Comparing single-layer and double-layer closure techniques in cesarean sections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Reflexology and hand massage after cesarean section

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.