NCT03413774

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

January 22, 2018

Last Update Submit

January 22, 2018

Conditions

First Trimester Abortion

Outcome Measures

Primary Outcomes (1)

  • prevalence of lower genital tract infection

    candida, bacterial vaginosis , trichomonas , mycoplasmal or chlamydial infection

    At time of examination

Study Arms (2)

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

vaginal swabPROCEDURE

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

Also known as: high vaginal swab
Abortion groupControl group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Study Officials

  • Ahmed Maged

    professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 29, 2018

Study Start

October 1, 2014

Primary Completion

December 20, 2017

Study Completion

January 15, 2018

Last Updated

January 29, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)