- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679323
Evaluation of Early Discharge After Cesarean Section
The Effect of Early Versus Traditional Hospital Discharge on Activities of Daily Livingfor Women Undergoing Elective Cesarean Section.An Observational Cohort Study.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- AinShams university maternity hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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
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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
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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
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The first week after cesarean section
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound assessment
Time Frame: First postpartum visit 1 week after the cesarean section
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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.
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First postpartum visit 1 week after the cesarean section
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Return to normal bowel activities
Time Frame: First 48 hours after cesarean section
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Passage of flatus and stool after the cesarean section
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First 48 hours after cesarean section
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initiation of successful breast feeding
Time Frame: First postpartum visit 1 week after the cesarean section
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Start of lactation
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First postpartum visit 1 week after the cesarean section
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Neonatal readmission
Time Frame: First postpartum visit 1 week after the cesarean section
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The rate of neonatal admission and the reason will be assessed
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First postpartum visit 1 week after the cesarean section
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 1- Fikrie A, Zeleke R, Bekele H, Seyoum W, Hailu D, Wayessa ZJ, et al. 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);2(10): e0000696.
- 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.
- 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.
- 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
- 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.
- 6- Trikha A, Kaur M. Enhanced recovery after surgery in obstetric patients - Are we ready?. J Obstet Anaesth Crit Care 2020;10:1-3
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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