NCT04070118

Brief Summary

the purpose of the researchers; The aim of this study is to evaluate the consistency of niche dimensions measured by ultrasonography with visual measurement of the surgeon during the operation of the patient when presenting with pain in her current pregnancy. If patients who have had previous cesarean section present to the emergency department with pain or NST pain, a panic occurs immediately for operation. Purpose of researchers; The aim of this study is to investigate whether a really fine determination of the thickness of the old incision line is associated with full-thickness rupture or incomplete rupture, which appears to be an operation, and if a relationship is found, there is a limit for this thickness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

August 24, 2019

Last Update Submit

January 14, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Measure niche thickness with ultrasound

    Ultrasonography of Lower Uterine Segment Thickness in Pregnant Women Presenting with Term Pain and Previous Cesarean Section It will be given in mm.

    1 day

  • Measure niche thickness with visual evaluation of the surgeon

    Measured Lower Uterine Segment Thickness by Visual Evaluation of Pregnant Women Presenting with Term Pain and Previous Cesarean Section no rupture have full coat rupture have incomplete rupture; will be valued as.

    1 day

Study Arms (1)

patients with previous cesarean section

presenting to the emergency department with pain, previous cesarean section; Patients measured niche thickness before operation

Procedure: Measure niche thickness with ultrasound

Interventions

in patients with previous cesarean section who applied to the emergency department with pain and underwent surgery; Measure niche thickness before operation

patients with previous cesarean section

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

In Pregnant Women with Term Pain and Previous Cesarean Section; Patients with visual evaluation of the lower uterine segment thickness and ultrasound

You may qualify if:

  • Patients with a previous cesarean section
  • Those in term gestational week (37-42 weeks)
  • Those who apply to the emergency with pain

You may not qualify if:

  • Birden fazla sezaryen geçirilmiş öyküsü olan hastalar
  • Önceden geçirilmiş uterin cerrahisi olan hastalar
  • Miad olmayan gebeler
  • Plesantal yerleşim patolojısı olan gebeler

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pınar kadiroğulları M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 24, 2019

First Posted

August 28, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations