About this trial
The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
nulliparous
singleton
age 18-45
spontaneous pregnancy or autologous assisted fertilization
Disqualifiers
coagulopathy
autoimmune diseases
gestational diabetes
anticoagulant therapy
Trial design
Single group
Treatments tested in this trial
Hysterotomy closure
Procedure/SurgeryHysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.
Treatment groups
Trial outcomes
Primary outcomes
Intermenstrual bleeding reduction (days)
The primary outcome of the study is to evaluate weather there is a reduction of intermenstrual bleeding in the six months after cesarean section among the two groups of patients.
Secondary outcomes
Intra-operatory time
Evaluate evaluate weather there is a difference in operative time among the two groups of patients
Blood loss
Evaluate any difference in intra-operative blood loss (milliliters of blood)
Analgesics
Evaluate any difference in post-operative use of analgesics
Post-operatory recovery time
Evaluate any difference in post-operative recovery time (days)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.