Comparing single-layer and double-layer closure techniques in cesarean sections
Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
This study is testing whether closing the uterus with one layer or two layers after a cesarean section affects the amount and length of spotting women experience afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, Mi) |
| Trial ID | NCT06308172 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the differences in incidence and severity of isthmocele morbidity among women undergoing elective cesarean sections with either single or double-layer hysterotomy closure. The study will focus on measuring the median duration of intermenstrual spotting as the primary outcome. By standardizing surgical techniques and addressing limitations from previous studies, this research seeks to provide clearer insights into the potential complications associated with cesarean deliveries. The trial will include nulliparous women aged 18-45 with singleton pregnancies at 38-40 weeks gestation.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous women aged 18-45 who are undergoing elective cesarean sections.
Not a fit: Patients with coagulopathy, autoimmune diseases, or those undergoing spontaneous labor will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that minimize complications related to cesarean sections.
How similar studies have performed: Previous studies have shown mixed results regarding the impact of closure techniques on isthmocele incidence, indicating that this area remains an important field for further investigation.
Eligibility criteria
Show full inclusion / exclusion 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 * immunosuppressive therapy * endometriosis * uterine fibromatosis * spontaneous labour * connective tissue diseases
Where this trial is running
Milan, Mi
- Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Perugino, MD — Ospedale Policlinico Maggiore Ca' Granda Milano
- Study coordinator: Giuseppe Perugino, MD
- Email: giuseppe.perugino@policlinico.mi.it
- Phone: 3383030553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.