NCT03609281

Brief Summary

This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

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

July 15, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

July 15, 2018

Last Update Submit

April 20, 2019

Conditions

Cesarean Scar NicheCesarean Wound; DehiscenceCesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (5)

  • Scar characteristics

    Site of scar in relation to internal os of cervix

    6 months

  • Scar length

    length of scar in mm

    6 months

  • thickness of scar

    Scar depth in mm

    6 months

  • Scar volume

    Length multiplied by width multiplied by depth

    6 months

  • Scar vascularity

    Doppler on scar to assess vascularity

    6 month

Secondary Outcomes (1)

  • Scar defect or niche

    6 months

Study Arms (2)

Scheduled cesaren group

Patient delivered by elective cesarean section without labour pains

Radiation: Ultrasound assessement of uterine scar

Emergency cesarean group

Patients delivered by cesarean section due to an emergency

Radiation: Ultrasound assessement of uterine scar

Interventions

Ultrasound assessement of uterine scarRADIATION

3D ultrasound assessment of scar characteristics

Emergency cesarean groupScheduled cesaren group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All patients will be selected according to inclusion and exclusion criteria.

You may qualify if:

  • Primipara delivered by cs
  • Multipara with last delivery by cs
  • Full term delivery \>37 weeks
  • Double layer cesarean repair
  • Pfannenstiel incison

You may not qualify if:

  • Repeat cs
  • Any placental abnormalities
  • Preterm delivery
  • Single layer cesarean repair
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Algharbia, 31111, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal investigator

Study Record Dates

First Submitted

July 15, 2018

First Posted

August 1, 2018

Study Start

August 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) are secret

Locations

EG(1)