NCT06564064

Brief Summary

The effect of abdominal binders on patient's wellbeing after cesarean delivery

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 19, 2024

Last Update Submit

August 19, 2024

Conditions

Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean Section

Keywords

binders, cesarean section , VAS, QOR 40

Outcome Measures

Primary Outcomes (1)

  • The effect of abdominal binders on pain after cesarean section

    abdominal binders will be fit on patient abdomin 2 hrs post cs and VAS will be assessed 12 hrs post cesarean section

    6 months

Secondary Outcomes (1)

  • The effect of abdominal binders on patient's wellbeing after cesarean delivery

    one week postoperatively

Study Arms (2)

study group Study group(Group1)

ACTIVE COMPARATOR

25 participant will be in study group (abdominal binders)

Device: abdominal binder

Control group (Group 2)

PLACEBO COMPARATOR

25 participants will be in control group

Device: abdominal binder

Interventions

abdominal binderDEVICE

study group will be abdominal binders and control group will be control group , 12 hrs and one week later VAS and QOR 40 will assess patient,s wellbeing

Control group (Group 2)study group Study group(Group1)

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • any female post cesarean section of singleton 34 wks gestaion fetus with previous cs

You may not qualify if:

  • primary cs any hypertensive disorder with pregnancy any neurologiacal disease general anasthesia or vertical incision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

RECRUITING

Related Publications (6)

  • Ghana S, Hakimi S, Mirghafourvand M, Abbasalizadeh F, Behnampour N. Randomized controlled trial of abdominal binders for postoperative pain, distress, and blood loss after cesarean delivery. Int J Gynaecol Obstet. 2017 Jun;137(3):271-276. doi: 10.1002/ijgo.12134. Epub 2017 Mar 28.

    PMID: 28241386BACKGROUND

  • Gustafson JL, Dong F, Duong J, Kuhlmann ZC. Elastic Abdominal Binders Reduce Cesarean Pain Postoperatively: A Randomized Controlled Pilot Trial. Kans J Med. 2018 May 18;11(2):1-19. eCollection 2018 May.

    PMID: 29796155BACKGROUND

  • Karaca I, Ozturk M, Alay I, Ince O, Karaca SY, Erdogan VS, Ekin M. Influence of Abdominal Binder Usage after Cesarean Delivery on Postoperative Mobilization, Pain and Distress: A Randomized Controlled Trial. Eurasian J Med. 2019 Oct;51(3):214-218. doi: 10.5152/eurasianjmed.2019.18457.

    PMID: 31692751BACKGROUND

  • Saeed S, Rage KA, Memon AS, Kazi S, Samo KA, Shahid S, Ali A. Use of Abdominal Binders after a Major Abdominal Surgery: A Randomized Controlled Trial. Cureus. 2019 Oct 3;11(10):e5832. doi: 10.7759/cureus.5832.

    PMID: 31754567BACKGROUND

  • Terkawi AS, Tsang S, Abolkhair A, Alsharif M, Alswiti M, Alsadoun A, AlZoraigi US, Aldhahri SF, Al-Zhahrani T, Altirkawi KA. Development and validation of Arabic version of the Short-Form McGill Pain Questionnaire. Saudi J Anaesth. 2017 May;11(Suppl 1):S2-S10. doi: 10.4103/sja.SJA_42_17.

    PMID: 28615999BACKGROUND

  • Terkawi AS, Myles PS, Riad W, Nassar SN, Mahmoud M, AlKahtani GJ, Sala FJ, Abdulrahman A, Doais KS, Terkawi RS, Tsang S. Development and validation of Arabic version of the postoperative quality of recovery-40 questionnaire. Saudi J Anaesth. 2017 May;11(Suppl 1):S40-S52. doi: 10.4103/sja.SJA_77_17.

    PMID: 28616003BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

esraa s abd ellatif, resident

CONTACT

01157145274esraa011002@med.sohag.edu.eg

abdou s aitallah, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
participant and investigator both are masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study group (abdominal binders) and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sohag - El Maragha city

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

July 15, 2024

Primary Completion

October 1, 2024

Study Completion

October 15, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations

EG(1)