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Completed

NCT Number: NCT03413774

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

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

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Key information

Conditions

First Trimester Abortion

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Kasr Alainy medical school

Cairo, 12151, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal swab

Procedure

high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR

Other names: high vaginal swab

Primary outcomes

  1. prevalence of lower genital tract infection

    Time frame: At time of examination

    candida, bacterial vaginosis , trichomonas , mycoplasmal or chlamydial infection

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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