Cesarean Section Complications Clinical Trial
Official title:
Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 1, 2026 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano | Milan | Mi |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
Budny-Winska J, Zimmer-Stelmach A, Pomorski M. Impact 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. Adv Cli — View Citation
Di Spiezio Sardo A, Saccone G, McCurdy R, Bujold E, Bifulco G, Berghella V. Risk of Cesarean scar defect following single- vs double-layer uterine closure: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 201 — View Citation
Hegde CV. The never ending debate single-layer versus double-layer closure of the uterine incision at cesarean section. J Obstet Gynaecol India. 2014 Aug;64(4):239-40. doi: 10.1007/s13224-014-0573-9. Epub 2014 Jul 23. No abstract available. — View Citation
Marchand GJ, Masoud A, King A, Ruther S, Brazil G, Ulibarri H, Parise J, Arroyo A, Coriell C, Goetz S, Christensen A, Sainz K. Effect of single- and double-layer cesarean section closure on residual myometrial thickness and isthmocele - a systematic revie — View Citation
Qayum K, Kar I, Sofi J, Panneerselvam H. Single- Versus Double-Layer Uterine Closure After Cesarean Section Delivery: A Systematic Review and Meta-Analysis. Cureus. 2021 Sep 30;13(9):e18405. doi: 10.7759/cureus.18405. eCollection 2021 Sep. — View Citation
Verberkt C, Stegwee SI, Van der Voet LF, Van Baal WM, Kapiteijn K, Geomini PMAJ, Van Eekelen R, de Groot CJM, de Leeuw RA, Huirne JAF; 2Close study group. Single-layer vs double-layer uterine closure during cesarean delivery: 3-year follow-up of a randomi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intermenstrual bleeding reduction (days) | The primary outcome of the study is to evaluate weather there is a reduction of intermenstrual bleeding in the six months after cesarean section among the two groups of patients. | 6 months | |
Secondary | Intra-operatory time | Evaluate evaluate weather there is a difference in operative time among the two groups of patients | 6 months | |
Secondary | Blood loss | Evaluate any difference in intra-operative blood loss (milliliters of blood) | 6 months | |
Secondary | Analgesics | Evaluate any difference in post-operative use of analgesics | 6 months | |
Secondary | Post-operatory recovery time | Evaluate any difference in post-operative recovery time (days) | 6 months | |
Secondary | Time to full patient mobilization | Evaluate any difference in post-operative time to full mobilization | 6 months | |
Secondary | Isthmocele | Evaluate any difference in isthmocele incidence between the two groups | 6 months |
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