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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02361164 |
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Date of registration:
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06/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Birth Cohort Study for Respiratory Infections
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Scientific title:
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Prospective Two-year Observational Study to Evaluate the Effect of Bacterial Colonisation of the Nasopharynx on the Occurence of Acute Respiratory Infections in a Birth Cohort of Children and Their Mothers |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02361164 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Shafiqul Alam Sarker, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Center for Diarrheal Disease Research, Bangladesh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age: 18-35 years
- Parity: any but with history of previous normal delivery
- Weight: Body Mass Index greater than 18.5 but less than 35
- Past obstetric history: Uncomplicated pregnancy, unremarkable medical and obstetric
conditions
- Current pregnancy: Uneventful progression of pregnancy
- General health: Normal health related functional status during pregnancy
- Singleton pregnancy as determined by clinical examination and/or by ultrasonography
- Cephalic presentation as determined by abdominal clinical examination
- Expected to have normal pregnancy related outcome
- Written informed consent
Exclusion Criteria:
- Medical history: Known history of diabetes, hypertension, or any systemic disorder
- Gynecological history: History of major gynecological problem/treatment
- Complications in previous pregnancy
- Previous obstetric cholestasis
- Previous acute fatty liver disease
- Conditions during current pregnancy
1. RhD negative mother
2. APH/Placental abruption
3. Placenta Praevia
4. Unstable lie
5. Multiple pregnancy
6. Pregnancy induced hypertension (systolic > 140 mm of Hg, diastolic > 90 mm of Hg)
7. Severe pre-eclampsia or eclampsia
8. Gestational diabetes
9. Onstetric cholestasis
10. Current history of drug/alcohol abuse
11. BMI of less than 18.5 or more than 35. Severe pallor as detected clinically or by
HB level (< 7 gm/dL), and oedema
12. Blood samples drawn and tested for VDRL (Positive VDRL) Cephalopelvic
disproportion (CPD)
13. History of taking antibiotic within 3 weeks prior to this study
14. Patient unwilling to comply with study protocol
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Upper Respiratory Tract Infections
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Primary Outcome(s)
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Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota
[Time Frame: 2 years]
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Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)
[Time Frame: 2 years]
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Risk factors for recurrent Upper Respiratory Track Infection in terms of bacteria or virus, nutritional and immune status, as well as epidemiological factors
[Time Frame: 2 years]
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Secondary Outcome(s)
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Incidence of maternal urogenital infection
[Time Frame: 2 years]
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Birth outcome
[Time Frame: 2 years]
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Secondary ID(s)
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11.11.NRC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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