Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections

First Trimester Abortion Clinical Trial

Official title:

Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections in Rural Area in Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413774
• Other study ID #: 24
• Status: Completed
• Phase: N/A
• First received: January 22, 2018
• Last updated: January 22, 2018
• Start date: October 1, 2014
• Est. completion date: January 15, 2018

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint

Description:

The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint all patients were screened by serum samples to detect IgM / IgG to Chlamydia trachomatis (DRG Chlamydia Trachomatis IgM / IgG Enzyme immunoassay) and by high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR- (from +ve samples to chlamydial IgM / IgG).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1850
• Est. completion date: January 15, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• The Study group included Women with recent unexplained early miscarriage (pregnancy duration 12 weeks or less and miscarriage within 4 weeks)

• The control group included Women with any other gynecological complaint or in need of family planning

Exclusion Criteria:

• Miscarriage of Pregnancy duration more than 12 ws Documented causes of miscarriage as fetal or uterine anomalies, antiphospholipid syndrome, endocrine factors….etc

• Recent antibiotic, antifungal or antiprotozoal treatment

Related Conditions & MeSH terms

• Abortion, Spontaneous
• First Trimester Abortion
• Reproductive Tract Infections

Intervention

Procedure:
• vaginal swab
high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of lower genital tract infection	candida, bacterial vaginosis , trichomonas , mycoplasmal or chlamydial infection	At time of examination