ISRCTN - ISRCTN27523895: Hospital discharge on the first versus second day after planned cesarean delivery

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

Contact information

Type

Scientific

Primary contact

Prof Peng Chiong Tan

ORCID ID

Contact details

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

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