID: 33179268 BACKGROUND

• 4- Gupta S, Gupta A, Baghel AS, Sharma K, Choudhary S, Choudhary V. Enhanced recovery after cesarean protocol versus traditional protocol in elective cesarean section: A prospective observational study. J Obstet Anaesth Crit Care 2022;12:28-33

  BACKGROUND

• Ghaffari P, Vanda R, Aramesh S, Jamali L, Bazarganipour F, Ghatee MA. Hospital discharge on the first compared with the second day after a planned cesarean delivery had equivalent maternal postpartum outcomes: a randomized single-blind controlled clinical trial. BMC Pregnancy Childbirth. 2021 Jun 30;21(1):466. doi: 10.1186/s12884-021-03873-8.

  PMID: 34193059 BACKGROUND

• 6- Trikha A, Kaur M. Enhanced recovery after surgery in obstetric patients - Are we ready?. J Obstet Anaesth Crit Care 2020;10:1-3

  BACKGROUND

MeSH Terms

Interventions

Activities of Daily Living

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ahmed M ElMaraghy, MD

  Ainshams university maternity hospital

  PRINCIPAL INVESTIGATOR

• Ahmed H Naguib, MD

  Ainshams university maternity hospital

  STUDY DIRECTOR

• Ahmed M Fahim Hemaid, MD

  Ainshams university maternity hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 11, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)