Post-caesarean abdominal binder use: a study assessing maternal acceptability, satisfaction and body confidence

ISRCTN ISRCTN28754144
DOI https://doi.org/10.1186/ISRCTN28754144
Sponsor University of Malaya
Funder Universiti Malaya
Submission date
15/03/2026
Registration date
13/04/2026
Last edited
10/04/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Caesarean delivery is one of the most common surgical procedures performed worldwide. In Malaysia, about one in five women gives birth by Caesarean section. Although the operation is generally safe, many women experience pain, discomfort, and reduced mobility after surgery, which can affect recovery and daily activities.

An abdominal binder is a supportive elastic belt that is wrapped around the abdomen after surgery. It is sometimes used after Caesarean delivery to support the abdominal muscles and surgical wound. Some doctors believe that abdominal binders may help reduce pain, improve mobility, and increase comfort when women start moving after surgery. However, there is limited research on how acceptable or comfortable women find these binders and whether they improve confidence in movement during early recovery.

This study aims to evaluate whether wearing an abdominal binder after Caesarean delivery improves women’s satisfaction, comfort, and confidence in using their bodies during the first day after surgery.

Who can participate?
Women undergoing planned Caesarean delivery at the University Malaya Medical Centre.

What does the study involve?
Participants who agree will be randomly assigned to one of two groups. One group will wear a standard abdominal binder for the first 24 hours after surgery. The other group will wear a similar binder that does not apply pressure (a sham binder). Both groups will receive the same standard postoperative care and pain relief.

Researchers will ask participants about their comfort, satisfaction, and confidence in moving around 24 hours after surgery using simple questionnaires. Pain levels and the time taken to first walk after surgery will also be recorded. Participants will return for follow-up around seven days after surgery to assess wound healing and whether they continued using the binder.

What are the possible benefits and risks of participating?
The results of this study will help doctors understand whether abdominal binders are helpful and acceptable to women recovering from Caesarean delivery. This may help improve postoperative care and recovery for mothers after surgery.

Risks not provided at time of registration

Where is the study run from?
University of Malaysia.

When is the study starting and how long is it expected to run for?
April 2026 to December 2026

Who is funding the study?
University of Malaysia.

Who is the main contact?
Dr Khaulahradhiah Sahid, khaulahradhiah@ummc.edu.my, radhi_keir88@yahoo.com

Contact information

Dr Khaulahradhiah Sahid
Principal investigator, Public, Scientific

University of Malaysia Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13, Petaling Jaya, Wilayah Persekutuan
Kuala Lumpur
50603
Malaysia

Phone +60 0188722389
Email khaulahradhiah@ummc.edu.my

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlPlacebo
AssignmentParallel
PurposeSupportive care
Participant information sheet 49208_PIS_v4.0_30Dec2025.pdf
Scientific titlePostoperative satisfaction and acceptability following caesarean delivery: a randomized controlled trial comparing abdominal binder with sham binder use
Study acronymABCD
Study objectives To determine the impact of post-Caesarean application of abdominal binder based on patient-reported outcome measures of acceptability, satisfaction and confidence.
Ethics approval(s)

Approved 25/02/2026, Medical Research Ethics Committee Unversity of Malaya Medical Center (Lembah Pantai, Kuala Lumpur, 59100, Malaysia; +60 0379493209; ummc-mrec@ummc.edu.my), ref: 2025723-15382

Health condition(s) or problem(s) studiedPost cesarean delivery
InterventionEligible participants will be fitted with an appropriately sized abdominal binder (elastic, breathable, latex-free binder size S/ M/L/XL) after transfer out from the operating theatre. For the application of the appropriate abdominal binder according to the abdominal circumference, the abdomen will be measured with a standard measuring tape. Participants will be instructed to wear the binder continuously for the first 24 hours, only removing it for hygiene or clinical indications. Nursing staff will check binder fit and ask for symptoms of irritation or discomfort, and document any removals.

The method of randomisation will be by sealed envelopes.

Control/ Sham group: Participants allocated to the control group will receive a sham binder (tension-free binder). Binders will be pre-marked, and patients will be instructed to fasten the binder only up to the marked site to prevent tension application. The type and quality of the binder will be identical to that of the intervention group.

Standard care: Both groups will continue to receive routine postoperative care and standard analgesia according to hospital protocols. Compliance with the abdominal binder will be monitored, and time off from the use of the abdominal binder will be recorded. Any skin changes while on the abdominal binder will be assessed and recorded.
Intervention typeOther
Primary outcome measure(s)
  1. Patient's acceptability of the binder use measured using a 3-point Likert scale at 24 h, once only
  2. Patient satisfaction with binder use measured using a Verbal Numerical Rating Scale (VNRS) 0–10 (0 = not satisfied at all, 10 = very satisfied) at 24 h, once only
  3. Body confidence measured using a 2-item questionnaire: 1. “How well supported does your abdomen feel when you move around?” 2. How confident do you feel about using your body (standing, walking, and sitting) since surgery?” rated on a 5-point Likert scale: 1 = Not at all, 5 = completely at 24 h, once only
Key secondary outcome measure(s)
  1. Pain measured using VNRS 0–10 at first ambulation and at 24 h
  2. Time to first ambulation measured using data collected from Electronic Medical Records (EMR) at one time point
  3. Continued use of binder and wound assessment measured using the Redness (Hyperemia), Edema, Ecchymosis, Discharge, Approximation (Coaptation) (REEDA) at the postnatal clinic follow-up at day 7, once only
  4. Reason for early discontinuation measured using data collected from Electronic Medical Records (EMR) at 24 h before and after discharge
Completion date31/12/2026

Eligibility

Participant type(s)
Age groupAdult
Lower age limit18 Years
Upper age limit45 Years
SexFemale
Target sample size at registration150
Key inclusion criteria1. Age ≥18 years
2. Gestational age ≥36 weeks
3. Able to provide informed consent
Key exclusion criteria1. Caesarean delivery performed under general anaesthesia
2. Intraoperative blood loss >1 litre
3. Presence of abdominal drain or additional surgical procedures
4. History of chronic pelvic pain
5. Inability to fit the abdominal binder
6. Unable to attend physical clinic follow-up
Date of first enrolment13/04/2026
Date of final enrolment06/11/2026

Locations

Countries of recruitment

  • Malaysia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other files version 2.0 07/11/2025 16/03/2026 No No
Participant information sheet version 4.0 30/12/2025 16/03/2026 No Yes
Protocol file version 4.0 30/12/2025 16/03/2026 No No

Additional files

49208_PIS_v4.0_30Dec2025.pdf
Participant information sheet
49208_Protocol_v4.0_30Dec2025.pdf
Protocol file
49208_ConsentForm_v2.0_07Nov2025.pdf
Other files

Editorial Notes

10/04/2026: Study’s existence confirmed by the Medical Research Ethics Committee Unversity of Malaya Medical Center, Malaysia.