Uterine Inflammatory Characteristics

NCT04747418 | Completed

• 1 other identifier: 7975-20-SMC
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

Data regarding fertility following niche repair is limited. It has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. One possible theory refers to inflammatory process at the area of the niche that harms the endometrial environment. Due to the aforementioned, the aim of our study is to compare the inflammatory characteristics of women with cesarean uterine scar to those without.

Conditions

Cesarean Section Complications; Fertility Disorders

Keywords

Cesarean Section Complications; Fertility Disorder; Inflammatory characteristics

Outcome Measures

Primary Outcomes (1)

• Level of inflammatory cytokines ( Granulocyte Macrophage colony stimulating factor(GM-CSF), Interferone-GAMMA, Interleukin(IL)-1,IL-2,IL-5,IL-6,IL-7,IL13,IL-15, IL-17, IL-22, IL-23,IL-31,IL-33,IL-36, Tumor Necrosis Factor (TNF) -ALPHA )

  All parameters will be evaluated in picogram/milliliter

  Through study completion, an estimated period of 1 year

Secondary Outcomes (4)

• Niche characteristics-Residual myometrial thickness

  During sonographic evaluation performed immediately following diagnostic hysteroscopy

• Niche characteristics-Adjacent myometrial thickness

  During sonographic evaluation performed immediately following diagnostic hysteroscopy

• Niche characteristics-Depth

  During sonographic evaluation performed immediately following diagnostic hysteroscopy

• Niche characteristics-Length

  During sonographic evaluation performed immediately following diagnostic hysteroscopy

Study Arms (2)

Study Group: Women with low segment uterine scar following cesarean delivery

Women with low segment uterine scar following cesarean delivery, with no other abnormalities observed during diagnostic hysteroscopy

Procedure: Diagnostic Hysteroscopy; Procedure: Trans-vaginal ultrasound

Cohort Group: Women with no uterine scar

Women with no uterine scar, with no other abnormalities observed during diagnostic hysteroscopy

Procedure: Diagnostic Hysteroscopy

Interventions

Diagnostic Hysteroscopy PROCEDURE

Collection of first 5 cc of normal saline from the output port during diagnostic hysteroscopy

Cohort Group: Women with no uterine scar; Study Group: Women with low segment uterine scar following cesarean delivery

Trans-vaginal ultrasound PROCEDURE

Trans vaginal ultrasound performed immediately following the diagnostic hysteroscopy ( as sonohysterography)

Study Group: Women with low segment uterine scar following cesarean delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with low segment uterine scar following cesarean delivery ( Study group ) and women with no uterine scar ( Controls), that have no abnormal finding on diagnostic hysterocopy.

You may qualify if:

• Fertility age 18-45
• No abnormal finding during hysteroscopy

You may not qualify if:

• Women with other uterine scars (following myomectomy, T/J scar)

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (13)

• van der Voet LF, Bij de Vaate AM, Veersema S, Brolmann HA, Huirne JA. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding. BJOG. 2014 Jan;121(2):236-44. doi: 10.1111/1471-0528.12542.

  PMID: 24373597 RESULT

• Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.

  PMID: 21858885 RESULT

• Roberge S, Boutin A, Chaillet N, Moore L, Jastrow N, Demers S, Bujold E. Systematic review of cesarean scar assessment in the nonpregnant state: imaging techniques and uterine scar defect. Am J Perinatol. 2012 Jun;29(6):465-71. doi: 10.1055/s-0032-1304829. Epub 2012 Mar 7.

  PMID: 22399223 RESULT

• Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.

  PMID: 26409016 RESULT

• Wang CB, Chiu WW, Lee CY, Sun YL, Lin YH, Tseng CJ. Cesarean scar defect: correlation between Cesarean section number, defect size, clinical symptoms and uterine position. Ultrasound Obstet Gynecol. 2009 Jul;34(1):85-9. doi: 10.1002/uog.6405.

  PMID: 19565535 RESULT

• Brown K, Tkacz Z. Hysteroscopic and laparoscopic management of caesarean scar (niche) defects in symptomatic patients. J Obstet Gynaecol. 2018 Jul;38(5):730. doi: 10.1080/01443615.2018.1444394.

  PMID: 29944046 RESULT

• Vervoort AJ, Van der Voet LF, Witmer M, Thurkow AL, Radder CM, van Kesteren PJ, Quartero HW, Kuchenbecker WK, Bongers MY, Geomini PM, de Vleeschouwer LH, van Hooff MH, van Vliet HA, Veersema S, Renes WB, van Meurs HS, Bosmans J, Oude Rengerink K, Brolmann HA, Mol BW, Huirne JA. The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial. BMC Womens Health. 2015 Nov 12;15:103. doi: 10.1186/s12905-015-0260-8.

  PMID: 26563197 RESULT

• van der Voet LF, Vervoort AJ, Veersema S, BijdeVaate AJ, Brolmann HA, Huirne JA. Minimally invasive therapy for gynaecological symptoms related to a niche in the caesarean scar: a systematic review. BJOG. 2014 Jan;121(2):145-56. doi: 10.1111/1471-0528.12537.

  PMID: 24373589 RESULT

• Hemminki E. Impact of caesarean section on future pregnancy--a review of cohort studies. Paediatr Perinat Epidemiol. 1996 Oct;10(4):366-79. doi: 10.1111/j.1365-3016.1996.tb00062.x.

  PMID: 8931052 RESULT

• Naji O, Wynants L, Smith A, Abdallah Y, Saso S, Stalder C, Van Huffel S, Ghaem-Maghami S, Van Calster B, Timmerman D, Bourne T. Does the presence of a Caesarean section scar affect implantation site and early pregnancy outcome in women attending an early pregnancy assessment unit? Hum Reprod. 2013 Jun;28(6):1489-96. doi: 10.1093/humrep/det110. Epub 2013 Apr 12.

  PMID: 23585560 RESULT

• Gurol-Urganci I, Bou-Antoun S, Lim CP, Cromwell DA, Mahmood TA, Templeton A, van der Meulen JH. Impact of Caesarean section on subsequent fertility: a systematic review and meta-analysis. Hum Reprod. 2013 Jul;28(7):1943-52. doi: 10.1093/humrep/det130. Epub 2013 May 3.

  PMID: 23644593 RESULT

• Vissers J, Hehenkamp W, Lambalk CB, Huirne JA. Post-Caesarean section niche-related impaired fertility: hypothetical mechanisms. Hum Reprod. 2020 Jul 1;35(7):1484-1494. doi: 10.1093/humrep/deaa094.

  PMID: 32613231 RESULT

• Vitale SG, Ludwin A, Vilos GA, Torok P, Tesarik J, Vitagliano A, Lasmar RB, Chiofalo B. From hysteroscopy to laparoendoscopic surgery: what is the best surgical approach for symptomatic isthmocele? A systematic review and meta-analysis. Arch Gynecol Obstet. 2020 Jan;301(1):33-52. doi: 10.1007/s00404-020-05438-0. Epub 2020 Jan 27.

  PMID: 31989288 RESULT

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Aya M Mohr-Sasson, M.D

  Sheba Medical Center, Tel-Hashomer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 10, 2021
• Study Start: February 1, 2021
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

IL (1)