Uterine Inflammatory Characteristics

December 3, 2023 updated by: Dr. Aya Mohr-Sasson, Sheba Medical Center

Uterine Inflammatory Characteristics Following Cesarean Delivery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Aya Mohr Sasson, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an estimated period of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Niche characteristics-Residual myometrial thickness
Time Frame: During sonographic evaluation performed immediately following diagnostic hysteroscopy
Evaluated in millimeters
During sonographic evaluation performed immediately following diagnostic hysteroscopy
Niche characteristics-Adjacent myometrial thickness
Time Frame: During sonographic evaluation performed immediately following diagnostic hysteroscopy
Evaluated in millimeters
During sonographic evaluation performed immediately following diagnostic hysteroscopy
Niche characteristics-Depth
Time Frame: During sonographic evaluation performed immediately following diagnostic hysteroscopy
Evaluated in millimeters
During sonographic evaluation performed immediately following diagnostic hysteroscopy
Niche characteristics-Length
Time Frame: During sonographic evaluation performed immediately following diagnostic hysteroscopy
Evaluated in millimeters
During sonographic evaluation performed immediately following diagnostic hysteroscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Aya M Mohr-Sasson, M.D, Sheba Medical Center, Tel-Hashomer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7975-20-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will be available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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