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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03306953
Other study ID # 5678
Secondary ID
Status Completed
Phase N/A
First received October 6, 2017
Last updated February 1, 2018
Start date October 11, 2017
Est. completion date January 20, 2018

Study information

Verified date February 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date January 20, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Rectus muscle approximation
The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.

Locations

Country Name City State
Egypt Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital Cairo Greater Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early pain score Early pain score will be assessed by an investigator for patients 24 hours after cesarean section
Secondary Late pain score Late pain score will be assessed by an investigator for patients 48 hours after cesarean section
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