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CompletedNCT03306953Updated Feb 5, 2018

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

An interventional study of Rectus muscle approximation in Pain, Postoperative, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Pain, Postoperative

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03

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous abdominal or pelvic surgery
  • Medical or psychiatric disease
  • Previous pelvic inflammatory disease
  • Obesity
  • Allergy to analgesics
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
280 participants (actual)

Study arms

  • Active comparator
    Rectus muscle approximation

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

    Procedure: Rectus muscle approximation

  • No intervention
    Control

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

Interventions

  • ProcedureRectus muscle approximation

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

05

What researchers measure

Primary outcomes

  1. Early pain score

    Early pain score will be assessed by an investigator for patients

    Time frame: 24 hours after cesarean section

Secondary outcomes

  1. Late pain score

    Late pain score will be assessed by an investigator for patients

    Time frame: 48 hours after cesarean section

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Study locations

1 site
  • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
    Cairo, Greater Cairo 11956, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03306953
Lead sponsor
Cairo University
Responsible party
Eman Omran (principal investigator, Cairo University) — Principal investigator
First posted
Oct 11, 2017
Start date
Oct 11, 2017
Primary completion
Jan 15, 2018
Completion
Jan 20, 2018
Last update
Feb 5, 2018

Study contacts

Eman F Omran, M.D.
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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