Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2012-07-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mother/child pair
Mother/child pair.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Shafiqul Alam Sarker, M.D.
Role: PRINCIPAL_INVESTIGATOR
International Center for Diarrheal Disease Research, Bangladesh
Locations
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International Center for Diarrheal Disease Research
Dhaka, , Bangladesh
Countries
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Other Identifiers
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11.11.NRC
Identifier Type: -
Identifier Source: org_study_id
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