The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation

NCT ID: NCT03306953

Last Updated: 2018-02-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2018-01-20

Brief Summary

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This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery.

Detailed Description

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This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2 groups. Rectus muscle approximation will be done to the first group. The second group will be the control group.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Rectus muscle approximation

Three sutures will be done for the the purpose of rectus muscle approximation in cesarean section.

Group Type ACTIVE_COMPARATOR

Rectus muscle approximation

Intervention Type PROCEDURE

The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.

Control

No approximation for the rectus muscle will be done for the control group in cesarean section.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rectus muscle approximation

The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women who will undergo first elective cesarean section
* Singleton pregnancy

Exclusion Criteria

* Previous abdominal or pelvic surgery
* Medical or psychiatric disease
* Previous pelvic inflammatory disease
* Obesity
* Allergy to analgesics
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Eman Omran

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman F Omran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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5678

Identifier Type: -

Identifier Source: org_study_id

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