Relation between chronic endometritis and recurrent miscarriage

• Register: ANZCTR
• Last refreshed on: 14 November 2022
• Main ID: ACTRN12618000561280
• Date of registration: 13/04/2018
• Prospective Registration: Yes
• Primary sponsor: Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
• Public title: Relation between chronic endometritis and recurrent miscarriage
• Scientific title: Relation between chronic endometritis and recurrent miscarriage
• Date of first enrolment: 08/05/2018
• Target sample size: 120
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000561280.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial;
• Phase: Not Applicable

Countries of recruitment

Kuwait

Contacts

• Name: Prof Ibrahim A. Abdelazim

• Name: Prof Ibrahim A. Abdelazim

Key inclusion & exclusion criteria

Inclusion criteria: Patients and methods: Analysis of the hospital records over the last 5 years from January 2012 to January 2017 to identify women with unexplained recurrent miscarriage, after approval of the Obstetrics and Gynecology department.
Inclusion criteria includes; women who will give consent, >20-40 years, with 3 or more miscarriages before 22 weeks’ gestation.

Exclusion criteria: Exclusion criteria includes; family history of RM, uterine abnormalities, hormonal or metabolic disorders, severe male factor infertility, previous surgery for myoma and/or endometriosis, clinical or ultrasound diagnosis of endometriosis, known clinical autoimmune disease, anti-phospholipid syndrome (APS), thrombophilic condition requiring anticoagulant therapy, and unwilling to give informed consent.

Age minimum: 20 Years
Age maximum: 40 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Chronic endometritis ;
Chronic endometritis

Reproductive Health and Childbirth - Antenatal care

Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Intervention(s)

Analysis of the hospital records over the last 5 years from January 2012 to January 2017 to identify women with unexplained recurrent miscarriage, after approval of the Obstetrics and Gynecology department of Ahmadi hospital. Inclusion criteria includes; women who will give consent, >20-40 years, with 3 or more miscarriages before 22 weeks’ gestation.
Studied women will go under diagnostic hysteroscopy in the follicular phase of the menstrual cycle, and endometrial biopsy for histological examination.
Studied women diagnosed with chronic endometritis during hysteroscopy will scheduled for endometrial biopsy in the follicular phase of the subsequent cycle, The endometrial biopsy will be cultured for the common infectious pathogens which include; Neisseria gonorrhea, Chlamydia trachomatis, Mycoplasma species, Ureaplasma urealyticum, and yeast at the endometrial levels.
Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Duration of observation for each studied woman will be 5 weeks,

Primary Outcome(s)

Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Studied women will go under diagnostic hysteroscopy in the follicular phase of the menstrual cycle, with thorough evaluation of the endometrial mucosa.
Chronic endometritis defined as demonstration of micro-polyps that fluctuate in the cavity, stromal edema, and focal or diffuse hyperemia.
The surgeon will take an endometrial biopsy from studied women with evidence of chronic endometritis during hysteroscopic examination for histological examination. Studied women diagnosed with chronic endometritis during hysteroscopy will scheduled for endometrial biopsy in the follicular phase of the subsequent cycle, for cultural, and histological examinations.
Endometrial samples were diluted in 2 ml of saline, and divided into 2 samples, one for cultures, and the other placed in formalin for histological examination.
[Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Duration of observation for each studied woman will be 5 weeks,]

Causative organism for chronic endometritis using culture for the endometrial samples taken during hysteroscopy. [Results of endometrial culture takes about 3-5 days. ]

Secondary Outcome(s)

None [None ]

Secondary ID(s)

None

Source(s) of Monetary Support

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Secondary Sponsor(s)

Ibrahim A. Abdelazim

Souad Al-Ajmi

Mohannad AbuFaza

Ethics review

Status: Approved
Approval date: 25/12/2017
Contact:

Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.

Results

• Results available: Yes
• Date Posted: 22/11/2021
• Date Completed: 01/10/2020