Plain English Summary
Background and study aims
The Caesarean delivery rate is steadily increasing and now accounts for 20-30% of deliveries in many developed countries. There has been a steady decline in the length of time mothers spend in hospital after giving birth including after Caesarean delivery. Earlier discharge may give more opportunity for family members to be together as they get to know the baby, contributing to improved bonding, more involvement of the father in caring for the baby and decreased exposure of the mother and baby to hospital-acquired infection. However, earlier discharge may cause a delay in treatment if unsuspected complications were to arise. We are doing a study to compare discharge on Day 1 (next day) versus Day 2 (current standard) after an uncomplicated elective Caesarean delivery in healthy women who have made a good physical recovery and whose baby is also fit for discharge.
Who can participate?
Healthy women aged 18 and above, at term with a singleton pregnancy, admitted for a planned Caesarean delivery.
What does the study involve?
Participants are assessed on the day after the Caesarean to see whether they have recovered sufficiently to be considered for Day 1 discharge. If the mother and baby are considered fit, they are randomly allocated to be discharged either on Day 1 or Day 2. If they are not fit for discharge, they are discharged only when they are ready with standard follow-up to come. Participants attend follow up appointments after 2 and 6 weeks where they receive routine medical assessment and complete questionnaires. If they are not able to come for the follow-ups, we call them by telephone to get their responses to the questionnaires.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Antenatal and postnatal wards, University Malaya Medical Centre, Kuala Lumpur, Malaysia.
When is the study starting and how long is it expected to run for?
November 2010 to April 2012
Who is funding the study?
Department of Obstetrics and Gynaecology, University Malaya Medical Centre, Malaysia.
Who is the main contact?
Prof P C Tan
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
811.7
Study information
Scientific title
Hospital discharge on the first versus second day after planned cesarean delivery: a randomized trial
Acronym
Study hypothesis
Post caesarean Day 1 (next day) compared to Day 2 discharge will result in equivalent patient satisfaction and exclusive breastfeeding rates at 6 weeks.
Ethics approval
University of Malaya Medical Centre Medical Ethics Committee, 22/09/2010, ref: 811.7
Study design
Randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Caesarean delivery
Intervention
Hospital discharge after planned caesarean delivery: Day 1 (next day) or Day 2
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Patient satisfaction with allocated hospital discharge protocol assessed 2 weeks after discharge (5-point Likert scale)
2. Self reported exclusive breastfeeding at 6 weeks
Secondary outcome measures
At 2 weeks:
1. Satisfaction with discharge protocol based on the full 5-point Likert scale
2. General well being score using a 10 point numerical rating scale (NRS)
3. Recommendation of their timing of discharge after cesarean to a friend (5-point Likert scale)
4. Preferred length of hospital stay after cesarean
5. Infant feeding status
6. Baby unscheduled medical consultation
7. Maternal antibiotic
8. Cesarean wound condition
At 6 weeks:
1. General well being score [Numerical rating scale (NRS)]
2. Maternal unscheduled medical consultation
3. Baby unscheduled medical consultation
4. Maternal antibiotic
5. Cesarean wound condition
6. Assessment of maternal anxiety and depression using the Hospital Anxiety and Depression scale
Overall trial start date
05/11/2010
Overall trial end date
15/04/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Planned cesarean delivery
2. Age ≥ 18 years
3. Gestation ≥ 37 weeks
4. A singleton pregnancy
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
360
Participant exclusion criteria
1. ≥ 2 previous Cesarean
2. Major praevia
3. Grossly fetal anomaly
4. Pre eclampsia
5. Established medical disorders (e.g. pregestational diabetes, epilepsy, cardiac disease, renal disease, connective tissues disease, anti-phospholipid syndrome)
Recruitment start date
05/11/2010
Recruitment end date
15/04/2012
Locations
Countries of recruitment
Malaysia
Trial participating centre
University of Malaya
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya (Malaysia)
Sponsor details
Department of Obstetrics and Gynaecology
Faculty of Medicine
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Sponsor type
University/education
Website
http://medicine.um.edu.my/?modul=DEPARTMENTS&pilihan=Obstetrics_and_Gynecology
Funders
Funder type
University/education
Funder name
University of Malaya (Malaysia)
Alternative name(s)
University of Malaya, UM
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Malaysia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23104019
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23168750
Publication citations
-
Results
Chiong Tan P, Jin Norazilah M, Zawiah Omar S, Hospital Discharge on the First Compared With the Second Day After a Planned Cesarean Delivery: A Randomized Controlled Trial., Obstet Gynecol, 2012, doi: 10.1097/AOG.0b013e3182723a95.
-
Results
Tan PC, Norazilah MJ, Omar SZ, Hospital discharge on the first compared with the second day after a planned cesarean delivery: a randomized controlled trial., Obstet Gynecol, 2012, 120, 6, 1273-1282, doi: http://10.1097/AOG.0b013e3182723a95.