New method for closing surgical incisions after cesarean sections to prevent complications
Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
This study is testing a new way to close surgical cuts after cesarean sections to see if it can help prevent complications like irregular bleeding and pelvic pain for women having their first cesarean delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 183 (estimated) |
| Ages | 17 Years to 50 Years |
| Sex | Female |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT04766073 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel incision closure technique aimed at preventing the formation of niches after cesarean sections. A niche is a complication characterized by a defect in the uterine wall that can lead to various symptoms such as irregular bleeding and pelvic pain. The study will involve women undergoing their first cesarean delivery, who will be randomly assigned to receive either the new closure method or standard care. The primary goal is to assess whether this unique suture technique can effectively reduce the incidence of niche formation compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates for this study are women who are undergoing their first cesarean delivery and are willing to consent to participate.
Not a fit: Patients who are having a repeat cesarean section or those requiring urgent/emergent cesarean deliveries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications associated with cesarean sections, improving quality of life for affected women.
How similar studies have performed: While previous studies have explored various surgical techniques for cesarean sections, this specific approach to preventing niche formation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women at first cesarean delivery * Women who consent to the study Exclusion Criteria: * Women who are having a repeat caesarean section * Refusal to participate in the study * Urgent or emergent cesarean delivery
Where this trial is running
Jerusalem
- Hadassah Medical Organization — Jerusalem, Israel (Recruiting)
Study contacts
- Principal investigator: Hila Hochler, MD — Hadassah Medical Organization
- Study coordinator: Hadas Lemberg, PhD
- Email: lhadas@hadassah.org.il
- Phone: +972 2 6777572
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.