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

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

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

Study Overview

• Status: Completed
• Conditions: First Trimester Abortion
• Intervention / Treatment: Procedure: vaginal swab

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 Type: Observational
• Enrollment (Actual): 1850

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Abortion group; 910 women attended Fayoum University hospital outpatient gynecology clinic with recent first trimesteric spontaneous miscarriage	Procedure: vaginal swab; high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR; Other Names: high vaginal swab
Control group; 940 women attended Fayoum University hospitalpresented for any other gynecological complaint	Procedure: vaginal swab; high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR; Other Names: high vaginal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of lower genital tract infection	candida, bacterial vaginosis , trichomonas , mycoplasmal or chlamydial infection	At time of examination

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Pregnancy Complications; Abortion, Spontaneous; Reproductive Tract Infections
• Other Study ID Numbers: 24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No