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 design	Randomized trial
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
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

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"	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 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?
Results article	results	01/12/2012		Yes	No
Results article	results	01/12/2012		Yes	No