Hospital discharge on the first versus second day after planned cesarean delivery

ISRCTN ISRCTN27523895
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Peng Chiong Tan
Scientific

Department of Obstetrics & Gynaecology
Faculty of Medicine
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Study information

Study designRandomized trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleHospital discharge on the first versus second day after planned cesarean delivery: a randomized trial
Study objectivesPost 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) studiedCaesarean delivery
InterventionHospital discharge after planned caesarean delivery: Day 1 (next day) or Day 2
Intervention typeOther
Primary outcome measure1. 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 measuresAt 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 date05/11/2010
Completion date15/04/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants360
Key inclusion criteria1. Planned cesarean delivery
2. Age ≥ 18 years
3. Gestation ≥ 37 weeks
4. A singleton pregnancy
Key exclusion criteria1. ≥ 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 enrolment05/11/2010
Date of final enrolment15/04/2012

Locations

Countries of recruitment

  • Malaysia

Study participating centre

University of Malaya
Kuala Lumpur
50603
Malaysia

Sponsor information

University of Malaya (Malaysia)
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
ROR logo "ROR" https://ror.org/00rzspn62

Funders

Funder type

University/education

University of Malaya (Malaysia)
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2012 Yes No
Results article results 01/12/2012 Yes No