NCT07114705

Brief Summary

Aim of the work This study aims to investigate the relationship between the number of previous cesarean sections (CS) and the incidence of a cesarean scar niche.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Aug 2025

Status
not yet recruiting

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 Progress70%
Aug 2025Sep 2026

Study Start

First participant enrolled

August 2, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 3, 2025

Last Update Submit

August 3, 2025

Conditions

Keywords

Scar niche

Outcome Measures

Primary Outcomes (1)

  • Name Presence of Cesarean Scar Niche

    Detection of cesarean scar defect (niche) using transvaginal ultrasound.

    At time of ultrasound evaluation

Study Arms (1)

Group 1: Women with 1 Previous Cesarean Section or more

Diagnostic Test: Transvaginal ultrasound

Interventions

This is the only method

Group 1: Women with 1 Previous Cesarean Section or more

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes women of reproductive age who have undergone one or more cesarean section deliveries. Participants will be recruited from obstetrics and gynecology outpatient clinics. The study focuses on evaluating the presence and severity of scar niche in relation to the number of cesarean sections.

You may qualify if:

  • History of at least one previous cesarean section in non pregnant women.

You may not qualify if:

  • Women with known uterine anomalies (e.g., bicornuate uterus, uterine septum). Previous uterine surgery other than CS (e.g., myomectomy). History of uterine rupture in previous pregnancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at obs gyna department sohag university

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 11, 2025

Study Start

August 2, 2025

Primary Completion (Estimated)

August 2, 2026

Study Completion (Estimated)

September 2, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08