Frequency of Isthmocele Following Single- Vs Double-layer Uterine Closure.
Frequency of Isthmocele Following Single- Vs Double-layer Uterine Closure. a Prospective and Retrospective Multicenter Observational Study
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Lorenza Driul
- Phone Number: +00393358385138
- Email: lorenza.driul@uniud.it
Study Contact Backup
- Name: Silvia Zermano
- Phone Number: +00393468624022
- Email: silvia.zermanso@asufc.sanita.fvg.it
Study Locations
-
-
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Udine, Italy, 33100
- Recruiting
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine
-
Contact:
- Lorenza Driul
-
Contact:
- Lorenza Driul
- Phone Number: +00393358385138
- Email: lorenza.driul@uniud.it
-
Contact:
- Silvia Zermano
- Phone Number: +00393468624022
- Email: silvia.zermano@asufc.sanita.fvg.it
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing elective or emergency/emergency caesarean section at the centres involved.
Exclusion Criteria:
- Age <18 years;
- Pregnant women at the time of ultrasound assessment;
- Refusal to perform transvaginal ultrasound;
- Type of hysterorrhaphy performed during surgery not known;
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
|
single layer
patients who underwent caesarean section with hysteroraffia performed in single layer
|
|
double layer
patients who underwent caesarean section with double-layer hysteroraffia
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of isthmocele
Time Frame: 3-4 months post cesarean section
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Different features of isthmocele according to type of hysteroraffia
Time Frame: 3-4 months post cesarean section
|
To determine whether there are differences in isthmocele volume and residual myometrial thickness between patients undergoing hysteroraffia by single or double layer.
|
3-4 months post cesarean section
|
|
The role of anamnestic data of patients as risk factor for isthmocele
Time Frame: at enrollment
|
Assess the impact of anamnestic data as possible risk factors for the development of isthmocele in the population considered.
|
at enrollment
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- 154230
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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