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

Launched by FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO · Mar 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different methods of closing the uterus after a cesarean section (C-section) can affect women's health, particularly looking at a condition called isthmocele, which can lead to problems like spotting between periods. Researchers want to find out if closing the uterus with one layer of stitches is better or worse than using two layers in terms of how long women experience spotting after surgery.

To participate in this study, women need to be between 18 and 45 years old, having their first baby through an elective C-section at 38 to 40 weeks of pregnancy. They should not have certain medical conditions, like bleeding disorders or autoimmune diseases. If eligible, participants will help researchers understand more about the best ways to close the uterus after a C-section and what effects this can have on their recovery. This trial is currently looking for volunteers, so if you meet the criteria and are interested, you could play an important role in improving future care for women undergoing C-sections.

Gender

FEMALE

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
• • immunosuppressive therapy
• • endometriosis
• • uterine fibromatosis
• • spontaneous labour
• • connective tissue diseases