The never ending debate single-layer versus double-layer closure of the uterine incision at cesarean section.
C V Hegde
https://pubmed.ncbi.nlm.nih.gov/25136167Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID06308172
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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of single-layer versus double-layer hysterotomy closure techniques on the development of cesarean niche (isthmocele) and related morbidity in women undergoing elective cesarean sections. The study aims to compare the incidence and severity of isthmocele and to determine if there is a reduction in the median duration of intermenstrual spotting between the two closure methods. This randomized controlled trial addresses limitations of previous research by standardizing the surgical technique and focusing on women without labor during cesarean delivery. The study involves two groups: one receiving a single-layer unlocked suture closure of the hysterotomy and the other receiving a double-layer unlocked suture closure. Both techniques are being assessed to understand their effects on post-cesarean scar formation and symptoms. The intervention is performed during elective cesarean sections on singleton pregnancies at 38-40 weeks gestation. The trial does not include blinding and uses randomized allocation. Participants will be followed for six months after surgery to assess outcomes such as intermenstrual bleeding duration, intraoperative time, blood loss, use of pain medications, recovery time, time to full mobilization, and the presence of isthmocele. Data collection includes monitoring surgical and recovery parameters as well as symptom tracking. The study helps determine which closure technique may reduce complications after cesarean delivery and improve patient recovery.
CONDITIONS
Brief Title
Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Who Can Participate
Age: 18Years +
FEMALE
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
- Elective cesarean section planned
- Provided informed consent
You will not qualify if you...
- Coagulopathy
- Autoimmune diseases
- Gestational diabetes
- Use of anticoagulant therapy
- Use of immunosuppressive therapy
- Endometriosis
- Uterine fibromatosis
- Spontaneous labour
- Connective tissue diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery plus hospital stay for recovery
Participants undergo an elective cesarean section with either single-layer or double-layer hysterotomy closure.
1 surgical visit and hospital stay
Post-operative Follow-up
Duration - 6 months
Participants are monitored for recovery, intermenstrual spotting, and uterine niche development.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano
Milan, Mi, Italy, 20122
Actively Recruiting
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Research Team
G
Giuseppe Perugino, MD
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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Published Research Related To This Trial
Single- Versus Double-Layer Uterine Closure After Cesarean Section Delivery: A Systematic Review and Meta-Analysis.
Kaif Qayum, Irfan Kar, Junaid Sofi...
https://pubmed.ncbi.nlm.nih.gov/34729282Effect of single- and double-layer cesarean section closure on residual myometrial thickness and isthmocele - a systematic review and meta-analysis.
Greg J Marchand, Ahmed Masoud, Alexa King...
https://pubmed.ncbi.nlm.nih.gov/34955322Single-layer vs double-layer uterine closure during cesarean delivery: 3-year follow-up of a randomized controlled trial (2Close study).
Carry Verberkt, Sanne I Stegwee, Lucet F Van der Voet...
https://pubmed.ncbi.nlm.nih.gov/38154502Impact of selected risk factors on uterine healing after cesarean section in women with single-layer uterine closure: A prospective study using two- and three-dimensional transvaginal ultrasonography.
Joanna Budny-Wińska, Aleksandra Zimmer-Stelmach, Michał Pomorski
https://pubmed.ncbi.nlm.nih.gov/34738347Risk of Cesarean scar defect following single- vs double-layer uterine closure: systematic review and meta-analysis of randomized controlled trials.
A Di Spiezio Sardo, G Saccone, R McCurdy...
https://pubmed.ncbi.nlm.nih.gov/28070914