Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
150 participants
Dec 1, 2021
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- nulliparous
- singleton
- age 18-45
- spontaneous pregnancy or autologous assisted fertilization
- gestational age 38-40 weeks
- elective C-section
- informed consent
Exclusion Criteria9
- coagulopathy
- autoimmune diseases
- gestational diabetes
- anticoagulant therapy
- immunosuppressive therapy
- endometriosis
- uterine fibromatosis
- spontaneous labour
- connective tissue diseases
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Interventions
Hysterotomy 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.
Locations(1)
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NCT06308172