Unexplained Early Miscarriage : Role and Prevalence of Lo... | NCT03413774

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

NCT03413774

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 29, 2018Actual

Enrollment

1,850Actual

Phase

Not provided

Conditions

First Trimester Abortion

Interventions

vaginal swab

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2014Actual

Primary Completion Date

Dec 20, 2017Actual

Completion Date

Jan 15, 2018Actual

First Submitted Date

Jan 22, 2018

First Submission Date that Met QC Criteria

Jan 22, 2018

First Posted Date

Jan 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2018

Last Update Posted Date

Jan 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,850Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaginal swab	Procedure	high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR	Abortion group Control group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Maged	professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school		Cairo		12151	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided