Status:
UNKNOWN
Improving Maternal Nutrition in Matlab
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Obstetrical and Gynaecological Society of Bangladesh (OGSB)
Conditions:
Gestational Weight Gain
Eligibility:
FEMALE
18-39 years
Phase:
NA
Brief Summary
Background: Maternal undernutrition and inadequate gestational weight gain (GWG) are prevalent in rural communities of low- and middle-income countries (LMICs). In Matlab, Bangladesh, 54% of the women...
Eligibility Criteria
Inclusion
- Pregnant women permanently residing in the icddr,b service area of Matlab fulfilling the following criteria:
- Inclusion Criteria:
- aged 18-39 years
- in the first trimester of pregnancy (before 14 weeks of gestation)
- BMI 16-24.99 kg/m\^2 measured on enrollment
- willing to participate in the study
- Exclusion criteria
- multiple pregnancy (carrying two or more fetuses)
- threatened abortion, persistent pervaginal bleeding, or cervical incompetence
- history of three or more consecutive abortions
- history of gestational diabetes, macrosomia, gestational hypertension, preeclampsia/eclampsia in a prior pregnancy
- chronic diseases, such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, Crohn's disease, ulcerative colitis, diabetes mellitus, thyroid dysfunction, immunological diseases, malignancy or any other diseases which could impede compliance with the study protocol
- taking medications known to influence fetal growth, such as insulin, thyroid hormones, glucocorticoids
- known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder
- scored as moderate or worse on enrollment on any one of the subscales of the Depression, Anxiety and Stress Scales-21 (DASS-21)
- inability to read or write Bengali
- belonging to moderately or severely food insecure households as measured by the Household Food Insecurity Access Scale (HFIAS)
- having a plan to move or deliver outside the study area
- women practicing some form of vegetarianism
- women belonging to a household from which another woman is already enrolled in the study
Exclusion
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT04868669
Start Date
January 15 2020
End Date
October 31 2021
Last Update
May 3 2021
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh
Chāndpur, Bangladesh