Hospital discharge on the first versus second day after planned cesarean delivery
ISRCTN | ISRCTN27523895 |
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DOI | https://doi.org/10.1186/ISRCTN27523895 |
Secondary identifying numbers | 811.7 |
- Submission date
- 29/05/2012
- Registration date
- 06/06/2012
- Last edited
- 30/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Department of Obstetrics & Gynaecology
Faculty of Medicine
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Study information
Study design | Randomized trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Hospital discharge on the first versus second day after planned cesarean delivery: a randomized trial |
Study objectives | 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(s) | University of Malaya Medical Centre Medical Ethics Committee, 22/09/2010, ref: 811.7 |
Health condition(s) or problem(s) studied | Caesarean delivery |
Intervention | Hospital discharge after planned caesarean delivery: Day 1 (next day) or Day 2 |
Intervention type | Other |
Primary outcome measure | 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 study start date | 05/11/2010 |
Completion date | 15/04/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 360 |
Key inclusion criteria | 1. Planned cesarean delivery 2. Age ≥ 18 years 3. Gestation ≥ 37 weeks 4. A singleton pregnancy |
Key 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) |
Date of first enrolment | 05/11/2010 |
Date of final enrolment | 15/04/2012 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
50603
Malaysia
Sponsor information
University/education
Department of Obstetrics and Gynaecology
Faculty of Medicine
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Website | http://medicine.um.edu.my/?modul=DEPARTMENTS&pilihan=Obstetrics_and_Gynecology |
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https://ror.org/00rzspn62 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/12/2012 | Yes | No | |
Results article | results | 01/12/2012 | Yes | No |