- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02679365
Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain
July 30, 2017 updated by: dr mohammed elsafty, Ain Shams Maternity Hospital
In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain.
One closure technique is double lock technique and the other is the conventional continuous non-locking technique.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- first cesarean section
Exclusion Criteria:
- urgent cesarean section
- previous abdominal surgery
- previous cesarean section
- obstetric and medical complications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: group a
This arm will have lower segment cesarean section done with double locking technique for closure of Rectus Sheath.
|
|
ACTIVE_COMPARATOR: group b
This arm will have lower segment cesarean section done with continuous non-locking technique for closure of rectus sheath.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative pain evaluated by VAS
Time Frame: first week postoperative
|
first week postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
operative time
Time Frame: intraoperative
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (ACTUAL)
July 1, 2017
Study Completion (ACTUAL)
July 1, 2017
Study Registration Dates
First Submitted
February 7, 2016
First Submitted That Met QC Criteria
February 9, 2016
First Posted (ESTIMATE)
February 10, 2016
Study Record Updates
Last Update Posted (ACTUAL)
August 1, 2017
Last Update Submitted That Met QC Criteria
July 30, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2476ASU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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