Clinical trial NCT06308172: Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Official title: Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section; Dehiscence
Uterine Bleeding
Uterus; Scar
Uterus Abnormal
Cesarean Section Complications
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: Cesarean section, the most widely performed surgical procedure globally, has seen a significant increase in rates over the past decades, rising from 12.1% in 2000 to 21% in 2015 for various reasons. A recognized complication of cesarean sections is the formation of a uterine niche, commonly referred to as isthmocele. However, the true incidence of this post-operative complication remains uncertain, with reported figures ranging widely from 7% to 80%. The considerable variability in these estimates is attributed in part to the varying sensitivity of diagnostic tools. Moreover, there is a lack of consensus in the literature regarding the definition of a cesarean niche, particularly concerning the dimensions of the defect.

Recent well-designed randomized controlled trials have investigated the long-term outcomes of single versus double-layer hysterotomy closure during C-sections. These studies found no significant differences in isthmocele incidence or intermenstrual spotting. However, limitations such as the lack of correlation between symptom severity and uterine defect dimensions, the inclusion of women in labor, and relatively short follow-up periods are acknowledged weaknesses, prompting the need for further analysis.

Our objective is to compare the outcomes of single versus double-layer hysterotomy closure in terms of intermenstrual spotting and isthmocele incidence in singleton women undergoing elective C-sections. Crucially, standardizing the surgical suturing technique is essential to mitigate potential misleading outcomes resulting from inter-operator variations.

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

Primary outcomes:
measure: Intermenstrual bleeding reduction (days)
timeFrame: 6 months
Secondary outcomes:
measure: Intra-operatory time
timeFrame: 6 months
measure: Blood loss
timeFrame: 6 months
measure: Analgesics
timeFrame: 6 months
measure: Post-operatory recovery time
timeFrame: 6 months
measure: Time to full patient mobilization
timeFrame: 6 months
measure: Isthmocele
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano
state: Mi
Study officials:
affiliation: Ospedale Policlinico Maggiore Ca' Granda Milano
name: Giuseppe Perugino, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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 review and meta-analysis. Turk J Obstet Gynecol. 2021 Dec 24;18(4):322-332. doi: 10.4274/tjod.galenos.2021.71173.
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 randomized controlled trial (2Close study). Am J Obstet Gynecol. 2024 Sep;231(3):346.e1-346.e11. doi: 10.1016/j.ajog.2023.12.032. Epub 2023 Dec 26.
citation: 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 Clin Exp Med. 2022 Jan;31(1):41-48. doi: 10.17219/acem/142519.
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. 2017 Nov;50(5):578-583. doi: 10.1002/uog.17401. Epub 2017 Oct 9.