The Use of Abdominal Binders in Patients Undergoing Cesarean Sections

NCT ID: NCT02129894

Last Updated: 2014-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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To see if the use of Abdominal Binders improves patients out comes after cesarean delivery

Detailed Description

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Inclusion: All patients admitted to labor and delivery

Consented patients who had a cesarean delivery will be randomized using a number table to receive or not receive an abdominal binder.

Outcomes: On postoperative days 1 and 2, patients were asked to complete a pain visual analog scale and the validated Symptom Distress Scale. Postoperative hemoglobin and hematocrit were also recorded.

Conditions

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Cesarean Section Post Operative Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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abdominal binder

Post cesarean section patients will get a abdominal binder placed

Group Type ACTIVE_COMPARATOR

abdominal Binder

Intervention Type DEVICE

placement of abdominal binder

No Abdominal Binder

Post cesarean section patients will not have abdominal binder

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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abdominal Binder

placement of abdominal binder

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Women undergoing cesarean section for any indication

Exclusion Criteria

* unable to give consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Luke's University Hospital

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James N Anasti, MD

Role: CONTACT

484-526-4670

Facility Contacts

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James N Anasti, MD

Role: primary

484-526-4670

References

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Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

Reference Type DERIVED
PMID: 32871021 (View on PubMed)

Gillier CM, Sparks JR, Kriner R, Anasti JN. A randomized controlled trial of abdominal binders for the management of postoperative pain and distress after cesarean delivery. Int J Gynaecol Obstet. 2016 May;133(2):188-91. doi: 10.1016/j.ijgo.2015.08.026. Epub 2016 Jan 14.

Reference Type DERIVED
PMID: 26892694 (View on PubMed)

Other Identifiers

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SLHN-50-14

Identifier Type: -

Identifier Source: org_study_id

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