Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

Qualifiers

nulliparous

singleton

age 18-45

spontaneous pregnancy or autologous assisted fertilization

Disqualifiers

coagulopathy

autoimmune diseases

gestational diabetes

anticoagulant therapy

Trial design

Treatments tested in this trial

  • Hysterotomy closure

Treatment groups

150 Participants
are divided into 2 treatment groups