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Uterine Inflammatory Characteristics

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ClinicalTrials.gov Identifier: NCT04747418
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Cesarean Section Complications Fertility Disorders Procedure: Diagnostic Hysteroscopy Procedure: Trans-vaginal ultrasound

Detailed Description:

Background As the rate of caesarean section continues to increase, concern regarding the association between delivery by caesarean section and long-term maternal morbidity has been growing . In the past decade, several articles have described a defect that can be seen on ultrasound at the site of the caesarean delivery scar, known as a 'niche' . A 'niche' describes the presence of a hypoechoic area within the myometrium of the lower uterine segment, reflecting a discontinuation of the myometrium at the site of a previous cesarean delivery. An incompletely healed scar is a long-term complication of cesarean delivery and is associated with symptoms such as postmenstrual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. Furthermore, it can increase rates of complications during gynaecological procedures and it is associated with higher complication rate in subsequent pregnancy including: risk of rupture and morbidly adherent placenta.

Lately, a surgical resection of the abnormal myometrial area has been proposed mainly for symptomatic women, or for women that are planning future pregnancy. Different techniques have been used including hysteroscopy, laparoscopy and vaginal repair. Consideration of the surgical approach is usually determined by the patient's plans for fertility and by niche thickness. For women who do not desire pregnancy and whose niche thickness is >3 mm, a hysteroscopic approach is considered. Patients who desire future fertility, especially those with <3 mm of myometrium at the niche site, is usually recommended laparoscopic resection.

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. Additional theories address the mechanical changes influencing the myometrium and the discontinuation of the endometrium at the site of the niche. Gurol Urganci et al. reported in a meta-analysis including 16 studies, that caesarean delivery reduces the probability of subsequent pregnancy by 10% [relative risk (RR) 0.91; 95% 0.87-0.95] on average, compared with a previous vaginal delivery, however, none of the studies included in the meta-analysis evaluated the relation between subsequent fertility and the presence of a niche. So far there is no definite proof for niche as a cause of infertility. Should this be supported by randomized controlled trials, it would be grounds for providing treatment that will expectedly lead to beneficial effects on reproductive outcomes. This yet needs to be proven in.

Due to the aforementioned, the aim of our study is to compare the inflammatory characteristics of women with cesarean uterine scar to those without.

Material and Methods This is a prospective study including all women visiting hysteroscopy ambulatory clinics for diagnostic hysteroscopy . All women meeting inclusion criteria will sign informed consent prior to the hysteroscopy after given explanation by one of the research team. During hysteroscopy 5 cc of the flushed water, that usually is drilled into a collecting bin that is thrown away, will be collect threw a small outlet port using a syringe connected to the outlet port of the hysteroscope. Women with normal diagnostic hysteroscopy will be included in the study. Those with low segment cesarean deliver scar will comprise the study arm and will be compared to women with no uterine scar (controls). Samples will be send to the IVF laboratory for analyzing inflammatory characteristics. Date regarding demographics, obstetrical and gynecological history will be collected from women's medical records. Primary outcome is defined as the level of inflammatory cytokines as a composite outcome

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Uterine Inflammatory Characteristics Following Cesarean Delivery
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Collection of first 5 cc of normal saline from the output port during diagnostic hysteroscopy

Procedure: Trans-vaginal ultrasound
Trans vaginal ultrasound performed immediately following the diagnostic hysteroscopy ( as sonohysterography)
Cohort Group: Women with no uterine scar
Women with no uterine scar, with no other abnormalities observed during diagnostic hysteroscopy
 Procedure: Diagnostic Hysteroscopy
Collection of first 5 cc of normal saline from the output port during diagnostic hysteroscopy


Outcome Measures
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Primary Outcome Measures :
  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 ) [ Time Frame: Through study completion, an estimated period of 1 year ]
    All parameters will be evaluated in picogram/milliliter


Secondary Outcome Measures :
  1. Niche characteristics-Residual myometrial thickness [ Time Frame: During sonographic evaluation performed immediately following diagnostic hysteroscopy ]
    Evaluated in millimeters

  2. Niche characteristics-Adjacent myometrial thickness [ Time Frame: During sonographic evaluation performed immediately following diagnostic hysteroscopy ]
    Evaluated in millimeters

  3. Niche characteristics-Depth [ Time Frame: During sonographic evaluation performed immediately following diagnostic hysteroscopy ]
    Evaluated in millimeters

  4. Niche characteristics-Length [ Time Frame: During sonographic evaluation performed immediately following diagnostic hysteroscopy ]
    Evaluated in millimeters


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Women with other uterine scars (following myomectomy, T/J scar)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747418


Contacts
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Contact: Aya M Mohr-Sasson, M.D 0523692906 mohraya@gmail.com
Contact: Aya M Mohr- Sasson, M.D 0523692906 mohraya@gmail.com

Locations
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Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Aya Mohr Sasson, M.D         
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Aya M Mohr-Sasson, M.D Sheba Medical Center, Tel-Hashomer
More Information
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Publications of Results:

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Responsible Party: Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04747418    
Other Study ID Numbers: 7975-20-SMC
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will be available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Aya Mohr-Sasson, Sheba Medical Center:
Cesarean Section Complications
Fertility Disorder
Inflammatory characteristics