Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Recruiting
N/A
Interventional Study
Cesarean Section; Dehiscence
Uterine Bleeding
Uterus; Scar
Uterus Abnormal
Cesarean Section Complications
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 150 (estimated)
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Other
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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 respec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* nulliparous
* singleton
* age 18-45
* spontaneous pregnancy or autologous assisted fertilization
* gestational age 38-40 weeks
* elective C-section
* informed consent
Exclusion Criteria:
* coagulopathy
* autoimmune diseases
* gestational diabetes
* anticoagulant therapy
* im…
Contacts