Health TrialsbyHealthPanel

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

ConditionIsthmocele
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorLorenza Driul

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years;

Pregnant women at the time of ultrasound assessment;

Refusal to perform transvaginal ultrasound;

Type of hysterorrhaphy performed during surgery not known;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: single layer
Group B: double layer

Trial outcomes

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).

Time frame
3-4 months post cesarean section

Secondary outcomes

1

Different features of isthmocele according to type of hysteroraffia

To determine whether there are differences in isthmocele volume and residual myometrial thickness between patients undergoing hysteroraffia by single or double layer.

Time frame
3-4 months post cesarean section
2

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

Assess the impact of anamnestic data as possible risk factors for the development of isthmocele in the population considered.

Time frame
at enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lorenza Driul

Lead sponsor

University of Udine

Sponsor institution

Source ClinicalTrials.gov
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