First Trimester AbortionNCT03413774
Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections
An observational study of First Trimester Abortion, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- First Trimester Abortion
- What is being tested?
- vaginal swab
- Type of treatment
- Surgery or procedure
- How many people
- 1,850 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2014to 15 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- First Trimester Abortion
- Being tested
- vaginal swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal swabProcedure or surgery
Also called high vaginal swab
high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR
| Study group | Role | What they receive |
|---|---|---|
| Abortion group | 910 women attended Fayoum University hospital outpatient gynecology clinic with recent first trimesteric spontaneous miscarriage Receives: Procedure: vaginal swab | |
| Control group | 940 women attended Fayoum University hospitalpresented for any other gynecological complaint Receives: Procedure: vaginal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of lower genital tract infection
candida, bacterial vaginosis , trichomonas , mycoplasmal or chlamydial infection
Measured: At time of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Oct 2014
- Primary completion20 Dec 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Trimester AbortionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413774
- Sponsor's protocol ID
- 24
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2018
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections in Rural Area in Egypt
- ClinicalTrials.gov ID
- NCT03413774
- Acronym / sponsor ID
- 24
- Conditions
- First Trimester Abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,850 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abortion group | – | Procedure: vaginal swab910 women attended Fayoum University hospital outpatient gynecology clinic with recent first trimesteric spontaneous miscarriage |
| Control group | – | Procedure: vaginal swab940 women attended Fayoum University hospitalpresented for any other gynecological complaint |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal swabAlso: high vaginal swabhigh vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR | Procedure or surgery | Abortion group, Control group |
Primary outcome
prevalence of lower genital tract infection
Time frame: At time of examination
candida, bacterial vaginosis , trichomonas , mycoplasmal or chlamydial infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Research on Equity in Abortion Care by TeleHealth
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GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA
Miscarriage in First Trimester, Prenatal Genetic Diagnosis
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GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
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RecruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Trimester Abortion, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of lower genital tract infection (time frame: At time of examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.