NCT04891042

Brief Summary

The importance of isthmocele development due to primary cesarean section at the latent or active phase of labour

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 12, 2021

Last Update Submit

May 12, 2021

Conditions

Uterus; Scar

Outcome Measures

Primary Outcomes (1)

  • Isthmocele Development

    ISTHMOCELE DEVELOPMENT ACCORDİNG TO CERVİCAL DİLATATİON AND EFFACEMENTS

    10 months

Study Arms (2)

Latent Phase of Labour

Active Phase of Labour

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale pregnant patients between 32 and 41 weeks of gestation and who haven't received cesarean in their previous delivery will be included in the study
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant Patients at the age of minimum 18 to 45 and with the gestational weeks between 32 to 41, with no history of caesarean section and no confirmed placenta previa and/or invasion anomaly

You may qualify if:

  • Pregnant women with the gestational weeks between 32-41 primigravida or multigravida with no history of caesarean section

You may not qualify if:

  • Gestational age below 32 weeks
  • Confirmed Plasenta Previa and/or placental invasion anomalies
  • A history Caeserean Section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Maternity and Childrens Training and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

RESUL KARAKUS, MD

CONTACT

00905059164216resul-karakus@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 18, 2021

Study Start

February 1, 2021

Primary Completion

May 2, 2021

Study Completion

December 2, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)