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Antenatal Nutrition Counselling and Low Birth Weight in Sylhet Division

BDCTR ID
BDCTR-2026-000131
Sponsor
Bangladesh Medical University
Information provided by
Dr Nasrin Akter, Associate Professor (Responsible Party)
Last Update Posted
2026-09-30

Active, not recruiting

No longer looking for participants

Study Record Versions

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Viewing V1 (2026-09-30)

Study Details

Study Identification

Unique Protocol IDBMU-PAED-2026-007
Brief TitleAntenatal Nutrition Counselling and Low Birth Weight in Sylhet Division
Official TitleA Pragmatic Trial of a Structured Antenatal Nutrition Counselling Package to Reduce Low Birth Weight
Secondary IDs

Study Status

Record Verification2026-09
Overall StatusActive, not recruiting
Study Start2026-03-01
Primary Completion2027-03-31
Study Completion2027-06-30
First Submitted
First Submitted that Met QC Criteria2026-02-24
First Posted2026-02-24 [Actual]
Last Update Submitted that Met QC Criteria2026-09-30
Last Update Posted2026-09-30 [Actual]

Oversight

U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Product manufactured in and exported from the U.S.
Data MonitoringNo

Study Description

Brief SummaryThis trial evaluates a structured antenatal nutrition counselling package delivered at community clinics to reduce the rate of low birth weight.
Detailed DescriptionPregnant women in participating clinics are allocated to the counselling package or usual antenatal care. Birth weight is recorded at delivery.

Conditions

ConditionLow Birth Weight Maternal Nutrition
Keywordsantenatal care nutrition low birth weight maternal health

Study Design

Study TypeInterventional
Primary PurposePrevention
Study PhaseN/A
Interventional Study ModelParallel Assignment
Number of Arms2
MaskingNone (Open Label)
AllocationRandomized
Enrollment1800 [Estimated]

Arms and Interventions

ArmsAssigned Interventions
Experimental: Nutrition counselling packageBehavioral: Structured antenatal nutrition counselling Counselling sessions with dietary guidance and supplementation support.
Active Comparator: Usual antenatal care

Outcome Measures

Primary Outcome MeasuresProportion of infants born weighing under 2,500 grams Time Frame: At delivery
Secondary Outcome MeasuresMean birth weight Time Frame: At delivery

Eligibility

Minimum Age18 Years
Maximum Age40 Years
Ages18 Years to 40 Years (Adult)
SexFemale
Gender-based Eligibility
Gender Eligibility Description
Accepts Healthy VolunteersNo
Criteria<p>Inclusion Criteria:</p><ul><li>Pregnant women aged 18 to 40 years.</li><li>Gestational age under 20 weeks at enrolment.</li></ul><p>Exclusion Criteria:</p><ul><li>Known multiple pregnancy.</li></ul>

Contacts/Locations

Central Contact PersonDr Nasrin Akter antenatal-nutrition@bmu.ac.bd
Study Officials
LocationSylhet, Sylhet, Bangladesh, 3100 Status: Active, not recruiting Facility: Sylhet MAG Osmani Medical College

IPD Sharing

IPD informationPlan to Share IPD: Not provided

References

Citations
Links
Available IPD/Information

Document Section

Documents