NCT03306953

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 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, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

October 6, 2017

Last Update Submit

February 1, 2018

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Early pain score

    Early pain score will be assessed by an investigator for patients

    24 hours after cesarean section

Secondary Outcomes (1)

  • Late pain score

    48 hours after cesarean section

Study Arms (2)

Rectus muscle approximation

ACTIVE COMPARATOR

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

Procedure: Rectus muscle approximation

Control

NO INTERVENTION

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

Interventions

Rectus muscle approximationPROCEDURE

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

Rectus muscle approximation

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Eman F Omran, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 11, 2017

Study Start

October 11, 2017

Primary Completion

January 15, 2018

Study Completion

January 20, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

EG(1)