Evaluation of Early Discharge After Cesarean Section

February 2, 2023 updated by: Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital

The Effect of Early Versus Traditional Hospital Discharge on Activities of Daily Livingfor Women Undergoing Elective Cesarean Section.An Observational Cohort Study.

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • AinShams university maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early discharge
Patients who will be discharged 24 hours after cesarean section
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of daily living
Time Frame: The first week after cesarean section
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound assessment
Time Frame: First postpartum visit 1 week after the cesarean section
Assessment of the wound by the Southampton wound scoring system will take place 1 week after the cesarean section. It categorizes wound complications on a grade from 0 to V, with the latter being deep or severe wound infection.
First postpartum visit 1 week after the cesarean section
Return to normal bowel activities
Time Frame: First 48 hours after cesarean section
Passage of flatus and stool after the cesarean section
First 48 hours after cesarean section
initiation of successful breast feeding
Time Frame: First postpartum visit 1 week after the cesarean section
Start of lactation
First postpartum visit 1 week after the cesarean section
Neonatal readmission
Time Frame: First postpartum visit 1 week after the cesarean section
The rate of neonatal admission and the reason will be assessed
First postpartum visit 1 week after the cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 7, 2023

First Posted (ACTUAL)

January 11, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Discharge of Patients After Cesarean Section

Clinical Trials on KATZ index of independence in activities of daily living

3
Subscribe