Evaluation of Early Discharge After Cesarean Section

NCT ID: NCT05679323

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Cesarean section (CS) is the most commonly performed surgical procedure worldwide that effectively prevents maternal and newborn mortality when used for medically indicated reasons. Compared with vaginal delivery, however, the procedure is associated with a higher risk of various maternal complications, such as maternal infection and subsequent pregnancy complications, and a higher likelihood of re-hospitalization within six weeks of delivery. Furthermore, the likelihood of maternal morbidity increases for mothers who repeatedly undergo cesarean delivery. CS typically implies a hospital stay for two to three days, whereas parous women are often discharged within a few hours after an uncomplicated vaginal birth. However, the period after CS includes recovery from surgery as well as adapting to motherhood.

According to World Health Organization, the cesarean section rate will increase to 28.5% of total live births by the year 2030. This huge volume of cesarean deliveries and increasing cesarean section rate has an incremental burden on the healthcare system, leading to higher bed occupancy and financial pressure on the patients and health facilities. Postpartum stay at hospitals is steadily declining in the UK and other countries due to cost savings. Rising hospital costs are one of the factors in early discharge.

According to The American College of midwifery and gynecology, earlier discharge is a choice if the baby is ready to go home, though, the mother should have basic requirements such as normal blood pressure, no symptoms of infection, and adequate pain control. Also, the National institute for health and care excellence (NICE) guidelines recommend "women who are recovering well, are apyrexial and do not have complications following Caesarean Section should be offered early discharge (after 24 hours) from the hospital and follow up at home.

Conditions

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Early Discharge of Patients After Cesarean Section

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early discharge

Patients who will be discharged 24 hours after cesarean section

KATZ index of independence in activities of daily living

Intervention Type 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

Traditional discharge

Patients who will be discharged 48 hours after cesarean section

KATZ index of independence in activities of daily living

Intervention Type 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

Interventions

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KATZ index of independence in activities of daily living

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohammed Elmaraghy

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M ElMaraghy, MD

Role: PRINCIPAL_INVESTIGATOR

Ainshams university maternity hospital

Ahmed H Naguib, MD

Role: STUDY_DIRECTOR

Ainshams university maternity hospital

Ahmed M Fahim Hemaid, MD

Role: STUDY_CHAIR

Ainshams university maternity hospital

Locations

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AinShams university maternity hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 36962571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33739430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33179268 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 34193059 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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8

Identifier Type: -

Identifier Source: org_study_id

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