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

NCT06308172 | Recruiting

• 1 other identifier: CSI/2021
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section; Dehiscence; Uterine Bleeding; Uterus; Scar; Uterus Abnormal; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Intra-operatory time

  6 months

• Blood loss

  6 months

• Analgesics

  6 months

• Post-operatory recovery time

  6 months

• Time to full patient mobilization

  6 months

Study Arms (2)

Single-layer

EXPERIMENTAL

Patients who are randomized in this arm undergo a single layer-hysterotomy closure

Procedure: Hysterotomy closure

Double-layer

EXPERIMENTAL

Patients who are randomized in this arm undergo a double layer-hysterotomy closure

Procedure: Hysterotomy closure

Interventions

Hysterotomy closure PROCEDURE

Hysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.

Double-layer; Single-layer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nulliparous
• singleton
• age 18-45
• spontaneous pregnancy or autologous assisted fertilization
• gestational age 38-40 weeks
• elective C-section
• informed consent

You may not qualify if:

• coagulopathy
• autoimmune diseases
• gestational diabetes
• anticoagulant therapy
• immunosuppressive therapy
• endometriosis
• uterine fibromatosis
• spontaneous labour
• connective tissue diseases

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano

Milan, Mi, 20122, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 25136167 BACKGROUND

• 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.

  PMID: 34729282 RESULT

• 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.

  PMID: 34955322 RESULT

• 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.

  PMID: 38154502 RESULT

• 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.

  PMID: 34738347 RESULT

• 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.

  PMID: 28070914 RESULT

MeSH Terms

Conditions

Uterine Hemorrhage; Cicatrix; Uterine Anomalies

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Officials

• Giuseppe Perugino, MD

  Ospedale Policlinico Maggiore Ca' Granda Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Perugino, MD

CONTACT

3383030553; giuseppe.perugino@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients are recruited and randomly assigned to either the "single-layer" or "double-layer" arm of the study. The randomization process occurs on the day of the cesarean section. Following randomization, patients are informed about their assigned group, and the cesarean section procedure is then carried out.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: December 1, 2021
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available by may 2025
• Access Criteria: Data will be shared upon reasonable request

Locations

IT (1)