Actively Recruiting
Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-03-13
150
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Nulliparous women
- Singleton pregnancy
- Age between 18 and 45 years
- Spontaneous pregnancy or autologous assisted fertilization
- Gestational age between 38 and 40 weeks
- Scheduled for elective cesarean section
- Provided informed consent
You will not qualify if you...
- History of coagulopathy
- Presence of autoimmune diseases
- Diagnosis of gestational diabetes
- Current anticoagulant therapy
- Use of immunosuppressive therapy
- Diagnosis of endometriosis
- Presence of uterine fibromatosis
- Experiencing spontaneous labor
- Presence of connective tissue diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano
Milan, Mi, Italy, 20122
Actively Recruiting
Research Team
G
Giuseppe Perugino, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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