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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
Trial Contacts
| ContactsICMJE | Contact information is displayed when a study is open for participants to join. |
|---|
Study Record Dates
| First SubmittedICMJE | Not provided |
|---|---|
| First PostedICMJE | 2026-02-24 |
| Last Update Posted | 2026-09-30 |
| Last Verified* | 2026-09 |
Outcome Measures
| Primary Outcome Measures*ICMJE | Proportion of infants born weighing under 2,500 grams [Time Frame: At delivery] |
|---|---|
| Secondary Outcome Measures[*]ICMJE | Mean birth weight [Time Frame: At delivery] |
| Other Pre-specified Outcome Measures | Not provided |
Trial Description
| Brief Title*ICMJE | Antenatal Nutrition Counselling and Low Birth Weight in Sylhet Division |
|---|---|
| Official Title*§ICMJE | A Pragmatic Trial of a Structured Antenatal Nutrition Counselling Package to Reduce Low Birth Weight |
| Acronym[*] | Not provided |
| Brief Summary* | This trial evaluates a structured antenatal nutrition counselling package delivered at community clinics to reduce the rate of low birth weight. |
| Detailed Description | Pregnant women in participating clinics are allocated to the counselling package or usual antenatal care. Birth weight is recorded at delivery. |
| Study Type*ICMJE | Interventional |
| Study Phase*ICMJE | N/A |
| Study Design*§ICMJE | Allocation: Randomized Interventional Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Condition*ICMJE | Low Birth Weight Maternal Nutrition |
| Keywords | antenatal care nutrition low birth weight maternal health |
| Intervention*ICMJE | Behavioral: Structured antenatal nutrition counselling — Counselling sessions with dietary guidance and supplementation support. |
| Study Arms*ICMJE | Experimental: Nutrition counselling package Interventions: Behavioral: Structured antenatal nutrition counselling Active Comparator: Usual antenatal care |
| Publications | Not provided |
Recruitment Information
| Recruitment Status*ICMJE | Active, not recruiting |
|---|---|
| Enrollment (Anticipated)*§ICMJE | 1800 |
| Study Start Date*§ICMJE | 2026-03-01 |
| Primary Completion Date* | 2027-03-31 (Final data collection date for primary outcome measure) |
| Study Completion Date*§ICMJE | 2027-06-30 |
| Eligibility Criteria*ICMJE | <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> |
| Sex/Gender*ICMJE | Sexes Eligible for Study: Female |
| Ages*ICMJE | 18 Years to 40 Years (Adult) |
| Accepts Healthy Volunteers*§ICMJE | No |
| Location CountriesICMJE | Bangladesh |
Administrative Information
| BDCTR NumberICMJE | BDCTR-2026-000131 |
|---|---|
| Other Study ID Numbers[*]ICMJE | BMU-PAED-2026-007 |
| Has Data Monitoring Committee | No |
| Studies a U.S. FDA-regulated Drug Product | Not provided |
| Studies a U.S. FDA-regulated Device Product | Not provided |
| Device Product Not Approved or Cleared by U.S. FDA | Not provided |
| Pediatric Postmarket Surveillance of a Device Product | Not provided |
| Product Manufactured in and Exported from the U.S. | Not provided |
| IPD Sharing StatementICMJE | Plan to Share IPD: Not provided |
| Current Responsible Party* | Dr Nasrin Akter, Associate Professor |
| Current Study Sponsor*ICMJE | Bangladesh Medical University |
| CollaboratorsICMJE | Not provided |
| InvestigatorsICMJE | Not provided |
| Registry Account | Imported legacy public registry |
Symbol Legend
- *
- Required
- *§
- Required if Study Start Date is on or after January 18, 2017 — required for every BMU study
- [*]
- Conditionally required
- No Symbol
- Unmarked fields are optional. If no information is provided, fields will be labeled as “Not provided”.
- ICMJE
- Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP