Frequency of Isthmocele Following Single- Vs Double-layer Uterine Closure.

NCT06708234 | Recruiting

• 1 other identifier: 154230
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to compare the frequency of isthmocele after caesarean section according to the type of hysteroraffia performed (single or double layer suture).

Conditions

Isthmocele

Keywords

isthmocele; cesarean section; ultrasound

Outcome Measures

Primary Outcomes (1)

• Frequency of isthmocele

  The main objective of this study is to compare the frequency of isthmocele after caesarean section according to the type of hysteroraffia performed (single or double layer suture).

  3-4 months post cesarean section

Secondary Outcomes (2)

• Different features of isthmocele according to type of hysteroraffia

  3-4 months post cesarean section

• The role of anamnestic data of patients as risk factor for isthmocele

  at enrollment

Study Arms (2)

single layer

patients who underwent caesarean section with hysteroraffia performed in single layer

double layer

patients who underwent caesarean section with double-layer hysteroraffia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients attending the Friuli Centrale University Health Authority - Obstetrics and Gynaecology of Tolmezzo

You may qualify if:

• Patients undergoing elective or emergency/emergency caesarean section at the centres involved.

You may not qualify if:

• Age \<18 years;
• Pregnant women at the time of ultrasound assessment;
• Refusal to perform transvaginal ultrasound;
• Type of hysterorrhaphy performed during surgery not known;

Sponsors & Collaborators

• Lorenza Driul: lead

Study Sites (1)

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine

Udine, Udine, 33100, Italy

RECRUITING

Central Study Contacts

Lorenza Driul

CONTACT

+00393358385138; lorenza.driul@uniud.it

Silvia Zermano

CONTACT

+00393468624022; silvia.zermanso@asufc.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, Head of the Clinic Gynecology and Obstetrics Clinic

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: May 9, 2024
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

IT (1)