NCT03701048

Brief Summary

During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

3.4 years

First QC Date

October 6, 2018

Last Update Submit

January 7, 2024

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain: Visual Analog Score

    Visual Analog Scores, minimum score is 0, maximum score is 10. Score 10 represents highest pain score.

    24 hours after the procedure

  • Postoperative interrectus distance

    Distance between the margins of the rectus muscles in centimeters will be measured with ultrasonography

    6 weeks after the procedure

Study Arms (2)

reappoximation of rectus muscle

ACTIVE COMPARATOR

During Cesarean Section rectus muscle will be reapproximated with interrupted sutures.

Procedure: Cesarean Section

no reappoximation of rectus muscle

ACTIVE COMPARATOR

During Cesarean Section rectus muscle will not be closed.

Procedure: Cesarean Section

Interventions

Cesarean SectionPROCEDURE

Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.

no reappoximation of rectus musclereappoximation of rectus muscle

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old women undergoing cesarean section

You may not qualify if:

  • grandmultiparas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni SSRTH

Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (1)

  • Lyell DJ, Naqvi M, Wong A, Urban R, Carvalho B. Rectus Muscle Reapproximation at Cesarean Delivery and Postoperative Pain: A Randomized Controlled Trial. Surg J (N Y). 2017 Aug 11;3(3):e128-e133. doi: 10.1055/s-0037-1604074. eCollection 2017 Jul.

    PMID: 28840194BACKGROUND

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Berna Aslan A Çetin

    KSSTRH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md, ObGYN, Principal Investigator

Study Record Dates

First Submitted

October 6, 2018

First Posted

October 9, 2018

Study Start

October 15, 2018

Primary Completion

March 15, 2022

Study Completion

April 1, 2022

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)