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

Completed

• Conditions: First Trimester Abortion
• Interventions: Procedure: vaginal swab

• Registration Number: NCT03413774
• Lead Sponsor: Cairo University

Brief 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

Detailed 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).

Study Timeline

• Study Start: 2014-10-01
• Primary Completion: 2017-12-20
• Status Verified: 2018-01
• Study Completion: 2018-01-15
• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Last Update Submitted: 2018-01-22
• Study First Posted: 2018-01-29
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1850

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	vaginal swab	940 women attended Fayoum University hospitalpresented for any other gynecological complaint
Abortion group	vaginal swab	910 women attended Fayoum University hospital outpatient gynecology clinic with recent first trimesteric spontaneous miscarriage

Primary Outcome Measures

Name	Time	Method
prevalence of lower genital tract infection	At time of examination	candida, bacterial vaginosis , trichomonas , mycoplasmal or chlamydial infection

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt